IRB Office use only
Date submitted______
Exp. Date_______
FB_____ Exp. ____
BU Charles River IRB
Amendment Request Form
This form is to be completed when a change (amendment) is requested to an IRB-approved study.
NOTE: All changes must be approved by the IRB PRIOR to implementation.
If the changes in this amendment require modification to the informed consent, a new version of the
informed consent will be approved and validated with an approval date. The expiration date of the study
WILL NOT CHANGE. Previously approved versions of the consent forms should be archived as they
are no longer valid and only the newly approved versions should be used.
Study Staff Changes: Changes to study staff can be made by submitting the Study Staff Amendment
Form. This form is located on the IRB website at: http://www.bu.edu/irb/application-forms/.
SECTION A: PROTOCOL AND CONTACT INFORMATION
Protocol Number:
Protocol Title:
Principal Investigator:
Department/School:
Email:
Telephone:
Additional Contact Person:
Email:
Telephone:
3468
Alcohol and implicit process in sexual risk behavior in MSM
Tibor Palfai
Psychological and Brain Sciences
[email protected]
617-353-9345
SECTION B: CHANGES MADE TO: (Check all that apply)
NOTE: You must submit a clean and tracked copy of any documents (Application, consent form,
letters, brochures, etc.) that are affected by the change
☐
Protocol Title
New Protocol Title:
☐
Consent/Assent Forms
Submit a tracked copy of the revised form
☒
Eligibility Criteria
☐
Study Procedures
Version: February 3, 2014
Page | 1
☐
Total Number of Subjects
• Current Number Approved:
• Requested New Number:
☐
Research Sites (Addition or Removal; provide a copy of the IRB approval letter for
each site being added)
• Name of Site:
• If IRB approval will not be obtained from the site, provide an explanation:
☐
Questionnaire/Survey (Revised/Addition/Removal)
Submit copies of any new or revised questionnaires/surveys. Revised documents should
include tracking to indicate the location of the changes.
☒
Recruitment Methods or Materials
Submit copies of any new or revised recruitment materials. Revised documents should
include tracking to indicate the location of the changes.
☐
Other
Provide a description of the change:
SECTION C: AMENDMENT DESCRIPTION
Provide a Brief Summary of the Change
Would like to include an additional exclusionary criteria to the protocol that would allow the
RA to exclude participants based on clinical judgment regarding the ability of the participant to
complete the tasks in the protocol as required. This may include but is not limited to judgments
regarding psychomotor abilities, cognitive abilities, and language abilities. This change is necessary
to ensure that participants can complete the response time tasks in the protocol.
Would like to have permission to include an additional advertisement that recruits for both the
experimental and experience sampling studies and provides participants with information about
compensation for both studies.
Provide the Justification/Rationale for the Change
This change is necessary to ensure that the data for the study may be used to test hypotheses as
described. If the tasks cannot be completed as required this will make the data unusable and will place
an undue burden on subjects
Version: February 3, 2014
Page | 2
Will there be a change to the Risks or Benefits to the Subjects
no
SECTION D: RE-CONSENTING OF ALEADY ENROLLED SUBJECTS
If the requested change could affect a subject’s willingness to continue taking part in the study,
these subjects must be re-consented.
Could the requested change affect a subject’s willingness to continue taking part in this research study?
☐YES*
☒NO
*If YES, please provide the plan for re-consenting already enrolled subjects
SECTION E: PRINCIPAL INVESTIGATOR CERTIFICATION
The signature line below must be signed by the PI of the study. If the PI is a student then THIS form
must also be signed by the Faculty Advisor.
By signing below I certify that:
• The information in this Application is true, complete, and accurate
• I will conduct this research in accordance with applicable laws, regulations, and BU CRC IRB
policies
PI Printed Name: ___________Tibor Palfai______________________________
Version: February 3, 2014
Page | 3
PI Signature: ______
_____________
Date:_4/4/16
If PI is a student, signature of the faculty advisor is required below.
By signing, the faculty advisor is also indicating agreement with the statements above.
Faculty Advisor Printed Name: ____________________________________________
Faculty Advisor Signature:____________________________________
Date____________
Submission
This form can be completed, signed, scanned and submitted to the IRB at [email protected]. Faxed
documents and handwritten materials are not accepted. Be sure to include all relevant attachments.
Version: February 3, 2014
Page | 4
Boston University Charles River Campus (CRC) IRB
Amendment Worksheet
Principal Investigator:
Tibor Palfai
Protocol Title: Alcohol and Implicit process in sexual risk behavior in MSM
Protocol #:
3468
IRB Analyst/Reviewer:
Shayne/Shannon
Include an additional exclusionary criteria that would allow the RA to exclude participants based on clinical
judgement regarding the ability of a participant to complete the tasks in the protocol.
REVIEW TYPE (EXPEDITED OR FULL BOARD)
1) EXPEDITED REVIEW:*
Note: Minor changes in previously approved research during the period (of one year
or less) for which approval is authorized may be reviewed by expedited procedures.
All of the answers to the questions below must be NO in order for this amendment to
be reviewed via expedited procedures.
Does the proposed change alter the risk to benefit assessment of the approved
study?
Does the proposed change affect the safety of the subjects?
Does the proposed change add new medical, social, or psychological risks?
Does the proposed change significantly alter the design or scientific aims of the
study?
Are there any significant new findings that might affect a subject’s willingness to
continue participation in the study?
*If expedited, is a content/secondary Reviewer required.
If yes, specify Reviewer:
2) FULL BOARD REVIEW:
Meeting Date: 4/19/2016, Response review 5/17/2016
Version: November 18, 2013
☐
Yes
No
☐
☐
Yes
No
☐
☐
Yes
No
☐
☐
Yes
No
☐
☐
Yes
No
☐
☐
Yes
No
☐
☐
Yes
☒
Boston University Charles River Campus (CRC) IRB
Amendment Worksheet
AMENDMENT REVIEW CRITERIA
There is sufficient justification/rationale for this modification
If NO, provide explanation:
All study documents have been revised per the amendment
If NO, provide explanation:
If subjects need to be re-consented, the process for re-consenting is described and
appropriate:
N/A
☒
If NO, provide explanation:
The study continues to meet the required criteria for approval under 45 CFR 46.11 (See
Criteria for Approval in the next box)
Yes
No
☒
☐
☒
☐
☐
☐
☒
☐
If NO, provide explanation:
Additional Comments:
CRITERIA FOR APPROVAL (ALL must be checked “Yes” in order to approve)
Yes
No
Risks to subjects are minimized by 1) using procedures which are consistent with sound
research design and which do not unnecessarily expose subjects to risk, and 2) whenever
appropriate, by using procedures already being performed on the subjects for diagnostic or
treatment purposes.
Risk/Benefit Analysis: Risks to subjects are reasonable in relation to anticipated benefits, if
any, to subjects, and the importance of the knowledge that may reasonably be expected to result:
☒
☐
☒
☐
Selection of Subjects: Selection of subjects is equitable:
☒
☒
☐
☐
☒
☐
Informed Consent: Informed consent will be obtained from each prospective subject:
Informed Consent Document: Informed consent will be appropriately documented:
ADDITIONAL CRITERIA FOR APPROVAL, AS APPLICABLE
Yes
No
N/A
☒
☒
☐
☐
☐
☐
Confidentiality: Confidentiality of data is maintained
☒
☐
☐
Vulnerable Populations: Additional safeguards are included for vulnerable
subjects:
Additional Comments:
☐
☐
☐
☐
☒
☒
Data and Safety Monitoring: Data is monitored to ensure subject safety:
Privacy: Privacy of subjects is protected:
Version: November 18, 2013
Boston University Charles River Campus (CRC) IRB
Amendment Worksheet
E-MAIL MODIFICATIONS REQUESTED BEFORE THE MEETING (Applies to Full Board Review
Only)
Were modifications e-mailed to the PI prior to the meeting?
N/A
☐
Yes
No
☒
☐
Date Modifications Sent to PI: 04/05/2016
List Modifications Below
On 4/5/2016 6:11 PM, Deal, Shayne C wrote:
Hello,
I’m in the process of reviewing your amendment submission for the above mentioned study. Please see my
comments/concerns below and address point-by-point:
1. The IRB application that was submitted contains many highlighted changes that are not described in the
amendment form. Clarify and if they are previously approved changes, please accept the changes and only
highlight the changes that are reflected in this current amendment submission.
2. Section B in the application states that funding has been requested? Was this obtained? If yes, I suggest
updating the application accordingly and adding this change to the current amendment form so we can
properly document the revision.
3. Section I, page 10 exclusion criteria should be updated with the revised process for assessment.
Because this amendment was submitted with the continuing review and affect the inclusion/exclusion criteria, it’s
most appropriate to be reviewed along with the continuing review at the next Full IRB Committee meeting, April
19th.
Once these issues have been addressed, I can continue to process your submission. Please be sure to highlight, or
mark any changes made to revised documents. Please also submit a cover letter that specifically addresses your
response point-by-point to each of these comments/concerns.
Thank you and please feel free to contact me if you have any questions.
PI RESPONSE
Date response received from PI: 04/06/2016
List Response Below
From: Palfai, Tibor [mailto:[email protected]]
Sent: Wednesday, April 06, 2016 3:41 PM
To: Deal, Shayne C <[email protected]>
Subject: Re: IRB Review of Amendment #4, 3468
Dear Shayne
Please find attached the following
The correct application with the relevant information tracked
The revised amendment form
Please let me know if you have any other questions
Version: November 18, 2013
Boston University Charles River Campus (CRC) IRB
Amendment Worksheet
Best regards,
Tibor
REVIEWER’S RECOMMENDATION*
Approval
Approval with conditions*
Deferred*
Disapproved
*Complete the Amendment Approval Checklist with the reviewer recommendation
Date:
Version: November 18, 2013
☐
☐
☐
☐
Boston University Charles River Campus Institutional Review Board
25 Buick Street
Room 157
Boston, Massachusetts 02215
T 617-358-6115
www.bu.edu/irb
Notification of IRB Review: Amendment #4
April 19, 2016
Tibor Palfai, PhD
Department of Psychology
648 Beacon Street
Boston, MA 02215
Protocol Title:
Protocol #:
Funding Agency:
Grant #:
IRB Review Type:
IRB Review Action:
Alcohol and Implicit Process in Sexual Risk Behavior in MSM
3468
NIH-NIAAA
R01-AA022301-01A1
Full Board
Deferred
Dear Professor Palfai:
On April 19, 2016, the IRB deferred the request for approval of the above-referenced protocol. The amendment was deferred because
of insufficient information regarding the objective exclusion criteria that would be used by the research assistants during screening..
The modifications required are:
1.
2.
3.
Per the Amendment request form, research assistants will exclude participants based on clinical judgment and these
judgments are related to psychomotor abilities, cognitive abilities, and language abilities. Clarify how you will avoid bias
and inconsistencies from the research assistants, who, in the absence of objective criteria, could exclude a subject from
participating based on personal judgement. Specify the criteria that will be used to exclude based on clinical judgment. For
example, subjects who are unable to use a computer will be excluded.
Clarify at what point during the study, the research assistant would make such a judgement. The application should detail this
process, and the time point(s) for this process to take place.
Provide the justification for this change. For example, is this change being requested as a result of your experiences with
enrollment into this study so far.
Please use the Request for Modification Response Form to respond to the modifications. The form can be located at
http://www.bu.edu/irb/. In addition, please submit the following documents along with this form: 1) a copy of all revised documents
in ‘Tracked Changes” format or similarly notated to indicate what changes were made and 2) a “clean” copy of all revised documents.
If a response to this letter is not received by the close of business on June 19, 2016, the IRB will withdraw the amendment from
review.
If you have any questions, please contact Shayne Deal at 617-358-6116.
Sincerely,
Sara S. Bachman, PhD
Charles River Campus IRB Chair
NOTE: The changes requested in this amendment cannot be implemented until the modifications have been addressed and
the IRB has approved the amendment.
REQUEST FOR MODIFICATION RESPONSE FORM
PROTOCOL INFORMATION
Protocol Number:
3468
Protocol Title:
Alcohol and Implicit Process in Sexual Risk Behavior in MSM
Principal
Investigator:
Response to:
Tibor Palfai
Initial Review
X Continuing Review
Amendment
Other Event
Instructions: Please respond to the IRB review by copying and pasting the comments from
the IRB review letter onto this form. Add your response DIRECTLY below each of the IRB
comments. Please include the following documents along with this form: 1) a copy of all
revised documents in ‘Tracked Changes” format or similarly notated to indicate what
changes were made and 2) a “clean” copy of all revised documents.
Principal Investigator’s Signature:
Date: 4/28/2016
The modifications required are:
Per the Amendment request form, research assistants will exclude participants based on clinical judgment and these
judgments are related to psychomotor abilities, cognitive abilities, and language abilities. Clarify how you will avoid
bias and inconsistencies from the research assistants, who, in the absence of objective criteria, could exclude a
subject from participating based on personal judgement. Specify the criteria that will be used to exclude based on
clinical judgment. For example, subjects who are unable to use a computer will be excluded.
There are certain objective criteria that may exclude individuals from participation such as the
inability to use a computer, inability to understand instructions with repeated direction for
computer tasks, inability to understand multiple items on questionnaires. RAs are trained to use
a high threshold for exclusion and that the inability to perform well on a task or failure to
understand a word or two would not be part of this exclusion. We are unable to anticipate every
potential outcome that might involve exclusion based on clinical judgment in advance.
However, we do intend to have procedures in place to minimize the potential for RA bias. The
procedures will be as follows. If the RA believes that a participant is unable to engage in the
study as required, he/she will contact the PI immediately [Palfai] to discuss the specific
concerns. Based on a description of these concerns, the PI will make a judgment about
whether to continue with the next segment. If for some reason the PI is not available, the RA
will complete all procedures if possible for session #1 and defer scheduling a subsequent
session until he/she has discussed this matter with the PI. The RA will make an effort to
complete all procedures in Session #1 unless the participant is unable to perform tasks. We
anticipate that this will be a very rare occurrence and would only be initiated if the participant
clearly cannot perform the tasks as required in the study.
Clarify at what point during the study, the research assistant would make such a judgement. The application should
detail this process, and the time point(s) for this process to take place.
This decision could be made at any time during the consent, screening, assessment processes
in session #1. The participant would be withdrawn and compensated for the section of the
procedure that he has completed. Participants are informed prior to the study that they will be
asked to complete specific questionnaires and tasks and that, based on their responses, they
will be eligible for the subsequent sections. Therefore, these procedures would not influence
their decision to participate as they are aware that they may be excluded at different points in
the process.
Provide the justification for this change. For example, is this change being requested as a result of your experiences
with enrollment into this study so far.
The use of this criterion is to formalize a process that is important to consider when requiring
participants to complete a series of tasks such as these in the study. Experiences with the use
of inclusion/exclusion criteria during the pilot phase have led to discussions among PIs and
research staff about how and whether these components should be modified for the main study.
One important conclusion is that the initial phase of screening and assessment needs to
determine whether the participant will be able to perform tasks prior to randomization to the
alcohol administration portion of the study. Experiences with the pilot phase has made it clear
that performance is the best threshold for screening in some cases rather than “objective”
demographic criteria. One experience with a disabled participant, for example, illustrated this
fact as this individual was capable of performing computerized tasks as required despite
apparent physical challenges. Conversely, another participant did not appear to understand the
instructions on varied components of the procedure despite efforts to repeat and clarify them.
These experiences as well as others in the pilot phase made it salient that participants may not
be able to complete the tasks as required and that they would need to be excluded prior to
randomization in the alcohol administration portion of the study. It should be noted, however,
that we have conducted a previous study with almost identical criteria with over 100 participants
and did not need to exclude patients for these additional “clinical judgment” reasons.
Consequently we believe that this will be a rare occurrence. However, we want to be as
comprehensive as possible in our inclusion/exclusion criteria in order to ensure that this study is
completed with high levels of internal validity.
From:
To:
Subject:
Date:
Martha Tompson
Deal, Shayne C
Re: Review of Palfai Deferred Amendment #4 response, 3468
Thursday, April 28, 2016 8:39:36 PM
No more. I feel that his response is reasonable.
Sent from my iPhone
On Apr 28, 2016, at 5:15 PM, Deal, Shayne C <[email protected]> wrote:
Just to confirm, you don't have any questions?
Thank you and please feel free to contact me if you have any questions,
Shayne C. Deal
Senior IRB Analyst
Charles River Campus IRB
Boston University
25 Buick Street
Boston, MA 02215 617-358-6116
On Apr 28, 2016, at 3:35 PM, Martha Tompson <[email protected]>
wrote:
I agree this is acceptable. Marcy Sent from my iPhone
On Apr 28, 2016, at 2:46 PM, Deal, Shayne C <[email protected]>
wrote:
Hi Marcy,
Could you take a look at Tibor Palfai’s response to
committee concerns? I think he’s addressed the issues
adequately. But I need your sign off before I can put the
response on the agenda for the next meeting (the
amendment was deferred).
Please let me know if you have any questions or concern
about the response. I can communicate those concerns to
Tibor and we can get everything cleared up prior to the
meeting.
Thank you and please feel free to contact me if you have any
questions,
Shayne C. Deal, CIP
Sr. IRB Analyst
Boston University
Charles River Campus Institutional Review Board
25 Buick Street, Room 157
Boston, Massachusetts 02215
www.bu.edu/irb
617-358-6116
<3468.4.28.Request-for-Modification-Reponseform.doc>
<Palfai_IRB_Application.4.28.16.tracked.docx>
IRB Office use only
Date submitted________
FB_____ Exp. ____
BU Charles River IRB
Application Form (Full Board and Expedited Review)
SECTION A: PROTOCOL AND CONTACT INFORMATION
Protocol Number (To be
assigned by IRB Office):
Protocol Title:
Principal Investigator:
Department/School:
Email:
Telephone:
Additional Contact Person:
Email:
Telephone:
3468
Alcohol and implicit process in sexual risk behavior in MSM
Tibor Palfai
Psychology
[email protected]
353-9345
SECTION B: FUNDING
Provide information regarding ALL funding sources in this section. This includes ANY
EXISTING FUNDING, PENDING FUNDING, OR FUNDING THAT HAS BEEN
APPLIED FOR TO SUPPORT THIS RESEARCH.
Please check all that apply:
This research is funded
x
Funding has been requested
Research is not funded
If the research is funded or funding has been requested, complete the box below. If you have
multiple funding sources, add additional boxes as necessary.
Sponsor Name
NIH/NIAAA
Title of Grant/Proposal
Alcohol and implicit process in sexual risk behavior in MSM
Sponsor Award #
R01 AA022301-01A1
(REQUIRED)*
*If Award # is pending,
put pending
Sponsor Grant/Proposal #
YES
NO
Is Boston University the Prime Awardee of the grant? MPI proposal
☐
☒
1
Version: January 9, 2014
X
Is Boston University receiving a sub-award?
BU received subaward from Syracuse University
*NOTE: Provide a copy of the grant application, funding proposal, scope of work, or sub-award
agreement. The University is required to verify that all funding proposals and grants have been
reviewed by the IRB before funds are awarded.
SECTION C: CONFLICT OF INTEREST
☒ YES
(REQUIRED)
for boston
contract
I confirm that all those responsible for the design, conduct, or reporting of
the proposed program, including at minimum, all Senior/key personnel in
the grant application, have completed the financial interest disclosure forms,
submitted them to the COI office, and completed training as dictated at
http://www.bu.edu/orc/coi/forms/, and as provided under the Boston
University Policy on Investigator’s Conflicts of Interest.
Of the financial interest disclosure forms submitted, has anyone checked “yes” to any of the
questions on either the FIND1 or NONFIND1 form?
☐ Yes*
☒ No
*If anyone checked “yes” to any of the questions on either the FIND1 or NONFIND1 form,
the IRB Director will contact the COI office to obtain the disclosure information.
SECTION D: TYPE OF REVIEW
For Guidance regarding Type of Review please refer to the following website:
http://www.bu.edu/irb/exempt-expedited-and-full-board/
I.
FULL BOARD
☒
Please refer to the IRB website for Full Board submission deadlines and meeting dates:
http://www.bu.edu/irb/meeting-dates/
II.
EXPEDITED
☐
In order to qualify for expedited review, the study must be no more than minimal risk* AND
must fall into one of the categories below. Check all that apply:
1. ☐ Clinical studies of drugs and medical devices only when an investigational new drug
application (IND) or investigational device exemption application (IDE) is not required
2
Version: January 9, 2014
2. ☐ Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as
follows:
a. From healthy, nonpregnant adults who weigh at least 110 pounds. For these
subjects, the amounts drawn may not exceed 550 ml in an 8 week period and
collection may not occur more frequently than 2 times per week; or
b. From other adults and children, considering the age, weight, and health of the
subjects, the collection procedure, the amount of blood to be collected, and the
frequency with which it will be collected. For these subjects, the amount drawn
may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and
collection may not occur more frequently than 2 times per week.
3. ☐ Prospective collection of biological specimens for research purposes by noninvasive
means. Examples include hair and nail clippings, saliva or cheek swabs, sweat, etc.
4. ☐ Collection of data through noninvasive procedures (not involving general anesthesia
or sedation) routinely employed in clinical practice, excluding procedures involving xrays or microwaves. Where medical devices are employed, they must be
cleared/approved for marketing.
Examples:
1. Physical sensors that are applied either to the surface of the body or at a distance
and do not involve input of significant amounts of energy into the subject or an
invasion of the subject’s privacy
2. Weighing or testing sensory acuity
3. Magnetic resonance imaging
4. Electrocardiography, electroencephalography, thermography, detection of
naturally occurring radioactivity, electroretinography, ultrasound, diagnostic
infrared imaging, doppler blood flow, and echocardiography
5. Moderate exercise, muscular strength testing, body composition assessment, and
flexibility testing where appropriate given the age, weight, and health of the
individual
5. ☐ Research involving materials (data, documents, records, or specimens) that have been
collected, or will be collected solely for nonresearch purposes (such as medical treatment
or diagnosis)
6. ☐ Collection of data from voice, video, digital, or image recordings made for research
purposes.
7. ☐ Research on individual or group characteristics or behavior (including, but not limited
to, research on perception, cognition, motivation, identity, language, communication,
cultural beliefs or practices, and social behavior) or research employing survey,
interview, oral history, focus group, program evaluation, human factors evaluation, or
quality assurance methodologies.
3
Version: January 9, 2014
Note: The IRB will make the final determination on the Type of Review
*Minimal risk means that the probability and magnitude of harm or discomfort anticipated in
the research are not greater in and of themselves than those ordinarily encountered in daily life of
normal persons or during the performance of routine physical or psychological examinations or
tests in normal persons
SECTION E: STUDY STAFF AND HUMAN SUBJECTS TRAINING
List ALL current members of the research team in the table below. Add more rows as
necessary.
BU INVESTIGATORS/STUDY STAFF
Name, Degree, &
Department/School
Tibor Palfai
Study Role (e.g. co-investigator,
research coordinator, research
assistant, project manager, lab
manager)
☐ CITI
☒ Other**:__BUMC________
Most Recent Date Completed: 6/2/13
Exp. 6/2015
X CITI
☐ Other**:__________
PI
Tracie Goodness
RA
Katherine Chavez
RA
Kelli Tahaney
RA
Human Subjects Training*
X CITI
X CITI__________
*For more information regarding the Human Subjects Training Policy, refer to the ‘Training’
section of the Policies & Guidance section IRB website:
http://www.bu.edu/irb/policiesguidance/. This site includes a Study Personnel Training List.
You can search this list by name to obtain the completion and expiration dates of training for
investigators and study staff.
**If the investigator/study staff did not complete CITI, you must submit a copy of his/her
training certificate.
NON-BU INVESTIGATORS/STUDY STAFF*
4
Version: January 9, 2014
☐ N/A
Name, Degree, & Affiliate
Study Role
Will IRB Approval be
Obtained from Affiliate?
☒ Yes: Provide copy of IRB
approval letter when available:
☐ No (provide reason): ______
☒ Yes: Provide copy of IRB
approval letter when available:
☐ No (provide reason): ______
Stephen Maisto, PhD
Syracuse University
Jeffrey Simons, PhD
University of South Dakota
*If IRB approval will be obtained from the affiliate site, only list the lead investigator from the
affiliate on this form.
If any of the investigators listed on this form are not affiliated with BU, provide a summary of
the study activities that he/she will conduct. If IRB approval is not being obtained at the affiliate
institution, provide an explanation.
SECTION F: LOCATION OF THE RESEARCH
*YES
☒
NO
☐
Will this research take place at sites/locations other than Boston University?
*If YES, please complete the boxes below
NOTE: You are responsible for obtaining permission/letters of support for research conducted
off-site. This may include locations such as schools, workplaces, community organizations, etc.
You must submit the letters/documentation of support with this application.
Institution Name and
Address (if known)
Describe Involvement
(recruiting, consenting, data
analysis, etc.) of the site. If the
site or the site staff is not
involved (engaged)1 in research
procedures, state NONE.
5
Version: January 9, 2014
IRB/Ethics Approval/Site
Permission Attached? If
no2, explain the plan to
obtain this approval. If the
site is not engaged in the
research, you do not need to
complete the box.
Syracuse University
All activities that are described in Pending IRB
BU application will also be
completed at the Syracuse site,
including: recruitment,
consenting, implementing
research protocols, data analyses,
and dissemination activities.
University of South Dakota There will be no recruitment of
Pending IRB
participants in this study. This
site will be responsible for data
storage and data management.
In particular this site will be
involved in management of
experience sampling data. This
site will also be involved in
dissemination activities.
1
Guidance on Engagement of Institutions in Human Subjects Research:
http://www.hhs.gov/ohrp/policy/engage08.pdf
2
If IRB approval will not be obtained at the site, describe the IRB oversight arrangements here:
YES*
☐
NO
☒
*YES
NO
X
Is the off-site location requesting that the Boston University IRB review the
protocol in place of local IRB review?
*If YES, complete the Single IRB Review Form “Boston University is
Institution A”: http://www.bu.edu/irb/application-forms/.
Is the BU PI the lead investigator OR is BU the lead site for this research?
Syracuse University is the lead site
*If YES, provide the following information in this box:
•
•
•
•
•
The plan for collection and management of data from all the sites
The plan for reporting and evaluating:
o Unanticipated problems
o Serious and/or continuing non-compliance
o Suspensions and terminations of research
The name of the Principal Investigator from each site
If IRB approval will be obtained at the site, confirmation that you have a copy (or will
obtain a copy) of the IRB approval letters and the IRB-approved protocols from each site
If IRB approval will be obtained at the site, confirmation that the site IRB has a
6
Version: January 9, 2014
federalwide assurance (FWA)
*YES
☐
NO
☒
Will this research be conducted outside of the United States?*
*If YES, complete the International Research Form at http://www.bu.edu/irb/
SECTION G: STUDY SUMMARY
Summarize the study in lay language (do not copy from the grant/scope of work/proposal,
etc.). This summary should include the research design, purpose, objectives, research
question, hypothesis, and any relevant background information.
Note: Do not include a list of citations in this section. Please limit this section to no more
than 300 words.
This proposal focuses on two aims relevant to HIV/AIDS: 1) How does substance use shift the
contribution of explicit (effortful) versus implicit (automatic) processes in decision-making about
HIV-risk behavior, and 2) How do laboratory methods and simulations relate to real world risky
behavior? The study incorporates an innovative pairing of an alcohol administration experiment
with a subsequent experience sampling (ESM) study to test the external validity of the
laboratory results. Interventions designed to reduce HIV risk behavior frequently focus on
educating people about risks, increase their motivation to avoid risks, and improving skills
congruent with healthy choice. However, there are considerable gaps in knowledge about the
processes involved in risky choice “during the heat of the moment.” Incorporating research on
automatic processes, implicit cognition, and associative memory into the study and prevention
of health risk behaviors is an important and largely unrealized opportunity for improving public
health. The proposed experimental study seeks to improve understanding of the role of alcohol,
implicit processes, and effortful control in risky sexual choice in men who have sex with men
(MSM). We propose that alcohol intoxication increases the strength of relatively automatic
approach biases toward sexual stimuli while simultaneously decreasing the role of more
deliberative decision-making processes controlled by executive brain functions. This shift
toward more implicit or automatic processes coupled with the decreased role of explicit decision
making processes increases the likelihood of sexual risk behavior and potentially limits the
effectiveness of interventions that focus solely on explicit processes to promote behavioral
change. The long-term aim of this research is explicating processes occurring in the “heat of the
moment” when an individual’s better judgment seems conspicuously absent and the drive for
immediate gratification peaks. The proposed study will lay a foundation for innovative
approaches to treatment that address both automatic and effortful processes to reduce sexual
risk behavior in MSM.
SECTION H: RESEARCH METHODS AND ACTIVITIES (Check all that
apply)
7
Version: January 9, 2014
☒
☐
☐
Collection of audio, video, digital, or image recordings
Biological samples → Complete Biological Samples Form:
http://www.bu.edu/irb/application-forms/
Examples: blood, hair, cheek swab, urine, tears, saliva, etc.
Collection of data that may be sensitive and if disclosed could put subjects at risk for
legal or social harms.
Examples: Illegal behaviors, HIV status, psychiatric illness, information related to
sexual behaviors, etc.
Coordinating Center/Lead Site
☐
Deception
☐
Devices → Complete Devices Form: http://www.bu.edu/irb/application-forms/
☐
Drugs → Complete Drugs Form: http://www.bu.edu/irb/application-forms/
☐
Ethnographic:
The study of people in their own environment through the use of methods such as
participant observation and face-to-face interviewing
Focus Groups
☒
☐
☐
☐
Genetics Testing → Complete Genetics Form: http://www.bu.edu/irb/applicationforms/
MRI
☒
Placebo: a placebo alcohol beverage will be administered to some participants in the
study
☐
Pregnancy Testing
☒
Randomization
☒
Surveys, interviews, questionnaires
☐
Secondary Data Analysis
☒
Other (please describe): alcohol administration
SECTION I: SUBJECT POPULATION
Number of Subjects to be Enrolled:
Would like to add 20 pilot subjects for this protocol
8
Version: January 9, 2014
330 participants in the study
+20 = 350 total
If you have sub-groups or more than one arm, please
separate out these enrollment numbers.
Note: Please account for subjects who may drop out or
be withdrawn from the study. Any subject who signs a
consent form is considered to be enrolled regardless of
whether they complete any study procedures
Check all categories that apply to your target population:
☒
Adults
☐
Children (< 18 years of age)
☐
Cognitively-Impaired Adults
☐
Non-English Speaking
☐
Prisoners
☐
BU Employees
☐
BU Students
☐
Wards of the state
☐
Other (please describe):
If Categories other than ‘Adult’ are checked, describe the additional safeguards that
have been put in place to protect that subject population. For Cognitively-Impaired
Subjects, provide the rationale for including this population in this research study.
Eligibility Criteria
Inclusion Criteria: Sexually active Men who Have Sex with Men (MSM) (i.e., past 3 mo at least
1 episode of sexual intercourse with man) between the ages of 21 and 50 will be recruited for
the study. Participants must be moderate to heavy drinkers (defined by Cahalan et al., 1969
9
Version: January 9, 2014
criteria below), not in a monogamous relationship, and HIV negative by self-report. Because
the terms “moderate” and “heavy” refer to study criteria defined by a complex algorithm and is
not consistent with colloquial uses of these terms, we have used the term “social drinker” in
recruitment materials to identify those who use alcohol consistently but do not self-identify as
alcoholic or otherwise in need of treatment. This term has been successfully used to recruit
the target population in previous work and has reduced the frequency of unsuccessful
screenings.
Exclusionary Criteria: Medical condition for which alcohol consumption would be
contraindicated. Treatment for emotional or substance use disorder (defined by current
treatment or treatment in the past 3 months) or any history of alcohol problems defined by
past or current treatment for alcohol dependence or B-MAST scores. Blood alcohol level
above 0 at baseline for session #2 is an exclusionary criterion. Use of medication for which
alcohol consumption would be contraindicated is an exclusionary criterion. For OTC
medications that are taken as needed, participants will be rescheduled for the alcohol
administration session if they have taken the medication within the past 24 hours.
In addition, the research assistant may exclude participants based on clinical judgment that
the subject may not be able to complete the protocol as required due to psychomotor,
cognitive or language difficulties.
There are certain objective criteria that may exclude individuals from participation such as the
inability to use a computer, inability to understand instructions with repeated direction for
computer tasks, inability to understand multiple items on questionnaires. RAs are trained to
use a high threshold for exclusion and that the inability to perform well on a task or failure to
understand a word or two would not be part of this exclusion. We are unable to anticipate
every potential outcome that might involve exclusion based on clinical judgment in advance.
However, we do intend to have procedures in place to minimize the potential for RA bias. The
procedures will be as follows. If the RA believes that a participant is unable to engage in the
study as required, he/she will contact the PI immediately [Palfai] to discuss the specific
concerns. Based on a description of these concerns, the PI will make a judgment about
whether to continue with the next segment. If for some reason the PI is not available, the RA
will complete all procedures if possible for session #1 and defer scheduling a subsequent
session until he/she has discussed this matter with the PI. The RA will make an effort to
complete all procedures in Session #1 unless the participant is unable to perform tasks. We
anticipate that this will be a very rare occurrence and would only be initiated if the participant
clearly cannot perform the tasks as required in the study.
SECTION J: RECRUITMENT
Provide a summary of the recruitment process, including who will recruit, when and
10
Version: January 9, 2014
where recruitment will occur, and how subjects will be identified.
Note: Submit any recruitment materials such as advertisements, brochures, flyers,
letters/e-mails, scripts, etc. Please submit these materials as separate documents in either
Word or PDF format.
Recruitment will be through ads placed on websites (e.g., craigslist), fliers, advertisements
placed in periodicals and newspapers relevant to the LGBT community, emails to relevant
organizations, and word of mouth.
SECTION K: CONSENT AND ASSENT
NOTE: Please refer to the consent and assent form templates on the IRB
website when creating your consent/assent documents. The templates include
the required elements of consent and will help to ensure that your
consent/assent form meets the requirements of the federal regulations and the
BU CRC IRB. The consent templates can be located at:
http://www.bu.edu/orc/forms/human-subjects/.
Provide a summary of the consent process, including who will consent, and when and
where consent will occur.
Note: Submit copies of all consent forms and scripts. Please submit these materials as
separate documents in Word format.
This study will involve a two stage consent process. First, participants will be consented for
the laboratory (alcohol administration) study (Part 1). Consent will be written informed
consent obtained by a trained research assistant at the beginning of the baseline session #1.
Consent will occur when the participant arrives at the laboratory. Please see attached
consent form. Participants who complete the baseline assessment and return for the alcohol
administration session #2 of the experiment will be informed about the experience sampling
study. Consent for the Experience Sampling Study (Part 2) will be obtained at the beginning
of Session 2 of the alcohol administration study for those subjects who are deemed eligible.
Those who agree will complete the consent form that is attached and then the details of the
Experience Sampling procedures will be explained to the participant. The ESM procedure will
now primarily use the smartphone app [Metricwire] to deliver the ESM questions. Those who
do not have a smartphone will be provided with a basic smartphone device and the ESM app
will be modeled. Participants will not receive the device until they complete the second phase
of the study.
Indicate the consent and/or assent process and document(s) to be used in this
study. Check all that apply
11
Version: January 9, 2014
N/A ☐
Consent: Adults (>18 years of age)
One of the following MUST apply
☒ Consent Form
☐
Verbal Consent (Script)
☐
Note: If written consent will not be obtained, complete the ‘Waiver of Written
Documentation Consent’ box (Box 1) located further down in this section
Consent will not be obtained
Note: If consent will not be obtained, complete the ‘Waiver or Alteration of
Consent’ box (Box 2) located further down in this section
N/A ☐
Assent of Children (< 18 years of age)
One of the following MUST apply
☐ Assent Form OR Parent Consent Form (older children may sign the parent consent form
along with their parents as long as the consent form is written at the grade level of the
subjects)
☐
Verbal Assent (Script)
☐
Assent will not be obtained
If assent will not be obtained, one of the following conditions must exist:
1. ☐ The capability of some or all of the children is so limited that they cannot
reasonably be consulted
2. ☐ The children are too young to provide assent
3. ☐ The intervention or procedure involved in the research holds out the prospect of
direct benefit to the health or well-being of the children and is available only in the
context of the research
4. ☐ The research meets the same conditions as those for waiver or alteration of
informed consent in research involving adults, as specified in the regulations at 45 CFR
46.116(d)*. (Complete the ‘Waiver or Alteration of Consent’ box (Box 2) located
further down in this section)
12
Version: January 9, 2014
*45 CFR 46.116(d):
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.116
Guidance on age requirements for obtaining assent:
• Parental Permission for minors under 6 years of age
• Verbal assent for minors 6-11 years of age
• Written assent from minors ages 12-17 (unless verbal consent is approved for the
parents/adult subjects
N/A ☐
Parental Permission
One of the following MUST apply
☐ Parental Consent Form
☐
Parental Verbal Consent (Script)
☐
Note: If written consent will not be obtained, complete the ‘Waiver of Written
Documentation of Consent’ box (Box 1) located further down in this section
Parental permission will not be obtained
If parental permission will not be obtained, one of the following conditions must
exist:
1. ☐ The research protocol is designed to study conditions in children or a subject
population for which parental or guardian permission is not a reasonable
requirement to protect the subjects (for example, neglected or abused children).
2. ☐ The research meets the same conditions as those for waiver or alteration of
informed consent in research involving adults, as specified in the regulations at
45 CFR 46.116(d)*. (Complete the ‘Waiver or Alteration of Consent’ box
(Box 2) located further down in this section)
*45 CFR 46.116(d):
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.116
Consent: Cognitively Impaired Adults (>18 years of age)
N/A ☒
Describe the process for the consent and/or assent process for enrolling cognitively
impaired adult subjects including how capacity to consent is determined and if there is
continual assessment of capacity.
13
Version: January 9, 2014
Assent will be obtained from:
☐ All Subjects
☐ Some Subjects, specify:
☐ No Subjects
☐
Consent will be obtained from the subject’s Legally Authorized Representative
(REQUIRED)
CONSENT OF NON-ENGLISH SPEAKING SUBJECTS
N/A ☒
Describe the process for obtaining consent from non-English speaking subjects. List the
individual who will serve as the interpreter and his/her qualifications.
NOTE: A copy of the translated consent along with the Attestation Form for Translation
of Consent must be submitted. The Attestation Form can be located at:
http://www.bu.edu/irb/.
BOX 1—WAIVER OF WRITTEN DOCUMENTATION OF
CONSENT
WAIVER OF WRITTEN DOCUMENTATION OF CONSENT N/A ☒
Yes
No
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
Either Criteria 1 or 2 must be met in order to qualify
☐ Criteria 1
The research is NOT FDA Regulated
The only record linking the subject and the research would be the consent
document
The principal risk would be potential harm resulting from a breach of
confidentiality
Each subject will be asked whether the subject wants documentation linking
the subject to the research and the subject’s wishes will govern
A written statement/information sheet will be provided to subjects. If NO,
14
Version: January 9, 2014
provide rationale for not providing this information
☐ Criteria 2
The research is NOT FDA Regulated
The research presents no more than minimal risk of harm to subjects
The research involves no procedures for which written consent is normally
required outside of the research context
A written statement/information sheet will be provided to subjects. If NO,
provide rationale for not providing this information
☐
☐
☐
☐
☐
☐
☐
☐
BOX 2—WAIVE OR ALTERATION OF CONSENT
WAIVER OR ALTERATION OF CONSENT
N/A ☒
All of the criteria below must be met in order to qualify
The research is NOT FDA Regulated
The research involves no more than minimal risk to the subjects
The waiver or alteration will not adversely affect the rights and welfare of
the subjects
The research could not practicably be carried out without the waiver or
alteration
Whenever appropriate, the subjects will be provided with additional
pertinent information after participation. If NO, provide rationale for not
providing this information:
Yes
No
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
SECTION L: STUDY PROCEDURES
In the box below provide a detailed description of the study procedures to be performed
(preferably in sequential order). Be sure to specify which procedures are for research purposes
versus which procedures are part of standard of care, if applicable. Be sure to include the
following information:
•
•
•
•
Methods of data collection
Details regarding research activities/procedures/interventions
Number, frequency, duration and types of subject contacts (visits, phone calls, internet
surveys, mailings, etc.)
Time required from each subject
Submit copies of all surveys, interview questions, assessments, screening scripts, etc. that
will be used during the conduct of this study. Please submit these materials as separate
documents in either Word or PDF format.
15
Version: January 9, 2014
Note: If subjects will have standard of care procedures in addition to research
procedures, clearly state which procedures are standard of care and which are for
research purposes only.
Recruitment and initial screening. Participants will be recruited via e-mail announcements,
fliers, advertisements in regional publications that cover social and other news events that are
of interest to the gay/lesbian population, internet social networking sites, and participant
driven recruitment (Maisto et al., 2012). Prior to screening, participants will be informed that
they will be asked a series of questions about alcohol and substance use as well as sexual
behavior. An RA will screen participants who respond over the phone to ensure that they
meet the initial inclusion criteria. Individuals who are eligible by phone screening will be
informed about the study and invited to continue screening at the laboratory. Participants will
be told that the first session will take up to 2 hours and will include additional screening for
eligibility, description of the experimental procedures, and completion of baseline measures.
They also will be informed that the second session will be the experimental session and may
involve the consumption of alcohol. Participants will be paid $50 for the first session if they
are eligible based on in-person screening, $75 for the second, and $15 for transportation for
the second session. Those who are not eligible based on the in-person screening will be paid
$20. Participants will be asked to refrain from use of alcohol or other drugs that are not
prescribed, including over-the counter drugs, for 24 hours before their appointments and not
to eat food for 3 hours before Session 2.
Measures
Screening Measures
The Brief Michigan Alcoholism Screening Test (B-MAST; Selzer et al., 1975) and the ASSIST
(National Institute on Drug Abuse; http://www.drugabuse.gov/sites/default/files/ pdf/nmassist.pdf)
will be used to screen for alcohol and drug problems. Alcohol problems are suspected for
scores > 5 (Maisto et al., 1995) and ASSIST scores of ≥ 4 are evidence of at least moderate
risk for drug problems. Evidence of either will exclude participation. The ASSIST also gives a
score for involvement in use of specific drugs in the last 3 months.
Those who are excluded from participation because of in person B-MAST scores will be
asked if they would like any information about services related to alcohol use (i.e. only after
rapport has been established with an in-person interview with the participant). For those who
report that they would like more information will be provided with the Mass. Government
website which helps link individuals to treatment programs across the state.
http://www.mass.gov/eohhs/gov/departments/dph/programs/substance-abuse/. Any
participants who are students will be encouraged to contact their student health services
center for further information on treatment that may be available through their own university.
We will not provide this information those on the phone as we do not believe that it would be
appropriate given the minimal contact, the fact that the study is not advertised as a treatment
study, and there are no measures that will be used to diagnose the individual as being alcohol
dependent.
Alcohol consumption. Alcohol consumption in the past 3 months will be assessed by three
indicators: (1) the Modified Daily Drinking Questionnaire (Dimeff, Baer, Kivlahan, & Marlatt,
1999), (2) binge drinking question (NIAAA National Advisory Council, 2004), (3) the QuantityFrequency-Variability Questionnaire (Cahalan et al., 1969) will be used to classify
participants’ usual drinking patterns in the last 90 days. Only individuals whose
patterns are classified as moderate or heavy drinkers will be included in the study as
determined by this Cahalan questionnaire will be included in this study. Moderate and heavy
drinkers are defined by a fairly detailed algorithm based on frequency of use and
16
Version: January 9, 2014
modal/maximum use patterns (88 potential combinations outlined in Cahalan et al., 1969, p
13-15). To provide the range of these scores, individuals may be defined as moderate
(lowest inclusion criteria level) if they consume 5-6 drinks per occasion at least once per
month to drinking 1-2 drinks per occasion if they consume alcohol more than once a day.
The Kinsey Scale (Kinsey et al., 1948; Kinsey et al., 1953) is a 7-point scale used to assess
self-identified sexual orientation, with zero representing exclusive heterosexuality and 6
representing exclusive homosexuality. Participants endorsing 3 or higher on the Kinsey Scale
will be included in this research.
PHQ-8. The Patient History Questionnaire-8 is an 8-item measure that screens for
depressive symptoms. It has been used extensively in research and clinical settings to
identify significant depressive symptoms. We will use a threshold of >15 to identify those who
may be experiencing moderate to severe depressive symptoms. These individuals will be
excluded from the study.
The Brief Symptom Inventory (BSI; Derogatis & Melisaratos, 1983) will be used to assess
participants’ psychological health. Symptoms related to the subscales of somatization,
obsession-compulsion, paranoid ideation and psychoticism will be used in the study. If
participants circle > 2 on any BSI item that may reflect acute psychiatric distress or thought
disorder the RA as trained by the PI will probe the participant further to obtain more
information and evaluate eligibility and potential need for a psychiatric referral.
Medical Condition Questionnaire will be a form listing major medical conditions (e.g., liver
disorders, heart disease, HIV+ serostatus) and use of medications that contraindicate alcohol
use. Participants will indicate on the form whether or not they have a condition that
contraindicates alcohol use but will not identify which ones.
Baseline Questionnaire Measures
Please note that the baseline questionnaires will be administered on the computer using
Qualtrics
Effortful Control Measure. This 23-item questionnaire is used to assess planning, problem
solving and goal setting abilities.
Drinking Motives Questionnaire and Sexual Motives for Drinking. These two measures
comprise a 25-item self-report assessment of reasons for consuming alcohol.
Sexual Alcohol Expectancies. This measure assesses expectancies about sex (e.g.,
performance) related to the consumption of alcohol.
Goal Systems Battery for Condom Use. This measure examines self-regulation
components related to the use of condoms. The 16-item measure assesses how participants
value, monitor, plan, and have confidence about, the goal of using condoms.
Self-efficacy and Intention to Use Condoms. Five items each are used to assess
components of self-efficacy regarding the use of condoms and planning related to condom
use. Five Likert scale items are used to assess the degree to which individuals take steps to
use condoms.
Multidimensional Condom Attitudes Scale. This 25-tem scale assesses individual
attitudes about their own use of condoms.
Sexual Sensation Seeking Scale. This 11-item scale assesses the propensity for
individuals to seek out novel or risky sexual stimulation
Short Inventory of Problems. This 20-item measure assesses the degree to which
individuals have experienced alcohol-related consequences in the past 90 days.
Behavioral Inhibition and Activation Scales. This 20-itm self-report measure assesses
dispositional differences in behavioral approach and avoidance systems
Positive and Negative Affectivity Scales. This 20-item measure assesses baseline
17
Version: January 9, 2014
differences in positive and negative affect.
Short Impulsive Behavior Scale (UPPS). This 20-item abbreviated measure assesses
different components of impulsivity including urgency, sensation seeking, premeditation, and
perseverance.
Computerized Baseline Measures
Working Memory Span Task: Symmetry Span. This computerized task is used to assess
individual differences in working memory. Participants are asked to retain information about
the placement of objects while solving a series of spatial problems.
Stop Signal Task. This computerized task is used to assess response inhibition.
Participants are required to inhibit key press responses when signaled by auditory cues over
a series of trials. Ability to inhibit is determined by the latency of auditory cue presentation
that can be inhibited by the subject.
Alcohol Approach-Avoid Implicit Association Test. This computerized measure presents
a series of alcohol and control stimuli to participants for speed of categorization. It is used as
an index of automatic appetitive responses to alcohol.
Participant Characteristics
Demographics will be assessed. Sexual Behavior Survey will be used to assess number of
lifetime sexual partners, sexual partners in the previous year, and sexual partners in the past
3 months as well as condom use (Gordon et al., 1997). This measure is used for screening
and participant description.
Dependent Variables
The primary dependent variable will be a latent sexual risk variable defined by 3 indicators,
Behavioral skills, Risk exposure, and Intentions. Each indicator will represent the mean score
from the two videos. Our previous work with these variables supports the use of the latent
construct (cf. Maisto et al., 2011). For exploratory purposes, we also include the CARE
(Fromme et al., 1999) to assess perceived risk in the videos.
Behavioral skills and risk exposure will be measured with two interactive videos developed for
the Maisto et al. (2012) experiment. As noted earlier, the procedures followed in developing
the videos were described in detail in Woolf-King, Maisto, Carey, and Vanable (2009). Both
interactive videos provide indicators of the behavioral skills needed for safer sex in situations
that would (1) be familiar to participants, (2) pose moderate difficulty to communicate feelings
about condom use, and (3) elicit moderate sexual interest. The first interactive video depicts
two men who had recently met and were eventually faced with the decision of having
sexual intercourse for the first time without the use of condoms. The second interactive video
depicts two men who were friends and were faced with their first sexual experience and
eventually the decision of whether their first sexual encounter together would involve the use
of condoms. The videos were enacted by professional actors according to a script and were
filmed by professional videographers.
Each interactive video has a risk exposure component and a behavioral skills component. For
the risk exposure component, each video begins by setting a scene in which “Jim” (the
protagonist) and “Dave” (the character with whom the participant will be asked to identify)
meet up with each other. The participant will be asked to make a series of binary choices
(yes/no) about engaging in various increasingly high-risk sexual activities with Jim, which
constituted the basis of the interactive risk exposure measure. The 5 choice points
were (1) “Do you go with Jim (the protagonist) to his apartment?”; (2) “Do you accept a drink
from Jim?”; (3) “Do you go upstairs with Jim (video 1)?” or “Do you get in the hot tub with Jim
(video 2)?”; (4) “Do you have anal sex with Jim?”; (5) “Do you have barebacked, receptive
anal sex with Jim?” Participants will receive 1 point for each time they answer “yes” and thus
18
Version: January 9, 2014
make a progressively risky choice. The risk exposure portion of the video will terminate with
the first “no” response to the choice points. Subsequently, the participant will go to
the fifth choice point to begin the behavioral skills component of the video.
The behavioral skills portion of the video will require participants to negotiate sexual situations
using verbal communication skills in an interactive role-play. Participants will be asked to
respond first to Jim’s comment that he desires to have unprotected anal sex and that there is
no cause for concern because he is safe (“prompt 1”). The video then will pause for 60
seconds to allow the participant to respond by speaking into a microphone placed next to the
computer monitor. Subsequently, Jim will deliver a second, more insistent comment that was
a reminder to the participant that UAI would not be risky and would be pleasurable and that
the participants could trust Jim (“prompt 2”).
Participants’ responses to each of the prompts will be scored (on a 0-2 scale) on the following
five dimensions (higher score = better communication skills): (1) use of an “I” statement of
intention of safer sexual behavior or refusal of unsafe sexual behavior; (2) presence of a
positive statement about the other person in the scenario; (3) provision of a statement of a
reason for safer sexual behavior; (4) suggestion of a specific alternative behavior that was
safer; and (5) indications that the participant’s response was direct, serious, and
clear. Scores for each of the response dimensions were assigned according to criteria
specified in a rating manual based on previous research by our team (Maisto et al., 2002,
2004a, 2004b). Two raters will independently code each of these five dimensions across the
two prompts and the two videos (117 participants x 5 dimensions x 2 prompts = total number
of codes). In Maisto et al. (2012), the two raters agreed on 93% of the codes, and the
discrepancies on the remaining codes were resolved through discussion. The latter
procedure will be followed in this study.
Intention to engage in unprotected sex after viewing each of two sexual video vignettes will be
rated on a 7- point rating scale (Bishop & Maisto, 2011). In addition, 5 items assessing
broader sexual intentions will be included (e.g., oral sex intention). This will provide the option
of using a multi-item outcome measure of risky sexual intention. Prior to forming the multiitem scale we will examine the covariance structure to determine an optimal internally
consistent group of items.
Working Memory: Operation Span Task will be will be administered during the alcohol
administration phase of the protocol. This task measures working memory by having subjects
maintain a series of letters in memory while solving math problems. The task takes about 10
minutes to administer.
Implicit Approach-Avoidance Task (AAT). The approach avoidance task utilizes the COGENT
toolbox in the Matlab programming environment. 20 images from the sexual stimulus
materials and 20 photos of condoms (e.g., condom wrappers, unrolled condoms, etc.) are
used as stimuli. Presentation of stimuli is randomly assigned by the program. Stimuli are
preceded by a 500 ms white cross (+) fixation point in the center of the screen. Following the
fixation point, a randomly assigned stimulus is presented. Participants have 1700 ms to
respond to the stimulus and there is a 1000 ms intertrial interval. These procedures have
been used successfully in previous research (see Hofmann, Friese, & Gschwendner, 2009;
Wiers et al., 2011). Each stimulus is presented in both a landscape and portrait format.
Participants are instructed to pull the joystick towards them when an image in portrait format
appears while simultaneously imagining they are pulling that image to them. They are
instructed to push the joystick away when an image in landscape format appears while
simultaneously imagining they are pushing that image away from them. Pushing the joystick
away causes the image to recede on the screen and pulling the joystick towards them causes
the image to zoom, thus providing a sense of avoidance and approach respectively. The
instructions are followed by 8 practice trials during which they receive feedback on their
responses. There are a total of 80 trials (i.e., each stimulus is presented once in each format).
19
Version: January 9, 2014
An index of sexual stimuli approach tendency (a D score) is calculated by subtracting the
mean response latency of the sex approach, condom avoid trials from the mean
response latency of the sex avoid, condom approach trials and dividing this by the subject’s
standard deviation of response times (Greenwald et al., 2003). Higher scores indicate faster
reaction times when approach is paired with the sexual stimuli and avoid is paired with the
condom stimuli. This reflects a bias to approach sexual stimuli relative to condom stimuli. We
will also examine implicit approach biases toward sexual and condom stimuli separately to
determine the effects of intoxication on each and the independent effect of the
implicit biases on behavior. However, we chose the combined measure as a primary variable
due to our pilot results and the nature of the behavioral choice (e.g., strength of sexual
attraction vs. strength of desire to use condoms). This coincides with the scenarios in which
the participant is deciding whether to have sexual intercourse without condoms. Strength of
approach vs. avoidance toward the sexual stimuli as well as condom stimuli is relevant to the
behavioral outcome, and our measure quantifies the relative response bias.
Manipulation Checks
Actual BAC will be measured by breath analysis (Alco-Sensor FST). Amount of alcohol
consumed in “standard drinks” will be estimated by each participant as will subjective
intoxication. Sexual arousal ratings. Participants rate level of sexual arousal on a 7-point
scale after viewing the videos.
Post-risk video ratings. Participants will use 7-point scales to rate how realistic the situation
was and how difficult it would be not to engage in risky sex if they actually were in the
depicted situation.
Procedure
Part 1. Alcohol Administration Study
Session 1. Participants will be breath tested, provide informed consent and complete the QFV
drinking assessment measure, SMAST, ASSIST, CES-D, BSI, Kinsey Scale, sexual behavior
survey, and the medical questionnaire in addition to an unstructured interview to determine
eligibility. Ineligible participants will be given $20 and finish the study. Eligible participants will
complete the remainder of the baseline alcohol self-report measures.
The first session including the consent, questionnaire and orientation to the ESM study will
take approximately 2 hours.
Part 1, Session #2 will begin approximately 1 week later depending on scheduling availability
but may occur anytime between 1 day and two weeks. Participants will be reminded that they
should not drive a car or bicycle to the second session and that they will be required to return
to a residence as a condition of participation.At the beginning of this session (Part 1, Session
#2), eligible participants will be reminded about the procedures and timeframe for the study.
In addition, they will be informed about the ESM study (Part 2), including the goals and
objectives of the sampling procedure. At this time they will be informed that the details of the
study and consented. Further description will be provided at the end of the second session.
Two RAs will conduct session 2, which will be conducted in the afternoon but begin no later
than 4 p.m. The first RA (RA1) will breath test the participant to ensure that his BAC is zero,
check compliance with instructions (e.g., not eating), weigh the participant to determine the
quantity of alcohol to be administered if relevant, and administer the baseline approachavoidance and working memory tasks. RA2 will tell the participant to which beverage
condition he has been assigned. The amount of alcohol received in the alcohol condition will
be determined by an algorithm developed by Curtin (Curtin, 2000). Participants in the alcohol
condition will receive a dose of alcohol (target BAC = .08%), administered in a chilled
beverage of 80-proof vodka mixed with tonic water and lime juice in a 1:4 ratio. Participants in
20
Version: January 9, 2014
the water control condition will receive a glass of chilled water. Placebo participants will
receive tonic water and lime juice served to enhance alcohol cues. Drinks will
be divided into three equal doses. Participants will sit alone in a comfortable setting while they
consume the drinks and will be asked to take about 6-7 minutes to finish each one. Research
personnel, who are responsible for administering outcome measures will not be aware of
participants’ beverage condition. The goal is to complete the outcome measures as the BAC
is ascending. The BAC is expected to reach its peak approximately 45 minutes after the
participants finish their third drink (Roine et al., 1991).
Following alcohol administration, participants will rest comfortably in the laboratory and be
given access to a computer and a table. The room is close to bathroom facilities and has a
one way mirror through which participants may be monitored. Emergency facilities are
available at area hospitals within 2 miles of the laboratory.
Part 2. ESM study.
The ESM part of the project will take place after the laboratory study. Those in the water
control or moderate alcohol groups will be used for the analyses regarding external validity,
and the full sample will be used for additional event-level analyses of sexual risk behavior.
Participants will be trained in the use of Experience Sampling and the use of the MetricWire
app. The program will prompt participants to complete 8 brief ~2 minute assessments at
random times within 2-hour blocks from 10:00 am and 2:00 am per day. In addition,
participants are requested to initiate a morning assessment shortly after waking. The validity
of the proposed sampling design is supported by previous research (Armeli et al., 2003;
Simons et al., 2010; Swendsen et al., 2000). Participants will complete questionnaires for 42
days divided into 2 segments of 3 weeks with a 3 week break in between to minimize fatigue.
They will receive $1.00 per random assessment, $3.00 per morning assessment, plus a
$23.00 bonus for completing a week of morning assessments (i.e., up to $100 week or
~14.29 per day).
The experience sampling thus provides time and date stamped assessments of substance
use, sexual arousal, sexual risk behavior, and relevant covariates. This will allow event-level
analysis of sexual risk behavior.
The app is designed to be used on the participants’ cell phones. For those who do not have a
cell phone, the experimenters will provide a phone with a minimal data plan. Participants will
be informed that (as per the consent), return of the phone is a precondition for compensation
on the experience sampling portion of the study.
ESM Measures
Location. Participants’ location will be assessed by a checklist. An item will assess whether
they are in a social group and whether individuals in their group are drinking (Simons et al.,
2005; 2010). Sexual arousal in the previous 30 minutes will be assessed by 3-items in the in
situ random prompts (Grov etal., 2010). Level of sexual interest, sexual arousal, and horny
are rated on 9-point scales Grov et al., 2010). Peak sexual arousal during the evening will be
the predictor for the analyses.Affect in the previous 30 minutes will be assessed by items from
subscales of the PANAS-X (Watson & Clark, 1994) and Larsen and Diener’s affect circumplex
model (Larsen & Diener, 1992). Positive affect will be
assessed by 5 items from the joviality subscale: happy, joyful, excited, energetic, and
enthusiastic. Items are rated on 9-point scales ranging from 1 = not at all to 9 = extremely.
Previous research supports the internal consistency and criterion validity of the assessment
(Simons et al., 2005; 2010). Additional items will assess negative emotions (Simons et al.,
2010).Alcohol and other drug consumption will be assessed using two approaches. First,
random in situ assessments of alcohol consumption will be conducted. Second, alcohol use
during the previous night will be assessed during each morning report. Participants will report
21
Version: January 9, 2014
the total number of standard drinks they consumed and the duration of the drinking episode,
which will allow estimation of BAC. Participants will also estimate their level of intoxication
during the drinking episode. This approach provides a reliable and valid estimate of
intoxication (Simons et al., 2010). Consistent with previous event level research on sexual risk
behavior among MSM (Grov et al., 2010), we will also assess use of marijuana,
cocaine/crack, amphetamines, hallucinogens, inhalants (e.g., poppers), ecstasy (MDMA),
GHB, Ketamine, tranquilizers, sedative/hypnotics, and narcotics. These will be assessed by
checklists in the in situ and morning assessments. Sexual behavior. The morning assessment
will assess sexual behavior during the previous night: (1) Did you engage in any sexual
activity last night with a male partner (e.g., kissing, fondling), (2) Did you engage in
oral sex last night with a male partner?, (3) Did you engage in anal intercourse last night with
a male partner, if yes (4) Did you use protection against STDs? Participants are explicitly told
that unless they know what their partner’s STI status is, it is considered sex without protection
unless they use a condom or barrier. A comparable item set will assess behaviors with female
partners. Similar items have been used in studies of risk behaviors (Neal & Fromme, 2007;
Simons et al., 2011). Indicators (summed across days) will be included as covariates to
control for frequency of oral sex and sexual intercourse. Indices of planning and self-efficacy
to use condoms will also be assessed during the sampling phase.
Contextual factors. The morning assessment will measure several contextual factors of the
previous night. First, a question will assess the social environment in respect to potential
sexual partners. These will be assessed separately for male and female partners. Were you
around a potential (male/female) sexual partner last night (check all that apply). 1. Alone (e.g.,
on a date, at home) with someone I have had sex with previously. 2. Alone (e.g., on a date, at
home) with someone I have not had sex with. 3. With a group that included someone I was
attracted to but had not had sex before. 4. With a group that included a former / current
sexual partner. 5. At a bar, club, etc. where there were people I was attracted to outside of my
group.
Second, if an individual endorses some sexual behavior (e.g., kissing, oral sex, intercourse),
five items will assess relationship factors. These will be done separately for male and female
partners.
[The full set of questions for the morning and sampling assessments are provided in the
Appendix]
Participants will be allowed to withdraw from the study and request withdrawal of their data at
any time during the study. If this request takes place, the research assistant will document
the time and date of the request, indicate whether this involves participation and/or data
withdrawal, and record relevant information regarding reason for withdrawal is the participant
chooses to provide it. This form will be signed by the RA. If this request takes place while the
participant is at the laboratory, the participant will be asked to co-sign the request. If the
request takes place during the ESM study and is made by phone, this will be documented and
the participant will not be required to return to the laboratory to withdraw.
PILOT STUDY
In order to test procedures and stimuli used in this protocol, we would like to propose a pilot
study to be conducted with up to 20 additional participants. This pilot study has two main
22
Version: January 9, 2014
goals. First, to test the baseline questionnaire and computerized measures described above.
And second, to provide pleasantness and arousal ratings of the sexual stimuli that are to be
used in the Approach Avoidance Task (AAT). The AAT in the main study seeks to examine
automatic approach responses to erotic cues. A current version of this task will be completed
by each of the participants. However, to maximize the ability of this task to measure this
construct, it is important to identify stimuli that are experienced by participants as pleasurable
and arousing (and to ensure that “control” stimuli are not). Consequently, participants will be
asked to complete a series of picture ratings of erotic and control stimuli (approximately 100
pictures) and rate them on the dimensions of pleasure and arousal. This portion of the study
does not require that data are linked to subsequent responses consequently there are
minimal risks to confidentiality associated with participation. Minimal risks include potential
mild discomfort to screening or assessment questions and potential discomfort associated
with the viewing of sexually explicit photographs. These risks are outlined in the study
consent forms. There are no other known risks to participation. A separate consent form has
been developed for the pilot study and is attached. The pilot study is estimated to take 2.5
hours and participants will be compensated for their time and effort in the sum of $50.
SECTION M: RISKS
Describe any expected risks to subjects. Consider physical, psychological, social,
political, legal, economic, or other risks that are related to the study.
The primary risks in this research are those related to consuming moderate doses of alcohol.
Alcohol is a known central nervous system depressant and can impair judgment, other
cognitive processes, and driving ability. In addition, completing the questionnaires may
increase awareness of potential problems with psychological functioning or alcohol use.
Participants will be provided with information on the consent form regarding community
counseling services that they may contact if they wish to do so. Second, the stimuli used in
the protocol involves presentation of sexual images that may produce discomfort for some.
Based on similar studies with this population, it is unlikely that these images will represent a
concern to participants. Third, the chance of the data being connected to the individual cannot
be totally eliminated during the project period. Participant questionnaires will be identified by a
unique code rather than name. Furthermore, the data on the palmtop computers are
encrypted first before being written for persistent storage on the PDA (Samsung Galaxy). The
encryption algorithm used is TripleDES (which meets level 1 for FIPS 140-2 encryption) as
implemented by Microsoft in their .Net 4.0 Cryptography class: Triple DES Crypto Service
Provider. During export, the encrypted data is being transferred via http(s) to the web server
where it is persisted to storage in a SQL Server database in the encrypted state. The web
server has a SSL certificate. We will also be revising our data transfer procedures; we will no
longer include the use of TrueCrypt and Spider Oak to transport data collected at BU to a
limited access server facility at Syracuse University. Instead, data collected from the BU site
will be transported via DatAnywhere across a secure link to project staff who will download
the data to a limited access server facility at Syracuse University. The data service will be
administered and supported by the Syracuse University IS&T Department. It will be used in
an ongoing basis throughout the duration of the project as needed. DatAnywhere allows the
transfer of data over an encrypted internet connection (https) and offers two-factor
verification. See attached DatAnywhere materials for further information. Records of
participants' names, email addresses and other contact information, and consent forms will be
collected and kept separately from the questionnaires at Boston University. All data will be
23
Version: January 9, 2014
kept in a secure file accessible only to primary research personnel. After completion of the
project, the master list connecting participants’ names to their id numbers will be destroyed.
Finally, individuals in the experimental study may be uncomfortable with the deception
involved in telling some of them that they are drinking a beverage containing alcohol when in
fact they are not. We will apply for a Certificate of Confidentiality from NIH to further protect
the participants’ data and identities.
Describe the plan to minimize risks. Include in the description the availability of any
medical or psychological resources.
A number of procedures will be used to reduce risk as much as possible. First, a comprehensive
screening process will be used to screen all individuals with contraindications to alcohol
consumption from participating in the experimental study, including medical conditions (such as
liver disorders, heart disease, diabetes, HIV+ serostatus), substance use problems or history of
treatment for the same, use of prescribed or over-the counter medications that interact with
alcohol, history of the flushing response in reaction to consuming alcohol, and psychiatric
problems or history of inpatient or day hospital treatment for the same.. The screening
procedures group contraindicated conditions so that risks can be evaluated while maintaining
the privacy of the participants regarding specific contraindicated conditions. In addition, only
individuals who drink alcohol in quantities comparable to the amounts that will be used in this
research will be included. Participants will be fully debriefed at the end of the studies about all
procedures and measures and will be free to withdraw from the research at any time. Where
relevant, safety precautions will follow NIAAA guidelines for alcohol administration studies with
humans (National Institute on Alcohol Abuse and Alcoholism, 1989, 2005). Along
these lines, individuals will agree in advance of their participation in the experiment to remain in
the laboratory until their BAC falls to .02%, and to take a taxi service ride [or other transportation
home that does not require operation of a motor vehicle] home or to a residence subsequently.
BAC below .02 will be confirmed by 2 readings. We have also assessed the need to medical
backup services based on the route of administration, population, and drinking status of the
sample. Eligible participants are moderate to heavy drinkers who have likely consumed similar
amounts in their daily lives. Given that this dose is not administered with any other drugs, we
believe that the likelihood of serious risk to health (i.e., requiring medical services) is very small.
Indeed, the investigators have completed a number of similar alcohol administration protocols
without incident. However, research assistants will be trained to properly monitor participants
following alcohol administration and to call 911 for an ambulance for transport to a medical
facility if necessary. There are several hospitals that are located within 2 miles of the research
facility. Although we think that this risk is extremely small, we will include these procedures in
the research protocol to ensure medical treatment if necessary Participants will be told in
advance that participation involves watching a video of a consensual sexual situation with two
men and that the approach-avoidance task includes erotic images of consensual sexual
situations between two men. For any emotional distress that develops or is detected in the
screening or debriefing (e.g., pertinent to alcohol use or HIV risk) trained RAs and the PIs will be
available for immediate counseling, and referrals will be provided at
counseling services in the community or at the respective universities as relevant. As discussed
above, those who are excluded from participation because of in person B-MAST scores will be
asked if they would like any information about services related to alcohol use . For those who
24
Version: January 9, 2014
report that they would like more information will be provided with the Mass. Government website
which helps link individuals to treatment programs across the state for further assessment
[http://www.mass.gov/eohhs/gov/departments/dph/programs/substance-abuse/.] Any
participants who are students will be encouraged to contact their student health services center
for further information on treatment that may be available through their own university.
To protect participants’ confidentiality, their protocols will be identified by code only. A master
list linking names to codes will be kept in a locked file accessible only to designated research
staff. This master list will be kept for purposes of contacting participants as needed. This list will
be destroyed at completion of the study. The data on the palmtop computers and the associated
web application are encrypted. All data will be kept in a secure file accessible only to primary
research personnel. No individual research participants will be identifiable in presentations or
publications of the data. Only group or summary data will be used. We will apply for a Certificate
of Confidentiality from NIH to further protect the participants’ data and identities.
If a participant notified us that he became HIV+ during the ESM study we will withdraw him from
the study and will provide appropriate referrals.
25
Version: January 9, 2014
SECTION N: BENEFITS
Describe the potential benefits to subjects related to the study. State if there are no
direct benefits.
NOTE: Compensation and/or course credit are not considered benefits.
Participants may learn something about the acute effects of alcohol and may feel positive
about their contribution to knowledge about factors affecting negative consequences of
alcohol use and risk for HIV transmission.
Describe the potential benefits to society and/or others related to the study.
By understanding mechanisms of action, research such as that proposed has the potential to
inform primary and secondary prevention interventions to reduce STDs, which likely would
increase their effectiveness. More broadly, the current study focuses on developing further
understanding of the etiology of alcohol-related problems. Understanding the etiology of
alcohol-related problems is important in two ways. First, knowledge of the precursors to
alcohol-related problems can be used to identify high-risk individuals and target secondary
prevention efforts. Second, understanding the etiology of alcohol-related problems can be
useful in developing effective intervention strategies.
SECTION O: COSTS/PAYMENTS
*YES
☒
NO
☐
Are there any costs to subjects as a result of participating in this study?
*If YES, provide a description of the costs: transportation to study site
☒
☐
Will subjects be compensated for participating in the study? Compensation may
include cash, checks, gift cards, lotteries, course credit, etc.
*If YES, provide a description of the compensation: For session #1, participants
26
Version: January 9, 2014
are paid $40 to complete initial screening and assessment and $20 if they are
found to be ineligible through screening. For session #2 they are paid $75 and
compensated $15 for each hour over 4 hours that they are required to stay in
the lab. Subjects are not permitted to drive to session 2. They are
compensated $15 for their transportation for phase 2.
Payment for Part 2 of the study is as follows:
Participants will complete questionnaires for 42 days divided into 2 segments of
3 weeks with a 3 week break in between to minimize fatigue. They will receive
$1.00 per random assessment, $3.00 per morning assessment, plus a $23.00
bonus for completing a week of morning assessments (i.e., up to $100 week or
~14.29 per day).
NOTE: Payments should be prorated to compensate subjects for time and
procedures completed
SECTION P: CONFIDENTIALITY OF DATA
Describe how data will be stored (e.g. paper, electronic database, etc.).
Consent forms and the master list will be stored in a locked cabinet in the researchers laboratory
All computerized data will be stored on a password protected computer in the research laboratory.
Protections for transferring these data to Syracuse for analyses are described above.
Per Boston University (BU) Record Retention Policy, records concerning human subjects must
be retained for 7 years. Please refer to the policy at:
http://www.bu.edu/policies/files/2012/05/Record_Retention_Policy_1-27-10.pdf. As the
investigator, you must also adhere to all applicable requirements as defined by regulatory
agencies (e.g. FDA, etc.) or Sponsors.
*YES
☒
NO
☐
Will you collect identifiable information? (e.g. names, social security numbers,
addresses, telephone numbers, etc.)
Names and telephone numbers are required
27
Version: January 9, 2014
For a complete list of personal identifiers, please refer to the IRB website:
http://www.bu.edu/irb/hipaaandphi/
*If YES, complete the box below
To complete payment names and ss# are required
Describe the coding system* that will be used to protect the information including who will have
access to the code.
*Coding system: Coding systems are used to: 1) protect the confidentiality of the research data
and 2) allow the investigator to link subjects to their responses. Each subject is assigned a
unique study ID at the beginning of the study. A separate document (key) should be maintained
that links the names of the subjects to the study ID numbers.
Each subject is assigned a unique ID and separate document kept by the PI is used to maintain
links to subject names
*YES
☐
NO
☒
Will you share data with others outside of the study?
*If YES, complete the box below
Describe how data will be transferred and how confidentiality will be maintained (e.g.
identifying information will not be sent outside, etc.)
See above
Describe how you will maintain the confidentiality of the data (e.g. locked cabinet,
password-protected files, encryption, etc.)
Note: Confidentiality refers to the researcher’s agreement with the participant about how
the subject’s identifiable private information will be handled, managed, and disseminated
For further assistance and/or access to resources regarding information security, please
refer to the BU Information Security website: http://www.bu.edu/tech/security/
28
Version: January 9, 2014
Data control procedures are described above
YES
☒
NO
☐
Will you obtain a Certificate of Confidentiality?
Certificates of Confidentiality are issued by the National Institutes of Health
(NIH) to protect identifiable research information from forced disclosure. They
allow the investigator and others who have access to research records to refuse to
disclose identifying information on research participants in any civil, criminal,
administrative, legislative, or other proceeding, whether at the federal, state, or
local level.
For more information about a Certificate of Confidentiality, please review the
NIH website at: http://grants.nih.gov/grants/policy/coc/
SECTION Q: PRIVACY
Describe how you will protect the privacy of subjects. Include the following information:
location of data storage, who will have access to study information, and location of study
visits.
Note: Privacy can be defined in terms of having control over the extent, timing, and
circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.
Privacy of data will be protected by limiting the access of data to study investigators and primary
research personnel only. Study visits will take place at a research laboratory in the Psychology
Department (Clinical Program) of Boston University. All consent forms will be stored separately from
questionnaire data in a locked cabinet. All electronic data will be stored on a password protected
computer in the laboratory backed up by a password protected BU server site.
SECTION R: MONITORING STUDY DATA
How will data be monitored:
Note: The Data and Safety Monitoring Plan should be tailored to the nature, size, and
complexity of the research protocol, the expected risks of the research, and the type of
subject population being studied.
29
Version: January 9, 2014
☒
Principal Investigator
☐
Monitor/Monitoring Group
☐
Data and Safety Monitoring Board (DSMB)
Note: The DSMB Charter must be submitted with this Application
For more information regarding a DSMB, please refer to the following website:
http://www.nidcr.nih.gov/Research/ToolsforResearchers/Toolkit/DSMBGuidelines.htm
Describe the plan for monitoring study data. This should include a description of how data
will be collected and analyzed as the project progresses to assure the appropriateness of
the research, its design, and subject protections.
Dr. Palfai, the PI of the BU site will be responsible for study integrity along with Dr. Maisto and
and Dr. Simons all will be responsible for the oversight of the proposed research and its
implementation. In this regard, PIs Maisto and Palfai will be responsible for the achievement of
the data collection part of Aims 1 (experimental study) and 2 (ESM study), Maisto in Syracuse
and Palfai in Boston. PI Simons will be primarily responsible for setting up the experience
sampling and implicit approach assessments, as well as all aspects of the data management
and analyses required to achieve both aims. The 3 PIs will have weekly conference telephone
calls about the research, its implementation, and administration. They also will communicate on
an ad hoc basis for these purposes by email and fax. PI Maisto will serve as the contact PI and
will assume fiscal and administrative management of the project.
SECTION S: HEALTH INSURANCE PORTABILITY AND
ACCOUNTABILITY ACT (HIPAA)
*YES
☐
NO
☒
Is this research being conducted in a covered entity?
The following components have been determined to be covered entities on the
Boston University Charles River Campus:
•
•
•
Sargent College Rehabilitation Services
o Physical Therapy Center at the Ryan Center for Sports Medicine
and Rehabilitation
o Sargent Choice Nutrition Center
The Danielsen Institute
Boston University Health Plan
30
Version: January 9, 2014
*If YES, contact the IRB office for assistance.
SECTION T: FAMILY EDUCATIONAL RIGHTS AND PRIVACY ACT
(FERPA)
*YES
☐
NO
☒
Does this study involve collection of information from student school/university
records?
*If YES, refer to the BU FERPA website for guidance:
http://www.bu.edu/reg/general-information/ferpa/
In accordance with FERPA, written consent must be obtained to access student records. The
consent must:
•
•
•
Specify the records that may be disclosed
State the purpose of the disclosure
Identify the person or class of parties to whom the disclosure can be made
Describe your plan for obtaining this information in accordance with FERPA:
Certification / Signatures
•
By submitting this protocol I attest to the fact that all research activities to be implemented
related to human subjects have been completely and accurately described herein.
•
I agree to conduct the describe research in an ethical manner.
•
I agree to comply with all institutional policies and procedures related to human subjects
research and will not begin any human subjects research activities until I have obtained full
approval from the IRB.
•
I agree to conduct the research as described in this protocol and not to make any changes
(except to eliminate immediate harm to subjects) without first obtaining approval for the
changes from the IRB.
31
Version: January 9, 2014
•
I agree to immediately report any unanticipated problems involving risks to subjects or
others, any subject complaints, and any incidents of non-compliance with the requirements of
this protocol as soon as I become aware of them.
•
I agree to comply with any relevant HIPAA and FERPA regulations if applicable.
•
I verify that all those responsible for the design, conduct, or reporting of the proposed
program, including at minimum, all Senior/key personnel in the grant application, have
completed the financial interest disclosure forms and completed training as dictated at
http://www.bu.edu/orc/coi/forms/, and returned the forms to the Office for Research
Compliance COI Unit. NOTE: If anyone checked “yes” to any of the questions on either
the FIND1 or NONFIND1 form, the IRB Director will contact the COI office to obtain
the disclosure information.
PI printed name _______________________________________
PI Signature:__________________________________________ Date: _______________
FACULTY Research:
The Department Chair signature is required: This application must be signed by the
Department Chair for all faculty researchers. If the PI is the Department Chair then signature by
the appropriate Dean is required. Department Chair signature is not required for student research.
By signing this form you are indicating that you have reviewed the application, the faculty/staff
person listed as PI on this protocol is a member of your department, and that he/she is qualified to
serve as the PI for this study.
Department Chair (print name):
Department/School:
Signature:
Date:
STUDENT Research
Student research: Student research must be signed by the faculty advisor AND the designated
School IRB pre-reviewer (if applicable) PRIOR TO submission to the IRB. Students should
32
Version: January 9, 2014
check with their School to determine if School IRB pre-review is required. Students must submit
a copy of their dissertation with the IRB Application
By signing this form you are indicating that you have reviewed the application, that you
agree to serve as the Co-PI for this study with the student and that you will be responsible
for the ethical conduct of this student’s human subjects research. .
Faculty Advisor (print name):
Signature:
Date:
IRB School Reviewer, if applicable (print name):
Signature:
Date:
33
Version: January 9, 2014