PROVIDENCE COLLEGE IRB INSTRUCTIONS AND SAMPLE APPLICATION TEMPLATE LAST REVISED MAY 3, 2015 These instructions have been developed in the form of a "sample application template." The study described herein is completely fictional Furthermore, as a template, these instructions do not capture much of the detail that must be included in most applications. Nevertheless, the outline and structure that has been incorporated in this document should help you identify the key mandatory characteristics of your application. Here are comments about the template, which has been appended to this document: Question 1: The project name is a working title. The IRB will assign an identification number to your application for tracking purposes. Question 2: The Principal Investigator (PI) is the lead researcher on the study. The PI may be a faculty member, administrator, or student at Providence College, or a faculty member at another institution. Before an IRB application is submitted, the PI must complete the required CITI training course. Question 3: If the PI is not a faculty member at Providence College, the PI must obtain a sponsor who is a faculty member or administrator at Providence College. The sponsor serves as a liaison between the PI and the IRB, and guides the PI through all aspects of the IRB application process. The IRB relies on the sponsor to attest to the integrity of the PI and the research project. Before an IRB application is submitted, the sponsor must complete the required CITI training course. Question 4: Any co-­‐investigator, research associate, or research assistant with access to participants or identifying information must be listed here. In student research courses, this list usually incorporates a class roster. Before an IRB application is submitted, all such individuals must complete the required CITI training course. Question 5: The preferred starting date is not necessarily the actual starting date. Although the IRB will make every reasonable attempt to accommodate preferences, no project can begin until the IRB issues an approval letter. Question 6: Many research projects in educational settings are eligible for exemption status if participants are placed at minimal or no risk. Questions 10 through 14 help the IRB assess the level of project risk. Question 7: Many survey, interview, or "public observation" projects are eligible for exemption status if participants are placed at minimal or no risk. Questions 10 through 14 help the IRB assess the level of project risk. Question 8: Certain projects that seek information from public officials or candidates for public office are held to a different exemption standard than projects that seek information from private citizens and other individuals. Question 9: Certain projects that review existing anonymous information are eligible for exemption status if participants are placed at minimal or no risk. Questions 10 through 14 help the IRB assess the level of project risk. Question 10: If a project places participants at risk of criminal or civil liability, of damaged employability or financial standing, or of undue embarrassment, it is generally not eligible for exemption status. In addition, it is often not eligible for expedited review status. Question 11: Any project that proposes to collect data from special populations is not eligible for exemption status or expedited review. Question 12: Any project that exposes participants to levels of discomfort or harm, that are greater than levels that they would ordinarily encounter in daily life, is not eligible for exemption status or expedited review. Question 13: Any project that deceives participants at any time is not eligible for exemption status or expedited review. Question 14: Any project that asks participants to provide any sensitive personal information about their attitudes, behaviors, experiences, or histories is not eligible for exemption status or expedited review. Question 15: You must identify each potential risk in your answer, and must explain how you plan to manage each risk by referring to relevant procedures or documents elsewhere in your application. You must also demonstrate that your project is grounded in some legitimate research question by including at least one reputable source citation. Question 16: You must explain how and where you will recruit participants, and why you will include or exclude individuals who volunteer to participate in your study. You must also estimate your sample size, and explain the special procedures that you will follow (such as seeking the Informed Consent of the parents and guardians of minors) when working with the special populations that you identified in Question 11. Question 17: Your Informed Consent procedure can be presented as a paper form, or as an online screen that must be "clicked through" by a participant in order to indicate acceptance. Each of the underlined words or phrases in the template Informed Consent form represents a required component of the form. Your Debriefing procedure represents the "final word" that you share with your participants at the conclusion of the data collection process. It must include reminders about any lingering risks or ongoing responsibilities that have been accepted by participants as a condition of joining the study. Question 18: You must describe your experimental protocols and your subsequent data storage and management activities. Your data must be stored in a secure place, with access that is restricted to individuals who have been named in Questions 2, 3, and 4 of this application. Confidentiality guarantees must be disclosed here as well. Question 19: Recruitment documents, Informed Consent and Debriefing forms, interview or survey questions or other data collection documents, written confirmations of support from other institutions or IRBs, and other documents should be merged into a single PDF file and uploaded here. Your answers to Questions 15, 16, 17, and 18 should refer to these documents. Every application, at a minimum, must include an Informed Consent process and data collection documents. Brief written confirmations of support are required from other organizations whenever researchers will rely on them for recruiting or data collection assistance, or whenever researchers are working with co-­‐investigators who are employed with organizations that maintain an IRB. Incidentally, in order to protect the confidentiality of your relationships with other institutions, we do not accept contracts, memoranda of agreement, or other lengthy documents as written confirmations of support. We simply require (and we only accept) brief written statements, customarily formatted as email messages that are sent to [email protected]. Question 20: You will receive a confirmation email message to your Providence College email account within 24 hours of submitting an application. If you do not receive a confirmation message, please contact the IRB immediately at [email protected]. Application: New Project Please complete this application if you are applying for IRB approval of a new project. You may not begin your research until the IRB approves your request in writing. 1. What is the name of your project? Attitudes Regarding Social Outcasts
2. What is the name, title, department, and school or college of the Principal Investigator? Mary Shelley, Student, Department of Cultural Sociology, Providence College
3. What is the name, title, department, and school or college of the Faculty Sponsor? Victor Frankenstein, Professor, Department of Cultural Sociology, Providence College
4. Who else will have access to participants during the time of data collection? Or access to data with identifying information? Henry Clerval, Assistant Professor, Department of Cultural Sociology, Pawtucket College
Robert Walton, a student assistant enrolled in SOC 101 during the Fall semester
5. When would you prefer to begin data collection activities? Are you facing a deadline? Because of a need to conduct focus group discussions with students before the end of
the fall semester, I would prefer to begin my activities no later than October 31, 20xx.
6. Will your research be conducted in established or commonly accepted educational settings, involving normal educational practices, such as: (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods? No. 7. Does your research involve the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior? No. 8. Are your participants elected or appointed public officials or candidates for public office? No. 9. Does your research involve the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, and are these sources publicly available or is the information recorded by the investigator in a manner such that subjects cannot be identified, directly or through identifiers linked to the subjects? No. 10. Could the data that you are collecting from participants place them at risk of criminal or civil liability, of damaged employability or financial standing, or of undue embarrassment? Yes. 11. Are you planning to collect data from participants who are not legally competent, who are mentally disabled, who are prisoners, who are pregnant, who are physically challenged, who are under 18 years of age, or who are members of other special populations? No. 12. Can you expect participants to experience levels of discomfort or harm that are greater than levels that they would ordinarily encounter in daily life? Yes. 13. Are you deceiving participants at any time, and to any extent? Yes. 14. Are you asking participants to provide any sensitive personal information about their attitudes, behaviors, experiences, or histories? Yes. 15. How do you describe your project? Does it place any participant(s) at risk? The renowned behavioral researcher Elizabeth Lavenza theorized that focus group
discussions about personal experiences with social outcasts could lead to greater
expressions of tolerance for such individuals (Sikes, London Journal of Victorian Social
Progress, January 1860). This project explores whether explicit discussions about past
experiences can generate such effects in contemporary Rhode Island.
Questions 10, 12, and 14 describe certain risks that will be managed via our experimental
protocols. They are:
(Q10) undue embarrassment due to the potential personal disclosure of the participants'
life experiences as a social outcast;
(Q12) because of the peer group setting, this embarrassment may lead to feelings of
discomfort during interactions with other participants;
(Q14) participants may perceive disclosures of such experiences as "sensitive personal
information."
These risks will be explicitly managed during the recruitment, selection, informed
consent, data collection, and debriefing processes and procedures. See 16, 17, 18, and 19,
below.
16. How do you describe your participant recruitment and selection criteria? Your target sample size and characteristics? I plan to distribute flyers at Providence College and Pawtucket College to recruit
participants who have life experiences as social outcasts. I have uploaded a copy of my
recruitment flyer (see PDF file uploaded in Question 19, below).
I will select the first 20 respondents who contact me by email and who volunteering to
join my focus group.
Please note that my recruitment flyer explicitly discloses that focus group participants
might experience feelings of undue embarrassment and discomfort while disclosing
information that may represent "sensitive personal information." The flyer advises
individuals to consider this risk before volunteering to join my focus group. 17. How do you describe your Informed Consent procedure? Your debriefing procedure? I will distribute Informed Consent forms at the beginning of my focus group session, and
to collect hand signed forms at that time. I will also distribute Debriefing Statement
forms at the conclusion of my focus group session, although I will not obtain signatures
on them. My student assistant Robert Walton will assist me with the distribution and
collection of Informed Consent forms.
I will verbally walk the group of participants through each line of each form, as soon as
I distribute each form. I will solicit questions and answer them at that time.
I have uploaded a copy of my Informed Consent and Debriefing Statement forms (see
PDF file uploaded in Question 19, below).
Please note that my Informed Consent form explicitly reiterates that focus group
participants might experience feelings of undue embarrassment and discomfort while
disclosing information that may represent "sensitive personal information."
The Informed Consent form reminds individuals that participation is voluntary, and that
they are free to leave the focus group at any time, without penalty and without
explanation, if they choose to do so. The Debriefing Statement repeats this information,
and provides participants with the contact information for the campus Counseling Center
if they feel embarrassment or discomfort after the conclusion of our session. 18. How do you describe your data collection procedure? Your data storage practices? After I collect the signed Informed Consent forms, I will distribute a brief list of
potential discussion questions and permit the group to select and discuss the questions
that interest them. I will only intervene in the discussion if the participants stray from
the list of questions.
All of the questions pertain to attitudes regarding Social Outcasts. I have uploaded a
copy of my question list (see PDF file uploaded in Question 19, below).
I will create a video recording of the focus group discussion. This recording is necessary
to test Elizabeth Lavenza's theory that body language and tone of voice reveal
subconscious attitudes (Lavenza, 1860).
My Informed Consent form contains a separate addendum for the video recording aspect
of the study. I will obtain a second signature on this addendum from participants who
consent to be recorded (see PDF file uploaded in Question 19, below).
19. Do you have recruitment consent, or debriefing documents to share with us? Interview or survey questions? Letters of support from other institutions or IRBs? Or other documents? Please upload a single PDF file here. Uploaded file (see following sheets of this application template document for copy) 20. By typing my Providence College email address into the box (below) as an electronic signature, I am certifying that, to the best of my knowledge, the information presented herein is an accurate reflection of the proposed research activities. I accept the responsibility for the conduct of this research, for the supervision of human participants, and for the maintenance of informed consent documentation (if any) as required by the IRB. Furthermore, I certify that the research procedures for this project and the methods of obtaining consent (if any), as approved by the IRB, will be followed during the period that is covered by this research project. I will not commence any data collection procedures until I receive the IRB's written approval to do so. In addition, if I wish to amend or modify any additional procedures in the future, or to extend the data collection period in the future, I will not implement such changes until I receive the IRB's written approval to do so. [email protected]
Attachment A: Cover Page Attitudes Regarding Social Outcasts Mary Shelley, Student, Department of Cultural Sociology, Providence College This PDF file contains the following attachments: A. This cover Page (1 sheet) B. Copy of Henry Clerval's Online Training Certification from Pawtucket College (1 sheet) C. Copy of Approval Letter from Pawtucket College IRB (1 sheet) D. Recruitment Flyer (1 sheet) E. Informed Consent Form (3 sheets) F. Debriefing Statement Form (1 sheet) G. Question List (1 sheet) Attachment B: Copy of Henry Clerval's Online Training Certification from Pawtucket College Attitudes Regarding Social Outcasts Mary Shelley, Student, Department of Cultural Sociology, Providence College ***** PRINT OUT FROM PAWTUCKET COLLEGE COMPUTER SYSTEM ***** Henry Clerval
Assistant Professor
Department of Cultural Sociology
Faculty Employee # 123456789
Date Printed:
Date of Certification:
Status:
October 2, 20xx
October 1, 20xx
Passed all three modules required by Pawtucket College IRB
Module 1:
Module 2:
Module 3:
The Belmont Report (Passing Score)
Informed Consent (Passing Score)
The Role of the IRB (Passing Score)
Attachment C: Copy of Approval Letter from Pawtucket College IRB Attitudes Regarding Social Outcasts Mary Shelley, Student, Department of Cultural Sociology, Providence College September 1, 20XX
Henry Clerval
Assistant Professor
Department of Cultural Sociology
Faculty Employee # 123456789
RE:
Protocol Number 00-001
Attitudes Regarding Social Outcasts
Dear Professor Clerval:
The Pawtucket College Institutional Review Board has reviewed your full review application. I am pleased
to report that the IRB has approved this application.
Federal regulations require continuing project approval at least annually (or more often under some
circumstances, such as with increased risk to participants). If you plan to continue data collection beyond one
year, please resubmit your application (allowing time for IRB review and approval). We ask that you inform
the IRB of any unanticipated adverse consequences that might arise as a result of this research. Also, you
must let us know if you make any substantive modifications to this project.
This approval expires after a period of one year.
Sincerely,
Pawtucket College
Institutional Review Board
Attachment D: Recruitment Flyer Attitudes Regarding Social Outcasts Mary Shelley, Student, Department of Cultural Sociology, Providence College ARE YOU INTERESTED IN JOINING A FOCUS GROUP CONVERSATION ABOUT LIFE?
YOU WILL BE PAID $10 FOR YOUR TIME!
PLEASE CONTACT ROBERT WALTON AT [email protected] IF YOU WISH TO
VOLUNTEER FOR THIS ACTIVITY.
IMPORTANT! Before you contact Robert, please consider that our focus group participants might
experience feelings of undue embarrassment and discomfort while disclosing information that may
represent "sensitive personal information." You should consider this risk before volunteering to join
the focus group.
Attachment E: Informed Consent Form Attitudes Regarding Social Outcasts Mary Shelley, Student, Department of Cultural Sociology, Providence College Thank you for expressing interest in joining our focus group! We will meet, as a group, to discuss
my research project Attitudes Regarding Social Outcasts.
For many years, researchers have noticed that people sometimes harbor unpleasant feelings
towards social outcasts. But some research studies have demonstrated that focus group
discussions about personal experiences with social outcasts can help people feel more tolerant
towards outcasts.
The purpose of my study is to learn whether focus group discussions can help promote tolerance
in Rhode Island today. We only have two criteria for joining our group: (a) you must be a current
full-time student at Providence College, and (b) you must be over 18 years of age.
This is an Informed Consent form. It is designed to let you know, in advance, what will happen if
you decide to join our focus group. If you sign this form and hand it back to the researcher, you are
telling us that you understand the information in this form, and that you agree to join our group.
Please keep in mind that your participation is voluntary. You do not need to participate in this
study, and even if you begin to participate in it, you can leave at any time. There is no penalty
whatsoever if you decline to participate, or if you leave after beginning to participate.
So, if you agree to join us, what procedures will we ask you to complete? When you enter our
focus group room, we will begin by welcoming every one, reminding them that we are video
recording the conversation, and then reminding them that they are free to leave at any time. Then
we will distribute a list of conversational questions about life development projects.
The participants will then introduce themselves to each other by name, and will begin to talk about
the questions. It will be an open conversation; I will only intervene in the discussion if the
participants stray from the list of questions. And then, after an hour, I will conclude the
conversation, thank every one, and hand each participant a Debriefing sheet with some helpful
"take away" information.
The sole compensation for your time is a $10 bill, which I will attach to each Debriefing sheet. Of
course, you may also experience the additional benefit of obtaining a better understanding about
social outcasts.
There is a risk, though, that you might experience feelings of embarrassment and discomfort if you
mention any sensitive personal information about yourself. You should consider this risk before
volunteering to join our group. Of course, you are always welcome to leave the group at any time,
and if you experience such feelings in the hours and days after our discussion, you can always call
the Student Counseling Center at phone extension x12345.
You should keep in mind that the other participants in your focus group will know what you say.
And you should also keep in mind that we are video recording the session in order to check, after
the session, whether your body language and tone of voice revealed your attitudes about social
outcasts. It's possible that you might not even be aware of your attitudes, and that your body
language and tone of voice can reveal them!
We have prepared an addendum to this Informed Consent form for the video recording activity; it is
attached to this form. Of course, we will follow strict data storage and confidentiality policies
regarding this information. The video will be stored on a secure server on the Providence College
campus, with access via a password that will only be known by me. If I present the results of my
research at a conference, or if I publish the results in a journal, I will not show any video clips of
you. And if I quote your verbal comments, I will keep the quote anonymous without revealing your
name.
If you have any questions, you are always welcome to contact me (Mary Shelley) at phone
extension x67890, or the Chair of the College Institutional Review Board (IRB) through the
Provost's Office in Harkins Hall. The IRB is the on-campus group that oversees all research
projects that involve human participants at Providence College.
Thank you, again, for your time! If you now understand all of the information in this form, and if you
wish to join our study as a participant, please sign below:
________________________________________
Name (Please Print)
________________________________________
Name (Please Sign)
________________________________________
Today's Date
REMINDER! We have prepared an addendum to this Informed Consent form for the video
recording activity; it is attached to this form.
Addendum to the Informed Consent Form
Video Recording Activity
We are planning to video record your focus group session. If you agree to be recorded with the
group, and if you agree that I can play video clips of you at research conferences, please sign
below:
________________________________________
Name (Please Print)
________________________________________
Name (Please Sign)
________________________________________
Today's Date
On the other hand, if you agree to be recorded with the group, BUT if you do not want me to play
video clips of you at research conferences, please sign below:
________________________________________
Name (Please Print)
________________________________________
Name (Please Sign)
________________________________________
Today's Date
Please note that you can still participate in the focus group, without any penalty, if you do not want
me to play video clips of you. However, you will need to agree to be recorded with the group if you
wish to participate in the study.
Attachment F: Debriefing Form Attitudes Regarding Social Outcasts Mary Shelley, Student, Department of Cultural Sociology, Providence College Thank you for participating in our focus group! Please note that your compensation -- a $10 bill -- is
attached to this form.
As you leave, please keep in mind that there is a risk that you might experience feelings of
embarrassment and discomfort if you mentioned any sensitive personal information about yourself
during our discussion.
If you experience such feelings in the hours and days after our discussion, you can always call the
Student Counseling Center at phone extension x12345.
Also, if you have any questions about the study, you are always welcome to contact me (Mary
Shelley) at phone extension x67890, or the Chair of the College Institutional Review Board (IRB)
through the Provost's Office in Harkins Hall. The IRB is the on-campus group that oversees all
research projects that involve human participants at Providence College.
Thank you, again, for your time!
Attachment G: Question List Attitudes Regarding Social Outcasts Mary Shelley, Student, Department of Cultural Sociology, Providence College Here is a list of conversational questions about life development projects. Please feel free to talk
about these questions. We will conduct an open conversation; your moderator will only intervene in
the discussion if the participants stray from the list of questions. And then, after an hour, your
moderator will conclude the conversation.
1. What do you know about social outcasts?
2. Are people tolerant of social outcasts when they encounter outcasts in the community?
3. What can people and organizations do to promote tolerance towards social outcasts?