Offices: Cincinnati, OH | Research Triangle Park, NC
www.sairb.com
MEMO
In response to client feedback, Schulman IRB has changed its informed consent (IC) version
control format. Schulman IC versions will shift from a date to a number (e.g., 1.0) for all new
studies submitted on or after May 2, 2016.
The whole number of the version number will change with each revision of the study-wide IC
template. For sites, the decimal number will be .0 if the site is using the sponsor’s approved
study-wide consent template and .1 if the site’s consent varies from the study-wide template. If
there is no study-wide template (such as a single site study), all ICs will have a decimal number
of .0.
The IC will also show the date the document was finalized. The sponsor’s approved study-wide
IC will include the date that the IC template was finalized with all edits accepted. Site-specific
ICs will include the date that the site was initially approved to conduct the study or the finalized
date of any revisions, whichever occurs later.
Each study-wide and site-specific approval letter will include the IC approval date, finalized date
and the version number.
Please find examples of the new version format beginning on page 2 of this document.
Offices: Cincinnati, OH | Research Triangle Park, NC
www.sairb.com
APPROVED: 05/02/2016
EXPIRATION DATE: 05/01/2017
May 2, 2016
FROM:
TO:
SUBJECT:
SPONSOR:
PROTOCOL NO:
PROTOCOL TITLE:
The IC Finalized date can be found in
this column, and it will correspond to
the date provided within the Schulman
approval box. It will also show the
version history of each Informed
Consent.
Schulman IRB ("Schulman" or the "Board")
PI First name- Initials - Last name, PI credentials
Initial Approval Documents
Each Informed Consent listing will include the
Sponsor Name
Schulman Version Number.
Protocol Number
Protocol Title
The following protocol items were reviewed and approved on the dates listed below:

Clinical Study Protocol Version 1.0 dated 04/26/2016:

Informed Consent (Schulman Version 1.0):

Informed Consent Sub-study (Schulman Version 1.0):
Review Type
Full Board
Full Board
Full Board
Approval Date
04/29/2016
04/29/2016
04/29/2016
IC Finalized
n/a
05/02/2016
05/02/2016
The following information is specific to the investigator referenced above:

Site(s) approval to conduct this study:

Site specific Informed Consent (Schulman Version 1.0):

Site specific Informed Consent Sub-study (Schulman Version 1.0):
Expedited
Expedited
Expedited
05/02/2016
05/02/2016
05/02/2016
n/a
05/02/2016
05/02/2016
The Board approved the items listed above. You must use only the "Schulman Approved" informed consent(s).
Please note: Effective for new studies submitted on or after 05/02/2016, Schulman has an updated informed consent versioning
process. For more information, please refer to the memo available at http://sairb.com/ICversioncontrolmemo.
In order to participate in this research study, an adult study subject must provide his/her own written consent for participation.
An adult subject is an individual who has attained the legal age for consent to treatments or the procedures involved in clinical
investigations, under the applicable law of the jurisdiction in which the clinical investigation will be conducted. The Board has
not approved consent of subjects via a legally authorized representative for this study. Accordingly, a subject must not be
enrolled in this research study via the consent of a legally authorized representative.
This approval will last 12 months.
If the study is expected to last beyond the approval period, you must request and receive re-approval prior to the expiration date
noted above. A report to the Board on the status of this study is due prior to the expiration date or at the time the study closes,
whichever is earlier. It is recommended that you submit status reports at least 4 weeks prior to your expiration date to avoid any
additional fees or lapses in approval. You can find the Study Status Report Form at www.sairb.com.
Approved investigators and sites are required to submit to Schulman for review, and await a response prior to implementing, any
amendments or changes in: the protocol; advertisements or recruitment materials ("study-related materials"); investigators (PI
and Sub-Is); or sites (primary and additional). Refer to www.sairb.com for comprehensive submission requirements.
Approved investigators and sites are required to notify Schulman of the following reportable events, including, but not limited to:
unanticipated problems involving risks to subjects or others; unanticipated adverse device effects; protocol violations that may
affect the subjects’ rights, safety, or well-being and/or the completeness, accuracy and reliability of the study data; subject death;
suspension of enrollment; or termination of the study. Refer to the "Event(s) That Investigators Have to Report to Schulman"
guidance document available on the Schulman WebPortal/SiteAccess and at www.sairb.com.
Investigator: PI First name PI Initials
Investigator Last name, PI credentials
All days in mm/dd/yyyy format.
IRB #:
Page 1 of 2
Protocol #:
Offices: Cincinnati, OH | Research Triangle Park, NC
www.sairb.com
Schulman IRB is in compliance with Part C Division 5 of the Canadian Food and Drug Regulations, the Tri-Council Policy
Statement (TCPS), the International Conference on Harmonization Good Clinical Practice Guidelines, the regulations of the
United States Food and Drug Administration as described in 21 CFR parts 50 and 56, and the United States Department of
Health and Human Services regulations 45 CFR part 46, and the Environmental Protection Agency 40 CFR 26.
The current Board Membership List is available to download at the link on SiteAccess at www.sairb.com. Please maintain the
appropriate Board Membership List with your study binder.
PLEASE REFERENCE IRB # _________ ON ALL CORRESPONDENCE FOR THIS STUDY.
WebPortal/Paperless
Investigator: PI First name PI Initials
Investigator Last name, PI credentials
All days in mm/dd/yyyy format.
IRB #:
Page 2 of 2
Protocol #:
SCHULMAN APPROVED
IRB # _________
Finalized Date: 05/02/2016
Schulman Version: 1.0
Finalized Date matches the IC
Finalized date on approval letter.
INFORMED CONSENT
TITLE: PROTOCOL TITLE
Schulman Version number as noted on
the approval letter.
PROTOCOL NO.: Protocol Number
SPONSOR: Sponsor Name
INVESTIGATOR: PI Name
TELEPHONE: Site Phone Number(s)
INTRODUCTION
Before agreeing to participate in this research study, it is important that you read and
understand the following explanation of the proposed research study. This consent
document describes the purpose, procedures, benefits, risks, discomforts and
precautions of the study. It also describes the alternative procedures that are available
to you and your right to withdraw from the study at any time. No guarantees or
assurances can be made as to the results of the study.
If you are not completely truthful with your study doctor regarding your health history,
you may harm yourself by participating in this study.
The study is being conducted by ____________. Your study doctor is being paid, in the
form of a research grant, to conduct this study.
Schulman Associates Institutional Review Board, Inc. (Schulman) has approved the
information in this consent document and has given approval for the study doctor to do
the study. An institutional review board (IRB) is an independent committee established
to help protect the rights of research subjects. This does not mean the IRB has
approved your participation in the study. You must think about the information in this
consent document for yourself. You must then decide if you want to be in the study.
1
Schulman Use Only: SR# 0
Offices: Cincinnati, OH | Research Triangle Park, NC
www.sairb.com
June 2, 2016
FROM:
TO:
SUBJECT:
SPONSOR:
PROTOCOL NO:
PROTOCOL TITLE:
The IC Finalized date can be found in
this column, and it will correspond to
the date provided within the Schulman
approval box.
Schulman IRB ("Schulman" or the "Board")
PI First name- Initials - Last name, PI credentials
Updated Approval Documents
Sponsor Name
Protocol Number
Protocol Title
The following protocol items were reviewed and approved on the dates listed
below:
Review type
Approval Date
IC Finalized

Revised Clinical Study Protocol Incorporating Amendment 1 dated 05/23/2016:
Expedited
06/02/2016
n/a

Revisions to the Informed Consent (Schulman Version 2.0):
Expedited
06/02/2016
06/02/2016

Revised Clinical Study Protocol Incorporating Amendment 2 dated 05/30/2016:
Expedited
06/02/2016
n/a
Based on review of the item(s) listed above, the Board revised the Informed Consent(s).
Please note: Effective for new studies submitted on or after 05/02/2016, Schulman has an updated informed consent versioning
process. For more information, please refer to the memo available at http://sairb.com/ICversioncontrolmemo.
Enclosed is the “Schulman Approved” revised Informed Consent(s). Provide the applicable revised Informed Consent(s)
to current subjects for review. Those who wish to remain in the study must sign. If enrollment remains open, use the
revised Informed Consent(s) in the initial consent process for prospective subjects.
Please refer to the Informed Consent comparison document(s) available for download on the SiteAccess at
www.sairb.com.
PLEASE REFERENCE IRB # _________ ON ALL CORRESPONDENCE FOR THIS STUDY.
WebPortal/Paperless
Each Informed Consent listing will include the Schulman
Version Number.
All dates in mm/dd/yyyy format
SCHULMAN APPROVED
IRB # _________
Finalized Date: 06/02/2016
Schulman Version: 2.0
Finalized Date matches the IC
Finalized date on approval letter.
INFORMED CONSENT
TITLE: PROTOCOL TITLE
Schulman Version number as noted on
the approval letter.
PROTOCOL NO.: Protocol Number
SPONSOR: Sponsor Name
INVESTIGATOR: PI Name
TELEPHONE: Site Phone Number(s)
INTRODUCTION
Before agreeing to participate in this research study, it is important that you read and
understand the following explanation of the proposed research study. This consent
document describes the purpose, procedures, benefits, risks, discomforts and
precautions of the study. It also describes the alternative procedures that are available
to you and your right to withdraw from the study at any time. No guarantees or
assurances can be made as to the results of the study.
If you are not completely truthful with your study doctor regarding your health history,
you may harm yourself by participating in this study.
The study is being conducted by ____________. Your study doctor is being paid, in the
form of a research grant, to conduct this study.
Schulman Associates Institutional Review Board, Inc. (Schulman) has approved the
information in this consent document and has given approval for the study doctor to do
the study. An institutional review board (IRB) is an independent committee established
to help protect the rights of research subjects. This does not mean the IRB has
approved your participation in the study. You must think about the information in this
consent document for yourself. You must then decide if you want to be in the study.
1
Schulman Use Only: SR# 0