IRB Approval

office 770.690.9491 toll free 1.888.636.1062 fax 770.690.9492
6300 Powers Ferry Road
Suite 600-351
Atlanta, Georgia 30339
www.sterlingirb.com e-mail [email protected]

STUDY APPROVAL – INITIAL
Date Issued:

June 13, 2019

Issued To:

Sponsor and/or CRO

Protocol Title:

Reaching Minority Men Where They Are

IRB ID:

7292-*MASTER
Please include the IRB ID# on all correspondence pertaining to this study.

Sponsor:

Centers for Disease Control and Prevention

Review Type:

Expedited

Review Determination:

Approved

Approval Date:

June 13, 2019

Contingency Verification Date (if applicable):
Study Expiration Date:

June 12, 2020

Study Status Report Due:

30 Days Prior to Expiration Date

Approved Principal Investigators:
7292-KEdwards (Kerstin Edwards)
Please see Section A for approved study items.
Please see Section B for additional study information.
Please see Section C for Sponsor Responsibilities.
The current Sterling IRB Membership List is available on our website, www.sterlingirb.com.

The above referenced study was reviewed and approved as indicated above. If applicable, satisfaction of the Boarddetermined contingencies was verified by the Chairman or his/her designee on the date listed above.
Sterling IRB will conduct continuing review of this study. Approval will expire on the Study Expiration Date listed above, and if
the study is to continue the Sponsor must receive Sterling IRB approval for study continuation prior to the expiration date.
The Sponsor should submit the Study Status Report not less than one month prior to the last Sterling IRB meeting
preceding the expiration date (form available in Sterling IRB’s web portal, SilverLink). If approval for study continuation is not
obtained prior to the expiration date, the study will be considered to be in noncompliance with Federal Regulations and IRB
requirements, may be suspended, and may be subject to termination.

APP806 Approval.Initial.Study Effective Date:5.29.19 Version: 1.1

office 770.690.9491 toll free 1.888.636.1062 fax 770.690.9492
6300 Powers Ferry Road
Suite 600-351
Atlanta, Georgia 30339
www.sterlingirb.com e-mail [email protected]

SECTION A:
•
•
•
•

APPROVED STUDY ITEMS

Protocol (March 1, 2019)
* Participant Informed Consent Form (Version Date: March 1, 2019)
* Reaching Minority Men Where They Are Survey Questionnaire Consent Form (FINAL 04/02/2019)
Waiver of Documentation of Informed Consent

Study Materials:
•
•
•

* Reaching Minority Men Where They Are Survey Questionnaire (FINAL 04/02/2019)
* Minority Men Focus Group Questions – Men with type 2 diabetes (Revised April 26, 2019)
* Minority Men Focus Group Questions – Men at risk for type 2 diabetes (Revised April 26, 2019)

Recruitment Materials:
•

* Telephone Recruitment Screening Script [Screener for focus groups with minority men with/at-risk for type-2
diabetes Revised April 26, 2019]

For approved recruitment/study materials, you may insert or change site-specific information without resubmitting to the IRB.
This is not applicable to the Informed Consent Form(s).

* For any approved items which are labeled with the asterisk (*) symbol, copies of these items can be found in SilverLink in
the Attachments page for this submission’s Event. Items not labeled with the asterisk (*) symbol will be provided by the
Sponsor/CRO.
You must use the most current Informed Consent Form(s) approved by Sterling IRB for consenting participants.
End of Section A

APP806 Approval.Initial.Study Effective Date:5.29.19 Version: 1.1

office 770.690.9491 toll free 1.888.636.1062 fax 770.690.9492
6300 Powers Ferry Road
Suite 600-351
Atlanta, Georgia 30339
www.sterlingirb.com e-mail [email protected]

SECTION B:

STUDY INFORMATION

Sterling IRB has determined that the research involves minimal risk.
Sterling IRB determined that this study represents the following category(ies) of research eligible for expedited review:
•
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)
•
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
End of Section B

APP806 Approval.Initial.Study Effective Date:5.29.19 Version: 1.1

office 770.690.9491 toll free 1.888.636.1062 fax 770.690.9492
6300 Powers Ferry Road
Suite 600-351
Atlanta, Georgia 30339
www.sterlingirb.com e-mail [email protected]

SECTION C:

SPONSOR RESPONSIBILITIES

The Sponsor is responsible for overseeing the initial and continuing review and approval of the proposed study. This
includes an expectation that the Sponsor will monitor the conduct of research in accordance with applicable regulations as
well as any other requirements established by the IRB at the time of approval. Please refer to Sterling IRB’s website, located
at www.sterlingirb.com, for a more detailed explanation of the Sponsor’s responsibilities.

•

Check all information in the Approval Document and Informed Consent Form(s) for accuracy. Let our office know
ASAP if there are any inaccuracies.

•

Please note the due date listed on the Approval Document for the Study Status Report. This report is required by the
Board and by Federal Regulations.

•

Sterling IRB has developed web-based content outlining the responsibilities of the Sponsor. This content can be located
on the Sterling website, www.sterlingirb.com.

•

Any changes to the research must be submitted in writing to Sterling IRB for review and approval prior to
implementation.

•

Sterling IRB should be informed immediately of any serious adverse reaction or should any unanticipated problems
involving risks to the subject or others occur, or if any other safety information becomes available, irrespective of
whether the event occurred at a Sterling IRB approved site.

•

Local prejudices or negative attitudes in the community toward the conduct of research projects must be reported
immediately.

•

State/provincial or local laws (including tribal law passed by the official governing body of an American Indian or Alaska
Native tribe) pertaining to Patient/Volunteer Bill of Rights and specific state/provincial or local laws (including tribal law
passed by the official governing body of an American Indian or Alaska Native tribe) laws concerning research which
affect the conduct of clinical research must be enforced.

•

Non-English speaking subjects enrolled in this study must be provided with an informed consent written in their fluent
language, which must be approved by Sterling IRB before use.

If you have any questions please call our office at 888-636-1062.
End of Section C / End of Document

APP806 Approval.Initial.Study Effective Date:5.29.19 Version: 1.1