Subject: Please read: Does your study need IRB review? If not sure, just ask!
From: Thierry van Bastelaer <[email-masked]>
To: Thierry van Bastelaer <[email-masked]>
Cc: Teresa Doksum <[email-masked]>
Date: Wed, 10 Sep 2014 02:06:19 +0000

Dear colleagues:

The role of Abt’s Institutional Review Board (IRB) is to protect the rights, safety, and data of people participating in research or evaluation conducted by Abt and its subcontractors.  Abt staff (and its subcontractors) are required to comply with all relevant U.S. and local laws on human subjects protections. The IRB helps ensure this by reviewing study protocols, informed consent documents, and procedures to protect study participants and the confidentiality of their data.

Even if you don’t usually conduct research or evaluations that need IRB review, please read this message – it is important for everyone to be aware of this information.

Here are some of the most important things we all need to know:

1. By law, the IRB’s review has to occur BEFORE study participants are recruited or before research data is obtained by Abt or its subcontractors.

2. Does your research, study, or evaluation need review by the Abt IRB? Contact the IRB if ANY of the following applies (or if you are not sure if they apply!)

ü  Testing out a new approach or intervention on people

ü  Using randomized design (also known as randomized controlled trial, random assignment study, experimental design)

ü  Collecting sensitive data about people (such as illegal behavior, HIV-related risk behaviors, stigmatized health conditions, use of family planning) or about health care facilities

ü  Collecting data from vulnerable populations (e.g., children, teenagers, pregnant women, persons living with HIV)

ü  Using a consent form or script (or not sure if consent needs to be obtained)

ü  Collecting blood samples for research purposes

ü  Using “mystery clients” (e.g., hiring people to pretend to be patients seeking care from a health care provider)

ü  Might want to publish your results in a journal as generalizable research/evaluation (required to have IRB review or exemption)

Examples of studies that may require IRB review:

Surveys/focus groups/interviews with people about reproductive health or family planning

Surveys/focus groups/interviews with vulnerable populations

Medical records review

Example of a study that does not require review by the IRB:

Interviews with professional stakeholders (e.g., health officials, government leaders) about non-sensitive topics such as how their program/policy operates

Examples of something that is not a study (and so does not require review by the IRB):

Routine project monitoring and progress reports

Internal quality improvement procedures

3. Abt staff need to comply with the requirements of all IRBs, not just the Abt IRB. Many countries have their own IRBs that need to review and approve Abt studies. Check with local officials such as the Ministry of Health or local universities. You can also check this list of international IRBs and laws: The International Compilation of Human Research Standards.

4. Here’s how to submit your study to the Abt IRB for screening and/or review:  Provide basic information about your study by filling out the one-page IRB Form A on AGI and email to [email-masked]. The IRB will use this to decide if the study requires review, or if it is eligible for exemption. Most studies are eligible for exemption from IRB review, although some may still require data security procedures to protect sensitive data. If review is required, the IRB will work with you to determine a schedule for review and to confirm which documents need to be submitted for review.

5. You can access IRB information, forms, and resources under AGI -> Projects -> IRB

6. Whom to Contact? For questions, trainings, or to submit a study protocol to the IRB, contact the Abt IRB Administrator, Katie Speanburg, at 617-520-2499 or e-mail [email-masked].

Other IRB resources:

Laurel Hatt, IRB member from IHD at 301-347-5608 or [email-masked]

Teresa Doksum, IRB Chair, at 617-349-2896 or [email-masked]

7. Most importantly:  Is it research? Does it need IRB review?  If in doubt, just ask! The Abt IRB is here to help figure it out. It’s easy, quick, and could save you a lot of time and money later on.

Thierry van Bastelaer

Acting Technical Deputy to the Vice-President, IHD

IHD

This email was sent bcc to All IHD.