Morehouse School of Medicine Internal Review Board

Who must apply for review of studies involving human subjects by the Institutional Review Board (IRB)?
Anyone who intends to conduct research that involves people must apply for and receive unconditional IRB approval (approval without contingency) before beginning the research. This applies to ALL research involving people, not just clinical research. Social science, behavioral, historic, linguistic and marketing research studies must be reviewed by, and receive approval from, the IRB (this is a representation of likely studies, and not an exhaustive list). Check with the IRB Office if you're in doubt about the need for IRB review (404-752-1973).

What is research?
Research is broadly defined as a systematic investigation designed to develop or contribute to generalizable knowledge, or investigation designed to test a hypothesis.

If I'm not applying for funding for my research study, do I still have to apply for review by the IRB?
Yes. Any research study involving human subjects must be submitted to the IRB for review, regardless of funding source.

What's the worst that can happen if I don't get IRB approval?
Aside from potential ethical implications for the subject and for the researcher, bypassing IRB review brings other risks: Students Dissertation or thesis work will not be accepted: Graduate students must present to the Graduate School evidence of IRB approval for their studies involving human subjects. Thesis or dissertation work will not be accepted without it. Degrees will not be awarded for work based on non-IRB-reviewed studies. Articles may not be published: Most professional journals require evidence of IRB approval when considering articles for publication. Faculty and Staff Funding may be withheld: Federal sponsors, and virtually all private sponsors, require IRB approval as a condition of funding. Sponsors may postpone review of proposals for which review is not complete or pending at the time of proposal submission. Some sponsors will not release funds to MSM for the researcher's use without IRB approval. Articles may not be published: Many professional journals require evidence of IRB approval when considering articles for publication. The MSM will not support unapproved research: Liability issues arising from unapproved research become the responsibility of the researcher. Persons conducting unapproved research are deemed to be acting outside the scope of authority granted them by MSM. MSM will not, therefore, provide a researcher of an unapproved study the resources to answer a liability complaint.

Where do I get an IRB Application for Review?
In Person Applications are available in the IRB office (room #316 MEB). Via the Web Human subjects information and application materials are available at http://web.msm.edu/irb/forms.htm By Phone You may call 404-752-1973 or 404-752-1711 to request an application form or ask questions about the IRB application process. By Email You may email smithjc@msm.edu or trottier@msm.edu to request an application form or ask questions about the IRB application and review process.

If I'm working with other researchers on this study, how should I fill out the application form?
The IRB will want to know the name and background of each person on the study (see application instructions), but only one person should be listed on the application form as project director. If necessary, submit affiliated staff information on an additional sheet of paper.

Where do I send my completed application, and what happens after I submit my form?
Return your completed application to the Institutional Review Board. If you're mailing your application from off-campus, the mailing address is: Morehouse School of Medicine Institutional Review Board 720 Westview Drive, S.W. Atlanta, Georgia 30310 Once the application is received, it is assigned a number and is routed for IRB review. There are three levels of IRB review. Researchers are notified as soon as possible, in writing, of the IRB'S decision.

I need to plan data collection around IRB approval. How long does review take?
PLEASE NOTE! You may not begin your research until the IRB has given your research study written unconditional approval. Review of Exempt or Expedited studies usually takes about ten working days. The review process for studies submitted for Full Board review can take up to a month or longer to complete. You should include sufficient time in your research plan as allowance for any IRB-required changes to the research study. Many revisions can be considered by the IRB Manager alone, or by a subcommittee of the IRB. Substantive revisions usually return to the Full Board for review at a convened meeting.

How often does the IRB meet?
The IRB generally meets once each month during the academic year (September through May) and once a month during the summer. A quorum of the IRB must be present for decisions to be "official."

What does the IRB look for in an application?
The IRB seeks Research design that's sound, given the proposed use of human subjects in the study, Equitable selection of subjects, Balanced risks and benefits, and A thoughtful and comprehensive informed consent process.

How do I know the IRB will understand my proposed research?
The IRB is a standing faculty committee of at least five individuals, including researchers and members of the community at large. Individual experiences and interests cross diverse areas. When review of a study requires expertise beyond that available on the IRB, the IRB seeks assistance from qualified persons outside its membership. While outside experts may inform the IRB's decisions, they do not vote on MSM research studies presented for review.

Do I have to attend the IRB meeting when my study is reviewed?
Generally speaking, no. If the IRB has several questions, or believes the researcher(s) could provide valuable insight for review, the IRB will set a mutually convenient time to meet with the researcher(s) to discuss the study.

How do I know when my study has been approved?
You will receive written notification of the status of your study following IRB review. The IRB will also identify any required revisions at that time.

I'm conducting all or part of my research off-site (at a non-MSM site). Should I apply for study approval through the other site's IRB and the MSM IRB?
If the other site has an IRB: Yes. Many hospitals, universities and other institutions have their own IRBs. If the site of your research has an IRB, the site IRB and the MSM IRB must both approve your study before you start. You may submit your study for review to MSM at the same time you submit your study to the other institution's IRB for review, or you may submit the study after the other institution's review is completed. Remember that review and approval requirements may vary among institutions, so you should familiarize yourself with each IRB's policies. You should also plan your research chronology accordingly. If the other site doesn't have an IRB: Elementary schools, nursing homes and community centers often serve as non-MSM research sites, and rarely have IRBs. You should ask appropriate personnel (e.g., school principal, director of nursing home, community center director) at the research site to provide a letter indicating that (s)he has read your research study, and that you, the researcher, have permission to conduct your research at his or her facility. Alternatively, appropriate personnel may co-sign, with you, an invitation-to-participate letter to indicate institutional permission for you to conduct your research on-site. The MSM IRB requires evidence of site permission for its review and approval of your study.

My study was approved, but now I want to modify it. How do I do that?
Changes to a research study must be reviewed and approved by the IRB prior to implementation. To submit proposed changes for IRB review, send a cover letter (be sure to include the IRB study number from your approval letter) with a summary of modifications you wish to make. Attach new or revised instruments, measures, consent documents, etc., as appropriate. Requests for modifications are reviewed at the same level as the original study, i.e., Full Board modifications are reviewed by the IRB at a convened meeting.

My study is going to take longer than the approval period to complete. Is it possible to extend the study? If so, how?
Yes. Any study in good standing may be extended. If your study will continue beyond the "approval expiration" date on your approval letter, complete the Annual Continuing Review Questionnaire when you receive it (60 days prior to study approval expiration), and attach a letter requesting a time extension for your study and a brief summary of findings to-date. If you are proposing changes to your study along with the extension, include appropriate materials as you would for a modification. Submit your extension request to the IRB. Requests for time extensions and annual renewals are reviewed at the same level as the original study - i.e., "Full Board" renewals are reviewed by the full IRB. You should plan accordingly to avoid disruption in data collection.

I still have questions, who can help?
Email or call the Regulatory Compliance Officer 404-752-1973 or 404-752-1711 for assistance.