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    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.”

    Where do I get an IRB Application for Review?
    IRBNet: www.irbnet.org
    Click the Forms and Templates tab and select the appropriate application or form to download to your computer.

    MSM Website:
    Human subjects information and application materials are available at http://web.msm.edu/irb/forms.htm

    Where do I send my completed application, and what happens after I submit my form?
    Submit all application materials through IRBNet.

    Once the application is received, it is assigned a number and is routed for IRB review. There are up to four levels of IRB review (IRB Office, pre-review, primary reviewer and full board) that may occur. Researchers are notified as soon as possible, via IRBNet, of the IRB’s decision.

    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.

    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 principal investigator. If necessary, insert additional sections for affiliated staff information.

    Can you unlock my study so I can upload another document?
    You will need to create a new package. You want to avoid creating a new study, when you are uploading documents to a locked study. To create a new package you will:

    1. Click on the Submission Manager on the left side of the screen
    2. Under the Submission Manager you will select study history (if study history is displayed, your history may come up once you click submission manager)
      1. A list of all packages that have been submitted will be displayed
      2. Your original submission will be listed as package 1 and any modifications, amendments or unanticipated adverse events will be listed as separate packages
    3. Select the Create new package button at the bottom of the study history page. PLEASE DO NOT SELECT NEW PROJECT. A new package will be added to your study history page named “new document package”.
    4. Click on the New document page text and use the drop down menu to upload the document.
    5. Select the Sign Study button on the left side of the screen. The PI or the PI designee MUST sign the study before it is submitted
    6. Then Select ‘Submit this Study’ on the left side of the screen
      1. Under ‘Submission Type’ select ‘ Continuing Review/Renewal
      2. Click Submit
      3. You will receive a confirmation message

    Consent

    Do I need to submit HIPPA forms to the IRB Office?
    The Morehouse School of Medicine IRB does require HIPAA authorizations for use or disclosure of protected health information to be combined with other regulatory requirements regarding informed consent to participate in research. This also applies to HIPAA waivers. The application for HIPAA waiver can be found in the library manger on IRBNet.

    HIPAA waiver request document

    HIPAA stand alone authorization

    http://www.msm.edu/exec_offices/compliance.aspx

    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 “Authorization Agreement” with MSM (Emory, CHOA, and Georgia Tech), the full application package may not need to be submitted. Contact the IRB office to discuss your particular situation.

    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, and submit 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. Additionally, if the site is “engaged in research”, other requirements apply. Contact the IRB office for further guidance.

    General

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

    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 the IRB review (404 752-1973).

    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 about a specific subject, they do not vote on MSM research studies presented for review.

    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.

    Do I have to attend the IRB meeting when my study is reviewed?
    Generally speaking, no. If the IRB has several questions, or believe 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 an email notification through IRBNet about the status of your study following IRB review. The IRB will also notify you by email of any required revisions

    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.
    • 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.
    • 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.

    I need to plan data collection around IRB approval. How long does the 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 Office alone, or by a subcommittee of the IRB. Substantive revisions usually return to the Full Board for review at a convened meeting.

    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, complete the amendment/modification form that describes the modifications you wish to make. Also include new or revised instruments, measures, consent documents, etc., and submit it on IRBNet. 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 application which will include 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 continuing review material on IRBNet. Continuing reviews 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. You should receive a reminder notification from IRBNet at 60 days and again at 30 days before the project expires.

    Recruitment for my study has been completed and I am analyzing the data. Do I still need IRB approval?
    Yes. Even though recruitment has ended, IRB approval is still required during the data analysis phase. Continuing Review Applications should be submitted on an annual basis until data analysis is complete.

    My study is finished (recruitment has ended and data analysis is complete) what type of notification do I need to give the IRB Office?
    Please fill out the study closing form and submit it on IRBNet.

    My study is an industry sponsored study, are there any other IRB requirements for submission of this study?
    Fee payment requirement

    Recruitment for my study has been completed and I am analyzing the data. Do I still need IRB approval?
    Yes. Even though recruitment has ended, IRB approval is still required during the data analysis phase. Continuing Review Applications should be submitted on an annual basis until data analysis is complete.

    Students

    I am a student and will be submitting an application to do my research study. Are there any special requirements for student investigators?
    No there are no special requirements for student investigators.

    Does our study have to undergo scientific review?
    For most student projects, scientific review is not a critical factor in the review process.

    Some of the professors are not in the directory to share the IRB application with, how do you add those people? And could you share it with committee members that are outside of MSM?
    In order for you to share your study with faculty members or persons outside of MSM, they must be registered with IRBNet. There are no exceptions.

    What is the time frame from submission to approval?
    Most student projects are reviewed and approved within 10 working days from submission.

    Once my study has been approved and during my methodology and data collection process, I decide not to use a survey or change to secondary data from primary or vice versa, would I need to redo my IRB application?
    You will need to submit an amendment to previously approved research.

    I still have questions, who can help?
    Email josmith@msm.edu or call the IRB Office at (404) 752-1973 or (404) 752-1102 for assistance.