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Bulletin #1 Submitting New Research Applications (4/2004)

  1. Computer-Based Training
    BEFORE you can submit an application to the NIEHS IRB, you must take the NIH course, "Protection of Human Research Subjects: Computer-Based Training for Researchers", which covers the essentials of human subjects protection. All researchers must take the course. Additionally, the Office of Clinical Research requires that Principal Investigators complete the Clinical Research Training Course. Both of these courses must be completed before the NIH Clinical Center will grant final approval on a protocol.

    These training courses are found on the Web at:
    Protection of Human Research Subjects for Researchers (http://ohsr.od.nih.gov/cbt/) Exit NIEHS
    Clinical Research Training Course (http://www.cc.nih.gov/researchers/training/crt.shtml) Exit NIEHS

    Update 9/2001: This Web site is accessible only by NIH/NIEHS staff. Outsiders will be directed to a similar course designed for Extramural researchers.

  2. Protocol in Standard Format
    Your research protocol must be formatted in the "standard format" IRB application (http://www.niehs.nih.gov/about/orgstructure/boards/irb/docs/niehs_irb_standard_format_04.doc)  Download Microsoft Word Viewer (33K). The application is also available as a PDF (http://www.niehs.nih.gov/about/orgstructure/boards/irb/docs/irb_stan_format_04.pdf)  Download Adobe Reader (25K).

    Protocols in Standard Format tell the IRB what you want to do and how you will minimize any associated risks. The IRB Administrator, Jane Lambert, can provide an electronic copy for you to complete.

    The NIH Office of Human Subjects Research (http://ohsr.od.nih.gov/info/info.html) Exit NIEHS has extensive information on human subjects research on their Web pages. Be reminded that the Clinical Center research is often the focus of these NIH materials, and may not be applicable to most of the human subjects research done at NIEHS. Please consult with IRB staff (http://www.niehs.nih.gov/about/orgstructure/boards/irb/help.cfm) if you have questions.

  3. NIEHS Clearances
    Once you have completed the standard format application you must see four people:

    Note: Protocols must have scientific approval before the IRB can proceed with review. This includes statistical review as well.

    1. William Schrader, Deputy Scientific Director or Dale Sandler, Acting Chief, Epidemiology Branch (Epidemiology Branch studies only)
    2. David Resnik, Bioethicist
    3. Perry Blackshear, Clinical Director
    4. Jane Lambert, IRB Administrator (must check the application for completeness and conformity with current regulations)

    We encourage you to see Jane Lambert early in the process of writing your application if you have questions. Her advice can save you considerable time. However, she cannot tell you what to do in your research; you must decide that yourself.

  4. IRB Review

    1. Expedited Review: Your application may be eligible for "expedited review" if it presents "minimal risk" to the human participants. Expedited review is done by the chair person or a designated subset of IRB members (http://www.niehs.nih.gov/about/orgstructure/boards/irb/members.cfm) as applications are received. Protocols eligible for expedited review do not need to wait for a full IRB meeting. Jane Lambert can determine if your application can be expedited.
    2. Full Review: If your application needs full IRB review, the IRB must receive the completed package, with all signatures down through and including the Clinical Director, 4 WEEKS BEFORE THE BOARD MEETS. (The IRB generally meets on the second Thursday of the odd-numbered months; however, additional meetings are scheduled as needed). Reviewers serve on the IRB in addition to their regular jobs, and they cannot do a careful review of your application if it is received late. Unfortunately we can make no exceptions to this requirement.

    For the schedule of IRB meeting dates and times, please see the IRB Meeting Schedule page (http://www.niehs.nih.gov/about/orgstructure/boards/irb/meetings.cfm).

    • New applications going before the full IRB are assigned a primary and secondary reviewer who may contact you with questions.
    • You are generally asked to prepare a 5-minute overview presentation using the NIH Protocol Review Standards (http://www.nihtraining.com/ohsrsite/irb/protocol.html) Exit NIEHS as a guide and to be available at the time of the IRB meeting when your application is considered, in case the Board wishes clarification.
    • After the meeting you may be asked to make modifications in your application. These modifications or stipulations will be provided in a memo to you within 10 working days of the IRB meeting.
    • You have one month to submit these requested changes; after that your application may require a new full IRB review.
    • You will be notified of approval of your application generally within two weeks after your final modifications are approved. The NIEHS chair signs approval, and the protocol is sent to the NIH Clinical Center where it receives final review and approval. You will receive a memo from the Protocol Services Center at NIH stating that your study has been approved, providing a protocol number for your study, and informing you of the date for your next review (continuing).

    You cannot use an IRB review from another institution in lieu of the NIEHS IRB review except in special circumstances. Occasionally, an NIH investigator may defer to another IRB for review; however, prior approval must be requested and given by the Office of Human Subjects Research at NIH. See Jane Lambert if you believe your study may be deferred to another IRB. Generally, Federal regulations require that each participating institution review the project independently.

    Briefly, here is the sequence of events:

    • 6 weeks or more before the IRB meeting is scheduled, see Jane Lambert for administrative issues, David Resnick for ethical and consent issues, and William Shrader or Dale Sandler for scientific review and approval.
    • 3-6 weeks before IRB meeting, work on protocol, using web resources, and advice of IRB staff as needed.
    • 4 weeks before IRB meeting, turn in your completed application.

Final Note:
The rules guiding the IRB are set out in the Federal Register (45 CFR 46). They are not negotiable. There can be severe penalties if they are ignored, as we have recently seen at several universities and hospitals. However, the interpretation and implementation of the rules varies with time and institution. We are trying to make the regulations less onerous, and we welcome your suggestions, especially about the educational materials and training programs that are now being developed.

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USA.gov Department of Health & Human Services National Institutes of Health
This page URL: http://www.niehs.nih.gov/about/orgstructure/boards/irb/apps.cfm
NIEHS website: http://www.niehs.nih.gov/
Email the Web Manager at webmanager@niehs.nih.gov
Last Reviewed: June 11, 2007