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NIH Guidelines – Conduct of Research (Gray Booklet)
Definition: A research benefit is considered to be something of health-related, psychosocial, or other value to an individual research subject, or something that will contribute to the acquisition of generalizable knowledge. Money or other compensation for participation in research is not considered to be a benefit, but rather compensation for research-related inconveniences.
Select appropriate benefit category for protocol under review by the IRB:
1. ________The research involves no prospect of direct benefit to individual subjects, but is likely to yield generalizable knowledge about the subject’s disorder or condition.
2. ________The research involves the prospect of direct benefit to individual subjects.
9. WHERE TO GO FOR HELP AND INFORMATION
1. For help to decide if your research involves human subjects, discuss it with:
* your Section, Branch, or Laboratory Chief,
* your IRB Chair,
* your Clinical or Scientific Director, or
* OHSR (301-402-3444)
2. To determine whether your proposed research activity is exempt from the requirement of NIH IRB review and approval:
* discuss it with your Section, Branch, or Laboratory Chief,
AND
* Complete the form entitled “Request for Review of Research Involving Human Subjects” at (http://ohsr.od.nih.gov) and send it to OHSR (Building 10, Room 1C116) for determination of exempt status.
3. For assistance in writing a research protocol:
* Ask your Section, Branch, or Laboratory Chief, and
* See “Protomechanics – A Guide to Preparing and Conducting a Clinical Research Study” at (http://www.cc.nih.gov/cc/protomechanics/index.html)
4. For help in planning a research study with challenging or complex ethical or regulatory considerations consult:
* your Section, Branch, or Laboratory Chief,
* your IRB Chair,
* OHSR (301-402-3444), or
* The Clinical Center’s Department of Bioethics (301-496-2429)
5. For educational materials or to arrange an educational program about human subject protections:
* Call OHSR (301-402-3444)
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