Human Subjects in Research: Things to Consider

If you are proposing to use human subjects in your NIH grant application there are a number of things to which you need to pay particular attention. This page provides some information regarding these issues. Complete and offiical guidelines for fulfilling the requirements for human subjects use in grant applications can be found in the PHS 398 Application Kit instructions .

As described in detail at the above web site, a grant application involving human subjects must include the following information:

1. A section labeled "Protection of Human Subjects" which describes the proposed involvement of human subjects, including an assessment of risk, the steps taken to protect the subjects from risk, potential benefits from the study to the subjects and others and the importance of the knowledge to be gained from these studes.
2. A plan must be provided describing the inclusion of women, children and minorities in the research project or adequate justification for why a particular category might be excluded (e.g., a study might propose to exclude children, given adequate justification).
3. A Table  indicating anticipated enrollment figures for the above categories (women, children and minorities) must be included.

IRB Approval

An Institutional Review Board (IRB) must approve the protocol you propose to employ in your research involving human subjects. However, this IRB approval is no longer required prior to review of your NIH grant application. If your priority score is determined to be sufficiently favorable, NIH staff will contact you requesting that you supply notification of IRB approval of your protocol. This change was made in part to reduce the burden on IRBs to review protocols for applications which will not receive serious consideration for funding. Notification by NIH to submit IRB approval forms is not a guarantee of funding! It merely indicates that the application is under further consideration.

Human Subjects Use Decision Chart

The definition of what constitutes human subjects research can be somewhat unclear at times. The Office for Human Research Protection (OHRP) has prepared a series of decision charts which can be useful in sorting through what constitutes human subjects research and when research might be exempt from IRB approval processes. Please see the Human Subject Regulations Decision Charts  for more information on this topic.

Additional Human Subjects Research Links

• The Elements of a Successful Informed Consent Training Video

Although not maintained by NIMH, the following links provide very useful summaries of NIH focused issues related to conducting human subjects research:

• Official Government Policy on Human Subjects in Research 
• NIAID Human Subjects Research Information 
• Office for Human Research Protection 
• NIH Information on Informed Consent