Scientific Review Officers like me often hear from reviewers about things that applicants have or haven’t done in their grant applications, and how those applications fare in peer review. Many of the issues are related to grantsmanship: writing a neat, tidy, clear and complete grant application that a reviewer will pay attention to despite having read umpteen other applications in the previous 48 hours. Others are more substantive issues with the science.
I would like to share some of the main issues we hear about, starting in this post with human research protections. And of course, I would like to get your additional thoughts and pointers—please comment below.
Human research protection—why it matters.
Of course, human research protection is about genuine care and concern for the individuals who volunteer for research. The Belmont Report and the Nuremberg Code remind us of cases when that may not have been so, and the work of the HHS Office for Human Research Protections makes clear our commitment to the protection of people who participate in research. (The same is true of the use of animals, and many of the points made below are relevant to animal protections as well.)
Independent assessment—NIH grant reviewers evaluate your proposed protections.
Reviewers like it when you clearly communicate your plan to protect your research volunteers. Your NIH review panel is charged with doing an independent review (PDF, 204KB) of your Human Subjects Plan. Though your work does need approval from your university’s Institutional Review Board (IRB), that approval can occur after the NIH review. (IRB approval is considered Just-in-Time information rather than being required at the time your grant application is submitted.) However, shortcuts like “the details are in the plan I will submit to the IRB” or “the IRB has already approved my plan” do not impress NIH reviewers. Give the reviewers enough information in the grant application so that they can assess the suitability of your plan themselves.
SF424—describing human research in your grant application.
You may already be quite familiar with the SF424 guide for preparing and submitting grant applications to NIH. If so, you will know that it is… DETAILED! But there are benefits to really reading it because it outlines (in addition to many other things) exactly what information about human research protections needs to go in your application. Pay particular attention to Part II: Supplemental Instructions for the Human Subjects Section.
Although the details can’t all be covered in this blog post, what is required in your application depends on how your activities are classified according to HHS definitions: Am I proposing Human Subjects Research? Is my Human Subjects Research exempt from regulatory requirements? Is this a clinical trial? Once this is determined, the SF424 provides guidance on:
- description of the Human Subjects Criteria (risks, protections, benefits, knowledge)
- inclusion of women, minorities and children (PDF, 88KB), possibly including a targeted enrollment table (Word, 48KB)
- data safety and monitoring plan and/or board
Selecting “No Human Subjects” or “Exempt Human Subjects?” Info is still required.
Pay close attention if you mark “No Human Subjects” but are proposing to use data/specimens from people, or if you think your research falls under Exemption 4. These determinations depend largely on whether data/specimens are permanently stripped of personal identifiers and the extent to which the researcher ever has access to personally identifiable information. You still need to include a Human Subjects Section, justifying why you classified the research the way you did. For applications claiming human subject exemptions other than Exemption 4, you also need to address inclusion.
No page limits, but don’t abuse it.
Although there are no page limits for the Human Subjects Section, you should try to be as succinct as possible while still providing the required information. You should also be sure that what you put there is related to protecting research participants, or there could be consequences.
It is not the place for:
- the extra pages of your research plan that didn’t fit
- details of your statistical analyses
- a list of collaborators
- additional references, publications, or letters of support
- any other non-human-subjects material
Scientific merit scores can suffer.
When something is missing from your plan to protect participants, the application may be flagged with a “code 44.” NIH does give you a chance to address that comment and have the code changed so the application can move forward. Providing more information after the fact may not be a problem, but you risk getting a poorer score. This is because reviewers “must factor their evaluation of the proposed plans to protect human subjects from research risks into their overall evaluation of an application’s scientific and technical merit.” If they find a problem with your plan, or if you don’t include enough information, it is factored into their overall evaluation of merit—your score.
I plan to write more posts like this. If there's a topic you'd like to see covered, please let me know by commenting below.