Why you shouldn’t cut and paste your grant application into INSPIR

April 2016 Issue

By John F. Ennever, MD, PhD, CIP,
Director, BMC/BUMC Human Research Protection Program

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Differing purposes of grant applications and INSPIR submissions

The purpose of a grant application is to obtain funding to test an idea.  It is part of a highly competitive process where the judges are scientific peers.  These peers evaluate the application on the basis of the importance of the science, the likelihood of success, and the track record of the applicant.  These and other factors result in a ranking of the application in relation to all of the others; and it is this relative ranking which ultimately determines whether or not funding is awarded. 

The purpose of an INSPIR submission is to obtain permission to use humans in research.  It is not part of a competitive process (the number of disapprovals is vanishingly small); and the IRB members (the judges in this review) are not scientific peers.  Several are not even scientists.  The IRB review of your INSPIR submission has a defined set of questions to answer.  If all are answered in the affirmative, the INSPIR submission is approved.

The questions that must be answered are:

  1. Are the risks to subjects minimized by the use of sound research design? 
  2. Are the risks to subject reasonable in relation to the benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result?
  3. Is the selection of subjects equitable?
  4. Will informed consent be obtained from each subject?
  5. Will informed consent be appropriately documented?
  6. Does the research plan have appropriate provisions to monitor the data collected to ensure the safety of subjects?
  7. Does the research plan have appropriate provisions to protect the privacy of subjects and the confidentiality of their data?
These are very different issues than those that are raised by the peer review of a grant application.  The only one that is directly addressed in the peer review process is the second part of Question 2.  (The IRB will actually use the fact that the proposed project has received a grant award as evidence of the importance of the knowledge that is likely to result from the research.)

 

Differing organizations of grant applications and INSPIR submissions

The typical organization of a grant application is built around the specific aims of the research, based on the sequence of and inter-relationships between the scientific questions to be answered.  For the INSPIR submission, on the other hand, the IRB needs to know what the experience will be for each set of subjects, both to evaluate the risks and benefits and to assess whether the consenting process clearly describes what will happen to the subjects.  So, if you are measuring saliva cortisol levels for specific Aim 1, doing an in-depth interview for specific Aim 2, and obtaining an exercise diary for specific Aim 3, then in the INSPIR submission, these should be grouped together if all will be done on the same subjects.

 

Differing need for details in grant applications and INSPIR submissions

INSPIR submissions need more detail about some study plans and less about others.  Say, for example, you plan to obtain blood samples either from healthy individuals or individuals with a specific condition.     The IRB will need to know the following:  how will the subjects be identified, who will approach them and obtain their consent, who will obtain the sample, how their privacy will be protected, and how the confidentiality of the data from their sample will be maintained.  None of this information would be contained within your grant application, but must be written in the INSPIR submission; and if missing, the INSPIR submission will be returned to you. On the other hand, an extensive description of and rationale for the procedures to be used in the analysis of the samples--which is, no doubt, a significant part of the grant application--is irrelevant to what the IRB needs for its determination.  (The grant application is required to be uploaded into INSPIR, and any IRB member who is interested in these details can find it there.)  Although you may think that it doesn’t hurt to include this level of detail, remember that IRB members have limited time just like you; and wading through extensive laboratory and statistical descriptions will make it harder for them to get a clear picture of what will happen to the human subjects in your research.  A happy IRB reviewer is in your best interest.

 

Summary

Cutting and pasting from your grant application into the INSPIR submission may seem like the best use of your time; but in fact, an investment of effort in supplying specific answers to the INSPIR questions is guaranteed to speed up your IRB review.