OHRP Guidance on Exemption Determinations

OHRP has come up with new guidance on exemption determinations (http://www.hhs.gov/ohrp/policy/exempt_res_det.html).

Although OHRP continues to recommend that investigators not be given the authority to independently make these determinations, they are more explicit in indicating that, under the regulations, institutions can adopt a policy that allows investigators to make their own exemption determinations. OHRP even gives examples of procedures which allow investigators to determine that their research is exempt, begin the research and then have the determination reviewed by an appropriate institutional office.

However, allowing investigators to make exemption determinations increases the likelihood that non-exempt research would be inadvertently conducted without IRB approval. This not only puts subjects at risk, but also puts the institution and the investigator at risk of non-compliance.

This guidance will likely be interpreted by investigators as blanket permission by OHRP for investigators to decide that their research is exempt without needing any other review. Institutions are advised to come up with a clear justification as to why investigator exemption determinations are not in the best interest of subjects, the institution or even the investigators.

While no one is questioning the ethics or integrity of investigators, they should not make these determinations for the following reasons:

1) No one can be totally objective about their own work. While we all try to be objective, human nature makes difficult to see all of the implications of work that is very familiar to us. Also, we tend to underestimate the risks in very familiar activities. So, every research activity needs an independent, objective review to ensure that the investigator has not overlooked some important implications for subjects in the research they are proposing.

2) Although it is assumed that exempt research has minimal risk for subjects, that is not necessarily the case. Although it may be less likely in this type of research than other types, exempt research such as interviews and surveys can harm subjects and the determination of risk, especially social and psychological risks, is more difficult than it may seem. The individuals making the exemption determinations must have sufficient knowledge and experience to evaluate the risks.

3) The exemption categories in the regulations are not as clear-cut as they may seem. Making an accurate determination with regard to whether research fits in a given category requires some training and experience with exemptions. Investigators generally do not have that level of experience.

We believe that investigators should not have the authority to determine whether their own research is exempt. That being said, it is incumbent on institutions that do not allow investigators to make exemption determinations to come up with determination procedures that are minimally burdensome and expeditious. Exempt research is generally innocuous and often time sensitive.

The exemption determinations do not have to be made by the IRB or even the IRB office, but the individual(s) making the determinations must be knowledgeable about the regulations and ethical principles. The institution must provide some sort of oversight over the process to ensure that accurate determinations are being made.

The process for requesting an exemption determination should not require investigators to fill out extensive forms. The reviewer does not need all of information that is needed for non-exempt research, only enough to make an accurate determination.

The process should also be as quick as possible. These are determinations that can be made in days, not weeks and often on the spot. Whoever is making the determinations should be readily available and provide quick turnaround.
Finally, a word to the wise with regard to OHRP’s examples of investigator determination policies , OHRP considers the conduct of non-exempt research without IRB approval as non-compliance. If, under OHRP’s examples, an investigator makes an exemption determination, begins the research and then an institutional review determines that it is not exempt, the conduct of that research prior to the institutional review would be non-compliance and would have to be reported to ORHP. We have confirmed this with OHRP.