When Exempt Does Not Mean Exempt

One of my first exposures to students creating a myth regarding arduous and nit-picking compliance was when I was in graduate school. A group of fellow grad students were trashing a staff member who was responsible for ensuring that all master's theses and doctoral dissertations complied with the defined format for acceptance as a bound document. The students ranted and raved and described the format checker as impossibly hypercritical. When it was my turn to submit my master's theses for format approval, I carefully adhered to the defined thesis format but still dreaded my interaction with this harsh and "crazy" woman. Can you imagine my surprise when the document was returned to me with only a few minor format corrections and the woman was actually very helpful, charming and professional? The myth surrounding her was inaccurate and undeserved. Rather than being nit-picky, she was merely conscientious and worked hard to ensure that the documents adhered to appropriate format. The students' repeated failure to get their documents approved resulted from their resistance to comply with the format guidelines rather than the fault of a hypercritical reviewer. The students propagated the myth because she did not lower her standards when students came to her office and stomped their feet. At least, that is my perception of this bit of my history.

During presentations on responsible research, I often ask the graduate students in attendance if they work with human research subjects. For those who affirm that their research does involve human research participants, I ask them for their impressions of the Institutional Review Board (IRB). At that point, I generally get some groans and someone describes the IRB as a "necessary evil". I'm ready for their predictable response, and proceed to present a long list of human rights violations committed by our academic ancestors. I then ask the students if they believe research has evolved past the need for oversight, or if violations of human welfare in research would increase if there were no oversight. The students laugh and admit that it would probably be very bad. I then ask if they stand by the assertion that the IRB is a "necessary evil," and they admit IRB oversight of human research is "necessary" but it is not "evil."

After this admission, the students generally assert that their initial dealings with the Human Research Protection Program (HRPP), which is the office that coordinates with Texas Tech's IRB office, can be confusing, frustrating and intimidating. Some confusion is due to lack of education on the subtleties of coercion of research subjects and/or maintaining privacy of subject data. Some of the frustration and intimidation can be a result of myths like I described above, inaccurate venting by colleagues that creates an inaccurate perception of the office personnel. However, some of the frustrations and confusion are an inherent part of understanding and adhering to federal definitions and guidelines. I'm not sure which is the case for all of the graduate students whom I have spoken to, but I thought I would try to address some of the more confusing features of IRB protocol submission. Specifically, I want to address the meanings of exempt, expedited and full board protocols.

Exempt and Expedited Protocols
Exempt and expedited protocols are federal designations (45 CFR Part 46.101) that refer to the magnitude of review that a protocol demands based the inherent risk of harm to human research participants. However, the terms are very misleading and confusing. The dictionary definition of exempt is: "Not required to do something that others are required to do." However, an exempt protocol does not mean that your research is exempt from submitting a protocol. The dictionary definition of expedited is: "To cause something to happen faster." However, an expedited protocol does not mean that a protocol will be reviewed and processed faster than any other submitted protocol.

An exempt protocol refers to a submitted protocol that involves minimal risk to research participants and thus is exempt from full IRB review and annual review. Specifically, the data collected in an exempt protocol is de-identified and thus is largely anonymous and cannot be traced back to the research participant. Thus it respects the privacy of participants. However, the researcher cannot make the determination that a research protocol is exempt from IRB review. The protocol must be submitted, and the HRPP staff makes the final determination that a protocol is exempt from further review. As an institution, Texas Tech University made the responsible decision that all human research studies would be reviewed. Therefore, contrary to what the dictionary definition would suggest, researchers are not exempt from submitting a protocol because they determine that there is no risk. Rather, researchers must submit the protocol, and the HRPP office determines that a protocol has minimal risk to human research subjects and thus is exempt from additional or annual review.

To make things even more confusing, there are research categories that are exempt from IRB oversight. However, if you think that your research is exempt from IRB oversight, it is worth a phone call to the HRPP office to ensure that your research is clearly exempt from oversight. If research data is inappropriately collected without an approved IRB protocol, in violation of U.S. regulations, the data cannot be published or utilized for a thesis or dissertation. Furthermore, the IRB cannot provide retroactive approval for data that is already collected. The data, time and resources invested in the research will have been wasted. This harsh penalty is one of the reasons for negative myths associated with HRPP office personnel. However, it is not the fault of the HRPP staff if researchers fail to submit a protocol. Rather, it is the staff's responsibility to enforce regulations.

As stated above, the expedited review is another misleading designation. Rather than a speedy review, which is what the designation implies, an expedited review applies to protocols for which the research only involves minimal risk to subjects. Because there is minimal risk, the review process does not require a full IRB review for approval. Research protocols that qualify for expedited review will only be reviewed by the designated reviewer or IRB chair. The IRB member conducting expedited reviews has full authority of the IRB but cannot disapprove a protocol. Any protocols that they would disapprove are referred for full board review.

Full Board Review
Unlike the exempt and expedited designations, full board review accurately expresses the procedure for protocol review. The contents of the protocol reveal the research has the potential for more than minimal risk to research subjects. Therefore, the protocol must be reviewed by the full IRB to assess the risks and benefits of the research. The board then determines if the research should commence as it is defined in the protocol or whether the research has to be modified to decrease the risk to the human participants.

In graduate school, I learned the truth regarding the "myths" associated with compliance personnel. Rather than encountering a bitter woman dedicated to holding back my thesis, I met a professional and helpful staff member whom I valued throughout the process of finalizing my dissertation. Similarly, I encourage students to talk to all compliance personnel at the university and make up your own mind about the "myths". Regarding the HRPP staff at TTU, I may be biased because I work across the hall from them, but I find them dedicated, friendly and professional. That does not mean that they will let you do whatever you want because you smile and treat them with courtesy. I have no doubt that they will fully review your protocol and provide you with a detailed analysis of all of the flaws. That's what they did to me, twice, and they are my friends across the hall. They have no choice but to fully review protocols and maintain a critical eye to all procedures. HRPP personnel carry the heavy burden of protecting human beings from harm during research. They also carry the burden of protecting young researchers from making mistakes that could cause unintended harm to their research participants.

Marianne Evola is senior administrator in the Responsible Research area of the Office of the Vice President for Research. She is a monthly contributor to Scholarly Messenger.