The Human Research Protection Program (HRPP) Office and the Institutional Review Board (IRB)

By Marianna Evola

Over the summer my role in responsible research expanded to include oversight of the HRPP office. Since that time, the office has begun to evolve a bit with both staff changes and an altered agenda. So, I thought that I would utilize my SM column this month to explain the services and structure of the HRPP office and the IRB. In addition, I wanted to describe the recent changes to the HRPP office and promote our education agenda. Thus, this contribution to the Scholarly Messenger will be a bit different from my standard anecdotal column on responsible research, but hopefully I will be able to fit in a story here and there.

So, what have been the recent changes in personnel for the IRB and HRPP office? About a year ago, the IRB was appointed a new Chair, Kelly Cukrowicz, Ph.D., and Associate Chair, Scott Burris, Ph.D., after the previous IRB chair stepped down. Similarly, earlier this year, the Section Manager of the HRPP office retired, which left us in search of a new manager, a challenging endeavor. However, we also found ourselves with an opportunity to contemplate ways of enhancing communication between the distinct responsible research divisions so that we could better serve our research community. As such, the first decision was made by my superiors, to incorporate my oversight on the HRPP office to enhance communication between the HRPP office, the Financial Conflict of Interest (FCOI) office and the Responsible Conduct of Research (RCR) training office. I was already overseeing FCOI and RCR training, so the addition of the HRPP office had become my new challenge. My first duty was to work with the IRB Chair and Associate Chair to find a new Section Manager for the HRPP office and over the summer we found an exceptional candidate, CassiDe Street, Ph.D. Dr. Street has been a strong addition to the responsible research division of the OR&I. And although change always comes with challenges, the transition has been much smoother than expected, no doubt due to the stability and support provided by the HRPP staff. After working with Drs. Cukrowicz, Burris and Street for the last few months I can readily assert that the new team is dedicated to promoting research and ensuring that human subject research is conducted in a safe and ethical manner.

So, to break up my enthusiastic albeit dull announcement about personnel changes, I'll interject an anecdote about my learning history to introduce the important services that the IRB and the HRPP provide to the TTU research community. For anyone that regularly reads my column, you are probably aware that most of my research was conducted under the review and approval of the Institutional Animal Care and Use Committee (IACUC). The IACUC committee oversees animal research in a similar manner to how the IRB reviews and oversees research with human participants. Many years ago, as a new graduate student, I held the misconception that an IACUC protocol was merely a required document that was utilized by some nameless bureaucrat who would check off a box labeled "complete", and then file the form away in a cabinet where it would never again be looked at by anyone. However, as my education continued, I learned that a research protocol was not just a dead form filed away in a cabinet. Rather, the protocol was a formal agreement which defined how I was to care for my animals and how I was to conduct my research. I was answerable to that agreement if anyone questioned my day-to-day research activities. Furthermore, I became aware that colleagues and animal facility support staff were familiar with our research protocol and they supervised my actions to hold me accountable if I violated protocol. In other words, research colleagues and staff watched and supervised my research activities and would report protocol violations to our lab managers or my advisor, especially when I was a new inexperienced graduate student researcher.

As I came to this realization, I also realized that some of my fellow graduate students were a bit offended by research oversight. Like my fellow students, I had learned the hard way that my research activities were supervised. However, unlike the other students, I was never bothered by the supervision because I had developed a considerably thick skin for oversight during my previous profession in the restaurant industry (another regular disclosure from previous columns). I'd had a career before research that consisted of continuous and sometimes unfair oversight. I was part of that oversight because I supervised and trained cooks. And as supervisor, I was accountable for every meal that was delivered to a customer. Waitresses would vocally point out problems with cooks or food because they were in the direct line-of-fire if a customer was unhappy. Health inspectors regularly invaded our work environment. Customers could be very demanding and critical as they ensured that their money was well spent. And sometimes, even when everything was right, no one was happy because of subjective preferences. In other words, I came to research from a very critical business.

Comparably, supervision of research was much easier to handle. Everyone was required to follow the research protocol every time, and if you did so, everyone was relatively happy. I say relatively happy because every research team regularly suffers from data frustrations. But data frustrations aside, no one was angry with you for the data as long as you accurately followed the research protocol. As such, to me compliance with protocol was easy. However for my fellow graduate students that had never dealt with notable supervision, they found the oversight invasive and thus, blindly resented the IACUC without considering that IACUC input could enhance the quality of research. I think that much of the human subject research community, especially junior researchers, are similarly resentful of the oversight provided by the IRB and HRPP. Because of demanding schedules, young researchers choose to resent oversight rather than contemplate how IRB input can enhance the quality and ethics of their research.

Now, after tossing around the IRB and HRPP acronyms for a couple of paragraphs, I thought that I would describe the roles of these two interactive branches of responsible research that focus on protecting human research subjects. I generally focus my column on student education and it is important for our student researchers to understand the infrastructure of protection that TTU has created to protect research subjects but also assist the research community. I will begin with a brief description of the IRB committee. The IRB, of course, reviews all proposed research that involves human research subjects. The IRB is an autonomous committee that is predominantly made up of faculty and a couple non-scientific community members. Thus, it is a committee of research peers that serve to review research protocols involving human subjects. Most of the faculty members that serve on the IRB do so as part of their service to the institution. They are very dedicated because service on the IRB demands a lot of work and valuable time from the committee members. There is no doubt in my mind that there are easier service activities for TTU faculty than service on the IRB.

Currently, all research at TTU that involves human research subjects must be reviewed and approved by the IRB before the research is conducted. Furthermore, federal and state research sponsors and many journals require researchers to provide documentation that their research has been reviewed and/or approved by the IRB. There are a few facets of the IRB that students should understand as they begin their work to get a new project approved by the IRB. First, the IRB is an autonomous entity within the university. What this means is that the IRB committee is an independent authority that decides whether or not to approve a research project. The institution cannot override IRB decisions, nor can the administration or the staff. Actually that is not entirely true, the institution can choose to be more restrictive than the IRB but it cannot force the IRB to be lenient.

The reason for IRB autonomy is to ensure that the IRB has the independent authority to protect human research subjects if and when the institution and administration have conflicting agendas regarding research productivity, sponsorship dollars or marketable intellectual property. It is a system of checks and balances for conflicting agendas within a big, complex institution. The IRB is made up of faculty peers so that pressure and influence is minimized as the committee makes difficult decisions. You see, staff are answerable to a hierarchy of authority within the institution (i.e., we have bosses) and as such, if staff served as the IRB, there could be a perception that pressure could influence staff decisions. In contrast, faculty, especially tenured faculty, are less susceptible to pressure and are more likely to act independent of an institutional agenda. So, the take home message for graduate students and junior researchers is that calling the HRPP office and pressuring staff will not pressure the IRB to approve your project. The staff do not have authority over the IRB and cannot override their decisions. The second take home message for students and junior researchers is that they should consider how they choose to communicate with their IRB reviewer/s because many members of the committee are senior faculty from various colleges. Students could be dismissing or offending senior faculty within their college when they dismiss reviewer concerns regarding their proposed project.

Another facet of the IRB committee that should be considered is that participation on the committee is voluntary and as such, membership on the committee changes. The IRB committee is constantly evolving. Existing members continuously expand their knowledge of regulations associated with utilizing humans for research and new members bring new opinions and ethics to the IRB committee. Because the committee constantly evolves, so do committee decisions. As such, previous IRB approval of research projects does not guarantee future approval by the IRB. Often students or junior faculty re-introduce a research protocol to the IRB that has, in the past, been readily approved. Thus, they sometimes have an expectation that the IRB will "rubber stamp" the previously approved project. Then, when the IRB reviewer/s have significant questions or concerns about the research, the researchers are dismayed and frustrated and is a natural occurrence of an evolving committee. Constant evolution is one of the IRB greatest strengths. The evolution ensures that the committee constantly reevaluates and rigorously contemplates the ethics associated with research. However this also translates into evolving committee decisions regarding the research that is conducted at an institution.

The bottom line is, the IRB takes responsibility for the ethics and safety of human subject research that is conducted at an institution. Since the IRB is willing to take on that considerable responsibility, they naturally have the authority to decide what human subject research is approved at the institution. Most members of the IRB are, in fact, researchers and as such, they understand the frustrations associated with research oversight. However, they are also very knowledgeable about historical and contemporary human rights violations that have occurred in the research community. As such, they take their responsibility very seriously. The committee does not want to be a blockade to research. However, their top priority is to protect human research subjects.
So, if the IRB has all of the authority what is the role of the HRPP office and how can they assist researchers? The HRPP is staffed by a section manager and three analysts that support the IRB in a large variety of ways. But more importantly for this article, the HRPP staff also assist researchers by 1) providing one-on-one consulting on IRB project development, 2) providing ethics education on conducting research with humans and are available for one-on-one education as well as group seminars and, 3) providing technical guidance for maneuvering the electronic submission program Cayuse IRB. For readers that are historically familiar with the HRPP office, they may know that in the past HRPP staff also served as project reviewers. At this time, the office is moving away from that service because we currently feel that research is best reviewed by researchers and peers because staff do not have same autonomy that a faculty committee holds, as described above. Furthermore, I will assert that the HRPP staff can best serve the research community through education and protocol consultation.

The HRPP staff have unique expertise on IRB project development because the staff have read large numbers of projects. The staff are familiar with IRB decisions, IRB expectations and how previous conflicts between the IRB and investigators have been resolved. As such, the HRPP staff can be a valuable resource to young researchers and students as they struggle to construct their first projects and seek IRB approval. Furthermore, the HRPP staff have engaged in considerable training regarding the complex regulations associated with conducting research with human participants and as such, they are a valuable resource to the TTU community as researchers work to figure out how to engage in creative research endeavors while complying with seemingly stringent regulations. Therefore, one of the most valuable services that the HRPP office can provide the research community is one-on-one consultation regarding project development. I encourage our young researchers and even senior researchers that are new to the IRB process to consult with the HRPP staff while constructing a new project. I am convinced that one-on-one consultation will enhance researcher/reviewer communication and decrease the frustration that is experienced by new/student researchers and their advisors.

So, if you do reach out to HRPP staff, what should you expect and how can the staff assist you with your project?

1. The HRPP staff have read a lot of projects and are highly familiar with the expectations of the IRB reviewers. Furthermore, there are some reviewers that have served for many years and as such, the HRPP staff know a lot about reviewer expectations. The staff can share this insight with our researchers.
2. The HRPP staff can provide expert input on the clarity of your project and provide you with insight on whether the content will confuse IRB reviewers. A research project must be written so that a non-expert can comprehend what is written and clearly understand the research protocol. Remember, a critical part of the IRB committee is made up of non-scientific community members that have not been trained in scientific jargon. The HRPP staff will assist researchers clarify their text.
3. Consulting with the HRPP staff should help faculty save time and eliminate frustration as they train student researchers to engage in the IRB process. It should also assist our IRB reviewers save time and effort as they work with our student researchers.
4. The HRPP staff may be able to provide researchers with insight on research designs that have been troublesome with past reviews. They have a lot of knowledge on past controversies and how design issues have been resolved.
5. The HRPP staff can help researchers interpret complex regulations associated with conducting research on humans. I say "interpret" because although there are a lot of regulations associated with human subject research, many of the regulations contain vague language which must be interpreted by local IRBs. Regulation language is often vague because the regulations must accommodate the creative nature of research. Research is a creative endeavor and as so regulations to specifically address every new research design. As such, the language can sometimes be vague and it is the role of the IRB to work with researchers to figure out how they can conduct their research without violating the rights of their research participants or exposing subjects to unnecessary risk. In other words, the regulations were not written to block research. Rather the regulations are written to ensure that research is conducted in an ethical manner with appropriate oversight to minimize any risk of harm to human research participants.

What are the limitations of HRPP authority?

1. The HRPP staff cannot approve a research project nor can the staff override decisions that are made by the IRB.
2. The HRPP staff cannot pressure IRB committee members to work faster or provide project approval. Anyone that is familiar with university dynamics is aware that pressure by staff seldom persuades faculty to work harder or comply. The communication dynamic between faculty and staff is one that beguiles university staff that also have a research history (such as myself). Faculty resistance to staff pressure makes the independent researcher in us smile and the staff in us scowl. Thus, staff pressure will seldom be of assistance to researchers that want to pressure reviewers. That being said, if researchers want to confirm that their project has not been lost in the system, feel free to communicate with staff to alleviate your concerns regarding the status of your project.
3. The HRPP staff will not write a project for students. It is the responsibility of students to construct their IRB project, the staff can only provide input and guidance regarding the clarity of student writing and the expectations of IRB reviewers.
4. The HRPP staff cannot design a project for students because the researchers are the experts on their projects.

The consulting role of the HRPP office is not a new agenda. Rather, the staff have always been willing to assist researchers construct their projects and communicate with IRB reviewers. However, since I have begun my oversight of the HRPP office, I'm surprised that I don't see more students seek out the assistance of staff. I believe, that much like my former fellow graduate students, students hide from compliance and oversight rather than seek out assistance from experts. I'm hoping that more of our young researchers take advantage of the one-on-one consultation that the HRPP staff is willing to provide and that it has a positive impact on project development and student training. We will be working to promote the service to students and assessing the impact of consultation on project review and approval. We are hoping that the education/consultation agenda of the HRPP office assists the research community as they prepare their projects for IRB review. 

 

Marianne Evola is the director of the Human Research Protection Program in the Office of Research & Innovation. She is a monthly contributor to Scholarly Messenger.

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