Event Recap: Understanding the IRB, Part I
Our Thursday Dialogue on October 12 about the complexities of the Institutional Review Board (IRB) regulatory framework turned into a very informative, interesting, and lively discussion. Marianna Azar, Graduate Center HRPP Program Manager, and Seth Schimmel, HRPP Program Assistant shared their knowledge and application of the federal guidelines, recent history of changes to the CUNY IRB structure, the transition from IRBNet to IDEATE, common reasons that protocols are returned, and advice for researchers going through the process for the first time. There was no doubt in my mind after I left the room that there is a need for more dialogue about this particular part of the CUNY bureaucracy. One faculty member remarked that the process, as it stands now, discourages young researchers from conducting their own research—despite being the reason so many young researchers are at the Graduate Center in the first place. Here’s an overview of what we discussed:
The dialogue started with the premise that it may help people who seek IRB approval for research to also understand how our individual IRB protocols are impacted by externalities. To begin at the federal level, I had done some prior research on the expansive federal guidelines for institutions that receive federal funding for research, and read about upcoming changes to the Common Rule, which could possibly be delayed. The time and effort needed for revising policies and procedures was also discussed, along with 45 CFR 46, the federal code of regulations that currently guide the HRPP office and the IRB overall. If this all seems complicated and a bit tough to digest, you are correct; it is complicated and tough to digest! Even for the program managers who review IRB protocols as their full-time job. Part of the complexity comes from the fact that all research with human subjects has been standardized under one umbrella. This makes the process exactly the same for a vast number of fields, including 15 different federal agencies. When the language of IRB questions may not seem to apply directly to different forms of research, the standardization allows for consistent procedures across all research, and for those reviewing protocols to apply their general understanding to the many different fields of research at CUNY.
CUNY IRB Structure
After this discussion, it became clear that it’s important to have a broad understanding of how the federal code of regulations impact how the CUNY IRB operates. The first thing to know is that CUNY applies for and receives federal funding for research, and wants to continue to do so. In return, we must comply by all of the regulations, which have been laboriously incorporated into all of the IRB processes, templates for necessary documents, and procedures to ensure compliance. The mechanism for the federal government to check compliance is through auditing our protocols. This happened several years ago, which led to some restructuring of how the IRB operates within CUNY. Given our vast number of campuses, each has at least one Human Research Protection Program (HRPP) manager, with the exception of two smaller campuses, whose HRPP office is administered through the central office. A faculty advisor is required to be part of student research protocols, and their main campus HRPP office will oversee the pre-review and oversight of the protocol. So, some GC students will interact with other campus HRPP offices, and should consult their campus website or the CUNY research website for details and contact information. The GC HRPP site is here.
After a research protocol is submitted, the HRPP managers review the documentation and check that it is 1) consistent—plans outlined in different sections match, 2) coherent—the protocol is understandable and will not cause confusion for the review board, and 3) compliant—adheres to all applicable CUNY and federal guidelines. This may take several revisions on the researcher’s part, but without this thorough review, protocols may be rejected once the reach the review board. HRPP managers also determine if the research protocol is exempt from IRB review, or recommend expedited review when the study poses minimal risk.
CUNY currently has three institutional review boards (1, 2, 3(expedited panel)), down from five boards in years past. Each IRB must have a minimum of five members consisting of faculty, staff, and students who are knowledgeable about research processes and guidelines, and must contain at least one member working in non-scientific areas and one member of the community. The composition of each board may vary, and additional members are allowed but not required, including in cases where outside consultants may be needed to understand unfamiliar research areas. You can read more about CUNY’s IRB member selection here. The IRBs meet twice a month. The Expedited board reviews protocols that are minimal risk, and the other two boards review protocols with greater than minimal risk or protocols that fall outside the expedited review categories. The bulk of the work is done ahead of time by the HRPP office, who checks for the 3 C’s (consistency, coherence, and compliance), and compliance is regulated by a Research Integrity Officer at each campus.
If you’re still reading, it means that you’ve managed to wrap at least part of your brain around this process, and if you’ve done any work on designing research, you may already be familiar with IDEATE, the protocol tracking software platform that is relatively new to CUNY. After usability complaints about another proprietary system, IRBNet, IDEATE was chosen as the new IRB compliance software. When we got to this part of the discussion (a topic I secretly wanted to avoid), eyes that were glazed over from regulatory and process discussions opened wider, and the conversation about the shared experience of using IDEATE bonded everyone in the room. What we learned is that no one is alone in feeling that there is something very very wrong with this platform, or possibly the server that it is hosted on. While no one wants to repeat the long process of manually moving IRB protocols to a third new system, it seems that the current platform is slow enough to break even the most patient among us. We shared some coping strategies, like copying and pasting questions out of IDEATE and into a document, while paying close attention to the fact that answering certain questions with a “Yes” may generate more questions. The branching logic and questions in IDEATE are not available in a document, so just pay attention and think through how each yes/no question should be answered before proceeding. We also discussed where to direct our complaints (email@example.com) about glitches in the software, to trust that something is happening after you click (just take a break, walk around, or check your text messages to distract yourself). After detailing all of the components of your research protocol in a separate document, ask you advisor to thoroughly review your study before you sit down and enter the details in IDEATE in one go. Minimizing the time spent in IDEATE was the best take-away advice from the session, but it’s clear that some advocacy is needed (in the form of frequent, detailed complaints to the email address above that include as many specifics as possible, including browser, operating system, time of day, screenshots to show what’s going wrong, and with a clear explanation of what went wrong) to move the needle in the right direction.
Common IRB Mistakes
By the end of the session, I think most of the people in attendance understood that research is complex, and that the multiple layers of regulations add to the complexity, but with justifiable reasons. We couldn’t leave the room without some concrete tips and advice from Marianna and Seth:
- Be patient; the process is complex, and takes a lot of time.
- Plan far, far in advance; if you are working with vulnerable populations like children under the age of 18 or prisoners, there are additional guidelines, additional forms, and even additional IRBs to deal with (like the Department of Education)
- Work closely with your advisor to review your protocol before submitting. Common mistakes can hold up the process, and delay your approval even further.
- Use the templates provided by the HRPP office. They are written to include all of the necessary components that are in compliance with federal and CUNY regulations. If a template doesn’t exist, reach out to your HRPP office for advice.
- If you are working in more than one language and your study will require translation, submit the whole protocol for approval in English first, then file an amendment with the translated documents.
- The best way to figure out IDEATE is to go through all of the tabs, and copy the questions into a separate document. There is unfortunately no comprehensive set of questions available because each study is unique, and the software developer does not provide training materials.
The combination of federal regulations, centralization of oversight, and especially our protocol-tracking software platform, IDEATE can negatively impact the research process for students and faculty, and the review process for Human Research Protection Program (HRPP) coordinators throughout CUNY. Federal regulations are obviously very difficult to change; revisions to the Common Rule were part of an ongoing discussion from 2005-2016. The HRPP offices are doing as much as they can to make the process easier, including creating videos to show you how to use IDEATE, creating pre-submission checklists, and having dialogues like this one. The research process is complex, and the protocol submission should be approached as a tool for ensuring that the steps of the design and relevant ethical questions are thoroughly addressed. While the software issues with IDEATE are frustrating, it may be possible to draw attention to this problem if more students and faculty are willing to advocate on their own behalf. The downside to centralization in this case is that the people who can make a difference seem far away or unreachable. For students who are just getting started doing research, don’t get discouraged, be patient, take advantage of the resources available, and don’t be afraid to ask the HRPP office for clarification on questions before submitting your protocol.