Brief Overview of IRB and Human Subject Protections Issues at the University of Richmond Dr. R. Kirk Jonas Chair, University of Richmond Institutional Review Board rjonas@richmond.edu Presentation to Dr. Kristin Bezio’s Junior Honors Tutorial Class Tuesday, Janurary 19, 2016 in Richmond Hall, Room 123

Why is human subject protection important to research? To ensure ethical horrors of the 20th Century are not repeated. To comply with the University of Richmond’s assurance contract with the U.S. government (OHRP of DSS) that stipulates that all human subjects’ research at the University will comply with the principles of the Belmont Report and the “Common Rule.” No one wants UR research to harm anyone. Learning about how to protect human subjects and how to gain approval from an Institutional Review Board (IRB) is an important element of research methods training. OHRP is Office for Human Research Protections (OHRP).

What constitutes human subject research? Human subject research is generally research involving living human beings, including collection of information about people. Most human subject research at the University of Richmond falls under the category of behavioral/ social science research, often from the collection of information from and about individuals through the use of surveys and interviews. All human subjects’ research is reviewed by an Institutional Review Board (IRB) for the Protection of Human Subjects of Research. The IRB at the University of Richmond works to (1) protect human subjects,(2) comply with federal regulations and best practices, and (3) educate students, faculty and staff on the importance of and processes for protecting human subjects.

What is an IRB? An IRB is the designated board of an institution (university, hospital, etc.) which ensures compliance with federal, state and international laws and best practices for the protection of human subjects of research. UR has a 10-member OHRP-registered IRB. The University of Richmond IRB Develops and implements institutional policies that operationalize sometimes obtuse regulations, (UR has an IRB Policy Guide.) Uses compliant and efficient practices to protect subjects and ensure compliant research activities. Informs and trains faculty, staff and students on human subject protections, Reviews research proposals. The IRB can approve proposals, “exempt” proposals, disapprove proposals, or return them for more information. Like other institutions, UR largely relies on “voluntary compliance.”

What IRBs want to do is minimize risk by clear and concise means

Because of research complexity and regulations, however, IRB’s are not always clear and concise.

Proposals do not always assess risk appropriately I keep a discrete file called “IRB Saves”. It includes proposals that came to the IRB on a variety of subjects that could have proven catastrophic to subjects (at the worst) and highly embarrassing or worse for the University.

UR IRB Policy The University of Richmond has elected to apply the “Common Rule” to all research conducted at the University. Student research is covered by UR’s IRB Policy Guide. UR undergraduates may be “principal investigators” or “PI’s”. The University of Richmond requires that students submit research proposals to the IRB and take online training courses on the protection of human subjects of research.

How do I know if human subject protections apply to my research? Generally, only an Institutional Review Board (IRB) can make this determination. UR’s IRB applies protections very broadly. Usually, if research involves only reviewing documents and secondary sources it is not reviewable by an IRB. Research involving obtaining information about living human beings (including their opinions) is human subject research and needs to be reviewed by the UR IRB. A determination by the IRB does not free a researcher of responsibility. The researcher – whether a faculty member, staff member, or student – always retains primary responsibility for the protection of subjects.

Researchers Working with Human Subjects Must Complete CITI Training The University of Richmond subscribes to a training program run by the Collaborative Institutional Training Initiative (CITI). All faculty, staff and students must take a course consisting of between one and 15 modules. https://www.citiprogram.org/

UR IRB Training Policy Information on registering for the basic human subjects research online training course can be found at the IRB website under “Researcher Training Requirements.” All students doing research involving human subjects need to complete an online CITI training course for “Students doing no more than minimal risk research.” This includes the module “Students in Research.” If you register correctly it takes about 45 minutes. Over 3,500 UR students have successfully completed this training since the adoption of the requirement in September 2008. Faculty and staff must complete a longer course that takes about two hours. Subsequent to completing the basic course, some students may need to complete “Optional Modules” depending on the specific research proposal (e.g. interviewing workers. Why workers?) Training must be complete before final IRB approval is given.

Registering for CITI Training Registration is the most difficult part of the CITI training process. Carefully follow the registration directions at http://irb.richmond.edu/training-requirements/students/index.html . Take the student course (and others if so directed).

How can I protect human subjects? Inform yourself of principles and practices associated with human subject protection and comply with them. Consult Dr. Bezio or Dr. Jonas (rjonas@richmond.edu or call 484-1565). Avoid the collection of potentially harmful information. Don’t ask subjects about illegal activity (e.g. legal status of U.S. residency, drug use or underage drinking). Such information puts subjects at criminal risk or potential damage to reputation. Avoid collecting personally identifiable information. Often the biggest study risk is the compromise of personal information. Rigorously protect collected information & dispose of it properly. Avoid using vulnerable groups as subjects (pregnant women, workers, children, prisoners). Stick to “minimal risk” topics. Inform and consent your research subjects. Stick to minimal risk topics. You are learning research procedures; not trying to win a Nobel prize.

What is “minimal risk” From 45 CFR 46.102(i) “Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”

What is “informed consent” and why is it important? Informed consent means that subjects know that they are part of a research project and have been made aware of the risks and benefits associated with the research as it applies to them. Informed consent is a process as well as a form. Examples are at the UR IRB website in the Submitting Proposals section. Responsible adults (usually persons 18 and over) may provide their own consent. The consent of parents/guardians of those not of age, as well as the assent of non-adults, is required. From a practical standpoint, limiting subject participation to adults can limit some of the risks associated with surveys, etc. and simplify IRB approval. Subjects should be given a blank copy of the consent form, which should include contact information for the researcher, the researcher’s supervisor, and the IRB. See “generic consent” form.

The Process in Brief There is an expedited process (review by only the IRB Chair) and a full submission process (review by the ten-member board). For both an expedited or full review: Carefully think through your project. Complete CITI training. Prepare your proposal; (http://irb.richmond.edu/submitting-proposals/expedited-review/examples.html). Get your faculty advisor’s approval. Email your proposal to the IRB. Respond to any IRB “conditions of approval” by the IRB. Receive IRB final approval. Conduct your research IAW (in accordance with) the approved proposal.

An “Expedited” Proposal Many minimal risk proposals can be reviewed and acted on by the IRB Chair. Many student proposals are designed more as learning experiences than as “generalizable research.” Develop a proposal reviewable by the expedited process. The expedited process is at: http://irb.richmond.edu under “Submitting Proposals”, “Expedited Review.” Expedited proposals include: A completed expedited review form. A complete list of questions (germane follow-ups are allowed). A completed consent form. Each consent form is created by the researcher & must address required elements of consent.

Questions Discussion