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 on International Study Thursday, April 21 from 9:30 am – 10:00 am Room 118, Richmond Hall

Why is human subject protection important to research? To ensure ethical horrors of the 20th Century are not repeated. To adhere to laws and regulations governing the ethical treatment of human subjects of research set by: The University of Richmond, The Commonwealth of Virginia, The United States government, and International laws and agreements. 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.

UR IRB Policy The University of Richmond has elected to apply the “Common Rule” to all research conducted at the University. As stated in UR’s IRB Policy Guide. UR undergraduates may be “principal investigators” or “PI’s” of projects. The University of Richmond requires that students submit research proposals to the IRB and take online training courses on protecting human research subjects. The UR IRB reviews international research, as it is required by law to do.

Human subjects protection for international research In July 2006, the U.S. Department of Health and Human Service determined that it was necessary to issue the following clarification. “HHS clarifies that the requirements of HHS regulations must be satisfied … regardless of whether the research is conducted domestically or internationally." http://www.gpo.gov/fdsys/pkg/FR-2006-07-07/html/E6-10511.htm

Protections apply to research conducted by University of Richmond “agents” Federal guidance stipulates that “an institution becomes ‘engaged’ in human subjects research when its employees or agents intervene or interact with living individuals for research purposes…” “Agents include all individuals performing institutionally designated activities …” including research abroad.

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/

Investigators doing international research must take at least 2 more CITI modules Accessing the two required CITI “international” modules. Go to your CITI account Main Menu.  (If you don’t have your password, request it from CITI; Dr. Jonas cannot access it.) In the middle of the Main Menu page you will see a section that says “University of Richmond Courses” with the word “Course” under it. Click on the course title “UR Students conducting no more than minimal risk research”.  You will see a list of optional courses.  Take the two modules that have “international” in the title.  They are: “International Studies” and “International Research – SBE”. Email Dr. Jonas when you have completed the modules as he does not receive completion reports for individual modules. He will check your record to ensure you have taken the correct modules.

How can I protect human subjects? Inform yourself of principles and practices associated with human subject protection and comply with them. Consult your international advisor or Dr. Jonas (rjonas@richmond.edu or call (804) 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.”

Assessing Risk Abroad is Difficult for the UR IRB Two IRBs will usually act on your proposal: the SIT IRB and the UR IRB. UR and SIT both have policies that only “minimal risk” student research projects will be approved. One thing that slows international projects is getting an assessment of risk that is relevant to where you are. UR often defers to SIT on risk. Projects involving controversial topics, interviews with children, employees, and groups are usually not “minimal risk.”

What is “informed consent” and why is it so 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.

Expedited Review Products The researcher must submit at least three products: A completed expedited review form. A complete list of questions (germane follow-up questions are allowed). A completed consent form. Each consent form is created by the researcher & must address required elements of consent.

Questions Discussion