Human Subjects Protection and Community-Engaged Research

Guideline Statement:

Federal regulations require that the subjects of research carried out by the university be informed of any risk associated with their participation in the research and that those risks be minimized to the greatest extent possible for the type of research being conducted.  This is referred to as “human subjects protection.”  At universities, Institutional Review Boards (IRBs) are constituted to evaluate research proposals, work with researchers, and issue decisions to protect the subjects of research.  At the University of Minnesota, the IRB, working collaboratively with the Human Research Protection Program in the Office of the Vice President for Research, provides oversight and ensures compliance with human subjects protection.

Reason for Guideline:

Community-engaged research can present challenges to researchers and those involved in human subjects protection.  These challenges are threefold.  First, by design, the involvement of community members occurs during the development of the research questions through development of the study design throughout the research process.  Therefore, it can be challenging to determine when IRB approval should be sought and when changes in protocols must be reported and approved.  Second, community members are often involved in both the role of research collaborator and research subject, making it difficult to know when to ensure consent to participate in the research.  And, third, for some research projects, it may become necessary to have community members (who are research subjects) identify other potential research participants.  This “snowball sampling” approach can be problematic for ensuring that participants do not feel coerced into participating in the study.

The Public Engagement Council invited Professor Michael Oakes, co-chair of the Faculty/Staff Social 3 Committee of the IRB at the U to a meeting to discuss these challenges.  The following are a set of frequently asked questions and answers resulting from that conversation.  Additional information is available at the Human Research Protection Program website (http://www.research.umn.edu/subjects/) and by contacting its staff at 612-626-5654.

FAQs:

Question:  Do projects that involve the community in either classroom- or research-based activities where information is collected from the public require human subjects review?

Yes, all projects in which human subjects are used as a source of information require a “human subjects review.”  In many cases, the review will result in either an “exemption” from a full review or an “expedited” review.  This occurs when the risks to the human subjects is extremely small.  The purpose of the review then is to ensure that the proper steps are taken to inform the subjects of the nature of the research or class project, to ensure that they are aware of any risks, and to provide contact information to the subjects for any additional questions they might have.

Question: Is there need for a new set of guidelines for the IRB, given the nature of community engaged participatory research?

No.  Since the goal of human subjects protection is to be respectful of research subjects and to ensure that they are not harmed or coerced, community-based projects should use the same procedures and processes as all other research or classroom-based projects involving human subjects.  At the University of Minnesota, the Human Subjects Protection Program would like to begin working with the instructor or researcher early on in the study development.  This early involvement in study design and protocol development will help ensure that the process and approvals occur more quickly and without surprises that could delay the project. 

Question:  Who is the subject in community-engaged research?

In this type of research, members of the community can be both researchers and subjects.  They provide information about the content of the research question, but they may be also involved in framing the research question and identifying subjects and protocols for the research.  This means that the line between subject and researcher becomes blurred.  Therefore, it is important to ensure that community member participation in the research is entirely voluntary and that community partners do not feel coerced. There are many ways to mitigate any potential coercion (i.e., the participant is empowered and has the option of saying no at any point).  As part of the IRB review process, University researchers will be required to demonstrate how potential subjects can “opt out” of participating.  In general, the best way to develop these processes is in collaboration with the IRB office.  

Question:  Can researchers approach the community directly prior to human subjects review and approval?

Yes.  In fact, initial conversations with community members are necessary to begin to shape the direction and/or scope of the research.  These conversations would be considered as part of the early stages of preparing for the research.  It is also during this early phase of the research that researchers should start having discussions with the IRB office about the project to ensure a smooth and successful IRB review process.   

Question:  What about instances where the research is not perfectly laid out from the beginning, but will be discovered and changed along the way?

The IRB process is designed so that changes can occur in the research protocols or processes.  For example, a project could receive “provisional approval,” for the research as it is laid out at the beginning.  If parts of the project change or evolve over time, the researcher can then submit an application for change of protocol. Again, the best way of ensuring a smooth and successful IRB review process is to be in touch with the IRB office throughout the project – from the initial community conversations through changes in research questions, participant groups, or protocols.

Question:  How do you demonstrate consent in an IRB application for engaged research?

The IRB is looking for a “consent process” first and foremost.  The IRB requires involved participants to receive an information sheet with the names of the researchers, an explanation of what the participants will be expected to do and any risks associated with their involvement, and contact information for the IRB office and University of Minnesota in case of questions or concerns.  This information sheet must be tailored to the “target” audience or engaged population.  It should be clear and written in language that is understandable by potential participants and not intimidating.  An intimidating or difficult to understand consent form or information sheet is “unacceptable” under the IRB framework. 

Engaged research doesn’t require a written consent form from involved participants. (In many cases, it is best not to require signatures, so that the study participants remain anonymous.) The regulations require that participants provide “informed consent.” Involved participants can provide verbal consent or provide consent by continuing to participate in the research.  A signed, written consent form is not necessary for most community-engaged projects.  What matters for engagement-related research is that the subject/participant understands what s/he is committing to do. 

Question:  What is the IRB’s position on “snowball sampling”?

Snowball sampling is a process by which a current participant provides the names of potential new participants in the study and the researcher then contacts those potential participants directly.  This method of contacting new study participants through their social network is often necessary in community-based projects.  The IRB does not prohibit snowball sampling; however, the IRB does frown upon it because of the possibility of participants feeling coerced into participation. A more acceptable approach is for the current participant to give the researchers information to others they may know.  If those potential participants then want to become involved in the research, they can contact the researchers directly. Staff of the IRB can assist researchers in modifying snowball sampling techniques to ensure that coercion and potential risks are mitigated.

Question:  What is the IRB’s position on researchers providing incentives to participants?

All researchers want high response rates, and some researchers have used drawings or raffles as a way to encourage participation.  The IRB does not like drawings or raffles (e.g., “be in our study and have a chance to win an a iPod”), since all participants are supposed to receive the same compensation for taking part in the study (i.e., the winner of the drawing receives greater compensation than the others who do not win).

Researchers should work with the IRB if they are interested in providing incentives for participation in a study.  Some approaches are more acceptable and appropriate than others and can provide researchers with additional information important to the study (e.g., data on non-respondents and selection bias).

Question:  Is there IRB training for researchers?

Everyone who does IRB-regulated research is required to do some form of IRB research training. CITI online training is one mechanism of doing this. Students and faculty advisors are required to get this training if they are going to be involved in research. The community members who are going to act as researchers also are required to have this training. This is a bit more difficult in terms of getting them access to the training (because CITI access requires an x500 number). The IRB office can help facilitate this. A temporary x500 number can also be issued.

In some instances, a member of the IRB office will visit an entire group and provide an hour-long training. Whether or not engaged community members are considered to be participants or researchers is a decision of the principal investigators. If they are considered researchers, they are required to receive the training.

Question: What is the IRB process when students are participating in community-based work as a part of a service-learning course?

The best path is for the instructor is to have a “class protocol approval.” In this process, the instructor informs the IRB office of the nature and scope of the class activities and the full class receives a waiver or IRB approval (depending on the situation).  The instructor then ensures that the students have appropriate human subjects training (CITI certification, for example) and that the approved protocols are followed. If students want to be involved beyond the scope of what has been approved for the class, the professor would need to contact the IRB office and modify the original application or apply for a separate approval.

Question: If research is not going to be published, does it need IRB approval? 

Whether the research is going to be published or not is irrelevant to whether the project needs IRB review and approval.  What matters is whether the research is intended to be generalizable.  If a study is designed to draw conclusions beyond the participants directly involved, then it is “regulated” by the IRB process.  These generalizable conclusions can either be published or not. 

In addition, there is a misconception that if research is going to be published, then it must have IRB approval. This statement is also not true. Many case studies are published and are not generalizable. These need not be IRB reviewed, since this is not regulated research. However, if a number of case studies are combined in an attempt to draw some sort of generalizability, then that study would require IRB approval.  There is a provision for getting approval for studies using existing data.

Question:  What is your advice to researchers leading community-engaged research projects?

It is extremely important to engage with the Human Research Protection Program office and the Institutional Review Board early on in the research process and throughout the research.  Not only can the staff and members of the IRB provide useful guidance on changes to federal regulations, but they can work with investigators to ensure compliance with federal regulations.  Like many federal regulations, the human subjects protection requirements are constantly evolving, so working with these professionals can help investigators stay abreast of new processes and practices.  Secondly, these professionals can also assist investigators in thinking through the research study to ensure that current regulations are met.

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