are accessed without their permission, even if the information is kept safe and confidential by researchers. Some people might feel offended if a research staff member asks them a personal question, for example, about their income, sexuality, or political views.
In some cases, the publication of research findings—even if individual participant identities are appropriately de-identified—could lead individuals or communities that share characteristics with participants to be viewed negatively by others. For example, a finding that a certain group of people has higher rates of drug use may stigmatize the entire group and result in social harm, even to those individuals who did not participate in the research. These types of group-level risks are important for researchers to keep in mind when planning a research study. Engaging members of the community and asking them how to anticipate and minimize such group-level risks may help in these situations.
More questions? See #12, #23, and #63.
Question #12 How Do I Identify Risks in My Research—and Minimize Them?
No matter what kind of research you are doing, you have a responsibility when designing and conducting research to (a) identify risks of participation, (b) consider the likelihood and magnitude of those risks, and (c) implement procedures to minimize those risks. When identifying risks for a particular research study, start by considering the topic under investigation and the methods of data collection and storage.
Social and behavioral sciences researchers investigate many different phenomena. Some topics of inquiry are quite benign, such as reasons people visit national parks. Such research likely has few risks. However, other kinds of research, such as interviewing individuals who are engaged in criminal activity, can be quite sensitive. In these situations, participants could feel anxious when describing past illegal activities (psychological risk). If others learned that a participant engaged in these activities, they may no longer trust the participant (social risk). Employers may be hesitant to hire the individual because of his or her previous illegal behavior (economic risk). In reality, most research asks about experiences, behavior, and opinions that fall somewhere between visiting national parks and engaging in criminal activity.
Beyond the specific topic of inquiry, you must consider risks that might arise from the methods used to identify and recruit participants and gather information. In the social and behavioral sciences, one of the main risks to consider is a potential violation of a person’s privacy. You must consider the psychological, legal, economic, or social harms that could potentially result if others learned that an individual was participating in—or was just being invited to participate in—a specific research study. For example, participants could be seen entering a drug treatment facility for a study interview, which might be embarrassing or stigmatizing (social risk). Or, participants’ employment (economic risk) or custody of their children (legal risk) could be jeopardized if someone sees them filling out a mailed or online survey about their drug use.
Risks from a breach in confidentiality of data are also important to consider. Participants could be harmed if unauthorized persons gained access to information collected as part of the study. For example, public embarrassment and marital discord could occur if personal data acknowledging a marital affair became public (say, for example, if data collected online were not appropriately protected). In research on employee job satisfaction, economic harm could occur and participants could lose their jobs, for example, if their supervisors learned of their dissatisfaction with the company’s sick leave policies.
A variety of methods can help you identify risks and take steps to minimize them. Conduct literature reviews of research studies with similar populations or those that used similar methods. Consult with experienced researchers who have conducted similar research. Talk with individuals who share characteristics with or represent the views of prospective participants to identify what risks they think the research might pose.
Once risks are identified, you must consider the likelihood and magnitude of those risks. Unfortunately, such estimation is not an exact science. Some probabilities can be determined based on systematically collected information. However, many probabilities—especially risks of extremely rare events—are impossible to quantify. Even when relevant empirical data on risk are available, humans’ estimation of future risk is subject to many biases. We tend to overestimate risk for those things we have directly experienced or heard about recently. Different researchers and institutional review board members may judge risks differently based on their own experiences.
More questions? See #17, #22, and #23.
Question #13 What Is Meant by “Minimal Risk”?
According to the federal research regulations, 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” (45 C.F.R. § 46.102(j)). Research studies are evaluated according to whether they pose more risk than what people face when going about their normal activities. Most social and behavioral sciences research meets the definition of minimal risk. However, determining the ordinary risks of daily living is tricky. Such risks can vary depending on where people live, their health status, their jobs, and the kinds of activities in which they regularly engage.
Every research study can be considered to pose either “no more than minimal risk” or “greater than minimal risk.” As described in more detail in Part 8: Negotiating the IRB Review Process, the type of institutional review board (IRB) review (exempt, expedited, or full board) that a research study must undergo is determined by whether the research study is deemed by the IRB to pose no more than minimal risk or greater than minimal risk. A comprehensive IRB application should clearly outline risks and provide information to help the IRB make the appropriate determination.
Researchers and IRBs may not always be consistent in their interpretation and application of the concept of minimal risk, due to the broad regulatory definition. For example, whose daily life should be considered—a person who represents the majority of people in a community, or a person who represents people who will likely participate in the research? Either standard may be applied by an IRB.
More questions? See #16, #77, and #79.
Question #14 What Are the Potential Benefits of Research?
A research study should be conducted only if it offers some benefit to science and society: that is, it answers a new question or adds new information to what is already known. Research may also benefit those who participate. Different kinds of benefits may be offered to participants, and these should be described in the research protocol and during the consent process. In order to be ethical, research must always have potential for social or scientific benefit, but it does not have to directly benefit participants.
Some research studies provide tangible benefits, such as resources or services (related to the study’s primary objective) that participants normally would not be able to access (or easily access) outside of study participation. For example, a study on weight loss may provide participants with services such as a health screening or resources such as books, step counters, scales, exercise equipment, or pre-made meals. In describing benefits to participants during recruitment and the informed consent process, financial payment for research participation should not be considered as a tangible benefit.
Participants may also receive intangible benefits from participating in a research study. Participants may learn more about a specific health issue, enjoy interacting with others, or appreciate the opportunity to share their experiences and views. For example, individuals who participate in qualitative interviews about a traumatic experience (such as domestic violence or a natural disaster) may have a positive emotional response from talking about their experience. In addition, some participants may feel good about participating in research because it may help others in the future. Similarly, participants may also benefit psychologically from participating in research, knowing that they are contributing to science or helping researchers find solutions to social problems that affect their community.
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