when there is potential to benefit from a research study, not all participants may experience benefit. As a result, some participants may regret participating in the research. Researchers must take care when describing the benefits to participants not to exaggerate their value. A good rule to follow is to state clearly that participants may receive some benefits, and emphasize only those benefits that all participants have an opportunity to receive.
In research that aims to evaluate the effects of an educational or behavioral intervention, researchers should not promise benefits in the form of specific outcomes. Consider, for example, the study of an educational intervention that aims to improve reading scores among elementary school children. If the research demonstrates that the intervention is efficacious, some participants who received the experimental intervention will in fact have received a benefit from research participation, that is, improved reading scores. However, researchers should not promise that children’s reading scores will improve if they participate in the study because the real purpose of intervention research is to gather data to determine the efficacy or effectiveness of an intervention so that individuals in the future can benefit, not individuals in the study. And even the best interventions do not work for everyone who tries them. Further, intervention research often includes a control group, which means that only some participants receive the experimental intervention, and others receive a placebo or no intervention—and therefore the likelihood of any benefit is low for those in the control group.
Research can offer benefits not only to those who participate, but also to the community in which the research is conducted. Such benefits can be tangible, such as paid employment opportunities, or intangible, such as development of research capacity. All kinds of research, regardless of the findings, ideally benefits science and society. For example, surveys, interviews, and ethnographic studies can identify root causes or correlational factors for social problems. Or, if an intervention is shown to be efficacious, it can be offered widely to benefit other individuals in the community and elsewhere. If the intervention is shown not to be efficacious, science still benefits because researchers can rule out what does not work; society benefits because citizens will not be offered (and their tax dollars will not pay for) programs that do not work.
More questions? See #15, #16, and #62.
Question #15 How Do I Design My Research So That the Risk–Benefit Balance Is Favorable?
The federal research regulations require that institutional review boards (IRBs) determine that the “[r]isks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result” (45 C.F.R. § 46.111(2)) from the research. This means that participants should not be subjected to risks when participating in research without the prospect of some benefit. Research does not have to provide direct benefits to those who participate, but there must be some potential benefit to science and society.
While there is no magic formula for determining a reasonable balance between research risks and potential benefits, you must honestly consider the following:
the anticipated risks of study participation;
the likelihood and magnitude of those risks, and steps you will take to minimize those risks;
the potential expected benefits of the research to participants; and
the potential knowledge that will be gained by your study.
When designing your research study, you will want to make sure you have clearly thought through all these issues and that, from your perspective, the potential benefits outweigh the risks. You will also want to ensure that this information is clearly described in your protocol, so the IRB has sufficient knowledge to make their determination. It is important to keep in mind that IRBs may view the risks and benefits of a particular study differently from the researcher who designed the study. Perceptions of risks and benefits may also vary among the different members of an IRB.
More questions? See #11, #12, and #14.
Question #16 How Do I Make Sure That Participants in My Research Do Not Overestimate the Benefits or Underestimate the Risks?
The term “therapeutic misconception” is used to describe when research participants incorrectly assume that they will directly benefit from taking part in a research study. However, the primary purpose of research is to gather generalizable knowledge to help people in the future; direct benefits cannot be assumed. The therapeutic misconception can occur if a participant does not fully understand the purpose of the research, or does not understand the differences between research and services. Individuals participating in research may incorrectly believe that the intervention or program being evaluated in a research study already has an evidence base to support its use. They may not realize that they are being asked to participate in research in order to gather needed evidence on whether the intervention works—or does not work.
Although the term was conceived of within the context of clinical research, therapeutic misconception can occur in social and behavioral sciences research. Researchers should be particularly aware of the potential for such misunderstanding when conducting research on behavioral or educational interventions. People tend to assume that any services offered are already proven to help. When recruiting for an intervention study, it is especially important to emphasize that you do not yet know if the intervention being offered will achieve the desired results.
Participants may also misunderstand the purpose of the research in nonexperimental studies that use surveys or interviews. For example, individuals might confuse a request to take a survey about their smoking habits with an offer to participate in a program designed to help them quit. Being asked to take part in an in-depth qualitative interview after a natural disaster could be mistaken for an offer of counseling or other mental health services. The potential for such conflation is particularly strong if the study is being conducted by a service provider or in collaboration with an agency that provides direct services.
The best way to limit potential misconceptions about research is to provide participants with clear information about the purpose and benefits of the research during the recruitment and informed consent process. For example, to explain the study purpose, you can include straightforward statements such as, “The purpose of the study is to find out if this program can help students improve their reading scores. We do not know if this program is better or worse than the current reading program offered. We are doing the research to answer this question.” Regarding benefits, you can include statements such as, “You will not receive any direct benefit from taking part in this research. However, if we find out that the program works, it can be offered to students in the future.”
More questions? See #11, #14, and #40.
Question #17 I Will Conduct Research on a Sensitive Topic. What Should I Do to Prevent Psychological Harms?
Research in the social and behavioral sciences may explore sensitive topics. A few examples include domestic violence, sexual assault, sexual practices, or the death of a loved one. Such research poses psychological risks such as sadness, anxiety, or embarrassment. You can take several steps to reduce the possibility that participants experience psychological harm from participating in research on sensitive topics.
You should consider the method of data collection, as different methods carry different kinds of risks. The thorough exploration of past experiences through in-depth interviews may increase the risk of psychological harm compared with surveys, which are usually more superficial. However, in-depth interviews involve a relational aspect that might provide greater opportunities for participants to make meaning of their experiences and thereby increase participants’ perceived benefits and contribution to science as compared with surveys. Conducting face-to-face, in-depth interviews also includes the possibility of other risks, such as a breach of privacy because the participants’ identities are known by the researcher, and they may be seen by others.
Methods to reduce the possibility of psychological harm include
limiting the number