A lighter load for researchers

For many psychology researchers, gaining approval from institutional review boards (IRBs) has been, at times, a frustrating aspect of their work. While IRBs have the important mission of protecting human research participants—and psychological researchers recognize the importance of that protection—psychologists have also raised concerns that the review process can overwhelm the research enterprise with red tape, particularly in relation to studies that typically do not cause bodily or other significant harm to participants.

In 2019, this situation improved when the federal government implemented a large-scale revision to its Federal Policy for the Protection of Human Subjectsopens in new window, the first part of which is known colloquially as the Common Rule. Under the revision, many psychological studies are now granted exemption from major IRB review, requiring only a short application form vetted by the IRB and the IRB’s subsequent go-ahead. The revision also lifted requirements for ongoing review of low-risk studies, clarified what is required for participant consent and information forms, and instituted a new policy that requires just one IRB to oversee cooperative studies or studies with interinstitutional collaboration.

“In the past, very few studies were exempt—nearly everything had to go through an IRB for full approval,” said Donelson (Don) R. Forsyth, PhD, professor emeritus at the University of Richmond and a member of the APA Committee on Human Research. “Now, most psychologists’ studies qualify for exemption, except those that could potentially cause physical, psychological, or emotional harm.” Often those are longer term studies investigating children or people with mental health conditions, he and others added.

But for a range of reasons—the timing of the revision in relation to the Covid-19 pandemic, overworked researchers and IRB members, and a lack of institutional and other forms of dissemination—many researchers are not fully aware of these changes. And without sufficient guidance, psychologists have tended to err on the side of caution and submit their application for full committee review, said clinical psychologist Chris Barry, PhD, a professor at Washington State University in Pullman and chair of the university’s IRB. “In my experience, a lot of psychological researchers are still holding onto the idea of better safe than sorry,” said Barry, who is also a researcher.

Indeed, while some IRBs are getting on board with the recent changes, there is more work to be done, noted Beth M. Schwartz, PhD, associate director of the Office of Applied Psychology at APA. A helpful change would be for institutions to create more informative IRB webpages that clearly explain which types of research are exempt, could be expedited, or need a full review, she suggested. These webpages could also include the IRB chair’s contact information in a prominent place so that researchers could easily reach out to ask questions before submitting an application—a simple action that could save a lot of time up front.

“Creating an easy, uniform system like this would minimize unnecessary work for researchers and IRBs alike,” Schwartz said.

Until more institutions implement clearer communications channels, what do researchers need to know to take advantage of these changes to the Common Rule while still protecting participants and avoiding future bureaucratic hassles?

Again, at most institutions, psychological scientists conducting low-risk research simply need to submit a short form to their IRB that outlines what participants are expected to do and how data security will be handled as well as copies of documents that participants will be using, such as surveys, consent forms, and recruitment materials. (At present many IRB websites include templates for long- and short-form research applications, consent forms, and more, and IRBs expect that researchers will use those forms.) In most cases, IRBs will approve the study, and researchers can proceed without ongoing review (qualifiers are noted below).

“It used to take 4 to 6 weeks for a study to get approved, sometimes longer, because we needed so much documentation,” said psychologist Robert Hymes, PhD, an associate professor at the University of Michigan–Dearborn and vice chair of the IRB for the University of Michigan. “Now, we can turn around exempted studies in about a week.”

Specifically, four out of seven potential exemptions in the revised Common Rule pertain to psychological studies:

• Exemption 1 pertains to studies in educational settings that specifically involve normal educational practices.
• Exemption 2 covers research that uses educational tests, surveys, interviews, focus groups, and observations of public behavior. IRBs used to require that data in these studies be collected anonymously, but no more. “Now you can collect data that are both sensitive and identifiable and get the exemption,” said psychologist Adam Mrdjenovich, PhD, who is the IRB health sciences and behavioral sciences research compliance specialist lead at the University of Michigan.
• Exemption 3 pertains to studies that use “benign behavioral interventions”—brief interventions that are unlikely to cause emotional discomfort. Examples include studies that employ cognitive tasks or intellectual assessment, gauge the benefits of educational materials on people’s health behavior, or present participants with workplace scenarios and ask them to take the perspective of a particular player. Even studies in this category that use concealment or deception are deemed exempt if participants have given their prospective agreement to participate in such research, Mrdjenovich said.
• Exemption 4 covers studies that involve working with secondary data, or data collected by someone besides the researcher. For psychologists, examples include retrospective medical or psychological chart reviews that assess the impact of an intervention on a particular population, the burden of a given mental health condition on a certain subgroup, or the use of resources in an institution or institutions. Previously, researchers could access sensitive information in these charts but not extract or record it, but now they can do that for the purposes of data storage and analysis. However, if they want to publish information based on the data, they must protect the confidentiality of participants’ information unless participants have provided permission for it to be included in such reports, Mrdjenovich said.

While these exemptions promise much greater latitude in what is required to move forward with a study, there are some qualifiers to consider, such as the above example on concealing participants’ identity. In general, the two main concerns about participant protection in psychological studies are invasion of privacy or breach of confidentiality and emotional distress or discomfort (unlike in medical studies, where the risk could be as great as death).

To this end, IRBs are taking a particularly keen eye to studies considered for Exemptions 2 and 3 that involve collecting sensitive data, for example related to mental health issues, alcohol and drugs, illegal conduct, sexual practices, financial information, discrimination, and anything that could be socially stigmatizing or damaging to a person’s reputation. In such cases, IRBs will conduct a limited review, which is less time intensive than a full board review. However, if researchers want to avoid that likelihood, “they’re better off making their data as de-identifiable or unidentifiable as possible,” said Barry.

Another big qualifier relates to protected populations. Formerly known as “vulnerable populations” and now described as “categories of subjects who are vulnerable to coercion or undue influence,” these groups include pregnant women, prisoners, and children as well as people who have a mental disability, are economically or educationally disadvantaged, or who have impaired decision-making ability. It does not mean that studies investigating these populations cannot be exempt, but IRBs will definitely examine them more carefully, Mrdjenovich noted.

For studies that are not exempt, researchers must continue to follow the basic procedures under the previous Common Rule, with modifications to the consent form and for cooperative studies as noted. In addition, if researchers conducting nonexempt studies want to use concealment or deception but do not want to debrief participants about that aspect of the design once the study is over, they must obtain IRB approval to omit that information from the consent form, Mrdjenovich noted.

Another big change from the former Common Rule is that most nonexempt studies are now free from having to undergo mandatory ongoing reviews, provided they pose minimal risk to participants. Before the revision, researchers were required to submit a “scheduled continued review” to the IRB every year or two, depending on the study and the institution. Researchers had to keep track of all aspects of their study—for example keeping a running tally of participants and documenting whether the study was following the original protocol or had deviated from it.

Now, the only studies subject to this process are nonexempt studies that involve very sensitive information or populations, Mrdjenovich said.

Meanwhile, the requirements for participant consent forms have also lightened considerably. Exempt studies simply require an information sheet—a template for which is typically available on IRB websites—that provides basic information about the study and informs participants that their data may be shared with others, in keeping with newer federal regulations requiring that all scientific data be available for possible replication.

However, researchers conducting nonexempt studies are still required to use consent forms, and there are changes to these forms that researchers are required to follow. Regulators want consent forms to be more transparent, so they now require a clear, up-front statement of study purpose, a detailed account of what participants will be involved in and agree to do, and a statement that researchers will share their findings with other scientists, if they plan to do that.

They also want the documents to be shorter and more user-friendly. “Overall, consent documents have gotten too long and too complex,” said Mrdjenovich, who reviews many IRB proposals. “I encourage researchers to put themselves in the shoes of the potential participant: What do they really need to know in order to make an informed decision?” (For guidance on streamlining consent forms, see Attachment A of the Secretary’s Advisory Committee on Human Research Protectionsopens in new window.)

Finally, the revised Common Rule made a major change related to cooperative studies. In the past, researchers often had different IRBs for different sites, but the new rule mandates that one IRB oversee the entire project.

Some researchers might not be happy with this change because they think it will prevent them from having local control of their part of the study, Forsyth commented. But overall, this change is for the better, he thinks: Not only does it encourage researchers to coordinate and integrate their data, but if a problem arises at one site, it will be shared with the entire research team and incorporated into the study design and findings. “That didn’t always happen in the past,” he said. That said, some settings and research partners still require researchers to submit IRB materials to their local IRB as well.

As researchers consider these changes and how they can streamline their research accordingly, they should not forget their duty to protect participants—important for both ethical and practical reasons, Hymes said.

“Because we have more discretion now, it is that much more important to take this responsibility seriously and to treat our participants as well as we possibly can,” he said. “After all, we’re dealing with human beings who are doing us a real service by participating in our studies. We also don’t want them to come back and complain that we haven’t treated them right or fairly.”

To maintain high ethical standards in relation to participants, it’s also a good idea for psychologists to refresh themselves on the APA’s ethical principles regarding research—Section 8 of the Ethical Principles of Psychologists and Code of Conduct—as well as on the terms of the Belmont Report, the U.S. Department of Health and Human Service’s ethical principles and guidelines for protecting human research subjects, Mrdjenovich added. The Belmont Report details the principles of respect, beneficence, and justice when working with participants.

“A lot of implementation now falls on researchers,” he said, “so I think having a solid grasp of the Belmont principles and how to enact and uphold them is really important.”

If researchers take sufficient care of their obligation to participants, however, the revised Common Rule offers an exceptional opportunity for researchers to put more energy into crafting and conducting research and less into filling out burdensome paperwork, Forsyth said.

“As a person who likes research and thinks the more research, the better—who believes in finding data-driven solutions to psychological experiences—I think these changes are great,” he said. “In my view, they are a clarification and an easing of difficulty.”