By Melinda Young, Author
The new Common Rule changes are complex, not always easy to interpret, and sometimes seem to add more burdens on IRBs — even as the overarching purpose is to reduce time spent on reviews.
The Office for Human Research Protections (OHRP) is trying to clarify some parts of the new Common Rule with three proposed guidance documents, published in the Federal Register in July 2018.
Based on the new Common Rule and proposed guidance about continuing review, IRBs would have to do extra work if they were to implement the continuing review changes before the delayed implementation date of Jan. 20, 2019, says Teresa Doksum, PhD, MPH, senior director of quality and research ethics and IRB chair, research integrity officer, at Abt Associates in Cambridge, MA.
Recent Common Rule guidance proposes early implementation.
“We were seriously considering implementing this continuing review, changing it, and went through the internal assessment process,” Doksum explains. “We wanted to give it the college try.”
But after speaking with other IRBs that chose not to implement the changes in 2018 and noting that early implementation would cause greater burden, the IRB decided not to implement it, she says.
“The continuing review is not one of the major burdens that a research team might have to go through, so it’s not that big a deal,” Doksum notes. “But if we had studies [now] that are not eligible to go through continuing review, in January we’d have to do a special review of those studies to make sure they complied with the requirements.”
“The draft guidance, I think, is a good summary,” Doksum adds.
The guidance covers these three areas:
• “Scholarly and journalistic activities deemed not to be research: 2018 requirements (http://bit.ly/2Nxndap).”
• “When continuing review is not required during the six-month delay period of July 19, 2018, through Jan. 20, 2019: 2018 requirements (http://bit.ly/2Calqqm).”
• “Elimination of institutional review board review of research applications and proposals: 2018 requirements (http://bit.ly/2N3Q6y1).”
The following is additional insight into the proposed guidance:
• Handling scholarly and journalistic activities. The guidance is a little less clear on journalistic activities, notes Beth E. Roxland, JD, MBioethics, associate in the division of medical ethics at New York University Langone Medical Center in New York City. Roxland also is a senior advisor on law, health policy, and ethics for Roxland Consultants.
“It could be because the Common Rule generally is focusing on academic activities or activities by research institutions, but it doesn’t focus on those outside of research settings, such as marketing groups,” Roxland says.
“If someone is doing a case study, getting a voice out there without conclusions about a population, then the guidance clarifies this is not research,” she adds. “If the purpose is not about generalizable knowledge about a population, then it’s not research.”
An OHRP official says the guidance was in response to an earlier controversy over oral history projects.
“The new guidance tries to clarify a longstanding view about whether certain activities fall under the rule’s definition of research,” says Irene Stith-Coleman, PhD, director of OHRP’s division of policy and assurances.
“About 15 years ago, there was a controversy located mostly in the area of oral history about whether the kind of recording of individuals’ memories of historical experiences was considered to fall under the rule or not,” she says. “The new provision is designed to explain more explicitly where the boundary is in those sorts of studies.”
The guidance suggests that some types of scholarly and journalistic activity could be deemed research.
“If someone obtains HHS funding to conduct a research study according to the standard practices typical of survey research, even if their academic discipline is in history or journalism, this activity could fall under 2018 requirements of research,” Stith-Coleman says.
“If, for example, a historian were to conduct a survey of senior long-term cancer survivors about attitudes toward cancer today versus 40 years ago, recruiting a sample of respondents of sufficient size to obtain generalizable results, according to standard statistical methods, this study could qualify as research,” she adds. “It might, however, be exempt under the 2018 requirement.”
• Not requiring continuing review. The guidance’s summary states that “unless an IRB determines otherwise, continuing review is not required in two circumstances:
- studies eligible for expedited review under the pre-2018 requirements;
- research that has progressed to a certain point.”
This summary language about when a continuing review can be stopped may sound a little vague, but the provision’s actual text is specific.
“The real dividing line is much clearer than is suggested by the summary language,” Stith-Coleman says.
The guidelines say that the 2018 requirements specify that any of the following circumstances must be met for continuing review to not be required, she states:
- “research that is eligible for expedited review, unless the IRB reviewer explicitly justifies why continuing review would enhance protection of research subjects;
- for studies initially reviewed by a convened IRB, once the following specified procedures are all that remain for the study:
- research eligible for expedited review, or
- unless continuing review is specifically mandated by the IRB, research that has progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study:
- data analysis, including analysis of identifiable private information or identifiable biospecimens, or
- accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.”
The guidance is complicated, and research programs should work together to figure it out, Doksum suggests.
“We did an inventory and found this continuing review change would only apply to 10 to 15 of our research studies,” she adds. “So it would not really reduce our burden and researchers’ burden significantly.”
• Eliminating IRB review of research applications and proposals. “The 2018 requirements no longer require IRBs to review and approve research applications or proposals during the certification process for human subject research that is supported by HHS,” Stith-Coleman says.
“However, IRBs are required to review and approve research protocols during the certification process for human subject research that is supported by HHS,” she adds. “In contrast, the pre-2018 requirements had IRBs review and approve both research applications or proposals and research protocols during the certification process.”