by Craig Klugman, Ph.D.
Yesterday, the Department of Health & Human Services released the long-awaited, and debated, new Common Rule. Many of the proposals that were released in earlier versions for public comment did not make their way into the rule. All IRB members will also need to undergo training to incorporate the new rules into their reviews. Most of the changes have a deadline of 1 year (January 2018) for enactment.
Though many experts in research ethics will be writing on this in great detail, I offer a brief synopsis of the changes here. However, keep in mind that the incoming administration has suggested they may rollback all executive orders made by the Obama administration in its last few months, if not during the entire Obama presidency. Thus, it is possible that these rule changes are rolled back very quickly.
Who is covered?
The new rules maintain that only federally funded clinical trials must be reviewed by an IRB.
For the first time, the rules adopt a definition of Clinical Trial as “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.” The new rules also offer separate definitions of “identifiable biospecimen” and “identifiable private information,” whereas previously, both were defined together.
The notion of what is “research” has also been altered. Research “means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” Thus the following ar eno longer research:
- “(1) Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research and historical scholarship), including the collection and use of information that focus directly on the specific individuals about whom the information is collected;
- “(2) Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority;
- “(3) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes;
- “(4) Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.“
Other definitions were tweaked (e.g. “private information”) or remain unchanged (e.g. “human subject”).
Biobanking specimens and information
One of the most controversial proposed changes was that of having to gain subject consent for use of banked specimens. This requirement has not been added. Thus, there is no necessity to get consent to do research on identifiable biospecimens. The new rules permit a broad, global consent when a specimen is taken, that would cover future research. This applies to “storage, maintenance and secondary research use of private information and identifiable biospecimens.” Consent is still not required to study non-identified information and biological material.
New Consent Forms
The new rules require a concise explanation early in a consent form listing the key information that a potential subject would need to know. This information should include purpose, risks, benefits and alternative treatments.
Also, federally funded clinical trial consent forms must be posted on a public website
Multi Institutional Studies
The rules require a single IRB to oversee multi-institutional research studies, though studies can be exempted.
The new real tweaks the exempt categories and creates some new ones. For example, among the changes here are exemptions for research using identifiable secondary information if the research is covered under HIPAA. Research that happens to include prisoners (or people who go to prison during the trial) but is not exclusively on prisoners may qualify for exemption (whereas previously any prisoner involvement required full review).
A new exemption is permitted for “benign” behavioral interventions in adults. Benign is “brief in duration, harmless, painless, not physically invasive, and not likely to have a significant adverse lasting impact.” This requires that subject identity is protected, that any disclosure would not place the subject at risk (criminal prosecution, financially, job, education, reputation), and that recorded information protects subject’s identity. The rule permits audiovisual recording.
In another case, “The final rule includes an exemption at § __.104(d)(2) that is a revised version of an exemption in the pre-2018 rule. The exemption applies to research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) uninfluenced by the investigator if at least one of three criteria is met:
- “The information obtained is recorded by the investigator in such a manner that the identity of the human subject cannot readily be ascertained, directly or through identifiers linked to the subjects;
- “Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or
- “The information obtained is recorded by the investigator in such a manner that the identity of human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by § __.111(a)(7) (which relate to there being adequate provisions for protecting privacy and maintaining confidentiality).”
Low risk studies are no longer required to have continuing review. This includes those that undergo expedited review, data analysis, or “observational follow up in conjunction with standard clinical care.”
Research in Foreign Countries
There are several other smaller changes. For example, in discussing research in foreign countries, the rule cited the Declaration of Helsinki as a standard that another nation may use. This reference has been removed.