On January 19, 2017, the Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS) and multiple federal agencies published final amendments to the Federal Policy for the Protection of Human Subjects (aka the "Common Rule"). Introduced in 1991 based on research ethics principles dating back to the early 1970s, the Common Rule was viewed by many as antiquated given shifts in research practices over decades.
Research enterprises previously based largely in academic and medical institutions expanded exponentially into private sector entities. Conducting research moved far beyond clinical trials to extensive assessments of biospecimens, genetic data and private health information.
In amending the Common Rule, OHRP attempts to simultaneously enhance protections for human subjects while limiting administrative burdens for researchers. It is a difficult balance given competing demands among researchers, subjects and funders reflected in thousands of public comments and multiple professional reviews.
While many of the changes to the Common Rule will not take effect until January 2018, essential themes already impact researchers, subjects, administrators and attorneys representing their interests. We lay out below 10 premier "take-aways" from the amended Common Rule including major changes to come and opportunities foregone.
1. Defining Human Subjects Research: What It Is and Is Not
A significant change to the Common Rule is its definition of "research," particularly concerning the types of activities that are excluded or exempted. OHRP largely retains the same basic working definition of "research" focused on systematic investigations designed to develop or contribute to generalizable knowledge.
However, several activities once viewed as research among institutional review boards (IRBs) are now explicitly categorized as "not research." These include scholarship, criminal justice data collections and activities in pursuit of national security objectives. Additional activities still classifiable as research are nonetheless "exempt" from the Rule's application including educational studies, behavioral assessments, public benefit program reviews and secondary studies or storage of some biospecimen and private data collections (discussed below).
2. Distinguishing Public Health Practice and Research
Additionally excluded from the Rule's application are public health surveillance activities. For decades, governmental public health authorities have contested with OHRP and IRBs on whether activities classifiable as public health surveillance (including epidemiologic investigations) somehow constitute human subjects research. Neither the prior version of the Common Rule, nor the subsequent HIPAA Privacy Rule, adequately addressed this issue.
Though not completely resolved, the distinction between public health practice and research is clarified. Routine and emergency public health surveillance activities conducted by governmental agencies and their contracted partners are not considered research. Explicit recognition of this distinction between public health practice and research may diffuse prior instances where IRBs unnecessarily required public health agencies to meet research requirements for surveillance activities.
3. New Requirements for IRBs and Multi-Institutional Studies
Effective January 19, 2020, the Rule generally requires multi-institutional studies to utilize a single IRB for human subjects research conducted within the United States. The reviewing IRB will be chosen either by the federal agency funding the project or by the lead research institution with federal approval.
Additionally, under the new Rule, studies on the HHS Secretary's list of expeditable research can be approved via expedited review, unless the reviewer determines that the study involves greater than minimal risk and documents the justification for their decision. IRBs do not need to conduct continuing review of studies approved via expedited review, unless reviewer explicitly justifies why continuing review would better protect research subjects.
4. Common Rule Coverage of Vulnerable Populations
IRBs must address the needs of vulnerable populations when considering participant selection, additional safeguards and IRB membership. "Vulnerability" under the amended Rule means exposure to coercion or undue influence, and not necessarily other types of vulnerability such as historical marginalization stemming from racial or gender discrimination.
The new Rule lists "children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons," as examples of vulnerable populations, but excludes pregnant women and people with physical disabilities. Additionally, in line with the person-first movement, the Rule replaces the term "mentally disabled person" with "individuals with impaired decision-making capacity."
5. Informed Consent Requirements
To make informed consent documents more comprehensible, the amended Rule requires consent forms to begin with a brief discussion of information (e.g., risks and benefits) most likely to assist a prospective subject or legally-authorized representative in deciding whether to participate in a study.
Furthermore, as a whole, informed consent must be organized to allow potential subjects to grasp the pertinent reasons for their participation. This is a marked departure from the haphazard listing of isolated facts that have often filled long and overly-complex informed consent forms. These changes help further the purpose of informed consent: to provide sufficient information so that every participant can intelligibly and voluntarily decide whether to enroll.
To increase transparency, either the federal agency supporting each clinical research trial or the institution conducting it must post one IRB-approved consent form on a publicly-available federal website.
6. Defining and Revising the Concept of Identifiable Biospecimens
In light of increased genetic research, the Rule newly defines "identifiable biospecimen" to include those human materials from which the identity of the subject could be readily ascertained. As tools and technologies advance, increasingly personal information can be generated from "non-identifiable" biospecimens, raising significant ethical questions for researchers.
In response, the Rule obligates federal agencies to reexamine and issue guidance on what constitutes an identifiable biospecimen every four years. Agencies must assess whether analytic technologies can generate identifying information from otherwise non-identifiable biospecimens. If so, consent must be obtained before applying the technology to the biospecimen. Though truly non-identifiable biospecimens are increasingly a fallacy, the Rule offers the flexibility needed to craft revised protections as technology advances.
7. Consent for Research Involving Biospecimens and Identifiable Data
Contrary to prior proposed revisions to the Rule, OHRP declined to extend the informed consent provision to non-identifiable biospecimens, instead requiring consent only for identifiable biospecimens. The Rule further permits researchers to seek broad consent for the storage, maintenance and secondary use of participants' identifiable information and biospecimens. Participants can grant researchers permission to re-use their biospecimens in unspecified, future studies without having to re-obtain the participants' consent.
Understanding genetic variation and associated health outcomes requires access to comprehensive collections of biospecimens and personal information. The Rule attempts to balance these interests with participants' desire for control over uses of their data. Where researchers clarify the scope of provided consent, participants can be better informed of the study's potential risks and future implications.
8. Review of Identifiable Data or Specimens for Prospective Research Subjects
Researchers' limited access to existing storages of private information and identifiable biospecimens to screen, recruit and determine the eligibility of prospective participants is authorized. Even where prior participants declined to grant researchers consent to re-use their biospecimens for secondary purposes, researchers can reexamine their stored biospecimens to determine if they would be ideal candidates for subsequent studies.
Allowing access to sensitive information outside the scope of consent may facilitate research efficiency, but is legally and ethically suspect. Individuals and their family members have an interest in protecting their genetic data from unwarranted accesses and disclosures. Without significant limitations and specific confidentiality mandates on the entities that can access the databanks, data breaches and resulting legal challenges may follow.
9. Status Quo on Privacy Safeguards
One's willingness to participate in a research study likely depends on the perceived level of privacy and security. Yet the Rule excludes a proposed provision that would have required researchers to implement and maintain reasonable and appropriate safeguards as specified by HHS to protect biospecimens and private information.
The implications of unauthorized accesses to participants' sensitive information warrant heightened protections. Release of Medicare or Social Security data can pose financial risks, while disclosure of chronic illness or mental health status could cause social or emotional damage. Investigators and IRBs have demonstrated competence in requiring appropriate privacy and security safeguards even without specific mandates from the Rule. However, they may not always have the needed expertise to evaluate the risks amidst increasing advancements in information technology.
10. Common Rule Coverage Limited to Federally-funded Research
Extending the Common Rule to cover certain types of non-federally funded clinical trials was considered and ultimately rejected by OHRP. As a result, the Rule still applies only to human subjects research conducted or supported by a federal department or agency that has adopted its provisions.
While it does not cover non-federally funded research, federal agencies can, and often do, require entities receiving federal research funds to apply Common Rule protections to all of the entity's research with human subjects.
Furthermore, most institutions voluntarily adopt policies requiring IRB approval for non-federally funded research and other Common Rule requirements. To this end, the Rule as amended will have broader applications than its limited jurisdiction suggests.
Underlying these and other Common Rule amendments is a balance between promoting modern research practices and respecting individual and group privacy. Allowing extensive, secondary uses of research banks based on subjects' initial broad consents and without heavy IRB oversight may generate new findings at less costs. However, unfettered access to identifiable data or specimens lends to public concerns over confidentiality, especially in an era of cyber-security threats, leading some to forego research participation altogether.
Whether the needs and interests of funders, researchers and subjects are properly accommodated in the revised Rule is open for debate. Yet, to the extent that it reflects the gamut of data and specimen collections, reframes informed consent practices, improves IRB oversight and allows for ongoing fine-tuning based on new findings or technologies, the revised Common Rule offers individuals greater protections against unethical practices.
James G. Hodge, Jr., JD, LLM, is Professor of Public Health Law and Ethics, and Director, Public Health Law and Policy Program at the Sandra Day O'Connor College of Law, ASU. Sarah Arnold, JD Candidate 2018, and Sarah Wetter, JD Candidate 2017, are Senior Legal Researchers with ASU's Public Health Law and Policy Program.
Suggested citation: James G. Hodge, Jr., Sarah Arnold and Sarah Wetter, Top Takeaways from the Common Rule Amendments, JURIST - Academic Commentary, Feb. 19, 2017, http://jurist.org/forum/2017/01/james-hodge-common-rule.php.
This article was prepared for publication by Kelly Cullen, a JURIST Assistant Editor. Please direct any questions or comments to him at firstname.lastname@example.org