By Michelle Blouin, Communications Associate, Access to Justice Lab
In the United States, federal regulations protect the autonomy of individuals participating in research. In many circumstances, that protection takes the form of insisting that a potential participant provides informed consent before they can be randomized to one or another treatment. Sometimes, however, it is possible to proceed without eliciting informed consent from study participants. In her fourth appearance on the Proof Over Precedent podcast, institutional review board expert Shannon Sewards discussed the complexities of the informed consent process and the ethical considerations associated with research in a legal setting.
“It’s all about balance,” said Sewards, Administrative Director of the Dartmouth Health Institutional Review Board (IRB) and former IRB administrator at Harvard University. “The balance is ensuring that individuals that decide to take part in research, that they are making an informed decision about that. And if not, they’re provided with information to do so but also creating a path that important research can move forward.”
To Inform or Not to Inform?
The informed consent process involves three key features, per the U.S. Department of Health and Human Services’ Office for Human Research Protections:
- Disclosing to potential research participants information needed to make an informed decision
- Facilitating the understanding of what has been disclosed
- Promoting the voluntariness of the decision about whether to participate in the research
The requirement to obtain informed consent from a potential research participant—outlined by the Federal Policy for the Protection of Human Subjects, known as the “Common Rule” and codified at 45 Code of Federal Regulations Part 46—is designed to safeguard the rights and welfare of human subjects. The process can be fraught with complexity in some legal research environments.
“In certain situations, it is permissible for a researcher to ask [for] and an IRB to grant a waiver of informed consent,” according to Jim Greiner, Faculty Director of the A2J Lab, who discussed the topic with Sewards. “That is a place where, in my view at least, there is a particularly poor fit between the regulations themselves and the legal setting.”
Those waivers or alterations of informed consent can ease some of a study’s complexity. A waiver would allow a research entity to forgo sharing study details about the potential treatment, risks, and scope of the research to the participant. A partial waiver, if approved by the IRB, would allow for some elements of informed consent to be withheld from a participant. For one class of studies, such a waiver can be granted if two initial elements must be true, according to Sewards: 1) the research must be subject to the approval of the state or local government, and 2) the research must involve public benefit and service programs. Such studies are rare.
Alternatively, an IRB can approve a waiver if the research meets five criteria:
- The research involves no more than minimal risk to the subjects.
- The research could not practicably be carried out without the requested waiver of alteration.
- The research could not practicably be carried out without using identifiable private information or identifiable biospecimens (if applicable).
- The waiver or alteration will not adversely affect the rights and welfare of the subjects.
- Whenever appropriate, the individuals will be provided with pertinent information after participation.
Medical Waivers
The IRB outlines its requirements for waivers and alterations, but each study and research setting has potential to offer nuanced responses to the criteria.
In the podcast, Sewards and Greiner discussed the medical environment and its version of waivers and alterations of informed consent. While much medical research follows HHS regulations, drug and medical device research follows the Food and Drug Administration’s regulations. Unlike the “minimal risk” requirement for a waiver per the HHS, the FDA’s allowance for an exemption requires that “human subjects are in a life-threatening situation, available treatments are unproven or unsatisfactory, and the collection of valid scientific evidence…is necessary to determine the safety and effectiveness of particular interventions.” Take, for example, a medical device akin to a defibrillator designed to treat cardiac arrest. Research of such a device could not be conducted without a waiver of informed consent, with an emergency setting equating to the research setting:
EMT: “Ok, Bob, before we can get you back to the land of the living, we just need you to sign this form here”
Bob: “—-”
The regulatory responses to a “life-threatening situation” in the legal world (e.g., incarceration) do not track with those in the medical world since the worst-case scenario in the legal environment (often) does not refer to life or death.
In less dire circumstances, and following the HHS regulations in medical research, however, a waiver might be granted for a study involving a large amount of data in which it would be impractical to obtain individual consent.
Legal Waivers
In a legal study, IRB approval of a waiver or alteration of informed consent may come down to balancing the need for rigorous research and the need to protect study participants. In an in-house example at the A2J Lab, we’re completing the Public Safety Assessment used to guide pretrial decisions, which looks at the effects of risk assessment instruments in criminal bail decisions. In this case, we randomized whether a judge had the risk assessment instrument when making decisions and then followed the cases to see if the tool was associated with better criminal justice outcomes for the individual. The Lab sought and obtained informed consent from judges. If the arrestees whom the judges’ decisions affected were considered study subjects under the Common Rule (a big if), then unless the IRB had allowed a waiver, then the Lab would have had to interrupt their process of preparing for a hearing during the few minutes they had to decide how to persuade a judge not to incarcerate them. That would likely not have been in the arrestees’ own best interest. Would the study qualify for a waiver of informed consent?
Let’s look at the criteria to see how the lab and IRB approached waiver eligibility for this research:
No more than minimal risk to the participant
The potential for greater incarceration due to the use of the risk assessment instrument is not out of the question. “It’s difficult to characterize that [risk] as minimal,” Greiner noted. In highlighting the need for respect for persons, Sewards suggested a balance also with advancing knowledge for the greater good: “What is the risk-benefit ratio?”
The research could not practicably be carried out without the requested waiver or alteration
Operationally, it would be difficult to obtain informed consent since jails and courts do not know ahead of time who will be arrested and appearing at a hearing with much time in advance.
The timing—which would be just before a hearing—is not conducive to obtaining informed consent. “It’s against the interests of the arrestees to distract them from a highly consequential hearing in which what they should be doing is thinking about what they’re going to say to the judge to get out of jail,” Greiner said.
The default process—that is, the one without the research—is difficult to identify since oftentimes the research occurs when a jurisdiction is thinking of transitioning to a system that includes pretrial risk assessment tools. So, informing participants of the default process isn’t possible when the process is shifting.
The research could not practicably be carried out without using identifiable private information
Due to court records being publicly available via the Freedom of Information Act, this factor does not apply, according to Sewards, though she allowed that some IRBs may interpret “identifiable private information” differently.
The waiver or alteration will not adversely affect the rights and welfare of the subjects
“ What would the consent process afford to the individual insofar as their rights and welfare in the decision to take part?” Sewards proposed. Given the circumstances of this particular research—involving individuals who have no control over the way in which the judicial proceeding is conducted—the rights are less likely affected than those participants in other research studies.
The individuals will be provided with pertinent information after participation
For the pretrial risk assessment study, the Harvard IRB required that participants have access to a one-paragraph description with A2J Lab contact information for questions about the study. Anyone choosing to “opt out” of the study would not opt out of the randomization process but rather would not have their data included in study results. Of the 20,000+ cases, not one participant contacted the A2J Lab about the study.
Even in cases in which the IRB decides against approval of a waiver or alteration of informed consent, Sewards suggested that researchers may appeal the decision. Respect for individuals and research for the greater good is a complex ethical balance that can only benefit from more information.
If you’re interested in more details of this project, listen to our Proof Over Precedent podcast episode on the topic.
Related “Ethics in the Law” series blog posts: