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FAQs: New York State Task Force on Life and the Law's Report and Recommendations for Research with Human Subjects who Lack Consent Capacity

These FAQs provide a better understanding of the purpose and key recommendations of the Report and Recommendations for Research with Human Subjects who Lack Consent Capacity. This document provides basic information on commonly asked questions. For a more comprehensive summary of the recommendations for Institutional Review Boards (IRBs), researchers, and Legally Authorized Representatives (LARs), see Section XI of the Report and Recommendations.

(1) Purpose and Scope of the Report and Recommendations

Why are these recommendations necessary?

American history has been rife with human subjects research (HSR) scandals, including several in New York, such as those that occurred at the Willowbrook State School and the Jewish Chronic Disease Hospital. In response, laws and regulations were enacted to ensure voluntary informed consent for participants and IRB oversight of HSR. This report provides guidance to ensure the ethical conduct of human subjects research with cognitively impaired adults.

While some institutions and investigators are conducting research with cognitively impaired adults, others are taking an extremely conservative approach and are excluding these individuals from research citing concerns about vulnerability and exploitation. Stakeholders, such as the research community and certain patients' rights advocates, argue that laws that exclude individuals who lack consent capacity actually disadvantage this population by preventing scientific advances for conditions that cause decisional incapacity. In other words, to learn about and seek cures for the broad range of diseases that impair cognition, research requires the participation of individuals who often cannot provide informed consent.

Thus, IRBs, investigators, and research institutions have sought guidance from the Task Force on how to conduct ethical research involving this vulnerable population. This report is in response to this appeal for guidance.

An underlying goal is to ensure that research protocols are available to all individuals, including this population, so that they may also have the opportunity to participate in research as their non-cognitively impaired peers, while also ensuring the appropriate level of protections. In order to ensure the consistently ethical conduct of such research, the report recommends additional and more extensive safeguards for individuals who lack consent capacity.

Are these laws? Regulations?

This Report and Recommendationsrepresents the advisory opinion of the New York State Task Force on Life and the Law. This report provides guidance and best practices that will assist research institutions, investigators, institutional review boards (IRBs), legally authorized representatives (LARs) (i.e., surrogate decision-makers), and others in the ethical conduct and responsibilities of research involving cognitively impaired adults.

How much research do these recommendations affect?

The majority of HSR conducted in the U.S. is subject to the federal Common Rule, which governs HSR that uses federal funding, is conducted by the federal government, or is overseen by a federal agency. New York law only applies to research not covered by federal law. New York law applies to only a minority of research activity in the State, because most research conducted in New York is either federally funded or otherwise subject to federal oversight. Where research is both federally and State funded, only the federal rules apply. Thus, these recommendations provide guidance and recommend oversight mechanisms for research conducted in the State involving individuals who lack consent capacity that is notsubject to federal oversight.

Are there already laws in place for research involving individuals who lack consent capacity in the State?

New York Public Health Law 24-A governs human subjects research that is conducted in New York State by providing mechanisms for ensuring voluntary informed consent for participants and IRB review of research protocols. It does not provide any special oversight mechanisms for research involving individuals who lack consent capacity. However, PHL 24-A explicitly acknowledges that such research will occur, by addressing the appointment of an LAR for research. The Task Force issued this report, which includes appropriate safeguards, to better facilitate the inclusion of cognitively impaired adults in research protocols.

(2) Process

What was the process by which the Task Force arrived at its recommendations?

The Task Force began this endeavor in December 2007 by gathering information from New York IRB chairs and members about their institutions' practices, if any, for conducting research involving the cognitively impaired, and their views on the regulatory landscape. Their input indicated that researchers and participants could benefit from guidelines to ensure consistent research practices.

Since 2007, the Task Force has examined the ethical and legal issues associated with research involving adults lacking consent capacity. It reviewed medical and policy literature on human subjects research, informed consent, surrogate consent, capacity assessment, risk-benefit analysis, research protections, adverse events, and related topics. It conducted extensive legal research of federal and state regulatory standards, including New York's, and case studies pertaining to human subjects research involving the cognitively impaired. It received presentations from several experts from research institutions and governmental entities. The Task Force analyzed previously-released reports and recommendations on human subjects research by the Department of Health and the public comments to these efforts, and stakeholders and other interested parties provided additional perspectives and input on this project.

In developing these guidelines, the Task Force considered and declined to recommend legislation governing research involving individuals who lack consent capacity. It concluded that because existing law permits research involving this population, no statutory change is needed.The Task Force therefore identified approaches that comply with current federal and state law, including the Common Rule and New York Public Health Law 24-A, to ensure ethical practices in research involving this vulnerable population. Moreover, the Task Force's recommendations consist of guidance as opposed to rigid rules or regulations.

(3) Key Issues and Recommendations

When may adults who lack consent capacity participate in research?

Adults who lack consent capacity may participate in research only when researchers and IRBs have ensured that there is justification for involving these individuals in the study. An IRB must ensure that the least burdened population is utilized and that cognitively impaired individuals are not selected for research because of ease of recruitment or availability. Furthermore, IRBs should pay particular attention to the rationale behind enrolling vulnerable patients for research protocols that do not explicitly study medical conditions that impair consent capacity.

How do IRBs evaluate the degree of risk for research involving adults lacking consent capacity and whether such studies should be approved?

One of the most complex ethical issues in conducting research involving these individuals is the degree of risk to which researchers may ethically expose this population. While upper limits on the level of acceptable risk may be necessary for some HSR studies, bright-line cut-offs are only appropriate in limited circumstances. The Task Force recommends that research should only be approved for individuals who have first explored all available treatment options and failed to receive any therapeutic benefit, and for those without any other known treatment options available.

When research involves vulnerable individuals, the Task Force recommends that IRBs may establish a lower ceiling for allowable risk or require a more favorable risk-benefit ratio for a protocol to be approved than they would for similar research involving non-vulnerable participants. However, for research that may offer a prospect of direct benefit, an IRB may allow a higher ceiling for allowable risk and allow a less favorable risk-benefit ratio for research.

Who may consent to research on behalf of individuals who lack consent capacity?

In all cases, researchers should obtain first-person informed consent from the participant wherever possible. When researchers are unable to obtain first-person informed consent from a participant, researchers may – depending on the nature of the study and the risk-benefit ratio – enroll an individual according to his or her research advance directive (RAD) or using surrogate informed consent, through the appointment of a legally authorized representative (LAR). Thus, it may be permissible for individuals lacking consent capacity to be enrolled in a research protocol with the consent of a LAR.

Currently, New York State has no legally defined hierarchy for identifying a LAR for research, and thus, in many cases, IRBs and researchers can look to the surrogate hierarchy for treatment decisions contained in the Family Health Care Decisions Act (FHCDA).

However, because LARs listed in a hierarchy often will have varying degrees of understanding of the wishes of the impaired individual regarding research participation, IRBs and researchers should consider limiting the classes of LAR(s) who are authorized to provide surrogate consent to research. The riskier the research protocol and more remote the prospect of benefit, the closer (by kinship or intimacy level) the LAR should be to an individual to consent to the impaired individual's participation.

How are capacity assessments made?

Particularly for cognitively impaired individuals, consent capacity is not simply either present or absent; instead, it can fluctuate over time. Depending on the degree of cognitive impairment, an individual may be able to provide first-person informed consent for a research study. Further, periodic re-evaluations of capacity may be required, depending on the participant, the research protocol, and the risk level involved.

Determining whether a participant has sufficient consent capacity depends not only on each individual, but also on the complexity of the research protocol and its risks and benefits. For instance, a drug placebo study that involves a high level of risk may require an individual to have full consent capacity to participate. Thus, the threshold for consent capacity (i.e., eligible candidates for research enrollment), varies between research protocols.

Ideally, independent evaluators (i.e., those not involved in research) should assess capacity to ensure that only appropriately screened individuals may be enrolled.

Is there a process for notice of capacity assessments or enrollment decisions to the participant? Can a research participant seek review of a LAR's decision to enroll him or her in a research protocol?

Yes. Procedures for providing notice to the participant and, if necessary, the LAR, regarding the capacity assessment and opportunities for objection and review are integral to the protection of all research participants. Researchers should provide notice to the participant and/or LAR that an assessment will be conducted, as well as the results of the assessment, and any consequences of a determination of incapacity. Further, as part of a research protocol, the Task Force recommends that potential participants and/or surrogate decision-makers should be notified of a planned capacity assessment, as well as the results of the assessment and any consequences of a determination of incapacity. Providing notice promotes transparency by alleviating any concerns that an individual might be involved in research without the knowledge of the participant or surrogate decision-maker. It also demonstrates respect for the prospective participant by presenting an opportunity for the individual or his/her surrogate decision-maker to object to either the capacity assessment or the results of the evaluation.

By making review procedures readily available, individuals will have an opportunity to request further information or a second opinion.

How may a LAR provide surrogate consent to research for an individual who lacks consent capacity?

In all cases, researchers should obtain first-person informed consent from the participant wherever possible. When seeking informed consent, research protocols should employ a dynamic process – one that facilitates ongoing discussion – about the risks and benefits of participation. The information should be presented using methods that are best suited to the capacity level of the target population. Further, participants and/or their LARs should understand the difference between the goals of research and the goals of clinical care to help dispel the therapeutic misconception. Finally, the use of a neutral discloser, a person not affiliated with the study, to present the information is recommended.

If an individual is unable to provide first-person consent, researchers may not enroll an individual in research unless a LAR provides informed consent and the individual provides assent to participation, or does not dissent.If the individual is unable to provide assent, researchers should look for signs of dissent, recognizing that for this population, dissent may not be obvious. If signs of dissent are present or – where assent is possible – assent is not provided, researchers may not enroll or allow continued participation of the individual in the study.

When determining whether an individual should participate in research, a LAR should use instructions from a RAD or similar type of advance directive, if such instructions exist; orthe participant's prior expressed wishes and preferences about research, if known. If there are no prior expressed wishes, the LAR should use either the best interest standard or substituted judgment. Also, to prevent undue inducement to consent to research, LARs may never be the true beneficiary of any financial compensation offered.

What additional oversight mechanisms should IRBs implement for research involving adults who lack consent capacity?

The amount and scope of additional safeguards that the Task Force recommends for research with this population depends on the level of risk and the likelihood of direct benefit that the research protocol offers to the research participant. The higher the risk or the less prospect of direct benefit, the more protections are recommended. In addition to IRB review and approval, protective measures may include, but are not limited to: (1) independent consent monitors (ICMs); (2) medically responsible clinicians (MRCs); (3) state multiple project assurances (MPAs); and (4) additional reporting requirements.

An ICM is an individual not affiliated with the study or research institution, who is designated by an IRB to monitor the informed consent process. The role and responsibilities of an ICM may vary, from monitoring the informed consent process to advocating on behalf of potential and current research participants. The IRB will determine the degree of involvement of the ICM.

An MRC is a licensed medical doctor skilled and experienced in working with the research population and is independent from the study, who acts as an active advocate for cognitively impaired individuals.

An MPA is an assurance between the Department of Health and a research entity or institution that pledges that all members of the entity or institution will comply with HSR policies issued by the State.

The following chart summarizes the first three measures to safeguard the rights and well-being of participants who lack consent capacity (the reporting requirements apply to all types of research studies).

  Minimal Risk Minor Increase Over Minimal Risk More Than a Minor Increase Over Minimal Risk
Prospect of Direct Benefit ICM – Usually Optional ICM – May Recommend ICM – Require
MRC – Optional MRC – Strongly Recommend MRC – Require
MPA – Support MPA – Support MPA – Support
No Prospect of Direct Benefit ICM – Usually Optional ICM – Require ICM – Require
MRC – Optional MRC – Require MRC – Require
MPA – Support MPA – Support MPA – Insufficient, DOH review required*

*Among its proposals for additional safeguards, the Task Force recommends that, for some research, the Department of Health may, within its discretion, convene a special review panel of experts who will examine the study and issue recommendations to the IRB on whether the study should be approved.