To provide written guidelines regarding additional protections for vulnerable subjects enrolled in research.
Federal Regulations require that Institutional Review Boards (IRBs) give special consideration to protecting the welfare of particularly vulnerable subjects participating in research. The Cottage Health System IRB considers populations likely to be vulnerable to coercion and undue influence, and those with diminished autonomy, to warrant additional considerations and protections regarding research oversight.
This policy currently reflects:
• 21 CFR 56 – IRB Functions and Operations
• 45 CFR 46 – Protection of Human Subjects
Vulnerable populations include those whose diminished autonomy compromises their ability to give informed consent to participate in research. Children, pregnant women, fetuses, the mentally handicapped, prisoners, and the economically or educationally disadvantaged are among the groups most often identified as being vulnerable. However, depending on the context of the research or other circumstances, numerous other groups may also be considered vulnerable. As a rule, anyone in a situation where his or her ability to give informed consent is compromised or eliminated should be considered vulnerable.
At the time of IRB review, each research study is evaluated for the possibility of enrolling vulnerable populations. Protocols which are specifically designed to include research on vulnerable populations (e.g. pediatric research) will initially be reviewed by the Full Board. The IRB shall evaluate the risks and benefits of the research, and ensure that the consent form properly conveys the nature, magnitude and probability of the risks and benefits clearly and accurately. The IRB will review the recruitment and consent processes to ensure that subjects are properly informed and not misled. The IRB will determine if additional safeguards are required. If regulations allow, it will also determine if the risks warrant the ability for the study to be reviewed by expedited review at future renewals.
Approval for research studies involving vulnerable populations is considered, if one of the following conditions is met:
- The research does not involve more than minimal risk to the participant;
- The research is likely to benefit the participant directly, even though the risks are considered to be more than minimal; or
- The research involves greater than minimal risk with no prospect of direct benefit to individual participants, but is likely to yield generalizable knowledge about the participant's disorder or condition.
Not all research is specifically designed to enroll a vulnerable population group; however, the type of research reviewed by Cottage Health System IRB affords a high likelihood of enrolling vulnerable individuals. The IRB shall pay careful attention to research involving such special classes of subjects, and shall consider requiring special procedures for protecting the rights and well-being of these subjects on a case-by-case basis.
VULNERABLE POPULATIONS IDENTIFIED BY FEDERAL REGULATIONS
Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research (45 CFR 46, Subpart B)
Special regulatory requirements govern the participation of pregnant women in research [45 CFR 46 Subpart B]. Research involving women who are or may become pregnant receives special attention from IRBs because of women's additional health concerns during pregnancy and because of the need to avoid unnecessary risk to the fetus. Please see IRB Policy 8012.29 IRB Guidelines for Research on Pregnant Women and Fetuses.
Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects (45 CFR 46, Subpart C)
Due to the special circumstances and stringent requirements set forth under 45 CFR 46, Subpart C, the Cottage Health System Institutional Review Board does not review research on prisoners. For special exceptions pertaining to research subjects who become incarcerated while enrolled in a research study, see IRB Policy 8012.28 Prisoners as Research Subjects.
Additional Protections for Children Involved as Subjects in Research (45 CFR 46, Subpart D)
Children are considered a vulnerable research population because their emotional and intellectual capacities may be limited and they are not of a legal age to give informed consent. The IRB is responsible for assuring that principal investigators conducting research with children comply with additional requirements as set forth by the Department of Health and Human Services in 45 CFR 46 Subpart D and Food and Drug Administration regulations at 21 CFR 50 Subpart D. During its deliberations, the IRB will consider the degree of risk and potential benefit of the proposed activity and whether it is appropriate to obtain the assent of the minor. Please see IRB Policy 8012.20 Children’s Assent Guidelines.
ADDITIONAL CLASSES OF RESEARCH SUBJECTS WHICH MAY REQUIRE SPECIAL CONSIDERATIONS AND PROTECTIONS
In addition to the vulnerable populations addressed in the federal regulations, the IRB shall consider the need to provide additional protection to other potentially vulnerable populations. Research subjects which may be defined as vulnerable can vary from institution to institution and from study to study. The following list of individuals has been identified as those which may need special consideration and protections:
- Acutely Ill Individuals
Individuals with acute medical conditions, such as those being admitted to the Emergency Department are unlikely able to provide informed consent. The emergent need for treatment may not allow sufficient time for even surrogate consenters to fully consider the research prior to enrolling. The lack of time and autonomy of the patient, coupled with the urgent need for care creates a circumstance of vulnerability for these individuals.
- Decisionally Impaired Individuals
For all research involving patients who lack capacity to consent or are decisionally-impaired, the capacity of the potential research subject shall be assessed prior to their enrollment and then periodically throughout the course of the research; it will never be presumed that a patient’s condition renders him/her incompetent. A legally authorized representative may consent to an individual's participation in research under the appropriate circumstances. Under limited circumstances, as determined by the IRB and based on risk, potential benefit, and the urgency of initiating treatment, approval for consent to be given by a surrogate such as next-of-kin may be granted for a protocol. Approval for the use of surrogate consent will be considered by the IRB for individual protocols in accordance with current federal and state regulations and guidance. See IRB Policy 8012.07 Guideline for Surrogate Consenting.
- Economically Disadvantaged Persons
The two primary reasons why economically disadvantaged individuals may need special considerations are:
- The possibility of undue influence of enrolling because of the amount of remuneration a participant may receive;
- The possibility of receiving otherwise unaffordable medical care and medications.
- Educationally Disadvantaged Persons
Obviously, if a potential research subject is unable to read and/or comprehend the nature of the research and the expectations or risks they may be exposed to, they are vulnerable to not being able to make a fully informed decision.
- Elderly/Aged Persons
As individuals grow older, their cognition may decline creating a constant or fluctuating lack of capacity. Such lack of capacity may not be readily recognizable by the investigator (especially if it is inconsistent or worsens over time while the person is enrolled in the research), making it possible for an investigator to enroll an individual in research who has not truly made a fully informed decision. This can be even more deleterious for elderly research subjects, because their age and health can potentially make them more sensitive to study procedures, and thus to adverse risks and side effects.
- Incapacitated Persons
Persons who are incapacitated may be helpless or powerless by illness or injury, including conditions such as lack-of-consciousness. This category may also include individuals who are incapacitated as a result of prescribed sedatives, anesthesia, or other medication. Other examples include: persons under the influence of, or dependent on, drugs or alcohol; those suffering from degenerative diseases affecting the brain; terminally ill patients; and persons with severely disabling physical handicaps.
- Individuals with Handicaps
Although mental incapacities are most frequently discussed regarding special classes of subjects, physical handicaps can also impact an individual’s decision-making capacity. Two primary examples include vision- and hearing-impairment, either of which can negatively affect a person’s ability to understand the research and/or comprehend the consent document.
- Mentally Disabled Persons
See Decisionally-Impaired Individuals above for more information.
Although being a member of a minority group does not in-and-of-itself designate vulnerability, cultural norms and language barriers can influence and potentially negatively affect an individual’s decision-making capacity.
- Students and Employees
The primary reason this group of individuals is considered vulnerable is due to the possibility of coercion. When an individual is in a situation where s/he may be positively or negatively affected for participating or abstaining, the individual loses his/her autonomy.
- Terminally Ill Patients
Terminally ill patients are those who are deteriorating from a life-threatening disease or condition for which no effective standard treatment exists. It is generally considered unacceptable to ask such persons to participate in research for which alternative, not similarly burdened, populations of subjects exist. Nevertheless, it may often be necessary to involve terminally ill patients in research concerning their disease and its treatment. Further, terminally ill persons should not be excluded from research in which they may want to participate simply because of their status. One can imagine that altruism and a desire to bring good from adversity may well motivate persons suffering from life-threatening illnesses to become involved in biomedical or behavioral research. Still, terminally ill individuals are a vulnerable population of research subjects, and therefore, require additional protection against coercion and undue influence [45 CFR 46.111(b)].
COTTAGE HEALTH SYSTEM POLICY
|ORIGINAL POLICY EFFECTIVE DATE:
||11/05 , 5/11
||4/06, 1/08, 1/09