It is important for researchers to keep in mind that risks may vary for particular groups, depending on the nature of the research being conducted. The Code of Federal Regulations at 45 CFR 46 identify three groups for which enhanced protections is required, and classify permissible research involving these protected groups based on degree of risk and type of individual subjects. Click on the links below to learn more about what is required for each of the populations (external link to HHS website).
-Pregnant women, neonates, and human fetuses
In addition to the three groups specified in 45 CFR 46, consider what protections or additional steps may be needed to minimize risk for your study population, such as outlining procedures for consenting individuals with diminished decision-making capacity, or specifying a plan to address incidental findings from your research.
Additional vulnerable groups that may need special protections or considerations are:
Individuals with physical disabilities
Individuals with mental disabilities or cognitive impairments
Economically disadvantaged
Socially disadvantaged
Terminally ill or very sick
Racial or ethnic minorities
Institutionalized persons (for example, persons in correctional facilities, nursing homes or mental health facilities)
See additional guidance and resources below on research involving these populations:
Adults with Impaired Decisional Capacity
Children
According to the New York State Department of Health IRB Guidelines (2016), “Individuals with psychiatric, cognitive, or developmental disorders may have reduced capacity to understand information presented to them. This may limit their ability to give truly informed consent. In addition, such individuals may be institutionalized, which could affect their perceptions of voluntariness. Care needs to be taken to distinguish between persons who are impaired and persons who have a condition that may cause impairment. It would be incorrect to assume that all of the subjects with decisional impairment will lack sufficient capacity to provide consent.
The legal standards for competence include the four related skills of communicating a choice, understanding relevant information, appreciating the current situation and its consequences, and manipulating information rationally. The capacity to provide consent is an essential component of valid consent. Assessment of the capacity to consent is part of the process of obtaining informed consent. The PI (or his/her designee) may only seek consent when he or she is satisfied that the person is capable of making the decision” (p. 53-54).
The researcher is ultimately responsible for ensuring that all subjects are capable of providing informed consent, or that consent is provided by a legally authorized representative (LAR). According to the New York State Department of Health IRB Guidelines (2016, p. 39), the following applies:
“Under DHHS and FDA regulations a “legally authorized representative” means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research. Unless the IRB has waived the requirement to obtain consent, when research involves adults unable to consent, permission must be obtained from a legally authorized representative.
When research is conducted in New York State, the following individuals meet this definition:
A court appointed guardian who is specifically given authorization to consent to participation in research.
In the absence of a court appointed guardian who is specifically given authorization to consent to participation in research, any of the following individuals, as defined in the New York Family Health Care Decisions Act, Mental Hygiene Law, and applicable NYS Public Health Laws:
A court appointed guardian who is specifically given authorization to consent to health care.
A previously designated health care proxy
Spouse (if not legally separated) or domestic partner
Children > 18 years of age
Parents
Siblings > 18 years of age”
Researchers submitting applications to the Keuka College IRB should use the following guidelines when conducting research with adults who may lack the ability to consent to research participation. Please note that these guidelines are general; consent protocols should be individualized to reflect the nature of the research, the characteristics of potential participants, and other variables. Guidelines:
Researchers will identify their intent to include individuals who may have impaired decisional capacity by checking the appropriate box on Section F of the Research Project Protocol.
Researchers will identify a process for determining potential participants’ capacity to consent to research. Options include:
Screening of potential participants through observation, chart review, or consultation. This option should only be used when participants are reasonably expected to lack the ability to give informed consent based on known characteristics (such as individuals with late-stage dementia or individuals with severe intellectual disability), or when individuals have a court-appointed LAR already in place. If in doubt, the researcher should always administer an individual decisional capacity screening.
Screening of potential participants through the “talk back” method, in which participants are provided with consent information and then asked to discuss/explain the required elements of consent. If this method is selected, 1) the researchers can create a simple rubric to document participants’ responses to the required elements of the consent form, or 2) the researchers can use the SUNY Upstate Consent Assessment Tool.
Screening of potential participants through the use of a standardized decisional capacity assessment, such as the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) or the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC).
If individuals are determined not able to give informed consent, the researchers must identify a process for a legally authorized representative (LAR) to give consent. If feasible, the participant should also be given the opportunity to provide assent (see Adult Assent Form).
If individuals are determined able to give informed consent, they should be provided with the Adult Consent form, which should be written in a way that is understandable to them. Researchers are responsible for considering the possibility that participants’ decisional capacity may change as the study progresses. If this could be the case, researchers must identify a plan for assessing and responding to changes in participants’ decisional capacity.
IRB that reviews studies involving children as subjects covered by 45 CFR part 46 subpart D and/or 21 CFR part 50 subpart D may approve only those studies that satisfy the conditions of all applicable sections of those subparts (45 CFR 46.403; 21 CFR 50.50).
In its review of proposed research involving children, the IRB must find that the research meets the conditions of:
1) 45 CFR 46.404 and/or 21 CFR 50.51 (research/clinical investigations not involving greater than minimal risk);
2) 45 CFR 46.405 and/or 21 CFR 50.52 (research/clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects);
3) 45 CFR 46.406 and/or 21 CFR 50.53 (research/clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects' disorder or condition).
If the IRB determines that the proposed research cannot be approved under these categories, then additional regulatory requirements under 45 CFR 46.407 and/or 21 CFR 50.54 (research/clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children) must be met. Both OHRP and FDA have issued guidance to assist IRBs with handling clinical investigations that include children as subjects and that have been referred under 45 CFR 46.407 or 21 CFR 50.54.[8]
In addition to the findings and determinations described above, the IRB must also determine that requirements for permission by parents or guardians and for assent by children are met (45 CFR 46.408; 21 CFR 50.55). If the proposed research involves children who are wards of the State or other agency, institution or entity, then the IRB must ensure that additional requirements are met (45 CFR 46.409; 21 CFR 50.56).
OHRP and FDA recommend that the IRB’s findings and determinations for studies involving children be documented in the minutes.
In most cases, individuals under the age of 18 are not legally able to give informed consent to participate in research. According to the New York State Department of Health IRB Guidelines (2016, p. 41-42), exceptions exist, in NYS, in the following cases:
“Minors, defined as individuals who meet one of the following criteria, do not
meet the DHHS and FDA definition of “children”: (Article 24-A §2504)
Married/widowed/divorced;
A parent;
In the case of medical, dental, health and hospital services relating to prenatal care, a female who is pregnant.
Individuals under the age of 18 when the research procedures are limited to:
Diseases dangerous to the public health;
Chemical dependency (Mental Hygiene Law §22.11) if, in the judgment of a physician, parental or guardian involvement and consent would have a detrimental effect on the course of treatment of a minor who is voluntarily seeking treatment for chemical dependence or if a parent or guardian refuses to consent to such treatment and the physician believes that such treatment is necessary for the best interests of the child.
Prenatal care in the case of pregnant children.
Certain outpatient mental health services as described in Mental Hygiene Law §32.21(c) through §32.21(e).”
Researchers submitting applications to the Keuka College IRB should use the following guidelines when conducting research with children. Please note that these guidelines are general; consent protocols should be individualized to reflect the nature of the research, the characteristics of potential participants, and other variables. Guidelines:
Researchers will identify their intent to include children by checking the appropriate box on Section F of the Research Project Protocol.
Researchers will develop a consent procedure that obtains informed consent from a LAR or another adult who meets the criteria stated above (link).
Researchers will develop a child assent procedure that allows each child the maximum opportunity to understand her/his role in the research study and to express her/his desire for participation or non-participation. If possible, this process should include a written child assent form with developmentally-appropriate language. If a written assent process is not possible, the researcher should explain why not, and provide alternative methods for providing information child participants.