Vulnerable Populations 45 CFR 46.111(b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards should be included in the study to protect the rights and welfare of these subjects. Some populations are inherently vulnerable due to a lack of autonomy or ability to understand research procedures. Enrolling these population in prospective research requires specific IRB approval. When completing the Initial Review Application, you will be asked to identify any of the following categories of vulnerable participants will be recruited/enrolled into your study. Children/Neonates Definition Children are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted. What is the requirement? Research must be specifically approved to include children. The regulations that the Einstein IRB follows when reviewing research involving children include: Subpart D – Additional Protections for Children Involved as Subject in Research 46.404 Research not involving greater than minimal risk. 46.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects. 46.406 Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject’s disorder or condition. How do I comply with this requirement? Initial Review Application: On the Vulnerable Participants page of the Initial Review Application, select the box for “children” if your research will include this group. You will be asked for additional details about the research. Regulations require that research fall under an approval category before children can be included. Please select the applicable category for your research and provide protocol specific justification for inclusion. Minimal Risk Research Greater than Minimal Risk Research with prospect of direct benefit Greater than Minimal Risk with no prospect of direct benefit Parental Permission: Unless the IRB has issued a waiver, parental permission will be required. Generally, one parent’s signature is required for minimal risk research or greater than minimal risk research with the prospect of direct benefit to the child. In contrast, both parents’ signature are required for greater than minimal risk research with no prospect of direct benefit to the child. Review our consent process and consent documentation guidance (on our Policies and Procedures page for information about waivers. Assent: Assent should be obtained whenever the children involved in the research are capable of comprehension and agreement. Below is the list of options provided, you should select all that apply: Assent will be obtained from all children capable of assenting Assent will not be obtained from children capable of providing assent Assent will not be obtained from any children If assent will not be obtained from some or all of the children, you will need to provide justification in a free text field in the initial review application. The UC Davis IRB does not generally require a separate assent document. Assent is documented in the Children’s Signature Block on the consent template. Ethical Considerations The research team and the IRB will need to consider the following criteria when evaluating research involving children: Risks presented to the children are not greater than minimal unless the adequate provisions are in place. In greater than minimal risk research involving children, the risk is justified by the prospective benefit. The anticipated benefit is favorable to the subjects There are adequate provisions in place regarding assent and parental permission In the case of greater than minimal risk research has no prospect of direct benefit to subjects, but will likely generate generalizable knowledge, the IRB must also consider whether: The risk is a minor increase over minimal risk The research procedures presented to the subjects are commensurate to those in their actual or expected medical or educational situations Generalizable knowledge is likely to be obtained Adequate provisions are in place for assent and parental permission Research with no prospect of direct benefit will present an opportunity to understand, prevent, or alleviate a serious problem Prisoners Definition A Prisoner is any individual involuntarily confined or detained in a penal institution. What is the requirement? Research must be specifically approved to include prisoners. The regulations that the Einstein IRB follows when reviewing such research include: Subpart C – Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects 46.306 Permitted research involving prisoners How do I Comply with this requirement? Initial Review Application: On the Vulnerable Participants page of the Initial Review Application, select the box for prisoners if this group may be recruited for your research. Note, the state of California does not allow state prisoners to be enrolled in clinical trials or other biomedical studies. Ethical Considerations Along with the requirements of subpart A, an IRB must make the following seven additional findings required by the regulations in order to review and approve research involving prisoners: The proposed research must fall into one of the categories under 45 CFR46.306(a)(2); The advantages associated with participation in the research should not be of such a magnitude that his or her ability to weigh the risks of the research against the value of receiving such advantages in the limited-choice prison environment is impaired; The risks are commensurate with risks that would be accepted by non–prisoner volunteers; Selection of subjects in the prison are fair to all prisoners, unless justification is provided by the principal investigator; The information presented in language that is understandable; Adequate assurances are in place that prevent a prisoners participation in the research to be taken in account by the parole board; If there is a need for follow-up with the prisoner after the research has concluded, provisions will be put in place for those examinations, and prisoners will be informed of this beforehand. Cognitively Impaired Adults Definitions Cognitively Impaired Adult means a person who has reached the legal age of consent but lacks the decision making capacity to comprehend the consent process and voluntarily choose to participate in research. Legally Authorized Representative (LAR) 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. If there is no applicable law addressing this issue, legally authorized representative means an individual recognized by institutional policy as acceptable for providing consent in the non–research context on behalf of the prospective subject to the subject’s participation in the procedure(s) involved in the research. What is the requirement? Adults who lack capacity to consent may only be enrolled in research studies relating to the cognitive impairment, lack of capacity, or serious or life-threatening diseases and conditions specific to the research subjects when the necessary study cannot be conducted using subjects who are not cognitively impaired. How do I Comply with this requirement? Initial Review Application: On the Vulnerable Participants page of the Initial Review Application, select the “Cognitively Impaired Adults” box when some or all of the research subjects may be adults who lack capacity to provide consent for participation in research. You will be asked to provide the following details about your consent process: Describe your process for determining whether an adult has capacity to consent: Will assent be obtained from all adults who lack capacity to consent and are capable of assenting? If research subjects regain capacity, will you obtain their consent? Ethical Considerations The IRB may approve the use of a LAR only in research studies relating to the cognitive impairment, lack of capacity, or serious or life-threatening diseases and conditions of the research subjects when the necessary study cannot be conducted using subjects who are not cognitively impaired. Some populations require additional protections only in specific situations. Targeted participants are groups that are capable of providing informed consent, however, there are additional considerations if the category of participant is targeted for research or if subjects’ status as a member of the population is recorded as part of the research data. The Initial Review Application will ask you to identify any of the following categories of vulnerable participants that will be targeted for prospective research: Pregnant participants/fetuses; students or direct reports of the PI; undocumented individuals; members of underserved communities; members of populations underrepresented in scientific research; members of populations experiencing disparities in health and/or access to health care.. Research does not need to be specifically approved to include populations listed under targeted participants. However, if these populations are specifically targeted for recruitment as part of the research, then the IRB must take this into account during review. Pregnant Participants/Fetuses Definitions A woman is assumed pregnant if she exhibits any of the qualified signs of pregnancy, such as missed menses, until the results of a pregnancy test are shown negative or until delivery. What is the requirement? The regulations that the UC Davis IRB follows when reviewing such research include: Subpart B – Additional Protection for Pregnant Women, Human Fetuses and Neonates in Research 46.204 Research involving pregnant women or fetuses. 46.205 Research involving neonates. 46.206 Research involving, after delivery, the placenta, the dead fetus or fetal material. 46.207 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates. How do I Comply with this requirement? Initial Review Application: On the Targeted Participants page of the Initial Review Application, select the box for “Pregnant Women/Fetuses” only if your research is targeting recruitment of either group or if a participant’s pregnancy status will be recorded as part of the research data. If are not targeting enrollment of pregnant women/fetuses and your research does not allow you to determine a woman’s pregnancy status, you do not need to select the box. Ethical Considerations Research must be considered ethically justified and satisfy a variety of conditions: Reasonable prospects the investigation will produce the desired results; A balance of potential benefits in relation to the potential risks; A justification for why the research is necessary; Monitoring for outcomes and the protection of human subject; and The benefits and burdens of the research are distributed evenly among potential subject groups. Students or Direct Reports of the PI What is the Requirement? Investigators should not use students of their classes as a convince sample for research. Whenever possible, researchers should collect information from participants who are not subject to the power dynamic of a teacher-student relationship. How do I Comply with this Requirement? Initial Review Application: On the Targeted Participants page, select the “Students or Direct Reports of The Principal Investigator” box only when the research seeks to enroll students or direct reports of the PI. If your research is not targeting either of these populations and the data you are collecting does not allow you to determine if the participants are students of the PI, you do not need to select the box. Ethical Considerations Because of the power relationship between students and their teachers, students may feel pressured to participate in research. Similarly, because of the power relationship between a supervisor and their direct reports, direct reports may feel pressured to participate in research. The IRB will determine if there are adequate protections to allow participants to choose to enroll in research without undue influence or coercion.
