This SOP outlines additional protections that researchers and IRBs should consider when proposed research activities involve potentially vulnerable populations, including students, employees, and adults with impaired decision-making capacity.
The inclusion of certain groups of participants who may be vulnerable to undue influence or coercion may require additional protections. When reviewing research involving vulnerable populations, the IRB applies any additional federal regulations, state and local laws, and institutional policies as applicable. The IRB evaluates whether additional safeguards have been included project to protect the rights and welfare of participants who may be vulnerable to undue influence. The IRB requires at least one or more knowledgeable individuals or have experience in working with these populations to be part of the review process.
3.1. Federal regulations require additional protections for participants vulnerable
to coercion or undue influence, such as children, prisoners, individuals with impaired
decision-making capacity, or economically or educationally disadvantaged persons.
These, and other individuals not specifically named in the regulations, may be
vulnerable to coercion or undue influence because their autonomy is limited in
some way, thereby affecting their ability to provide voluntary, informed consent.
(See SOP 014: Research Involving Children and SOP 047: Research Involving Prisoners.)
3.2. Pressures to participate may be subtle, as when research is conducted in settings
or institutions providing employment or services (e.g., medical care or education).
Individuals may believe that choosing or refusing to participate will influence
access to or the quality of employment opportunities or desired services. Research
should be designed to address any such potential pressures to maintain an individual’s
right to decline participation. Researchers and IRB should consider participant
selection, recruitment, and informed consent processes
3.3. Observation of these consent processes (e.g., by IRB members or other WVU OHRP staff) or other similar protections should be considered when concerns exist about whether potential participants can exercise free choice regarding research participation. Examples include research involving individuals whose willingness to participate may be unduly influenced by the expectation of potential benefits for their disease or condition, or those who may be in a position to fear negative consequences (real or perceived) from a supervisor or other authority figure for refusing to participate.
4.1. Students, including WVU students (e.g., undergrads, graduate students, medical
students, residents, fellows, doctoral students, etc.), can be recruited for research
participation. A student must not be required to participate in research (without
a comparable non-research alternative offered) as a course requirement. Individual
students, nor groups of students, should not be selected solely based on convenience
when they would not otherwise be appropriate for inclusion.
4.2. Recruitment of students as research participants must be designed to minimize
the possibility of coercion or undue influence. In general, potential participants
should be solicited from a broad pool of individuals meeting the conditions for
the research rather than by personal solicitation of specific individuals. Strategies
to minimize the potential influence of an investigator when recruiting their students
include recruitment by general announcements, postings or sign-up sheets, or other
methods that require a student interested in participation to initiate contact
with the researcher(s).
4.3. Researchers and IRBs must consider strategies to ensure voluntary participation
when the participants of research include students who receive instruction directly
from the researcher(s). Young students may volunteer to participate in research
to please a teacher or because they fear that failure to participate will negatively
affect their relationship with the teacher-researcher or faculty in general. Students’
cultural or religious backgrounds may also influence their choices. A student’s
decision about research participation must not affect (favorably or unfavorably)
grades, potential letters of recommendation, or other opportunities or decisions
made by teacher-researchers
4.4. Except in unusual circumstances, researchers should not enroll students from
their classes when the research involves greater than minimal risk without the
prospect of direct benefit to individual participants. Such research should occur
only when the IRB determines that adequate provisions have been made to minimize
the possibility of coercion, and it is determined that the research is of significant
importance and cannot be conducted without the enrollment of these students.
4.5. Additional safeguards may be needed to protect the privacy interests of research
participants when the participants are students. Classroom conditions may make
it difficult for researchers to keep an individual’s participation confidential,
which could pose risks to participants (e.g., when stigma is associated with the
condition or question in the project or when peer pressure is a component of the
research). In such situations, consideration should be given to whether conducting
the research off-site and/or outside of regular school hours may minimize potential
risks.
4.7. Protecting the confidentiality of research participants’ personal information when the participants are students may also present additional challenges. The extent to which personal information and/or research data may be accessible to parents, teachers, or others not directly involved in the research must be considered and disclosed to potential participants and their parents/guardians (as applicable) in the informed consent and assent processes (See SOP 012: Informed Consent Requirements, and SOP 015: Assent and Parental Permission.)
See below for more detailed FERPA and PPRA policies and procedures WVU OHRP and WVU IRB must follow when a research project is supported or funded by Department of Education (ED), or in some instances, research not directly funded by the ED but conducted in a school that receives funding from the ED.
4.8. WVU OHRP promotes compliance with FERPA via IRB review. If the IRB reviewer and/or convened committee is unable to appropriately assess FERPA and ensure compliance, WVU's General Legal Counsel and Ex Officio IRB member(s) will review the project as applicable to FERPA compliance. The IRB or WVU's General Legal Counsel and Ex Officio IRB member(s) may grant exceptions to parental/student consent to release student records for research, or they will identify an individual or committee with the authority to do so as needed.
4.9. An educational agency or institution may disclose personally identifiable information from an education record of a student without consent if the disclosure is to organizations conducting studies for, or on behalf of, educational agencies or institutions to:
4.9.1. Develop, validate, or administer predictive tests.
4.9.2. Administer student aid programs.
4.9.3. Improve instruction.
4.10. A school district or postsecondary institution that uses this exception is required to enter into a written agreement with the organization or researcher conducting the research that specifies:
4.10.1. The determination of the exception.
4.10.2. The purpose, scope, and duration of the study.
4.10.3. The information to be disclosed.
4.10.4. The information from education records may only be used to meet the purposes of the study stated in the written agreement and must contain current requirements in 34 CFR 99.31(a)(6) on re-disclosure and destruction of information.
4.10.5. That the study will be conducted in a manner that does not permit personal identification of parents and students by anyone other than representatives of the organization with legitimate interests.
4.10.6. That the organization is required to destroy or return all personally identifiable information when no longer needed for the purposes of the study.
4.10.7. The time period during which the organization must either destroy or return the information.
4.11. Education records may be released without consent under FERPA if all personally identifiable information has been removed including:
4.11.1. Student's name and other direct personal identifiers, such as the student's social security number or student number.
4.11.2. Indirect identifiers, such as the name of the student's parent or other family members; the student's or family's address, and personal characteristics or other information that would make the student's identity easily traceable; date and place of birth, and mother's maiden name.
4.11.3. Biometric records, including one or more measurable biological or behavioral characteristics that can be used for automated recognition of an individual, including fingerprints, retina and iris patterns, voiceprints, DNA sequence, facial characteristics, and handwriting.
4.11.4. Other information that, alone or in combination, is linked or linkable to a specific student that would allow a reasonable person in the school community, who does not have personal knowledge of the relevant circumstances, to identify the student with reasonable certainty.
4.12. WVU OHRP promotes compliance with PPRA via IRB review. If the IRB reviewer and/or convened committee is unable to appropriately assess PPRA and ensure compliance, WVU's General Legal Counsel and Ex Officio IRB member(s) will review the project as applicable to PPRA compliance. The IRB or WVU's General Legal Counsel and Ex Officio IRB member(s) may grant exceptions to parent/student consent to release student records for research, or they will identify an individual or committee with the authority to do so as needed.
4.13. No student shall be required, as part of any research project, to submit without prior consent to surveys, psychiatric examination, testing, or treatment, or psychological examination, testing, or treatment, in which the primary purpose is to reveal information concerning one or more of the following:
6.1. WVU students are offered the opportunity to participate in research (as participants)
in various ways. Examples include participation for credit as part of a course
requirement, for extra credit in a course, or in exchange for payment. A student
must not be required to participate in research for course credit unless a comparable
non-research alternative is also offered.
6.2. To minimize the potential for coercion, alternatives to participating in research
for course credit must be comparable in terms of time, effort, and fulfillment
of course requirements. Examples include reading and/or writing research papers,
attending research presentations offered by faculty, or observing the performance
of research projects.
6.3. All research participants, including students, must be free to withdraw from
participation at any point in a project without penalty. Students who withdraw
from a research project for course credit must receive full course credit for participation.
When payment is offered, credit for payment should accrue as the project progresses
(as appropriate to the research) and should not be contingent upon the student
completing the entire project.
6.4. Project-specific informed consent is required as described in SOP 012: Informed
Consent Requirements and SOP 016: Documentation of Informed Consent Process. Parental
permission and assent are required for any student who meets the legal definition
of a child/minor (See SOP 014: Research Involving Children).
6.5. The policy and procedures for offering extra credit as an incentive to WVU students for voluntary participation in research are outlined below:
6.6.1. The department wishing to offer extra credit as an incentive to student research
participation develops and submits an Extra Credit Policy Plan to WVU OHRP.
6.6.2. The WVU IRB Chair Committee reviews and approves the Extra Credit Policy Plan.
6.6.3. Upon approval, the department will receive an Extra Credit Policy Approval
Letter.
6.6.4. After receiving the approval letter, researchers can submit research protocols
providing extra credit opportunities to potential student participants
6.6.5. When a protocol is submitted for review, the reviewer(s) and/or WVU OHRP staff
should verify that an Extra Credit Policy Plan is on file for that department before
approval of the protocol.
6.6.6. If an Extra Credit Policy Plan is not on file, the reviewer(s) and WVU OHRP staff should inform the PI so that an Extra Credit Policy Plan can be submitted for review, or the extra credit language should be removed from the protocol.
7.1. Employees, including university employees (e.g., full-time, part-time, temporary,
visiting, student employee appointments, etc.) may be recruited for research participation.
However, an employee must not be required to participate in research as a condition
of employment. Individual students, nor groups of students, should not be selected
solely based on convenience when they would not otherwise be appropriate for inclusion.
7.2. Recruitment of potential participants who are employees must be designed to minimize
the possibility of coercion or undue influence. In general, potential participants
should be solicited from a broad pool of individuals meeting the conditions for
project, rather than from individuals who report directly to the researcher(s).
Strategies to minimize the potential influence of a researcher when recruiting
their employees include recruitment through a third party unassociated in a supervisory
relationship with the employee, postings or sign-up sheets, or other methods that
require an employee interested in participation to initiate contact with the researcher(s).
7.3. Researchers and IRBs must consider strategies to ensure voluntary participation
when the participants of research include employees who are directly supervised
by the researcher(s). An employee’s decision about research participation must
not affect (favorably or unfavorably) performance evaluations, career advancement,
or other employment-related decisions made by peers or supervisors.
7.4. Except in unusual circumstances, researchers should not enroll employees under
their direct supervision when the research involves greater than minimal risk without
the prospect of direct benefit to individual participants. Such research should
proceed only when the IRB determines that adequate provisions have been made to
minimize the possibility of coercion, and it is determined that the research is
of significant importance and cannot be conducted without the enrollment of these
employees.
7.5. Additional safeguards may be needed to protect the privacy interests of employees
who are also research participants. Workplace conditions may make it difficult
for researchers to keep an individual’s participation confidential, which could
pose risks to participants (e.g., when stigma is associated with the condition
or question under project or when peer pressure is a component of the research).
In such situations, research should be conducted off-site and/or outside of regular
work hours, when possible, to minimize potential risks.
7.6. Protecting the confidentiality of research participants’ personal information
when the participants are employees may also present additional challenges. The
extent to which medical information and/or research data may be accessible to supervisors
or others not directly involved in the research must be considered and disclosed
to potential participants in the informed consent process (See SOP 012: Informed
Consent Requirements).
7.7. In cases where regular workplace activities are also the research topic, researchers must clarify for potential research participants those activities that are optional and distinct from any mandatory workplace activities that would occur even without the research. When access to individuals or the site's facility is needed for recruitment and/or research activities, a letter of support from someone authorized to speak on behalf of the employees/site may be required.
8.1. Impaired decision-making capacity comprises a broad range of conditions. Examples
include healthy individuals in shock (temporary decisional impairment), those born
with severe intellectual disabilities (permanent decisional impairment), individuals
with age-related dementia (progressive decisional impairment,) individuals with
mental illnesses such as schizophrenia (fluctuating capacity), and individuals
under the influence of certain drugs (temporary and/or fluctuating capacity). Generally,
all adults should be presumed capable of providing informed consent unless there
is either specific evidence that an individual’s condition/disability would impair
reasoning or judgment or another indication that the individual is unable to understand
and choose whether or not to participate in research.
8.2. Researchers and IRBs should consider the capacity of potential research participants
to provide informed consent. Methods to assess capacity appropriate to the research
should be included when necessary. Key factors in individuals’ consideration of
research participation include an appreciation of how the risks, benefits, and
alternatives to participation apply to them personally. When the research involves
greater than minimal risk, an independent assessment of the potential participant’s
capacity to consent should be performed (or confirmed), except in unusual circumstances
where the IRB determines that the research is of critical importance and could
not be conducted if the independent assessment were to be required. Methods to
provide independent assessments include subjective assessments made by a qualified
professional independent of the research team or use of a valid objective instrument(s)
designed to evaluate capacity.
8.3. Federal regulations require additional safeguards to protect the rights and welfare
of research participants who are likely to be vulnerable to coercion or undue influence.
Among others, the regulations include children and individuals with impaired decision-making
capacity in this category. When children are the and adults with impaired decision-making
capacity are included in the research and the ability to provide informed consent
is in question, obtaining assent may be an appropriate safeguard (see “Assent of
Adults” below). Additional protections for adults with impaired decision-making
capacity should be proportional to the severity of the decisional impairment and
level of risk.
8.4. Researchers and IRBs should consider the following in their decision to enroll adults with impaired decision-making capacity:
8.5. Researchers and IRBs should consider additional safeguards, balancing the need for protection with the individuals’ right to autonomy. Examples of additional safeguards include (but are not limited to) the following:
8.6. Regulations require that IRBs regularly review research involving vulnerable
participants consider including one or more individuals who are knowledgeable about
and experienced in working with these participants. When reviewing research involving
adults with impaired decision-making capacity, WVU OHRP and WVU IRBs will include
an individual with appropriate background, knowledge, and experience, and/or a
representative of the relevant advocacy group as a member or consultant to the
IRB.
8.7. For more information about the requirements for involving adults with impaired decision-making capacity in research in life-threatening situations, see SOP 053: Emergency Use of Investigational Drugs, Biologics, or Devices and SOP 054: Planned Emergency Research
9.1. An adult with impaired decision-making capacity or other adult cognitively unable
to provide informed consent may participate in research only if a legally authorized
representative for that adult can give consent for participation in the research,
unless the requirement to obtain informed consent is waived by the IRB. If the
participant regains (or develops) the capacity to consent, then their informed
consent must be obtained for any further research, as the consent of the legally
authorized representative is no longer valid.
9.2. An adult with impaired decision-making capacity may be able to assent to participation.
The IRB is responsible for determining when the assent of some or all such adults
is required in proposed research and the appropriate method for documenting the
adult’s assent (if any), as described below.
9.3. Assent to participate in research by an adult with impaired decision-making capacity
(for whom a legally authorized representative will provide informed consent) is
to be obtained when, in the judgment of the IRB, the adult is cognitively capable
of providing assent. In determining whether proposed participants are capable of
providing assent, the IRBs will take into account the condition and psychological/emotional
states of the adults involved. The IRB’s determination of the participant’s capacity
to assent may apply to all or only some of the adults to be involved in a proposed
research activity.
9.4. Assent processes are to include the key elements of informed consent described
in SOP 014: Informed Consent Requirements and are to be provided in language appropriate
for an adult with impaired decision-making capacity, based on the nature of the
research and the expected ability of the prospective participant(s) to understand
the purpose and the procedures involved in the research.
9.5. The assent of adults with impaired decision-making capacity to participate in research is to be obtained, except in any of the following circumstances:
9.6. The IRB may determine that assent of some or all of the adults is not required.
If assent is not a requirement of some adults, the IRB will indicate which adults
(e.g., individuals with severe dementia) are not required to assent
9.7. When the assent of an adult with impaired decision-making capacity is required,
the IRBs must determine the appropriate method of documenting assent (if any).
This decision should be based on considerations such as the length and complexity
of the research and the adult’s condition and psychological/emotional state.
9.8. When documentation of assent is required, either of the two options below are considered adequate:
Please note: The IRB can also approve assent forms or revised consent documents
on a case-by-case basis in other formats to satisfy requirements for obtaining
and documenting assent of adults with impaired decision-making capacity.
9.9. When assent is not documented by use of a form or method as described above,
documentation of assent may be limited to verifying that assent took place using
a witness or other method. The IRB may also decide that documentation of assent
is not warranted. If verbal assent will be obtained, the IRB must review a written
description of the information (i.e., script) that will be provided to participants
during the assent process.
9.10. In some research, such as longitudinal projects involving progressive disorders
or aging populations, participants may be able to provide informed consent at the
beginning of their participation but may experience progressive or intermittent
symptoms that lead to decisional impairment during participation in the project.
In these situations, researchers should consider the need to discuss with prospective
participants whether the participant should designate someone at the beginning
of the project to serve as a legally authorized representative in the case that
the participant’s ability to assess their own needs/interests becomes compromised
during the project.
9.11. For cases in which the authority of a legally authorized representative for an adult participant’s participation in research is unclear, researchers and IRBs should consult with WVU’s General Counsel for Research for guidance.
WVU Policies:
SOP 012: Informed Consent Requirements
SOP 014: Research Involving Children
SOP 015: Assent and Parental Permission
SOP 016: Documentation of Informed Consent Process
SOP 047: Research Involving Prisoners
SOP 053: Emergency Use of Investigational Drugs, Biologics, or Devices
SOP 054: Planned Emergency Research
Federal Regulations:
21 CFR 56.111
45 CFR 46.111
AAHRP:
Standard II.4
