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Vulnerable Populations and Other Ethical Considerations
Certain populations are considered more vulnerable than others because of their particular conditions or situations in life. Research involving vulnerable populations requires additional protections that must be described in your proposal. The following is a list of some, but not all, potentially vulnerable populations. See below for a list of precautions to be taken for each of these groups.
- Decisionally impaired individuals
- Students or college employees
- Institutionalized individuals
- Economically or educationally disadvantaged individuals
- Non or limited English speaking people
- People living outside the US
- HIV-positive individuals
Other Ethical Considerations
Other things to consider in your research design are:
- How subjects will be recruited
- Payments to subjects
- Deception in research
- Research involving sensitive subjects
Children (defined as anyone under 18 years of age) can participate as research subjects only if the research meets certain standards. Specifically, the research may not be greater than minimal risk unless it provides a direct benefit to the child.
Written parental/guardian permission is required for studies involving children and, depending on the nature of the research and the availability of both parents or multiple guardians, the IRB may require that one or both parents/guardians provide written consent. Once parental/guardian permission has been obtained, the agreement or assent of the child is required.
The child's assent is documented with an assent form, a child-friendly document that outlines the essential information about the research. While the parents/guardians must provide legal consent for the child to participate in research, the child must always assent to his/her own participation; assent being an active affirmation of a desire to participate. Children who are able to read and write (usually grades 4 and older) should participate in the consent process by using an assent form written in language especially for the child. Forms available here: https://nook.marlboro.edu/public/academics/irb/forms
Research with children will be reviewed by the full IRB at a convened meeting. [url=https://nook.marlboro.edu/public/academics/irb/informed_concent]Please see the Informed Consent page for more information about obtaining informed consent in research done with children.[/url]
A prisoner is defined by federal regulations as any individual involuntarily confined or detained in a penal institution. This definition includes individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, as well as individuals being held prior to arraignment, trial or sentencing.
Research involving prisoners must have as its goal either a direct benefit to the individual subject or seek an understanding of issues and conditions specific to prisoners.
Research with prisoners will be reviewed by the full IRB at a convened meeting.
Decisionally Impaired Individuals
Decisionally impaired individuals are those who have a diminished capacity for decision-making and who may be unable to fully understand the risks of research. Research may only involve decisionally impaired individuals if it offers a direct benefit to the individual subject or to the subject's class or condition. If the subjects are not capable of giving consent for themselves, it must be obtained from their legal guardians. In that case assent from the subject must be obtained.
Marlboro College Students or Employees as Research Subjects
Students recruited as participants in faculty- or staff-initiated research, and employees recruited for research initiated by Marlboro faculty, staff or students, are considered vulnerable populations and special considerations apply for engaging them in research. Investigators should pay particular attention to the circumstances surrounding the research and whether the students/employees may feel pressured to participate in research because of their relationship with the investigator.
Investigators recruiting students or employees in research should:
- Make sure that subjects know that they may choose not to participate in the research and that the decision will not affect their grade/class standing or employment.
- Avoid using Marlboro College students, staff, or faculty strictly for convenience purposes – the population should be appropriate for the study.
- Research with students and employees may be expedited or exempted from continuing IRB review if it is minimal risk.
Institutionalized individuals, such as those at mental health institutions require special consideration. Written permission for the conduct of the research at the institution must be obtained from the appropriate officials at that institution. In addition, if the subjects are not capable of giving consent for themselves, it must be obtained from their legal guardians. In that case assent from the subject must be obtained.
Economically or Educationally Disadvantaged Individuals
Economically or educationally disadvantaged individuals may be particularly vulnerable to the risks of research. Educationally disadvantaged subjects may not be able to fully understand the concepts presented by the research and the investigator should take extra precautions to ensure that the subjects fully understand what is being asked of them.
Similarly, economically disadvantaged subjects may be easily persuaded to participate in research if the economic compensation is so great that it would result in the subject ignoring or disregarding the research risks because of the income generated by the study. In such cases investigators should be careful to set economic compensation at a meaningful level that compensates the subject for her/his time, but it not so great that it becomes coercive. It is also important in such cases that the risks to the subjects be made clear to the subjects.
Research with economically or educationally disadvantaged individuals may be expedited if it is minimal risk.
Non or Limited English Speaking people
Researchers should carefully consider the inclusion or the exclusion of potential participants who have limited literacy and/or English language skills. The ability to understand information about the research and provide voluntary consent is key to the autonomy of and respect for research subjects. The IRB is tasked with ensuring that the proposed research includes a consent process in the language most appropriate for the subjects.
If your potential participants speak English, but are unable to adequately read a consent document, a verbal consent process may be more appropriate. An oral consent script (i.e. what information will be read to and discussed with the participant) should be submitted for IRB review. For participants whose native language is not English, the researcher must carefully consider how these individuals would be consented into the study. If the study targets non-English speakers or if the majority of the participants are expected to be non-English speakers, then the consent process should be conducted in the language appropriate to those participants. An English version and a fully translated version of the consent form should be submitted for IRB review. The IRB would also expect that the study instruments (e.g. survey questions, interview questions, etc.) would also be translated into the appropriate language. The IRB should be informed of the researcher's ability and qualifications to conduct the consent and the research in a language other than English.
People living outside the US
Investigators conducting international research must provide the IRB with sufficient information on the setting(s) including any cultural or language considerations of the research, and demonstrate to the IRB that they have the necessary permissions to conduct the research in that setting. It is often helpful to have local collaborators involved in the study (as co-investigators, interpreters, community liaisons, etc.).
Research that requires oversight of multiple review boards should be appropriately planned for in your study timeline.
HIV Positive Individuals
HIV positive individuals will be considered a vulnerable population because of the risks of social stigma, employability and insurability facing them if their HIV status were revealed. The College will comply with federal and state guidelines, including those concerning notification of seropositivity, counseling, and safeguarding confidentiality where research activities directly or indirectly involve the study of human immunodeficiency virus (HIV).
Research with HIV+ individuals will be reviewed by the full IRB to ensure that the subjects' rights and privacy are thoroughly safeguarded. At such a review the IRB may determine that a particular research study is sufficiently low in risk so as to allow continuing review to be conducted on an expedited basis. Research about HIV/AIDS that does not include HIV+ individuals may be considered expeditable.
Recruitment and Advertisements
The IRB must review and approve all advertisements and recruitment materials before they can be used. If they are not submitted at the time of initial IRB review and approval, they must be submitted as an amendment before recruitment is initiated.
Advertisements/flyers should contain the following information:
- Names and contact information of the investigators
- Marlboro’s name and the researcher's affiliation
- Purpose of the research
- General eligibility criteria
- Accurate and honest description of benefits and/or compensation (free treatment, payment)
- Advertisements should not make extravagant claims, use attention-getting techniques, nor pressure readers to participate.
Payments to Subjects
It is sometimes appropriate to offer payment to subjects as compensation for their time and involvement and to cover expenses incurred by their participation. However, it is not appropriate to offer payment that is so high that it would encourage an individual to ignore or disregard the research risks – this amount can vary depending on the research population. Excessive compensation, whether in the form of money or in-kind payments, is coercive and will not be allowed.
Deception in Research
The use of deception in research raises special problems that the IRB will review closely. One consideration is whether the deception is necessary. An investigator proposing to use deception should justify its use. Deception should not be used if it places subjects at greater than minimal risk. The IRB may modify the normal informed consent process for research involving deception when subjects are not placed at risk. However, potential participants should be advised in the consent form that the information they are given is not complete and they should also debriefed after the research procedures are completed.
The debriefing should include a detailed description of the ways in which deception was used. The investigator is responsible for ensuring that the subject leaves the research setting with an accurate understanding of the deception. The debriefing process, including any written materials, should be explained to the IRB as a part of submitted protocols. The following statement, or some similar statement, must appear in every consent form/information sheet for studies involving deception:
Some research designs require that the full intent of the study not be explained prior to participation. Although we have described the general nature of the tasks that you will be asked to perform, the full intent of the study will not be explained to you until after the completion of the study. At that time, we will provide you with a full debriefing which will include an explanation of the hypothesis that was tested and other relevant background information pertaining to the study. You will also be given an opportunity to ask any questions you have about the hypothesis and the procedures used in the study.
Any interview, survey, or questionnaire that proposes to investigate opinions, behaviors, and/or experiences regarding, but not limited to, any of the following sensitive subjects requires IRB approval:
- Sexual orientation, incest, rape, sexual molestation, deviant sexual behavior or attitudes regarding sexual conduct (pedophilia, bestiality, etc.), practices of contraception, abortion, and/or pregnancy
- Substance use and/or abuse (including but not limited to: alcohol, marijuana, steroids, amphetamines, narcotics, and any prescription medication legally or illegally obtained)
- Questions about mental health (e.g. suicide, depression, obsessive compulsive behaviors like smoking, eating, gambling, etc.)
- Illegal or taboo behavior
- Traumatic experiences of an individual, including war or combat experiences of veterans