Justification of Sample Size
Women and Minority Populations
Vulnerable Populations
Payments to Subjects
Recruitment & Advertisements
Deception in Research
Gathering Information About Individuals or Research on “Secondary Subjects”
Use of Biological Agents & Radioactive Isotopes
Research should seek to engage a number of subjects sufficient to answer the research question posed and no more. Investigators should identify in the protocol the number of subjects required to conduct the study and provide justification for this amount.
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The benefits and burdens of research should be distributed fairly within society and investigators should always seek racial and gender equity in the recruitment of subjects. The specific exclusion of women or any group of minorities must be justified in the protocol. Investigators are expected to seek subjects appropriate for the study, and not merely convenience samples.
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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 the protocol. The following is a list of some—but not all—potentially vulnerable populations (see below for specific precautions to be taken for these groups):
- children
- prisoners
- pregnant women and fetuses
- decisionally impaired individuals
- students or college employees
- institutionalized individuals
- economically or educationally disadvantaged individuals
- HIV-positive individuals
Children in Research
Children (anyone under 18 years of age) can participate as research subjects only if the research meets certain standards, defined in the federal regulations (Subpart D of 45 CFR 46). 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. (See also section on Assent.)
Research with children will be reviewed by the full IRB at a convened meeting.
Prisoners
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.
Pregnant Women, Fetuses and Neonates
Research on pregnant women, fetuses and neonates may not include invasive procedures unless it provides a direct benefit to the mother and only exposes the fetus to minimal risk.
Survey and interview based research involving pregnant women may be expedited or exempted from continuing IRB review as long as the research satisfies one of the expedited/exempt criteria. However, research involving physical interventions should be reviewed by the full IRB at a fully 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. (see also section on Assent)
Research involving decisionally impaired individuals may be expedited if it is minimal risk and falls into one of the regulatory defined categories. Research with decisionally impaired individuals will not be exempted unless it is strictly observational in nature.
Students or Employees as Research Subjects
Students recruited as participants in faculty- or staff-initiated research, and employees recruited for research initiated by Smith 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.
- Provide students with an equal alternative to participation, which should be comparable in terms of effort, time commitment and credit given.
Research with students and employees may be expedited or exempted from continuing IRB review if it is minimal risk and falls into one the regulatory defined categories.
Institutionalized People
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. (see also section on Assent)
Research with institutionalized individuals may be expedited or exempted from continuing IRB review if it is minimal risk and falls into one the regulatory defined categories.
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 or exempted from continuing IRB review if it is minimal risk and falls into one of the regulatory defined categories.
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 exempt or expeditable.
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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. Excessive compensation, whether in the form of money or in-kind payments, is coercive and will not be allowed. Note: Due to state and federal income reporting laws, cash or in-kind payments above $25.00 must be reported. Please contact the Smith College Controller's office to discuss appropriate reporting mechanisms for your specific project and subsequent changes to consent language.
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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
- Smith'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.
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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. Federal regulations prohibit the use of deceptive techniques that place 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.
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Occasionally investigators will seek information about individuals who are not principals to the research. These individuals could be members of the principal subject's family, sexual partners, friends, co-workers, etc. Such individuals may be subjects in their own right, even if the investigator never has any contact with the individual. The federal regulations define a human subject, not only as someone with whom the investigator interacts, but also as someone about whom the investigator seeks information. Therefore, the IRB must evaluate the consent process for each class of subject and will expect the protocol to describe an appropriate consent process for each such class. It may be possible for the investigator to ask the IRB to waive the requirement for consent, but only under the following specific circumstances. Only the IRB can waive or modify the consent process. Researchers are not authorized to make this decision.
- The research involves no greater than minimal risk to subjects;
- The waiver or alteration will not adversely affect the rights and welfare of the subjects;
- The research would be impracticable without the waiver or alteration; and,
- The subjects will be informed of the study when it is over (if possible).
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All investigators who use biological agents or radioactive isotopes on Smith property are required to obtain approval from Smith's Biosafety Officer and Radiation Safety Officer, respectively. The IRB will require documentation of such approval.
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