VT Human Subjects Protection Tutorial
1. Welcome --- 2. Reason for Training --- 3. Importance of Compliance --- 4. History --- 5. Selection of Subjects --- 6. Recruitment --- 7. Consent --- 8. Paying Subjects --- 9. Confidentiality & Anonymity --- 10. Who Regulates Your Research? --- 11. VT IRB Submissions --- 12. Continued Compliance ---QUIZ
5 Selection of Research Subjects
The principle of justice is applied during the selection of subjects. There lies a moral requirement for fair procedures and outcomes in the selection of research subjects.
There are two levels of justice in selection of subjects:
- Individual: don’t offer potentially beneficial research to some individuals who are held in favor, and select only “undesirable” individuals for risky research.
- Social: draw a distinction between classes of subjects who ought and ought not to participate, based upon the ability of members of that class to bear burdens, and on the appropriateness of placing further burdens on already burdened persons.
There should be an order of selection of classes of subjects (e.g., adults before children).
Incarcerated or institutionalized subjects should be involved only when appropriate safeguards are met.
Injustice arises from social, racial, sexual, and cultural biases institutionalized in society. It is also injustice when vulnerable subjects (e.g., racial minorities, the economically disadvantaged, the very sick, and the institutionalized) are used because of their vulnerability and manipulability or for sake of convenience.
When determining the population of research, researchers must not target a specific gender or ethnicity unless it is appropriately justified.
Vulnerable Populations
Researchers must also provide compelling justification for the use of vulnerable populations within research. Individuals within vulnerable populations may have limited autonomy. In other words, they may not be able to provide sufficient informed consent. This may be because they cannot fully understand the research or are within a coercive environment.
Examples of vulnerable populations:
- Children
- Cognitively impaired
- Comatose patients
- Prisoners
- Pregnant women & fetuses (clinical studies)
- Students
- Employees
- Terminally ill
Children
"Children" are persons who have not attained the legal age for consent (18 years of age in most states), and thus cannot legally provide "consent" to treatments or procedures involved in research. In some instances, the child may be considered an "emancipated minor" as defined by applicable law in the jurisdiction where the research will be conducted, and may in that case provide legal consent.
"Assent" means a child's affirmative agreement to participate in research. It is an act signifying understanding (recognizing that the minor has not reached full legal age). Mere failure to object by the child should not, absent affirmative agreement, be construed as assent.
The assent process, while not legally binding, should involve taking the time to explain to a child, at whatever age they can begin to understand, what is going on in the proposed study, why the study is being done, what will be done to them, and that if they object, the research will be terminated, and they will not be punished or scolded. As children develop, they should gradually become the primary guardians of personal health and the primary partners in medical decision-making, assuming responsibility from their parents. Just as is the case with informed consent, the emphasis on obtaining assent should be on the interactive process in which information and values are shared and joint decisions are made.
"Permission" means the agreement of parent(s) or guardian to the participation of their child or ward in research. For most research studies, parents must provide their permission (parental consent) to allow their child to participate in the research study. [NOTE: Unless waived, it is required that a signed Parental Permission (Consent) form be on file for each participating minor. "Passive" consent, i.e., sending the child home with a form which states "please let us know if you don't want your child to participate", and then in the absence of a response (failure to object) from the parent, construing this to mean agreement that the child can participate, is not allowable.]
Cognitively Impaired
The predominant ethical concern in research involving individuals with psychiatric disorder (e.g., psychosis, neurosis, personality or behavior disorders), an organic impairment (e.g., dementia), cognitive disorder, or developmental disorders (e.g., mental retardation), or who are substance abusers is that their disorders (affecting cognitive or emotional functions) may compromise/diminish their capacity for judgment and understanding of the information presented and their ability to make a reasoned decision about participation. Others, including persons under the influence of or dependent on drugs or alcohol, those suffering from degenerative diseases affecting the brain, terminally ill patients, and persons with severely disabling physical handicaps, may also be compromised in their ability to make decisions in their best interests.
Many individuals with disabilities affecting their reasoning powers may be residents of institutions responsible for their total care and treatment. The impact of institutionalization may further compromise their ability to exercise free choice (voluntariness). (These concerns apply both to voluntary patients and those committed involuntarily.) The eagerness for release may induce an institutionalized person, especially one who is involuntarily confined, to participate in research out of a desire to appear "rational" and "cooperative" to those who will make decisions about his or her release. Persons who are institutionalized, particularly if disabled, should not be chosen for studies that bear no relation to their situation just because it would be convenient for the researcher.
As a general rule, all adults, regardless of their diagnosis or condition, should be presumed competent to consent unless there is evidence of serious mental disability that would impair reasoning or judgment. Even those who do have a diagnosed mental disorder may be perfectly able to understand the matter of being a research volunteer, and quite capable of consenting to or refusing participation. Mental disability alone should not disqualify a person from consenting to participate in research; rather, there should be specific evidence of individuals' incapacity to understand and to make a choice before they are deemed unable to consent.
Persons formally adjudged incompetent have a court-appointed guardian who must be consulted and consent on their behalf. Officials of the institution in which incompetent patients reside (even if they are the patient's legal guardians) are not generally considered appropriate, since their supervisory duties may give rise to conflicting interests and loyalties. Family members or others financially responsible for the patient may also be subject to conflicting interests because of financial pressures, emotional distancing, or other ambivalent feelings common in such circumstances.
Students
The problem with student participation in research conducted at the university is the possibility that their agreement to participate will not be freely given. Students may volunteer to participate out of a belief that doing so will place them in good favor with faculty (e.g., that participating will result in receiving better grades, recommendations, employment, or the like), or that failure to participate will negatively affect their relationship with the investigator or faculty generally (i.e., by seeming "uncooperative," not part of the scientific community). A way to protect against coercion is to require that faculty-investigators advertise for subjects generally (e.g., through notices posted in the school or department) rather than recruit individual students directly. Requiring participation in research for course credit (or extra credit) is also controversial, though common in the social and behavioral sciences. As with any research involving a potentially vulnerable subject population, IRBs must pay special attention to the potential for coercion or undue influence and consider ways in which the possibility of exploitation can be reduced or eliminated.
Another concern raised by the involvement of students as subjects is confidentiality. As with research involving human subjects generally, the Virginia Tech IRB is aware that research involving the collection of data on sensitive subjects such as mental health, sexual activity, or the use of illicit drugs or alcohol presents risks to subjects of which they should be made aware and from which they should be protected, to the greatest extent possible. The close environment of the university amplifies this problem.
If a research project includes the need to access student records (i.e., SAT or GRE scores, or student GPA), a separate signed consent/permission form must be obtained from the student subject and submitted to the Registrar's office.
Employees
The issues with respect to employees as research subjects are essentially identical to those involving students as research subjects: coercion or undue influence, and confidentiality. Employee research programs raise the possibility that the decision will affect performance evaluations or job advancement.
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