Additional Categories of Vulnerable Subjects
Students and Employees
Investigators should detail any extra precautions taken to safeguard the rights and welfare of subject populations. In the case of using employees or a student "subject pool," the IRB should ensure that consent for participation is sought only under circumstances, which minimize the possibility of coercion or undue influence, and that genuinely equivalent alternatives to participation are available.
It is not uncommon for research projects to involve students, either those enrolled in a specific course or those enrolled in university programs. For instance, it is common practice for medical students to serve as subjects in biomedical research or for psychology students to serve as subjects in behavioral research. The obvious concern is that their participation may not be truly voluntary, because of a desire to appear particularly cooperative or highly motivated, or because participation in research is a course requirement.
Various procedures have been suggested to reduce the possible unintended coercion, while still permitting students to participate as subjects in research. These include:
- Posting IRB approved advertisements throughout the university to recruit subjects from a broad base of students.
- Offering students the opportunity to participate in "mass screenings" with follow-up with those who meet research criteria. It should be clearly stated that participation in the screening, as well as participation in the research is voluntary.
- Avoiding any personal solicitations by students, faculty, GTAs or RAs for fellow students or faculty.
- Providing a number of research projects from which to chose, if participating as a research subject is a course requirement.
- Providing alternative and equal methods for meeting course credit (or extra credit) requirements, such as attending a series of research presentations by faculty, writing a brief paper, conducting one's own research.
Researchers need to exercise special caution when they desire students in a class to participate in research at the same time. Unintended coercion must be avoided by (1) ensuring that participation is voluntary, (2) that no one knows who is and is not participating, and (3) a time and effort equivalent alternative is provided for those who wish not to participate. Course grades should not be based on research participation. Basing grades on research participation is coercive and should be avoided.
A researcher should not have access to the data collected until after the class grades have been posted. Researchers often ask a colleague not affiliated with the research or class to administer the evaluation and hold the data until after the grades are posted.
University employees, such as faculty, office staff, lab technicians, and postdoctoral fellows, are similar to students in that they are vulnerable to perceived, even if not intended, pressures to appear cooperative and supportive of their supervisor's work. Accordingly, many of the same procedures described above to reduce the likelihood of coercion in recruiting student volunteers apply equally to university employees.
In addition to requiring the equitable selection of women as research subjects, Federal regulations require the equitable selection of minorities as research subjects. The inclusion of minorities in research is important both to ensure that they receive an equal share of the benefits of the research and to ensure that they do not bear a disproportionate burden.
Most research will affect all population groups. In order to contribute to the pool of generalizable knowledge, investigators are required to include the widest possible range of population groups in the research. However, sometimes minorities are subject to a different risk. For example, some research pertains to conditions such a sickle cell anemia or Tay Sachs disease that specifically affect only a few minority groups. Other research focuses on characteristics of diseases or effectiveness of therapies in particular populations ( e.g., HIV transmission, treatment for hypertension), and may concern conditions or disorders that disproportionately affect a certain racial or ethnic group. Exclusion or inappropriate representation of these groups, by design or inadvertence, would be unjust. Further, to the extent that participation in research offers direct benefits to the subjects (in HIV research, for example, the receipt of a promising new drug), under-representation of minorities denies them, in a systematic fashion, the opportunity for direct benefit. A glaring example of this type of research abuse of minority population's bearing the burden of research can be found in the United States Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male (Tuskegee Syphilis study), in which a group of African-American men suffering from syphilis were left untreated, despite the availability of penicillin, in order to study the natural course of the disease. Due to these concerns, the Federal regulations require that research design include diverse populations.
Economic or Educationally Disadvantaged
The Department of Health and Human Services recognizes that certain populations may require additional protections because they are economically or educationally disadvantaged. The IRB will attempt to safeguard every subject's rights and welfare by making sure that any possible coercion or undue influence is eliminated (e.g., compensation that is not commensurate with risk, discomfort, or inconvenience involved, or recruiting in institutional settings where voluntary participation might be compromised).
Terminally Ill Subjects
Subjects with a terminal illness may be willing to "try anything" that might offer hope of either a cure or a slowing of the disease process. Others, aware that nothing further can be done to cure their disease, might fear abandonment by the medical establishment and agree to participate in research as a means of maintaining contact with physicians expert in treating their condition. On the other hand, many terminally ill individuals are willing to submit to considerable discomfort and risk for the possible benefit of future subjects suffering from the same condition, and will volunteer for Phase I clinical trials or basic research about their particular condition in hopes of helping other, similarly situated subjects in the future.
Investigators should be sensitive to these matters and explain with care and clarity the likelihood (or lack thereof) that research subjects will experience any personal medical benefit from their participation in a particular study. This is especially important in Phase I drug studies, since the research is designed to evaluate a potential treatment for their illness and as a result, may obscure the fact that the dosage subjects will be given is not expected to produce a therapeutic result. At the same time, it is important not to treat terminally ill subjects as incompetent or incapable of autonomous decision-making, just because they are critically ill.