· participants should not be excluded from research on the basis of criteria such as gender, sexual orientation, race, national origin, religion, creed, education or socioeconomic status
· participants should not be included in research simply because of their easy availability, compromised position or because of racial, social, gender, economic or cultural biases
· one group of research participants should not be systematically selected to bear the burdens of research that will benefit another group
· a group of participants should not be systematically excluded from participation in research that could benefit that group.
Selection of research participants must be equitable within the confines of the study.
The concept of “equitable selection” is based on the “distributive justice,” principle of the Belmont Report, which requires the fair selection of research participants and the equitable distribution of the burdens and benefits of research.
To protect potentially vulnerable participants, the National Commission for the Protection of Human Subjects has recommended a hierarchy of preference in the selection of subjects for research: adults before children; competent individuals before incompetent individuals; non-institutionalized individuals before institutionalized individuals. The Commission also believed that those who are already burdened (e.g., by disabilities or institutionalization) should not be asked to accept the burdens of research unless other appropriate subjects cannot be found.
Women and members of minority groups and their subpopulations must be included in all clinical research, unless a clear and compelling rationale and justification establishes to the satisfaction of the IRB that inclusion is inappropriate with respect to the health of the participants or the purpose of the research. Exclusion under other circumstances may be made based on a compelling rationale and justification. Cost is not an acceptable reason for exclusion except when the study would duplicate data from other sources. Women with childbearing potential should not be routinely excluded from participation in clinical research.
Investigators should answer all questions in the protocol application about the proposed study population and participant selection criteria and methods.
Investigators are asked to describe:
· the characteristics of the targeted participants, including gender, age ranges, ethnic background, and health/treatment status
· the criteria for selection and exclusion
· whether the study targets or excludes a particular gender or ethnic or racial group
· where participants will be found and how they will be recruited
· the rationale for the involvement of any special groups including prisoners, pregnant women, institutionalized individuals or individuals with cognitive impairments.
Investigators must also justify any proposed involvement of disproportionate numbers of racial or ethnic minorities or vulnerable groups and detail any extra precautions taken to safeguard the rights and welfare of subject populations. The inclusion of women and members of minority groups and their subpopulations must also be addressed.
Before approving any research protocol, UW-Madison IRBs evaluate whether the selection of research participants is equitable within the confines of the study.
The IRBs examine the characteristics of the subject population outlined in the protocol, the exclusion and inclusion criteria and the procedures for identifying and recruiting subjects. The IRBs will pay close attention to the special problems raised by the selection of participants from vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
The IRB also looks at the purposes of the research, specifically, whether the nature of the research requires or justifies using the proposed participant population and whether there is an intention for that population to benefit from the research. The setting in which the research will be conducted and the manner in which participants will be recruited may also affect the equitable selection of participants.
Studies with the potential to address issues relevant to both sexes must recruit both genders, and minority populations should be included in a study population wherever feasible. Researchers must justify the exclusion of any group of individuals. The IRB makes exceptions if there is adequate scientific justification for exclusion, such as when a disease predominates in one gender or the focus of the research question is on a specific group.
The IRB will closely examine research that requests recruitment of subjects solely due to their easy availability, compromised position, or susceptibility to manipulation, such as students, patients, or laboratory employees. The protocol should clearly articulate how the recruitment will avoid the appearance of coercion when selecting subjects who are in a dependent relationship to the investigator. IRBs will consider the extent to which a proposed subject population is already burdened by poverty, illness, poor education, or chronic disabilities in deciding whether they are a suitable subject population.