RECRUITMENT AND SELECTION OF SUBJECTS
The Belmont Report describes how the principles of respect for persons, beneficence, and justice are relevant to research involving human subjects. The principle of respect for persons demands that subjects' decisions whether to become involved in research must be voluntary and informed. Investigators have a responsibility to recruit subjects in such a manner that they not feel pressured to agree, and that they have ample time to discuss the study procedures and to ask questions.
Justice in particular relates to the selection of research subjects. The selection process needs to be scrutinized in order to determine whether some classes (e.g. welfare patients, racial and ethnic minorities, or persons confined to institutions) are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied. Whenever research leads to the development of therapeutic devices and procedures, justice demands both that these not provide advantages only to those who can afford them and that such research should not unduly involve persons from groups unlikely to be among the beneficiaries of subsequent applications of the research.
The selection of subjects must be fair and equitable. In assessing whether selection of subjects is equitable, the IRB takes into account the purposes of the research and the research setting Potentially beneficial research should not be offered only to some patients who are pleasant to work with; likewise, higher risk or research with no potential benefit to the subjects, should not be targeted only at "undesirable" populations. Social justice requires that distinction be drawn between classes of subjects that ought, and ought not, to participate in any particular kind of research, based on the ability of members of that class to bear burdens and on the appropriateness of placing further burdens on already burdened persons. Thus, it can be considered a matter of social justice that there is an order of preference in the selection of classes of subjects (e.g. adults before children) and that some classes of potential subjects (e.g. the institutionalized mentally infirm or prisoners) may be involved as research subjects, if at all, only under exceptional conditions.
One special instance of injustice results from the involvement of vulnerable subjects. Certain groups, such as racial minorities, the economically or educationally disadvantaged, the very sick who may have impaired decision-making capacity, mentally disabled persons and the institutionalized may continually be sought as research subjects, owing to their ready availability in settings where research is conducted. Given their dependent status and their frequently compromised capacity for free consent, they should be protected against the danger of being involved in research solely for administrative convenience, or because they are easy to manipulate as a result of their illness or socioeconomic condition. For similar reasons, staff and students are considered vulnerable as well. Guidelines for the inclusion of staff and students are found later in this section. Because the IRB needs to be particularly cognizant of the special problems of research involving these vulnerable populations, the investigator will supply a discussion of the reason for including such groups, how their autonomy will be assured and how risks to these subjects will be minimized. Other vulnerable populations of concern include groups such as children, prisoners, pregnant women. The regulations contain special "Subparts" which define the criteria and conditions that must be met in order to involve pregnant women and fetuses, prisoners and children as research subjects. See the IRB Forms for the complete policies regarding inclusion of vulnerable populations.
STAFF AND STUDENTS AS SUBJECTS
"Student" means any individual who is enrolled at UTHSCSA in the School of Medicine, School of Allied Health Sciences, School of Nursing, Dental School or Graduate School of Biomedical Sciences or in the sister schools located on the UTHSCSA campuses, such as the Houston School of Public Health and the UT Austin's extension of its Clinical Pharmacy program. It also means those individuals who are in training as Interns, Residents, Fellows, or Postdoctoral trainees, including individuals enrolled at a school or training facility other that the UTHSCSA training or work program.
"Staff" means all other UTHSCSA employees, including faculty.
IRB Policy Guidelines:
UTHSCSA students and staff have the same rights as any other potential subject to participate in a research project, irrespective of the degree of risk, provided all of the following conditions exist:
- The research must not bestow upon participating UTHSCSA subjects, any competitive academic or occupational advantage over other UTHSCSA students or staff who do not volunteer, and the researchers must not impose any academic or occupational penalty on those UTHSCSA students or staff who do not volunteer.
- UTHSCSA students and staff must not be systematically treated differently from non- UTHSCSA subjects as part of the project.
- Due to the potential for perceived or real coercion to participate, UTHSCSA students and staff who desire to participate in the research must not be under the direct supervision of the principal investigator or listed research collaborators.
- Recruitment of UTHSCSA students and staff must be handled through general announcements or advertisements, rather than through individual solicitations. Personal solicitations increase the likelihood that participation will be the result of undue influence, either because of the relationship between the recruiter and the prospective subject, or methods of communication employed by the recruiter that may act to persuade prospective subjects to participate, thus compromising the voluntariness of the agreement to participate.
SCREENING STUDIES TO IDENTIFY ELIGIBLE SUBJECTS
Minor procedures may be performed for the purpose of identifying a pool of eligible research subjects. Consent is required for all study procedures. See page 32 for more details.
MEDICAL/DENTAL AND OTHER RECORD REVIEW TO IDENTIFY POTENTIAL SUBJECTS
Whether it is permissible for an investigator to perform a chart or record review to obtain names and other identifying information for recruiting purposes depends on the policies established by the covered entity (the institution that is responsible for the records). The covered entity may require partial waivers to permit identification and/or recruitment using PHI to be obtained by chart review. Requests for partial waivers are made to the IRB, using the appropriate form: the H-1 to identify and the H-2 to recruit. The covered entity may require the partial waivers be granted by their own privacy board. This will vary and is determined by the covered entity that holds the records to be reviewed, not by the IRB. Recruitment should be in a sensitive manner and the source of the information should be identified. For most studies, it is appropriate and desirable to include the primary physician or care provider in the communication link with the patient.
Whether it is permissible to use records of previously performed research to identify potential subjects for a new study would have to be determined on a case by case basis. The confidentiality and authorization section of the consent form determines the extent to which the identifying information and the PHI may be disclosed from the research records. If it states that the records will be kept confidential, without indicating that information will be shared with other researchers, then it would be a breach of confidentiality to release names from research records to other investigators for their studies. Release of subject's names must be in accordance with the authorization signed within the original consent or with the specific authorization of the subject
SOLICITATION OF SUBJECTS THROUGH ADVERTISEMENTS
The use of advertisements (e.g., notices on bulletin boards, paid and unpaid newspaper solicitations, solicitation by electronic mail, WEB sites, letters to private practitioners, signs, or pamphlets, etc.) to solicit volunteers for research must have IRB approval. Such advertisements are an extension of the informed consent and subject selection process.
The IRB reviews advertisements to determine that (1) they are neither misleading nor coercive to potential subjects; and (2) in treatment protocols, no claims are made, either explicitly or implicitly, that a proposed treatment is safe and effective or equivalent or superior to any other treatment.
Advertisements should contain the following:
- The name and address of the investigator
- The purpose of the research
- In summary form, the eligibility criteria
- A straightforward, truthful description of the benefits, if any
- The location of the research and the person to contact for additional information
Submission and approval procedures:
- Identify method(s) of advertisement for research subjects in the protocol.
- Submit bulletin board notices for IRB approval prior to posting. The IRB will return the advertisement with a dated IRB approval stamp. Subsequent changes in the content of an advertisement must be approved by the IRB.
- If you plan to advertise in a newspaper, a WEB site, or other media advertisements, submit the text or a printed copy of the WEB information or other item for IRB approval. Solicitation of subjects within the context of a published or broadcast "news" release is not appropriate.
- Submit other forms of advertisement (e.g., electronic mail, letters to private practitioners, letters to potential subjects, etc.) for IRB approval.
A proposed recruitment method which involves offering cash and/or tangible non-cash incentives to residents, fellows, private physicians, or others (i.e., finder's fees) is not permitted by institutional policy and cannot be approved by the IRB.