Recruitment and selection of subjects must be equitable within the confines of the study. The investigator may not arbitrarily exclude participants on the basis of gender, race, national origin, religion, creed, education, or socioeconomic status.
Equitable - fair or just; used in the context of selection of participants to indicate that the benefits and burdens of research are fairly distributed.
Inclusion of Women and Minorities in Clinical Research
Cultural diversity in subject selection is strongly encouraged. Clinical studies should be inclusionary, designed in such a way that the subject pool is representative in gender, race, ethnicity, and age of the local population affected by the condition being studied. Exclusion of particular subgroups may be justified in the following cases:
- A specific scientific question is more appropriately addressed with a more targeted group,
- Specific known risks of intervention (or other participation) warrant exclusion of specific groups,
- Gender- or racial-neutrality has been previously demonstrated,
- Redress of gaps in medical knowledge about specific groups,
- Multicenter studies may achieve overall balance by choosing centers with complementary minority representation.
Subject enrollment need not be sufficient to provide high statistical power for calculating effects of gender and minority status on intervention effect in all cases. Investigators planning phase 3 clinical trials in which prior studies suggest a clinically “significant difference” in effect among subgroups or those in which differential effects are uncertain are encouraged to design the subject pool in sufficient numbers so as to provide a “valid analysis” in each subgroup.
Economically Disadvantaged Subjects
Investigators should consider added costs related to the research that might prevent participation by the economically disadvantaged. Justification for such cost must be fully explained in the IRB application.
Financial remuneration, reward, reimbursement for expenses, or other inducement for participation should not be so great as to be coercive to potential participants and should constitute reasonable compensation for the inconvenience of participating.
Clinical studies should be advertised to and made accessible to an equitable group of individuals. In cases in which recruitment and/or retention of women or minority subjects may be difficult, a proactive program may be employed. Cultural sensitivity in approaching potential subjects is to be encouraged (e.g., respectful of language and custom). Barriers to participation in underrepresented groups should be anticipated and overcome prospectively (e.g., compensation for child care, lost wages or transportation; waiving of residency requirements; translation of advertising or educational literature and informed consent for non-English speakers). The extent of compensation will be reviewed critically by CPHS to ensure that it is appropriate to the context of the study and not potentially coercive to vulnerable subgroups. In order to ensure a diverse study population with sufficient statistical power to examine major gender and ethnic effects, large studies may consider the use of quota systems to manage enrollment.
To overcome lingering distrust of the medical and scientific establishment in minority populations, outreach programs may be used to inform local minority groups about the individual and collective benefits of participation in biomedical research. Follow-up in these groups with modest advertising of individual projects and discussion of results may be employed.
Prospective participants often have their first contact with a research coordinator or third party who follows a script to determine basic eligibility for the specific study. The IRB must review these procedures to assure that they adequately protect the rights and welfare of the prospective participants. The IRB must have assurance that any information collected about prospective participants will be appropriately handled. An investigator may contact potential subjects by telephone only if the investigator has ethically permissible access to the potential subject. If not, a recruitment letter stating that the investigator may call should be sent to the potential subjects. Repeated attempts to contact a research subject may be necessary and appropriate. However, once a subject is contacted, a single informed refusal to participate concludes the investigator's efforts. If an investigator plans to make repeated attempts to contact a subject, the subsequent methods should be described in the original protocol or in a request for change
All advertisements and recruitment methods must be reviewed and approved by the IRB prior to implementation to assure that the information does not promise or imply a certainty of benefit beyond what is contained in the protocol and the informed consent document.
Students and UT Employees as Subjects
It is acceptable to enroll students in the UT Health Science Center at Houston, provided that:
- The students are not working in the same laboratory as the PI;
- The students do not report directly to the PI;
- The students are not in a class over which the PI has direct responsibility;
- Students, Staff, or Technicians enrolled in the study do not work in a laboratory that is in the sphere of influence of the PI;
- Recruitment does not involve coercion or undue influence.
Dear Patient Letters
The investigator may ask physician colleagues to send out general “Dear Patient” letters describing the study. The investigator may draft the letter with the treating physician’s signature, but may not have access to the patient names or the mailing addresses. If the investigator wants the letters to be individualized for the patients, the personalized information would have to be entered by the treating physician. Dear Patient letters should be submitted to CPHS for review and approval.
Dear Doctor Letters
The investigator may send a letter to colleagues (“Dear Doctor letter”) asking for referrals of potential or eligible subjects who are interested in the study. Communications directed to colleagues do not require IRB approval, but this method of recruitment should be stated in the protocol.
If the investigator is planning to use a business, listserv, school, advocacy groups, etc. to recruit subjects, the IRB will need to see a letter from that organization giving the investigator permission to recruit.
Guidelines for Recruitment Flyers, Ads, Posters, & Brochures
Recruitment Information should include some of the following elements (those in bold are mandatory):
- “Research” is specified.
- The ages for eligibility.
- Inclusion/Exclusion criteria (e.g., “Right-handed Participants only”).
- The purpose of the research must be clearly stated.
- The amount of time required to complete the study.
- Any benefits (Note: a straightforward and truthful description of the benefits to the subject for participation in the study, e.g., no charge for taking part in the study, no-cost health examination, or providing treatment and counseling for the drug addictions.)
- Any risks.
(Note: most research will be “minimal risk”. That is, research involves no more risk than those associated with ordinary daily life. This may be communicated as something like: “There are no known risks associated with this study other than the potential for mild boredom or mild fatigue.” If there are minimal risks other than mild boredom or mild fatigue, you may either include them or state that they will be discussed prior to the beginning of the study.)
- The contact person’s name is identified.
- The institution is identified.
- Monetary compensation information is optional.
(Note: Although the consent document must specify the EXACT amount of any financial compensation, recruitment materials should state that monetary compensation will be provided.
- The location of the research.
Things that should be avoided:
Do not emphasize monetary compensation.
Do not state the amount of compensation.
Do not use catchy words such as “exciting”, “cutting-edge”, etc.
Do not recruit children directly.
Do not misstate information contained within the protocol.
Other methods may be acceptable. Please contact the IRB office (email@example.com) for assistance if a method is questionable or you are unsure if it will be appropriate.
CPHS HELPLINE 713-500-7943
iRIS HELPLINE 713-500-7960
UTHealth’s Compliance Hotline (1-888-472-9868)
IRB OFFICE HOURS Thursdays from 1 to 4pm, via the Teams Room at this link
How can we improve this site?