• CONTACT HRPP
• Program Feedback
• IRB Staff
• Campus Consults



• WHAT'S NEW
• Human Research News



• FOR RESEARCHERS
• Meeting Calendars
• IRB Descriptions
• Forms
• Policies & Guidance
• HIPAA
• Investigator Survey
• Other Resources
• Participants' Bill of Rights
• Certification, Education and Training



• FOR AND ABOUT IRB MEMBERS
• Meeting Calendars
• IRB Member rosters
• Checklists for Members



• FOR RESEARCH PARTICIPANTS
• Información Para Participantes
• Participant Survey



• ABOUT UCLA IRBS
• Federalwide Assurance
• Human Research Policy Board

Minorities

In addition to requiring the equitable selection of women as research subjects, federal regulations require the equitable selection of minorities as research subjects [45 CFR 46.111.(a)(3)]. The inclusion of minorities in research is important both to ensure that they receive an equal share of the benefits of research and to ensure that they do not bear a disproportionate burden (Please see Appendix 8 for a detailed explanation).

Most diseases 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 their research. However, sometimes minorities are subject to a different risk. For example, some research pertains to conditions such as 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 also 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 populations’ bearing the burden of research can be found in the 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. Investigators submitting protocols for HSPC review which do not call for heterogeneous study populations are required to justify, in writing, in their submissions, why a homogeneous study population has been chosen.

After a heterogeneous population has been chosen, investigators should pay careful attention to the following two issues:

1. Special vulnerabilities: The DHHS recognizes that certain subject populations may require additional protections because they are economically or educationally disadvantaged. The HSPC 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). Investigators should address these issues specifically when submitting protocol information to the HSPC for review.

2. Consent Form Presentation: Effort should always be made to ensure that the consent process and the relationship between the investigator and prospective subjects are safeguarded. The federal regulations require the translation of consent documents into the language which is most easily understood by research subjects; the possibility of illiteracy should be accounted for, as should the need for communicating in non-English languages. The FDA indicated in October 1995, that non-English speaking subjects must have informed consent form information presented in a written language that they understand. [21 CFR 50.20 -27 and FDA Information Sheets, October 1, 1995, p 49] A potential subject’s inability to read or to read English is not an appropriate basis for exclusion from most research.

The HSPC approved informed consent documents should be available in English and other languages as appropriate to the subject population(s). For investigators proposing to use non-English language consent documents, quality assurance procedures should be developed such as translation of the consent document from English to the second language and then back to English, to ensure that the information is correctly conveyed. The HSPC is required to review all non-English consent forms and recruitment tools. The role of cultural norms of subjects should also be addressed. This information should be provided in a clearly identifiable form to the HSPC for review.