Guidelines are presented which were developed to aid federal, state, and local agencies prepare regulations concerning the use of mentally retarded subjects in biomedical and pharmacological research projects. Guidelines are set forth for the following topic areas (sample subtopics in parentheses): the formation of a Professional Review Committee to monitor the conduct of research; the formation of a Committee on Legal and Ethical Protection; researchers and the research setting (qualifications, appropriate medical supervision); types of research (categories of biomedical and pharmacological research); informed consent (competent institutionalized mentally retarded individuals, elements of informed consent, coercion); withdrawal of consent; ongoing review; and enforcement mechanisms (prevention of abuses, sanctions). (CL)