Legal and ethical issues in psychiatric genetic research

D. Shore, K. Berg, D. Wynne, M. F. Folstein

Research output: Contribution to journalArticlepeer-review

14 Scopus citations


Genetic research may uncover the causes of severe mental disorders, and many projects have been undertaken to locate the genes responsible for schizophrenia, bipolar disorder, and Alzheimer disease. A number of sensitive legal and ethical issues have been raised, including 1) protection of confidential data concerning research subjects; 2) the assessment of types and degree of risk to subjects who participate in such studies; 3) the legal and ethical acceptability of substituted judgment on behalf of patients who may not be competent to provide informed consent; and 4) the separation of research and clinical roles in areas such as genetic counseling. Federal regulations and other guidelines are of limited value in dealing with such concerns, and many important human subjects issues will need to be dealt with by the investigator, subject to approval by a local Institutional Review Board. There does seem to be general agreement that informed consent must be obtained, potential risks of research need to be minimized, and confidentiality of sensitive data must be protected.

Original languageEnglish (US)
Pages (from-to)17-21
Number of pages5
JournalAmerican journal of medical genetics
Issue number1
StatePublished - 1993
Externally publishedYes


  • confidentiality
  • informed consent
  • psychiatric genetics
  • research risks

ASJC Scopus subject areas

  • Genetics(clinical)


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