Researchers, and the IRBs that review their research, are responsible for developing appropriate methods to safeguard the confidentiality of subjects' data. Appropriate methods will vary greatly depending on factors such as the sensitivity of the information obtained, the subject population, applicable federal confidentiality regulations and the design of the study.
In all cases, the researcher should explain to research subjects the limitations to the protection of identifiable information. (See Chapter 4
, Informed Consent.)
Since most research records are potentially subject to subpoena, a Confidentiality Certificate should be obtained from the Department of Health and Human Services (DHHS) or the Department of Justice whenever identifiable data which may place a subject in legal jeopardy or cause loss of employment, social standing etc. is to be collected.
Article 33.13 of the Mental Hygiene Law specifies the conditions under which patient medical records may be released. Those that directly apply to research are: