IRB Manual
      5.1 Confidentiality

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:

"with the consent of the patient or client or of someone authorized to act on the patient's or client's behalf, to persons and entities who have a demonstrable need for such information and who have obtained such consent provided that disclosure will not reasonably be expected to be detrimental to the patient, client or another provided, however that release of such information to a patient or client shall not be governed by this section."

"with the consent of the appropriate commissioner to: qualified researchers upon the approval of the institutional review board, or other committee specially constituted for the approval of research projects at the facility , provided that the researcher shall in no event disclose information tending to identify a patient or client."

NOTE: Employees of facility who have access to records for clinical purposes must also satisfy one of the above conditions in order to access patient/client records for research purposes.

5.1.1 Alcohol and Drug Abuse Programs

DHHS regulations (42 CFR Part 2) require that the records of patients who are treated in discrete, identifiable alcohol or drug abuse programs or who are treated by specialized alcohol or drug treatment personnel be kept confidential and disclosed only:

with the written consent of the patient, or
pursuant to an authorizing court order in accordance with 42 CFR Part 2 based upon a finding of good cause. (See 5.2 for information about confidentiality certificates.) or
to medical personnel in a medical emergency or to qualified personnel for research, audit or program evaluation.

Use of patient records for research purposes must receive the prior approval of an institutional review board and must meet the requirements of 45 CFR 46.

The program may disclose to a parent that a minor has applied for treatment without the minor's consent when, in the program director's judgement, the minor lacks the capacity to make a rational decision on the issue of notification, the situation poses a substantial threat to the life or physical well-being of the minor or any other person, and this threat may be alleviated by such notification.

These regulations do not protect any information about a crime committed by a patient either at the program or against any person who works for the program or about any threat to commit such a crime.

These regulations do not protect any information about suspected child abuse or neglect from being reported under State law to appropriate State or local authorities. This exclusion only covers the making of the initial report. The initial report includes the initial telephone call and completion of the Department of Social Services form. Any subsequent follow-up, or investigative efforts to obtain additional information are protected and may only be disclosed as authorized by the regulations.

2000 Research Foundation for Mental Hygiene, Inc. All Rights Reserved.
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