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Dear Colleague Letter: Disclosure of Information

November 12, 1998

TO: Chairs of Departments which submit protocols to the Institutional Review Board for the Protection of Human Subjects
FROM: John Attinasi, Chair of IRB

RE: Disclosure of Information obtained while conducting Research and Procedures for Submissions to the Institutional Review Board for the Protection of Human Subjects

Dear Chairperson:

In the 1998-99 year, members of your department will no doubt submit protocols for approval of research involving human subjects on behalf of students they advise and for their own research. In the past delays have occurred due to predictable issues, which this memo addresses.

The first concerns sensitive data which researchers sometimes gather. Under law, evidence of certain types of abuse must be reported, and other data, which may concern illegal activity may be subpoenaed. It is therefore important that sponsors review the wording of consent and confidentiality language offered to subjects. The other point concerns data regarding identification of subjects.

Mandatory Disclosure

First, please note that reporting child abuse is mandatory and must be reported in many instances, according to the Child Abuse and Neglect Act, (Penal Code, sections 11165-11174). According to Article 2.5 of the penal code it is a crime for certain professionals and lay persons who have a special working relationship or contact with children not to report suspected abuse to the proper authorities. Elder abuse and other categories of vulnerable persons may also be covered. Researchers attempting to obtain data in confidence have on occasion written in the consent form statements to the effect that no one will have access to answers. In fact, several types of activities must be reported, and it would be valuable to review the attached brief regarding such mandatory reporting. Subjects must know that they are at such risk.

Also, it is possible that information obtained in research may be subpoenaed, and if so, legal liability for the researcher may be involved. This has relevance in certain types of research where questions are asked regarding illegal activities. Therefore it is necessary for researchers to disclose to subjects the potential of compromise of confidentiality in some forms of data gathered.

Racial/Ethnic Categories

Second, a wide range of ethnic categories appears in protocols. We encourage you to ask faculty to use one of the two formats attached, taken from two recent protocols. One follows the US Census categories, except that it combines "Hispanic" with other racial/ethnic categories into a single question. The other asks subjects to list the group with whom they most closely identify. That form of the question recognizes that ethnicity is a social and political identifier more than a biological category.

For specific research purposes, other finer categories of identification [Middle Eastern, Central American, Hindu, Jewish] may be asked, although there is no consensus that these are racial/ethnic rather than regional or religious categories. The IRB urges you to be flexible, but standardized on ethnic/racial identifier questions.

Thank you, in advance, for disseminating this memo to your faculty and keeping copies in your department files.

Sincerely,

John Attinasi Chair,
Institutional Review Board for the Protection of Human Subjects, Research Office, CSULB

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