IRB Manual
      2.3 Confidentiality of Information Received as an IRB Member


IRB members have a legal and ethical duty to maintain the confidentiality of all information they receive in their capacity as members of the IRB.  First, research subjects have a legal right to privacy with regard to all information assembled or created regarding their participation.  Second, as clinical research requires expertise and resources, the law seeks to encourage such efforts by affording confidentiality to sponsors’ proprietary information and investigators’ intellectual property. Thus, protocols, data, etc are also confidential. When necessary, the IRB, as a body, may share information with non-members (e.g., IRB consultants, quality assurance monitors);  however, individual IRB members may not.

New York’s Freedom of Information Law provides standards and procedures when someone seeks IRB information, and all requests are to be forwarded to the OMH Central Office Records Access Officer, Public Information Officer, or the OPWDD Central Office Records Access Officer, as appropriate.  If an IRB member wishes to use information him or herself (e.g., in a graduate school paper), he/she must obtain prior approval of the investigator or sponsor.

The reasons for confidentiality are clear.  A breach of the duty could result in serious consequences, including the member’s removal from the IRB and/or loss of the statutory right to legal representation and indemnification as described in Section 2.2. of the IRB Manual.  To ensure that IRB members are fully aware of, and committed to this responsibility, each IRB member is required to sign the attached confidentiality agreement which must be submitted to the IRB chairperson and kept on file in the IRB records.  


(Name of Facility)



I, ___________________________ (please print),  understand that documents and other information which I acquire as an IRB member are provided to me solely for use in fulfilling my responsibilities on the Institutional Review Board (IRB) and are to be kept confidential. Examples of such information are: human subject identifying data or medical information; proprietary information; trade secrets, medical or scientific data; research designs, concepts, discoveries or inventions; or any other information designated as, or reasonably understood to be, confidential.  I agree to handle them accordingly.

I agree to not to discuss, disclose, or reproduce any confidential information except to carry out my functions as an IRB member, or as otherwise required by law.  I agree to direct any requests for information that I receive to a person designated by the Office for Mental Health (or Office for People with Developmental Disabilities) as the Central Office Records Access Officer under the New York Public Officers Law, and to obtain written authorization from the Principal Investigator or the sponsoring organization before using any information from or about a protocol for any personal purpose.  However, if I have also received information which would otherwise be deemed confidential under this agreement through other lawful means for other lawful purposes, this agreement does not restrict my use of such information for such purposes.

I understand that the disclosure of information could violate the privacy rights of research subjects, the intellectual property rights of investigators and/or the proprietary rights of research sponsors, and that irreparable harm could result. I also understand that such disclosure could result in my removal from the IRB and the loss of my rights to indemnification and representation under the New York Public Officers Law.  I agree that the duty of confidentiality with regard to information I obtain as an IRB member continues after my IRB membership ends.

I further understand that this agreement does not preclude appropriate oversight agencies, such as the federal Office for Human Research Protections, from lawfully obtaining such information through their existing authority as required for the proper discharge of their duties.

Signature                                                                          Date



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