Members of the Data and Safety Monitoring Board (DSMB) are selected by NIEHS to reflect the disciplines and medical specialties necessary to interpret data from the study(ies) named above. All members of the DSMB are required to be completely independent of the studies being reviewed and all members are required to sign a DSMB Conflict of Interest and Confidentiality statement.

A conflict of interest exists when a DSMB member has a financial interest that could be affected by the study or a relationship with a study investigator that is likely to bias his or her review of it. An individual who has a financial conflict of interest with a study may not participate on its DSMB unless he or she receives a waiver from the NIH institute or center ethics official. Appearance of a conflict of interest should be avoided whenever possible; however, if it is established that there is no real conflict of interest and the NIEHS ethics official determines that the integrity of the study would not be impaired, the individual in question may participate in the DSMB. Such actions by the NIEHS ethics official shall be made in writing and become part of the DSMB record.

It is the responsibility of each DSMB member to notify the NIEHS ethics official of any conflict of interest situations that may pertain, whether real or apparent. Conflict of interest can include personal, professional, financial or proprietary interest. Potential conflicts that develop during the member’s tenure on the DSMB must also be disclosed. Disclosure will serve to protect the integrity of the DSMB and its role in monitoring and oversight of clinical studies and will also help protect the DSMB member from allegations of inappropriate behavior. Failure to disclose a conflict of interest will lead to removal from the DSMB. The NIEHS ethics official may independently determine that a particular situation involves a conflict of interest and consequently exclude the member from the DSMB.

The following should be considered in assessing whether or not there is a conflict of interest.

• Employment: Current or recent (within the past year) employment (e.g., full- or part-time salaried employee, consultant, or other recipient of honoraria; member of board of directors or advisory committee) with an institution or organization that is directly involved with conducting the research or that could receive financial benefit from the results of the study would generally be considered to be a conflict of interest.

• Financial Benefit: An individual who has received or could receive direct financial benefit, other than from employment, of any amount from an individual, institution or organization involved with the study, other than the NIH, may have a conflict of interest. Financial benefit may include stock ownership or prior research funding from an institution or organization involved in the study, whose product is being evaluated in the study or competes with a product being evaluated in the study, or which could otherwise receive financial benefit from the results of the study. Regardless of the level of financial involvement, if the individual feels unable to provide objective advice, he/she must not serve on the DSMB.

• Intellectual property: Intellectual property ownership, such as copyrights, patents, trademarks, trade names, or trade secrets related to the study may be considered a conflict of interest.

• Relatives or Associates: A conflict of interest may exist if a close relative or professional associate of a member receives or could receive financial benefits from or provides financial benefits to the study or investigators. An apparent conflict of interest may also exist with a professional associate that includes any colleague, scientific mentor, or student with whom the DSMB member is currently conducting research or other professional activities or with whom the DSMB member has personally worked or published with within three years.

• Longstanding Disagreements: A conflict of interest may exist when a DSMB member has had longstanding scientific or personal differences with the study or its investigator(s) that may compromise objectivity.

Confidentiality and Non-Disclosure of Materials and Proceedings

Materials and information made available to the DSMB that are not in the public domain, as well as the discussions that take place during the meetings, are strictly confidential and must not be disclosed to or discussed with anyone who is not a member of the DSMB. Furthermore, confidential information obtained as a DSMB member may not be used by the member for personal benefit or for the benefit of the member’s family, associates, or of organizations with which the individual is associated or has a financial involvement.

DSMB Certification Regarding Conflict of Interest, Confidentiality, and Non-Disclosure

NAME:                                                                                                                                 

Primary employer:                                                                                                                

[ ] I have read the attached NIEHS DSMB Conflict of Interest and Confidentiality Form and hereby certify that I do not have a conflict of interest or have discussed and resolved with the NIEHS ethics official any potential conflict of interest with the study(ies) reviewed by this DSMB.

[ ] I fully understand the confidential nature of the DSMB process and agree not to disclose or discuss the materials associated with the review or substance of any confidential discussions about the studies with any individual not a member of the DSMB or NIEHS staff or to use the information for my personal benefit or the benefit of others.

To be completed annually.