HVTN Agreement on Confidentiality and Use of Data/Specimens

In consideration of my access to the materials, records, biological specimens, data and/or information described below for HVTN-approved uses, I agree as follows:

1. "Confidential Information" means the following:

• any study material containing a study participant’s, or potential study participant’s, name, unique ID number, contact information or other personally identifiable information;
• protocols, consent forms, and protocol-specific forms;
• data obtained from participants enrolled in an HVTN trial, including but not limited to:
  •       label information on biological specimens,
  •       laboratory test results for participants or potential participants, or
  •     ?  any medical records of participants or potential participants;?
• Investigator’s Brochures or other product/device information supplied or communicated by the study product and/or device manufacturer, company, and/or sponsor of HVTN trials or other information, such as development plans and corporate strategy with regard to HIV vaccine development, identified by these entities as proprietary or confidential; and/or
• any information disclosed at an HVTN meeting that is described as confidential.

2. Participant Biological Specimens and/or Data. If I request and obtain biological specimens and/or data obtained from participants enrolled in HVTN trials for the conduct of HVTN-approved use (“Use”) of such biological specimens and/or data, I agree that such biological specimens and/or data shall:

• be used solely by me or by individuals whose participation is required to complete the Use and who have each signed this Agreement or other appropriate written agreement for such Use (“Collaborator(s)”). I will ensure that those under my direct supervision and those under each such Collaborator’s supervision understand and agree to the terms of this Agreement,
• be used in accordance with the participant’s informed consent,
• be used in compliance with the HVTN Manual of Operations,
• be used solely for the Use,
• not be used for research or any other use that is subject to consulting or licensing obligations to any for-profit organizations,
• not be used in any manner in human subjects or for any diagnostic purpose,
• not be used, either alone or in conjunction with any other information in any effort whatsoever to establish the individual identities of any of the participants from whom biological specimens and/or data were obtained, and
• not be transferred to third parties by me for activities outside the Use without the prior written consent of the HVTN and under the appropriate written agreement.

 3. Publication of Results of Use of Biological Specimens and/or Data.  I agree to promptly contact the HVTN for a determination of which HVTN publication policy applies and of any clinical trial agreement or other contractual agreement terms (collectively “Terms”) that govern any publication or presentation of the results of the Use (“Results”) of the biological specimens and/or data received under this Agreement. I hereby agree to publish or present the Results in accordance with such Terms.  I will not disclose in any publication or presentation any study participant identifiers or any personally identifiable information obtained from the biological specimens and/or data that I obtain under this Agreement.

4. I will not make use of, disseminate, disclose or in any way circulate any Confidential Information except as permitted in writing by the HVTN. If I am required by law to disclose any Confidential Information, I will promptly notify the HVTN to permit the HVTN to seek an appropriate protective order or waive the requirements of this Agreement. I understand and agree that Confidential Information may be published or otherwise disclosed in accordance with the HVTN Manual of Operations, provided, however, that no disclosure may be made which permits identification of any individual participant or the participant's physician unless permitted by applicable law and approved by a local Institutional Review Board/Independent Ethics Committee. Except as required in Section 2 above, I understand that I may disclose Confidential Information I receive under this Agreement to other persons who have signed a HVTN Agreement on Confidentiality and Use of Data/Specimens but only after I have confirmed with the HVTN that such Agreement is current.

5. I agree not to disclose any computer password or otherwise permit unauthorized users to have access to or to view Confidential Information on secure websites or web portals that have been made available to me by the HVTN. If I am authorized to view another person’s email for work purposes, I will not exceed the scope of the authorization.

6. I agree to use the Confidential Information only at my place of employment except to the extent required to conduct HVTN-approved uses of the Confidential Information provided to me. I also agree to establish and maintain appropriate administrative, technical, and physical safeguards to protect the confidentiality of any Confidential Information that I receive under this Agreement.

7. The obligations of confidentiality imposed on me by this Agreement do not apply to any information that is now in or hereafter comes into the public domain through no improper action or inaction by me.

8. I agree to comply with all applicable laws, rules and regulations regarding the confidentiality of individually identifiable health care information and the use of biological specimens and data obtained from participants enrolled in HVTN trials.

9. I agree to notify the HVTN immediately should I become aware of an actual breach of confidentiality or a situation which could potentially result in a breach, whether this is on my part or on the part of another person.