HOW TO PRINT To print this page, use your browser's print button. To print the entire document, download the PDF or click here and use your browser's print button. SAMPLE LANGUAGE Sample 1 Sample 2 Sample 3 TOOLS & BACKGROUND MATERIALS Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule National Standards to Protect the Privacy of Personal Health Information in Research
MAIN POINTS Every effort should be made to protect participants' privacy and maintain confidentiality. Potential participants should be told: Who will have access their personal information and research results That, in spite of efforts to protect participants' identities, potentially identifiable data may become publicly known.

Appendix M-III-B-2-d
Interest of the Media and Others

NIH GUIDELINES: "To alert subjects that others may have an interest in the innovative character of the protocol and in the status of the treated subjects, the subjects should be informed of the following:

• That the institution and investigators will make efforts to provide protection from the media in an effort to protect the participants' privacy, and
• That representatives of applicable Federal agencies (e.g., the National Institutes of Health and the Food and Drug Administration), representatives of collaborating institutions, vector suppliers, etc., will have access to the subjects' medical records."

Appendix M-IV
Privacy and Confidentiality

NIH GUIDELINES: "Indicate what measures will be taken to protect the privacy of subjects and their families as well as maintain the confidentiality of research data. These measures should help protect the confidentiality of information that could directly or indirectly identify study participants.

Appendix M-IV-A. What provisions will be made to honor the wishes of individual human subjects (and the parents or guardians of pediatric or mentally handicapped subjects) as to whether, when, or how the identity of a subject is publicly disclosed.

Appendix M-IV-B. What provisions will be made to maintain the confidentiality of research data, at least in cases where data could be linked to individual subjects?"

DISCUSSION
Privacy and Confidentiality: Protection of participants' privacy and the confidentiality of research data are issues that investigators and institutional review boards (IRBs) and institutional biosafety committees (IBCs) routinely consider. Gene transfer research presents special challenges to privacy and confidentiality protections. These issues should be handled according to basic ethical principles as well as extant law (e.g., Health Insurance Portability and Affordability Act of 1996). Many IRBs and IBCs provide guidance about confidentiality protections that may be adapted to address the implications of participation in gene transfer research.

In particular, investigators should address potential participants' concerns about protection of their identities against undesired intrusions by the media and others (privacy) and about limiting access to study information that might identify them (confidentiality).

Maintaining Contact Information: Long-term follow-up of gene transfer research participants and the desire for autopsy information may require keeping basic contact information for participants as well as preserving links between names, contact information, and study results for many years. The consent form should alert potential participants that long-term follow-up will require the investigator to keep contact information, sometimes for long periods.

Stored Data and Specimens: Sometimes data or specimens collected as part of the gene transfer study may be stored for use in other research. In such cases, the investigator should:

• Explain how participant information and specimens will be secured in order to protect against inadvertent or unauthorized disclosure.
• Employ a separate consent form and procedure for research with stored specimens.

IRBs and IBCs can provide guidance for investigators about the uses of stored specimens, including model consent language.

Reporting Requirements: While every effort should be made to keep confidential any information that identifies the participant, certain groups or individuals may inspect and/or copy participant research records for quality assurance and data analysis. The potential participant should be informed that information obtained in connection with the study may be disclosed to:

• Local hospitals or treatment centers
• Staff or agents of the study sponsor
• U.S. Food and Drug Administration
• National Institutes of Health (NIH)
• Governmental agencies in other countries where the study drug may be considered for approval
• IRB and IBC

Public Discussion: An additional concern arises in gene transfer studies with regard to the privacy of participants after an adverse event. Gene transfer safety information must be reported to the NIH Office of Biotechnology Activities. These reporting requirements have been developed to keep gene transfer research as safe as possible for all research participants. Potential participants should be told before they enter a gene transfer study that adverse events and other safety information derived from their research experience could be discussed at a public session of the NIH Recombinant DNA Advisory Committee. Although individually identifiable information is not released or discussed at these meetings, they often draw public and media attention.

Media Interest: Because of the high degree of public interest in gene transfer research, the local or national media may seek information on or interviews with study participants. Investigators must be sensitive to the needs and interests of participants, both when public interest arises from positive information and when it arises from adverse events. Potential participants should be informed that every effort will be made to keep personal information confidential, but it is unwise to imply that the media will never discover or report the identity of individuals. Moreover, sometimes research participants may choose to permit disclosure of their identities, and even to participate in media coverage. Therefore, investigators should discuss the circumstances in which information would be provided to the media. The investigator should also acknowledge that sometimes disclosure of only a small amount of information might lead to the identification of the participant.

Publication of Research Data: Research results are often published in medical literature or used for teaching purposes. Potential participants should be informed that a publication will not individually identify them and that any potentially identifying information, including family pedigrees, photographs, and audiotapes or videotapes, will be used only with their explicit permission.

SAMPLE LANGUAGE

Sample 1

We will try to keep your identity and other information collected in this study confidential. There may be some exceptions when the law requires disclosure. Representatives of [study site], and/or the Food and Drug Administration, and/or the National Institutes of Health, or other regulatory agencies outside [study site] may ask to review the data collected from this study. These groups can have access to your name and medical records.

It is possible that the media may want to find out about you because you took part in this study. We will take every precaution to protect your privacy and that of your family. We will also maintain the confidentiality of the research data. To lower the chance that your identity will be made public, all requests for information will be directed to the [study site] Public Relations Office. Despite these efforts, reporters may try to find out who you are without the approval of the [study site]. If the media succeed, they might ask to interview you and your privacy may be invaded. Every effort will be made to protect your privacy but it may not be possible to do so.

Sample 2

If you become part of this study, investigators and their assistants can look at your medical records as necessary for the purposes of this study. The U.S. Department of Health and Human Services, employees of the study sponsor, the sponsor's monitor, contractors, and auditors, may do so as well.

The media may be interested in this study. You can talk to reporters about being in the study if you want to. The investigators will not talk about the results of the study until study information has been published in a scientific journal. Investigators will not give away your identity to news reporters at any time.

Sample 3

Because this study involves gene transfer, safety information must be reported to the Recombinant DNA Advisory Committee of the National Institutes of Health. This information is available to the public. However, no information by which participants can be identified will be reported with the safety information.

The media (TV, newspapers, radio, Internet, etc.) may also want to know about this study. We will try our best to protect your privacy. However, because we have to share safety information, it is always possible that the media could find out who has been in the study.