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SPECIAL PRECAUTIONS FOR AUDIO AND VIDEO RECORDINGS

CONFIDENTIALITY AND FORM B. 

Since the regulations require CRP to evaluate the means by which the investigator will maintain the anonymity of the subjects or the confidentiality of identified data, you must address these questions on form B, ordinarily in Section V, Specific Risks and Protection Measures. You must also address these same questions in any informed consent document or statement so that the subject will clearly understand the degree to which you will maintain confidentiality and the means by which you will maintain it. Provide detailed description of the means by which you will preserve the anonymity of individual subjects and the means you will use to secure the confidentiality of the data on each of the subjects. In addressing these issues, answer any of the following questions that may be relevant to the project:

1. How and exactly where will you store the data, and will the data include reference to the identities of individual subjects?

2. Who will have access to the data and with what need and qualifications?

3. Will you (or your research associates or any other persons) use the data in any way other than for analysis as set forth in the project proposal?

4. How and in what form will you disseminate the data?

5. For how long will you store the data, and how will you sips of it?

Your answers to these questions should comprise a comprehensive and coherent account that shows clearly how you will maintain the confidentiality of the subjects’ identity and identified data. If you are submitting a Form A (certification of exemption from review), indicate whether you will maintain subject anonymity or confidentiality of unidentified data. If the latter, include an abbreviated account of the means.

NONCONFIDENTIALITY

Most research benefits from maintaining the anonymity of the subjects and the confidentiality of identified data. However, the nature of the project will ultimately determine whether anonymity and confidentiality are required or even possible. Although neither anonymity nor confidentiality are necessary for research approval by CRP, the use of nonconfidential procedures may place the subject at risk greater than that inherent in the use of procedures that maintain the confidentiality of subject data. Risks may include physical, psychological, and social harms. The following Questions indicate some of the typical risks emerging from the loss of confidentiality:

1. Would the dissemination of research findings that reveal the personal identity of subjects create embarrassment for the individual subject, the subject’s family, the subject’s business, or the entire group of subjects.

2. If responses, observations, or information on the subject became known outside the research project, would they place the subject at risk of criminal or civil liability?

3. Would revelation of identified information about research subjects jeopardize their financial standing, employment , or employability?

4. Does the information about eh subject include socially sensitive aspects of behavior, such as illegal conduct, drug use, sexual behavior, or the use of alcohol?

5. The Committee on Research Participation must make a judgment as to whether the project makes adequate provisions for subject privacy and data confidentiality. Therefore, any project that proposes a set of procedures that will not maintain privacy and confidentiality bears the burden of justifying (on Form B) those procedures.

The justification for nonconfidential procedures must explain to the satis fact of CRP; that they are necessary to the project. It must also satisfy the Committee that the investigator has instituted suitable measures to protect the subject from any harm that might result from revelation of identified data. Finally, the justification must also show that the potential benefits from the project  outweigh any risks that might accrue to the subject. If not fully justified, the Committee may request that the investigator institute procedures that better secure subject privacy and data confidentiality.

In Addition to justifying to CRP any procedures that do not assure confidentiality to subject identities, you must also ensure that the subjects clearly understand this fact. The consent document or statement must explain to the subjects to what uses you or others will put their identities or the identified data. The consent form should also tell the subject what risks may follow from such uses, as we'll as what benefits (either to the subjects or to others) will likely follow from these uses. Since the subject’s consent to participate may well rest upon such information, you should provide the subject with complete and honest explanations, leaving nothing vague.

    THE CONFIDENTIALITY OF AUDIOTAPES AND VIDEOTAPES

The use of audio or cid recording inherently precludes assurance of anonymity to the human subjects of research. Their  use also elevates concerns over the preservation of confidentiality of subject identities, since these media often enable the ready identification of subjects by any viewers. Recognizing that recordings are a significant tool for research, we must recognize as well the increased responsibility that accompanies their use. The following notes do not exhaust the subject, but from a starting point for ensuring that recorded research complies with both the regulations and the highest standards of ethical and professional research practice.

1. The need for audio and video recordings: Because recordings by nature may jeopardize the confidentiality of subject identity and data, you should demonstrate on Form B a clear need for using recordings in the conduct of your research. If recording threatens confidentiality more than other means of data acquisition, the mere convenience of recording to the investigator my not sufficiently justify the use of recordings. You must also justify any supplementary, non research uses of the recordings. Again, convenience to the investigator or to the support of these non research functions may not provide sufficient justification for their use if not using the recordings beyond the research context will better hold confidential the subject’s identity.

2. Recordings used only for the research project: Wen used only within the scope of the research project, recordings have specific functions and a limited lifetime. On Form B, explain the need for recording, the specific uses to which you will put the recordings, the methods or analysis, who will have access to the recordings, where you will sort them, when you will erase them, and ay other matters related to holding the subjects identity confidential. Within the context of this explanation, describe how you will hold confidential the subjects identity and data. In order fully to inform the subject about the research use of the recordings, address each of these matters within the informed consent documents and the explanation of informed consent on Form B.

3. Recordings for research and for other purposes: Archival storage (as in oral history) and teaching (as in educational, psychological, and medical settings) represent two of the growing number of supplementary uses for recordings. These supplementary uses preclude guarantees to the subject of strict confidentiality, since the investigator cannot fully control who will hear or view the recordings and thereby recognize the subject. As a consequence, investigators need to consider carefully two additional facets of their project design: the need for both research and non research uses of the same recordings and full disclosure to the subjects. 

On Form B, in addition to addressing the matters listed for research use of recordings specify fully andy supplementary uses you propose for the recordings , the individuals or groups who will use them or control their use, the individuals or groups will hear or see them, the functions or purposes the tapes will fulfill, the need to use the research recordings for these purposes, the time period the recordings will be so used, and the final disposition of the recordings. All relevant items on this list should also appear in the informed consent documents and statements given to subjects. these documents should not only make the subject aware of the uses, but as well alert the subject to the consequences of the potential absence of confidentiality. If someone other than the investigator will control the non research uses of the recordings, provide the subject with a separate release form that gives rights of ownership or use of the tapes to the individual, group, or institution. Do not combine the release form with the informed consent document.

4. Additional auditors and viewers of recordings: Project directors often use judges, reviewers, and other researchers to form a panel of experts to hear or see tapes and to analyze their contents. In addition, supplemental uses of recordings open them to auditors and viewers other than the investigator. Whenever other individuals or groups will hear or view recordings made within your research project, include the following information on Form B: The names of the viewers (if available, otherwise the group identity), their credentials that qualify them to hear or see the recordings, and their functions with respect to the recordings. Also provide this information to the potential subjects of the project in the informed consent documents.

5. Subject review of recordings: After making recordings, investigators ordinarily should permit subjects (or the parents of minors who are subjects) to review the recording and to reaffirm their permission for their inclusion in the research study. This step may hold special importance for the parents of children who appear in the tapes. Parents may have many reasons for excluding the use of a recording including the observation of nonsocial behavior by their children or the revelation of private family information. Review by subjects or subject parents protects against unintentional and unplanned braces of confidentiality. If the circumstances of the research do not permit subject or parental review of the recordings, describe and justify on Form B the alternative procedures which the project will use. 

6. Consent Recorded: Ordinarily, investigators should obtain written consent from recorded subjects. However, were the PI proposes to record the subject’s voice with using the subject’s name, the consent form may constitute the only definitive link between the subject and the project. In such cases, to preserve the subject’s privacy, investigators may request waiver of normal written consent procedures and approval to provide the subject with a written explanation of the project that embodies all the requisite elements of written consent. The subjects’s consent to participate would then be recorded as part of the recorded interview. Since this procedure is a waiver of normal consent procedures, the investigator must specifically request and justify its use. This requirement applies to all affected projects, whether submitted on Form A or Form B.

In all cases, maintaining the confidentiality of identified information is the norm against which CRP must measure all requested variations . All departures from the standards of confidentiality will stand upon a clear need and a high sensitivity to protecting human subjects from consequent risks. In developing a justification for the use of recordings in research, you may wish to consult with member of CRP or its Chair, usually through the Office of Research Compliances.