Certificates of Confidentiality: Legal Counsels' Experiences with and Perspectives on Legal Demands for Research Data

Wolf, Leslie E.; Dame, Lauren; Patel, Madhabhai M.; Williams, Brett A.; Austin, Jefferey A; Beskow, Laura M.

doi:10.1525/jer.2012.7.4.1

Cited by 17 publications

(13 citation statements)

References 3 publications

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“…Apply for a Federal Certificate of Confidentiality, (http://grants.nih.gov/grants/policy/coc), if appropriate, describe this in the consent form. Be aware that a Certificate of Confidentiality provides some protection, but is not an absolute guarantee against disclosure (Beskow, Dame, & Costello, 2008; Wolf et al, 2012). …”

Section: Pragmatic Lessons Learned About Project Management and Data mentioning

confidence: 99%

Planning for Long-Term Follow-Up: Strategies Learned from Longitudinal Studies

et al. 2015

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Preventive interventions are often designed and tested with the immediate program period in mind, and little thought that the intervention sample might be followed up for years, or even decades beyond the initial trial. However, depending on the type of intervention and the nature of the outcomes, long-term follow-up may well be appropriate. The advantages of long-term follow-up of preventive interventions are discussed, and include the capacity to examine program effects across multiple later life outcomes, the ability to examine the etiological processes involved in the development of the outcomes of interest and the ability to provide more concrete estimates of the relative benefits and costs of an intervention. In addition, researchers have identified potential methodological risks of long-term follow-up such as inflation of type 1 error through post-hoc selection of outcomes, selection bias and problems stemming from attrition over time. The present paper presents a set of seven recommendations for the design or evaluation of studies for potential long-term follow-up organized under four areas: Intervention Logic Model, Developmental Theory and Measurement Issues; Design for Retention; Dealing with Missing Data; and Unique Considerations for Intervention Studies. These recommendations include conceptual considerations in the design of a study, pragmatic concerns in the design and implementation of the data collection for long-term follow-up, as well as criteria to be considered for the evaluation of an existing intervention for potential for long-term follow-up. Concrete examples from existing intervention studies that have been followed up over the long-term are provided.

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Section: Pragmatic Lessons Learned About Project Management and Data mentioning

confidence: 99%

Planning for Long-Term Follow-Up: Strategies Learned from Longitudinal Studies

et al. 2015

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“…4 In other instances, litigants’ interest in the data may relate to individual participants, rather than the research per se, and may not be anticipated. 5 …”

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confidence: 99%

Certificates of Confidentiality: Protecting Human Subject Research Data in Law and Practice

Wolf¹,

Patel²,

Tarver

et al. 2015

J. Law. Med. Ethics

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Answering important public health questions often requires collection of sensitive information about individuals. For example, our understanding of how HIV is transmitted and how to prevent it only came about with people's willingness to share information about their sexual and drug-using behaviors. Given the scientific need for sensitive, personal information, researchers have a corresponding ethical and legal obligation to maintain the confidentiality of data they collect and typically promise in consent forms to restrict access to it and not to publish identifying data.The interests of others, however, can threaten researchers' promises of confidentiality when legal demands are made to access research data (e.g., through subpoena). In some cases, the subject of the litigation is tightly connected to the research questions, and litigants' interest in the data is not surprising. Researchers conducting studies on tobacco or occupational or other chemical exposures, for example, are relatively frequent targets of subpoenas.

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“…In crafting our simplified language, we attempted to remain faithful to the substance of NIH’s version, which states: “With this Certificate, the researchers cannot be forced to disclose information that may identify you, even by a court subpoena.” Despite this strong assertion, it is unclear whether Certificates can provide such absolute protection in all circumstances (Beskow et al 2012; Beskow, Dame, and Costello 2008, 2009; Wolf et al 2012). Thus, developing consent descriptions of Certificates that are both simple and accurate is critically important.…”

Section: Discussionmentioning

confidence: 99%

“…First, standard confidentiality protections, especially maintaining data in coded form, appear to be reassuring to many of our participants. Together with the perception of Certificates as providing “extra” protection—a view shared by IRB chairs (Beskow et al 2012) and institutional legal counsel (Wolf et al 2012) and supported by legal analysis (Wolf et al 2013)—this suggests that developing simple, non-technical descriptions of basic protections may be beneficial (Albala, Doyle, and Appelbaum 2010; Breese et al 2004; Kass et al 2011; Paasche-Orlow, Taylor and Brancati 2003). …”

Section: Discussionmentioning

confidence: 99%

Research Participants’ Understanding of and Reactions to Certificates of Confidentiality

Beskow

Check

Ammarell

2014

AJOB Empirical Bioethics

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Background Certificates of Confidentiality are intended to facilitate participation in critical public health research by protecting against forced disclosure of identifying data in legal proceedings, but little is known about the effect of Certificate descriptions in consent forms. Methods To gain preliminary insights, we conducted qualitative interviews with 50 HIV-positive individuals in Durham, North Carolina to explore their subjective understanding of Certificate descriptions and whether their reactions differed based on receiving a standard versus simplified description. Results Most interviewees were neither reassured nor alarmed by Certificate information, and most said it would not influence their willingness to participate or provide truthful information. However, compared with those receiving the simplified description, more who read the standard description said it raised new concerns, that their likelihood of participating would be lower, and that they might be less forthcoming. Most interviewees said they found the Certificate description clear, but standard-group participants often found particular words and phrases confusing, while simplified-group participants more often questioned the information’s substance. Conclusions Valid informed consent requires comprehension and voluntariness. Our findings highlight the importance of developing consent descriptions of Certificates and other confidentiality protections that are simple and accurate. These qualitative results provide rich detail to inform a larger, quantitative study that would permit further rigorous comparisons.

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Certificates of Confidentiality: Legal Counsels' Experiences with and Perspectives on Legal Demands for Research Data

Cited by 17 publications

References 3 publications

Planning for Long-Term Follow-Up: Strategies Learned from Longitudinal Studies

Planning for Long-Term Follow-Up: Strategies Learned from Longitudinal Studies

Certificates of Confidentiality: Protecting Human Subject Research Data in Law and Practice

Research Participants’ Understanding of and Reactions to Certificates of Confidentiality

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