Access to medical records for research purposes: varying perceptions across research ethics boards

Willison, Donald J.; Emerson, Claudia; Szala-Meneok, Karen; Gibson, Elaine; Schwartz, Lisa; Weisbaum, Karen M.; Fournier, François; Brazil, Kevin; Coughlin, Michael D.

doi:10.1136/jme.2006.020032

Cited by 48 publications

(45 citation statements)

References 15 publications

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“…The proper approach to protecting indirectly identifying information in any format, not just electronic, is debated by ethicists and review boards. 20 We limited the specificity of data to make it unable to be traced back to a unique individual, for instance by asking for the year of operation rather than a specific date. However, given that the line between anonymous and identifying information is not always distinct, we would recommend that any study of human subjects use technology that formally meets HIPAA standards.…”

Section: Lessons Learned and Future Possibilitiesmentioning

confidence: 99%

Social Media Methods for Studying Rare Diseases

Stringer²,

et al. 2014

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For pediatric rare diseases, the number of patients available to support traditional research methods is often inadequate. However, patients who have similar diseases cluster "virtually" online via social media. This study aimed to (1) determine whether patients who have the rare diseases Fontan-associated protein losing enteropathy (PLE) and plastic bronchitis (PB) would participate in online research, and (2) explore response patterns to examine social media' s role in participation compared with other referral modalities. A novel, internetbased survey querying details of potential pathogenesis, course, and treatment of PLE and PB was created. The study was available online via web and Facebook portals for 1 year. Apart from 2 study-initiated posts on patient-run Facebook pages at the study initiation, all recruitment was driven by study respondents only. Response patterns and referral sources were tracked. A total of 671 respondents with a Fontan palliation completed a valid survey, including 76 who had PLE and 46 who had PB. Responses over time demonstrated periodic, marked increases as new online populations of Fontan patients were reached. Of the responses, 574 (86%) were from the United States and 97 (14%) were international. The leading referral sources were Facebook, internet forums, and traditional websites. Overall, social media outlets referred 84% of all responses, making it the dominant modality for recruiting the largest reported contemporary cohort of Fontan patients and patients who have PLE and PB. The methodology and response patterns from this study can be used to design research applications for other rare diseases. Pediatrics 2014;133:e1345-e1353 AUTHORS:

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Section: Lessons Learned and Future Possibilitiesmentioning

confidence: 99%

Social Media Methods for Studying Rare Diseases

Stringer²,

et al. 2014

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“…Regulators and research ethics boards have been criticized for giving undue weight to the privacy of the individual (National Academy of Sciences 2006), and researchers continue to complain that privacy rules impede research (Cressey 2007;Ness 2007). Some have questioned whether individual informed consent is even necessary for participation in health services research (Cassell and Young 2002), while others struggle to interpret how privacy guidelines may affect the work of research ethics boards and researchers (National Academy of Sciences 2000; Willison et al 2008). Data custodians, various institutions that collect data and research ethics boards have struggled to determine what PHI can or should be shared among institutions and with researchers (Kulynych and Korn 2003;Willison et al 2008).…”

Section: Discussionmentioning

confidence: 99%

“…Some have questioned whether individual informed consent is even necessary for participation in health services research (Cassell and Young 2002), while others struggle to interpret how privacy guidelines may affect the work of research ethics boards and researchers (National Academy of Sciences 2000; Willison et al 2008). Data custodians, various institutions that collect data and research ethics boards have struggled to determine what PHI can or should be shared among institutions and with researchers (Kulynych and Korn 2003;Willison et al 2008). The results of the present study indicate that this uncertainty extends to the level of members of various professional groups as well.…”

Section: Discussionmentioning

confidence: 99%

“…Inasmuch as it would be impractical to get consent for much of the research conducted on de-identified PHI, professionals who are less inclined to grant access to de-identified information need to be better informed about the ethical standards in this regard, about the role of research ethics boards and about what constitutes acceptable practice according to current standards. However, it is noteworthy that a recent study indicates wide variation among research ethics boards on these matters as well (Willison et al 2008).…”

Section: Discussionmentioning

confidence: 99%

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Sorry, You Can't Have That Information: Data Holder Confusion Regarding Privacy Requirements for Personal Health Information and the Potential Chilling Effect on Health Research

Pullman¹,

Buehler²,

Felt³

et al. 2009

hcpol

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This study, conducted in Newfoundland and Labrador, assessed the level of awareness, perceptions and concerns of healthcare providers, health researchers, data managers and the general public about the collection, use and disclosure of personal health information (PHI) for research purposes. Data collection involved surveys and followup focus groups with participants. Results indicate a poor understanding generally with regard to privacy rights and responsibilities. Many professionals are unfamiliar with the legislative environment for PHI, particularly as it pertains to the access and use of PHI for research purposes. Lack of familiarity with basic requirements for patient-based research, coupled with heightened sensitivity to privacy issues owing to various federal and provincial regulatory initiatives, could have a chilling effect on health research. Importantly, our results indicate that the public is much less concerned about the use of their PHI for health research purposes than are professionals who collect, store and share it. RésuméLa présente étude, menée à Terre-Neuve-et-Labrador, évalue le degré de sensibilisation, de perception et de préoccupation des fournisseurs de soins de santé, des chercheurs, des gestionnaires de données et du grand public au sujet de la collecte, de l'utilisation et de la divulgation des renseignements personnels sur la santé (RPS) à des fins de recherche. Les données ont été recueillies au moyen de sondages et de groupes de discussion auprès des répondants. Les résultats indiquent une faible compréhen-sion générale des droits et des responsabilités au sujet des renseignements personnels. Plusieurs professionnels ne sont pas familiers avec le contexte législatif des RPS, particulièrement en ce qui concerne l' accès et l'utilisation des RPS à des fins de recherche. Le manque de connaissances des exigences de base pour la recherche axée sur les patients, conjugué à la sensibilité des questions touchant aux renseignements personnels en raison des nombreux règlements fédéraux et provinciaux, pourrait causer des revers pour la recherche sur la santé. De plus, nos résultats indiquent que le public est beaucoup moins préoccupé par l'utilisation de leurs RPS à des fins de recherche que ne le sont les professionnels qui recueillent, gèrent et partagent ces renseignements.

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“…Willison et al 23 evaluated the diversity of conducts by the REC when approving protocols of which source of data consisted of medical files. They interviewed REC coordinators related to Schools of Medicine in Canada and reported that 47.0% of them require individual consent from the research subject.…”

Section: Discussionmentioning

confidence: 99%