(click here for PDFs of all resources below)
Relevant Policies
Data Management Sharing Policy
Genomic Data Sharing (GDS) Policy
Informed Consent for Secondary Research with Data and Biospecimens
Research on Public Views and Values
Baines R, Stevens S, Austin D, Anil K, Bradwell H, Cooper L, et al. Patient and Public Willingness to Share Personal Health Data for Third-Party or Secondary Uses: Systematic Review. Journal of Medical Internet Research. 2024 Mar 5;26(1):e50421.
Privacy, security, and data management/mismanagement concerns are the highest cited barriers to willingness to share personal health data for secondary use. Other factors include the perceived sensitivity of the data, the type of user requesting data access and their motivations, and clear benefits or incentives to share. Sharing was more acceptable if the user had the ability to impact patient care based on their findings, and least acceptable if the user was perceived to be motivated by profit. Control of one’s data and choices for sharing (i.e., dynamic consent) were the most cited methods for building trust in data sharing for secondary use. Financial compensation, in-kind compensation, recognition and expressions of appreciation at the group or individual level were most cited acceptable incentives to share data.
Garrison N, Sathe NA, Antommaria AHM, Holm IA, Sanderson SC, Smith ME, et al. A Systematic Literature Review Of Individuals’ Perspectives On Broad Consent And Data Sharing In The United States. Genetics in Medicine. 2016 Jul 1;18(7):663–71.
This systematic literature review was done to inform the creation of a nationwide, representative survey, and includes empirical studies about consent preferences for future/secondary research and data sharing. Broad consent was acceptable to most respondents when it was the only option presented. When other consent language was offered (e.g., tiered, study-specific), these were preferred over broad consent. Demographic data was inconsistent over the studies included, precluding conclusions about the impact of demographic variables such as race/ethnicity and socioeconomic status. Gender was the most consistently reported demographic variable, and the authors found that men preferred broad consent slightly more than did women.
Goodman D, Johnson CO, Wenzel L, Bowen D, Condit C, Edwards KL. Consent Issues in Genetic Research: Views of Research Participants. Public Health Genomics. 2016 Jul 5;19(4):220–8.
This survey study presented five scenarios in which re-consent or notification of previously consented research participants might be required or preferred: 1. Research on a related condition, 2. Research on an unrelated condition, 3. New genetic factors, 4. Sharing de-identified data outside of the institution, 5. Minors who reach majority age. Respondents were then presented with the following options: broad consent; choosing broad categories of research; and re-consent for each reuse of data. The authors surveyed members of a cancer registry—members with a history of cancer, relatives of someone with cancer, and a control group. A majority of respondents felt re-consent should be mandatory for all scenarios. Of the three potential alternatives, broad consent for all future research at initial consent received the highest approval. Participants with a history of cancer were more likely to feel that re-consent is necessary for scenarios 1-3. White males were more likely to feel that minors should be re-consented when reaching majority age.
Goodman D, Johnson CO, Bowen D, Smith M, Wenzel L, Edwards K. De-Identified Genomic Data Sharing: The Research Participant Perspective. J Community Genet. 2017 Jul 1;8(3):173–81.
Goodman et al. report the results from the PIP survey of members of a cancer registry. Questions addressed willingness to share research data, for what reasons, and with whom. Respondents felt their data should be made available to as many studies as possible. The most cited reason was to learn information about themselves. 80% felt a link between participants and their de-identified data should be maintained, and the majority felt the original researcher should maintain it. Most felt that researchers who used repository data were obligated to share results with the repository to enable return of results to participants. More than half were not concerned about re-identification and felt financial identity theft would be worse. Respondents were most comfortable sharing with researchers at the same institution, at non-profits, or at other universities.
Mathews DJH, Rabin JT, Quain K, Campbell E, Collyar D, Hlubocky FJ, et al. Secondary Use of Patient Tissue in Cancer Biobanks. The Oncologist. 2019 Dec 1;24(12):1577–83.
This focus group study discussed three specific scenarios of secondary research that falls outside of the original consent. There was general agreement that secondary use was okay, with the recognition that there were many who would likely feel differently. In four of the five focus groups, one or more of the participants were consistently against secondary use, citing the Henrietta Lacks case, a sense of violated trust, and a sense of a slippery slope of what might be allowed. There was agreement that re-consent should be attempted if possible/practicable, and no consensus on what to do if re-consent was not possible/practicable. Participants were aligned with the notion of using broad consent to avoid these scenarios.
Milne R, Morley KI, Almarri MA, Anwer S, Atutornu J, Baranova EE, et al. Demonstrating Trustworthiness When Collecting And Sharing Genomic Data: Public Views Across 22 Countries. Genome Medicine. 2021 May 25;13(1):92.
This analysis compares international responses to a survey about methods of building trustworthiness in genetic research. Across 20 of 22 countries surveyed, including the US, the highest valued method of building trustworthiness was transparency regarding who will benefit from access to the data. Transparency regarding the benefits of data use was also highly rated across many countries, suggesting that transparency regarding the potential benefits of research, to whom they will accrue, and how this will happen would go a long way to demonstrate trustworthiness in many places.
Rivera SN de, Creber RM, Zhao Y, Eslami S, Mangal S, Dugdale LS, et al. Public Perspectives On Increased Data Sharing In Health Research In The Context Of The 2023 National Institutes of Health Data Sharing Policy. PLOS ONE. 2024 Aug 28;19(8):e0309161.
This US-based nationally representative survey measured willingness to share particular types of data with particular outside entities. It also measured perspectives and attitudes about the 2023 NIH DMSP policy. More than half of respondents were willing to share de-identified data with various institutions: health policy institutions (78%), public health organizations (78%), health tech companies (74%), public platforms (71%), and private foundations (53%). Participants were least likely to share sexual health and fertility data. The majority of respondents (65%) agreed with the NIH DMS policy, and reported that it would not affect their willingness to participate in research (61%), but racial differences were noted with a higher percentage (28%) of Black participants indicating a decrease in willingness to participate in research studies with the updated policy in place. Open text comments in response to the DMSP policy were categorized into one of the following themes: supportive of policy (33%), supported limiting access to data (37%), prioritized transparency (22%), prioritized anonymity (17%), prioritized autonomy (6%).
Walshe J, Elphinstone B, Nicol D, Taylor M. A Systematic Literature Review Of The ‘Commercialisation Effect’ On Public Attitudes Towards Biobank And Genomic Data Repositories. Public Underst Sci. 2024 Jul 1;33(5):548–67.
Walshe et al. reviewed literature from 36 countries, with 40/104 papers from the US. Universally, there is more trust and willingness to participate in biobanks/repositories that are publicly owned and managed. Universally, private entities’ access to data lessens trust and willingness, and profit motives and societal benefits are seen as mutually exclusive. Some biobank governance strategies can mitigate decreased willingness through: prohibitions on the sale or renting of data, more restrictive and specific consent terms, or the use of derived profits to contribute to some public benefit or donor compensation.
Selected Data Sharing Frameworks
Carroll SR, Garba I, Figueroa-Rodríguez OL, Holbrook J, Lovett R, Materechera S, et al. The CARE Principles for Indigenous Data Governance. Data Science Journal [Internet]. 2020 Nov 4 [cited 2025 Jul 3];19(1).
The CARE principles were developed by an international consortium of Indigenous organizations and tribes. The principles—Collective benefit, Authority to control, Responsibility, and Ethics—are intended to ensure the rights of Indigenous people to self-determination and to address issues of privacy, future use, and collective interest.
Carroll SR, Garba I, Plevel R, Small-Rodriguez D, Hiratsuka VY, Hudson M, et al. Using Indigenous Standards to Implement the CARE Principles: Setting Expectations through Tribal Research Codes. Front Genet [Internet]. 2022 Mar 21 [cited 2025 Jul 3];13.
The CARE Principles were informed by and can be fulfilled via existing tribal research codes. Carroll et al. compiled relevant codes of conduct, which are largely aimed at researchers seeking to collect and use Indigenous data, and at the responsibilities and oversight of tribal leaders and committees.
Emmons KM, Mendez S, Lee RM, Erani D, Mascioli L, Abreu M, et al. Data Sharing In The Context Of Community-Engaged Research Partnerships. Social Science & Medicine. 2023 May 1;325:115895.
Emmons et al. provide recommendations for federal funding agencies to incentivize and ensure community engagement in data sharing decisions. Informed by the NIH’s principles of community engaged research, they recommend community access to data, mechanisms to ensure community understanding, like plain language DUAs and other resources, and models of financial benefit sharing.
Ghasemian M, Gerido LH, Ayday E. Safeguarding Privacy in Genome Research: A Comprehensive Framework for Authors. AMIA Jt Summits Transl Sci Proc. 2025 Jun 10;2025:177–86.
Ghasemian et al. developed guidance for authors who are submitting genomic data to journals that may require data sharing. Authors can use this framework to evaluate privacy protection measures and determine the risk of re-identification of the data relative to the GDS policy standards.
Lin D, Crabtree J, Dillo I, Downs RR, Edmunds R, Giaretta D, et al. The TRUST Principles for digital repositories. Sci Data. 2020 May 14;7(1):144.
Lin et al. articulate a set of principles—transparency, responsibility, user focus, sustainability, and technology—that can increase the trustworthiness of digital repositories. These principles and their related implementation recommendations are focused on building trust among users of repositories. There are also recommendations related to the protection of sensitive data.
Wilkinson MD, Dumontier M, Aalbersberg IjJ, Appleton G, Axton M, Baak A, et al. The FAIR Guiding Principles for Scientific Data Management And Stewardship. Sci Data. 2016 Mar 15;3(1):160018.
The FAIR Principles—Findability, Accessibility, Interoperability, and Reusability—were created to increase the utility of data for machine use. Amid a trend of generalist, decentralized repositories, a group of academics, industry representatives, funding agencies, and publishers created these guidelines that apply to digital objects across domains.