What are the best practices for informed consent in data sharing?

Data sharing is the process of making health information available to researchers, policymakers, or other stakeholders for various purposes, such as improving care quality, advancing scientific knowledge, or informing health decisions. However, data sharing also poses ethical and legal challenges, especially when it involves sensitive or personal data that could affect the privacy, autonomy, or dignity of patients. Therefore, informed consent is a crucial component of data sharing, as it ensures that patients are aware of the risks and benefits of participating in data sharing, and that they have the right to withdraw or limit their consent at any time. In this article, we will discuss some of the best practices for informed consent in data sharing, based on the principles of respect, transparency, and accountability.

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1 Respect patients' preferences

One of the best practices for informed consent in data sharing is to respect patients' preferences and values, and to avoid imposing any undue pressure or coercion on them. This means that patients should be given enough time and information to make an informed decision, and that they should be able to choose from different options of data sharing, such as opting in, opting out, or selecting specific data types or purposes. Moreover, patients should be able to change or revoke their consent at any time, and to access or delete their data if they wish. Respect also implies that patients should be treated as partners in data sharing, and that their feedback and concerns should be addressed and acknowledged.

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Diane Y. Petersen, M.D.

Retired Surgeon | Chair Tri Delta Foundation Board of Trustees | Women's Empowerment | Life Sciences | Committed to transforming national healthcare delivery to ensure quality, accessible, affordable care for all
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Data sharing is so vital in making scientific progress. Informed consent is one of the founding principles of research ethics. The patient must be informed of every aspect of their participation and choices in understandable terms. Highly structured, well organized, short readable content is imperative for the consent. Summaries and even audiovisual material may enhance comprehension. The examiner must be aware of any variations in the ability of the individual to assimilate consent information, such as language barriers, cognitive abilities, psychiatric disorders or in the individual's capacity for decision making.

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2 Provide clear and concise information

Informed consent in data sharing requires providing clear and concise information to patients, using language that is easily understandable and avoiding technical jargon or legal terms. This information should include the purpose and scope of data sharing, including who will access the data, for what reason, and for how long; the potential benefits and risks of data sharing, both for the individual and for society; the rights and responsibilities of the patient; the measures and safeguards in place to protect the data; the sources and methods of data collection; and the alternatives and consequences of not participating in data sharing.

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Diane Y. Petersen, M.D.

Retired Surgeon | Chair Tri Delta Foundation Board of Trustees | Women's Empowerment | Life Sciences | Committed to transforming national healthcare delivery to ensure quality, accessible, affordable care for all
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The amount of content for an informed consent can be overwhelming. The participants must fully understand and retain the information. The forms should not only be readable, concise, and contain all the pertinent information, but should also help the patient make a decision about whether to participate in the data sharing. Interventions such as extended discussion, question and answer sessions, short videos that complement written forms, and enhanced consent forms help to increase understanding and recall.

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3 Ensure accountability and transparency

A third best practice for informed consent in data sharing is to ensure accountability and transparency throughout the data sharing process, and to communicate any changes or updates to the patients. This means that patients should be informed of any incidents or breaches that affect their data, and of the actions that are taken to mitigate or prevent them. It also means that patients should be able to access and verify their data, and to request corrections or deletions if needed. Furthermore, patients should be informed of the outcomes and impacts of data sharing, such as the results of research, the policies that are influenced, or the benefits that are generated. Accountability and transparency also require that data sharing is conducted in accordance with ethical and legal standards, and that there are mechanisms for oversight, evaluation, and feedback.

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4 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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Courtney Almas

RN, BN, CCHN(C)
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Culturally competent and client-centered approaches are extremely important when obtaining informed consent. Some considerations to take into account are the client's language of choice, the provider's wording and body language when obtaining consent as well as how the client and/or their family prefer to provide consent.

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What are the best practices for informed consent in data sharing?

1

2

3

4

1 Respect patients' preferences

2 Provide clear and concise information

3 Ensure accountability and transparency

4 Here’s what else to consider

Patient Advocacy

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What are the best practices for informed consent in data sharing?

1

2

3

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1 Respect patients' preferences

2 Provide clear and concise information

3 Ensure accountability and transparency

4 Here’s what else to consider

Patient Advocacy

Rate this article

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