Data Access and Stewardship Module 6

The following information has been developed with assistance and input from Rebecca Spence, JD, MPH – Associate Counsel for Ethics, American Society of Clinical Oncology (ASCO) This information does not constitute an endorsement by ASCO Disclosure

Henrietta Lacks https://www.youtube.com/watch?v=y38pgPY6Zq0

Your Cells. Their Research. Your Permission? Review the New York Times opinion article “Your Cells. Their Research. Your Permission?” and consider the author’s questions from the article: “Should scientists have to ask permission to use all leftover clinical samples? Would you say yes? Is broad general consent enough, or do you want options for more control? Why? Should this apply to both tissues and genetic information, anonymous or not? What if this slowed scientific progress?” Source: Skloot, R. (30 December, 2015). Your Cells. Their Research. Your Permission? The New York Times. http://www.nytimes.com/2015/12/30/opinion/your-cells-their-research-your-permission.html?_r=0 Your Cells. Their Research. Your Permission?

Data Access & Stewardship Henrietta Lacks is an example of data that was obtained without consent and was NOT de- identified The cells are actually named after the patient (HeLa) The legal standard is that once material is out of your body, it is no longer yours You have no rights to ownership or compensation after removal The Henrietta Lacks story relates to the broader topics of data access and data stewardship. Data Access & Stewardship

Data Stewardship Data access – who can obtain and use data Who are the “right people” to have access to data? Yes – researchers No – insurance companies and marketers Etc. Data stewardship – “Responsibilities and accountabilities associated with: managing, collecting, viewing, storing, sharing, disclosing, or otherwise making use of personal health information” Source: American Medical Informatics Association Data Stewardship

Principles of Good Data Stewardship Transparency Provide notice regarding collecting, using, disclosing, and retaining data. Individual Participation Engage individuals, and to the extent practicable provide individuals with a meaningful choice as to participation. Purpose Specification Articulate the purpose(s) for using the data Data Minimization Only collect data that is directly relevant and necessary to accomplish the specified purpose(s) and only retain data for as long as it is necessary to fulfill the specified purpose(s) Principles of Good Data Stewardship

Principles of Good Data Stewardship (con’t.) Use Limitation Use and disclose data solely for the specified purpose(s). Data Quality and Integrity To the extent practicable, ensure that data is accurate, relevant, timely, and complete. Security Protect data through appropriate security safeguards Accountability and Auditing Organizations should be accountable for complying with these principles, providing training to all who use data, and auditing the actual use of data. Principles of Good Data Stewardship (con’t.)

Think back to the Common Rule that was covered in Module 5… In the US, ethical issues related to human subjects research are governed in part by the Common Rule Allows biological samples to be stored and used for research indefinitely as long as the sample is de- identified There is a debate in the healthcare research community over whether big data research should be treated as human-subjects research governed by the Common Rule Revisit – Common Rule

Council for Big Data, Ethics, and Society Statement: “The Council has reservations about the proposed revisions to the Common Rule centered on the assumption that public datasets pose few ethical risks to human subjects… ...even seemingly innocuous public datasets can disclose highly personal data when networked with other datasets. Therefore, ethics regulations should focus on what will be or could be done with datasets… We express concern that the new rule’s exclusion of all data science from ethics regulations on the basis of empirically suspect assumptions would weaken efforts to develop ethics review even outside of the Common Rule’s purview.” Metcalf, J., Keller, E.F. & boyd, d. (2016). Perspectives on Big Data, Ethics, and Society. Council for Big Data, Ethics, and Society. http://bdes.datasociety.net/council-output/perspectives-onbig-data-ethics-and-society/ Council for Big Data, Ethics, and Society

What is your reaction to the statement by the Council for Big Data, Ethics, and Society? How do you see the changes to the Common Rule as relevant to big data research and patient participation? What do you see as the ethical responsibilities of big data projects in terms of the protection and use of people’s data? Questions to Consider

Data Access More and more data is being collected… How do we access it? Who can access it? How do we ensure that only the appropriate people access it? What are the effects on privacy and security? Remember that privacy is the right to control access to ourselves and to our personal information Does the idea of “big data” drive expectations of broader access to data/information? Data Access

What Would You Do? Consider these scenarios: You are a patient receiving care at a cancer center that subscribes to a specific software platform (i.e. Flatiron’s OncologyCloud). What is a question you would ask your doctor regarding the stewardship of your personal health information? You are a caregiver for a patient living with ALS. Is there any information you would opt out of sharing on a patient-contributed data-sharing platform? If so, why? After participating in a DNA analysis and consenting for researchers to have access to your genomic information, you are contacted by a researcher to participate in a study based on information you provided. What questions would you want to ask about data access, ownership, and stewardship before deciding whether to participate? What Would You Do?

Applications to Patient Advocacy What are some questions about data access and data stewardship that patient advocates should ask when making decisions about big data participation or policy? Who will have access to my data? Will I be able to obtain access to my own data? How will the data stewards maintain privacy and security for my data? What will my data be used for? Etc. Applications to Patient Advocacy