We are conducting interviews and surveys with professionals who review research and with members of the public.
Our study will help policy makers to make recommendations about how to conduct Research on Medical Practices ethically and how to communicate with patients about it.
Main study questions:
- What do people think about the risks and benefits of Research on Medical Practices?
- What do people think about different approaches to letting patients know this type of research is being conducted?
The ROMP Ethics Study began in October 2013. Completed and planned milestones are listed below.
- Conducted focus groups with IRB members at the University of Washington, Seattle Children’s, and Stanford.
- Developed a survey for professionals who review research
- In collaboration with Public Responsibility in Medicine and Research (PRIM&R), surveyed a sample of PRIM&R members.
- In collaboration with Booster Shot Media, developed three informational videos for use in public surveys.
- Conducted focus groups with patients and parents at the University of Washington, Seattle Children’s, and Stanford.
- Developed a survey for patients and the general public.
- In collaboration with Turner Research, surveyed a nationally representative population group
- In collaboration with Providence Health System, surveyed patients who receive specialty medical care in Spokane, Washington (Jan-April 2015).
- Further explored issues of risk, consent, and willingness to participate via phone interviews with 25 of the Spokane survey participants (May 2015).
- In collaboration with Survey Sampling International, conducted 45 cognitive interviews to evaluate and improve survey questions (Aug-Oct 2015).
- In collaboration with Survey Sampling International, developed a revised population survey to evaluate impact of our animated narrative video on knowledge and attitudes compared to illustrated narrative (comics), informational video, and text information (Oct-Nov 2015).
- Publish our finding to inform policy recommendations to the U.S. Office for Human Research Protections (OHRP).
- Kelley M, James C, Alessi Kraft S, Korngiebel D, Wijangco I, Rosenthal E, Joffe S, Cho MK, Wilfond B, Lee SS. Patient Perspectives on the Learning Health System: The Importance of Trust and Shared Decision Making. Am J Bioeth. 2015 Sep;15(9):4-17.
- Wilfond BS, Magnus DC. The potential harms and benefits from research on medical practices. Hastings Cent Rep. 2015 May-Jun;45(3):5-6
- Magnus D, Wilfond BS. Research on Medical Practices and the Ethics of Disclosure. Pediatrics 2015; 135:2 208-210.
- Lantos JD. U.S. Research Regulations: Do They Reflect the Views of the People They Claim to Protect?. Ann Intern Med. 2015 May 19;162(10):690-6.
- Cho MK, Magnus D, Constantine M, Lee SS, Kelley M, Alessi S, Korngiebel D, James C, Kuwana E, Gallagher TH, Diekema D, Capron AM, Joffe S, Wilfond BS. Attitudes Toward Risk and Informed Consent for Research on Medical Practices: A Cross-sectional Survey. Ann Intern Med. 2015; 162(10):731-732.
- Kraft SA, Cho MK, Constantine M, Lee SS, Kelley M, Korngeibel D, James C, Kuwana E, Meyer A, Porter K, Diekema D, Capron AM, Alicic R, Wilfond B, Magnus D. A Comparison of IRB and Patient Views on Consent for Research on Medical Practices. Clin Trials 2016; 13: 555-565; doi: 10.1177/1740774516648907.
- Kraft SA, Constantine M, Magnus D, Porter KM, Lee SS, Green M, Kass NE, Wilfond B, Cho MK. A Randomized Study of Multimedia Informational Aids for Research on Medical Practices: Implications for Informed Consent. Clin Trials. Published online before print September 13, 2016; doi: 10.1177/1740774516669352.
- Kraft SA, Porter K, Wilfond BS, and the Research on Medical Practices Group. Research on Medical Practices and the Patient-Physician Relationship: What Can Regulators Learn from Patients? AMA Journal of Ethics. 2015; 17:1160-1165.
- Lee SS, Kelley M, Cho M, Kraft SA, James C, Constantine M, Meyer AN, Diekema D, Capron AM, Wilfond BS, Magnus D. Adrift in the Gray Zone: IRB Perspectives on Research in the Learning Health System. AJOB Empirical Bioeth. 2016; 7(2):125-134.
- Porter KP, Cho MK, Kraft SA, Korngiebel D, Constantine M, Lee SS, Kelley M, James C, Kuwana E, Meyer A, Diekema D, Capron AM, Magnus D, Wilfond BS. IRB Staff and Members’ Attitudes About Randomization in Research on Medical Practices: Variation in Regulatory Interpretations. IRB: Ethics and Human Research. 2017; in press.
References and Resources:
- RoMP Study Assesses Public Acceptability of Research Policies – ITHS newsletter (Spring 2014)
- SUPPORT Trial Sparks National Debate on Risk to Research Participants – Seattle Children’s Hospital
- Videos explain concepts of clinical research – Stanford Medicine (Sept. 19, 2014)
- Recruiting patients for research? Simple explanations, queries from doctors are best – Stanford Medicine (April 13, 2015)
- Study Finds Public Support for Research on Medical Practices – ITHS Newsletter