Study Details

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?

Study Progress

The ROMP Ethics Study began in October 2013. Completed and planned milestones are listed below.

Completed Activities

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).

Planned Activities

Publish our finding to inform policy recommendations to the U.S. Office for Human Research Protections (OHRP).

Study Instruments

IRB Focus Group Guide
Patient Focus Group Guide
General Population and Patient Survey
PRIM&R Member Survey
Greenwall Study Survey Instrument
Greenwall Study – Plain Text
Greenwall Study – Narrated Slideshows – Links to page that doesn’t exist for reference: https://rompethics.iths.org/study-details/greenwall-grant-narrated-slideshows/
Greenwall Study – Comics – Links to page that doesn’t exist for reference: https://rompethics.iths.org/study-details/greenwall-grant-comics/

Study Publications

Lantos JD, D’Angio C, Magnus D, Patrick-Lake B, Tyson J, and Wilfond B. OHRP’s Dangerous Draft Guidance. Bioethics Forum 12/21/2014
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, et al. Attitudes Toward Risk and Informed Consent for Research on Medical Practices: A Cross-sectional Survey. Ann Intern Med. 2015;162(10):731-732
Cho MK, Magnus D, Wilfond BS. Informed Consent for Research on Medical Practices. Ann Intern Med. 2015; 163: 725-726.
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.
Shah A, Porter K, Juul S, Wilfond BS. Precluding consent by clinicians who are both the attending and the investigator: an outdated shibboleth? Am J Bioeth. 2015; 15: 80-82.
Kelley M, James C, Kraft SA, Korngiebel D, Wijangco I, Joffe S, Cho MK, Wilfond B, Lee SS. The Role of Patient Perspectives in Clinical Research Ethics and Policy: Response to Open Peer Commentaries on “Patient Perspectives on the Learning Health System”. Am J Bioeth. 2016; 16: W7-9.
Kraft SA, Cho MK, Constantine M, Lee SS, Kelley M, Korngiebel D, James C, Kuwana E, Meyer A, Porter K, Diekema D, Capron AM, Alicic R, Wilfond BS, Magnus D. A comparison of institutional review board professionals’ and patients’ views on consent for research on medical practices. Clinical Trials. 2016; 13: 555-565.
Lee SS, Kelley M, Cho M, et al. Adrift in the gray zone: IRB perspectives on research in the learning health system. AJOB Empirical Bioeth. 2016: 7.
Kraft SA, Constantine M, Magnus D, Porter KM, Lee SS, Green M, Kass NE, Wilfond BS, Cho MK. A randomized study of multimedia informational aids for research on medical practices: Implications for informed consent. Clin Trials. 2017; 14: 94-102.
Kraft SA, Porter KM, Korngiebel DM, James C, Constantine M, Kelley M, Capron AM, Diekema D, Lee SS, Cho MK, Magnus D, Wilfond BS. Research on medical practices: Willingness to participate and the investigational misconception. IRB: Ethics and Human Research. 2017; 39: 10-16.
Kraft SA, Porter KM, Shah SK, Wilfond BS. Comprehension and Choice Under the Revised Common Rule: Improving Informed Consent by Offering Reasons Why Some Enroll in Research and Others Do Not. Am J Bioeth. 2017; 17: 53-55.
Porter K, Cho MK, Kraft SA, Korngiebel DM, Constantine M, Lee SS, Kelley M, James C, Kuwana E, Meyer A, Diekema D, Capron AM, Magnus D, Wilfond BS. Research on medical practices (ROMP): Attitudes of IRB personnel about randomization and informed consent. IRB: Ethics & Human Research. 2017: 39: 10-16.
Wilfond BS, Kraft SA. Attending to the Interrelatedness of the Functions of Consent. Am J Bioeth. 2017; 17: 12-13.

References and Resources

RoMP Study Assesses Public Acceptability of Research Policies – ITHS News (May 22, 2014)
SUPPORT Trial Sparks National Debate on Risk to Research Participants – Seattle Children’s Hospital – Link no longer exists
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 News (April 14, 2015)
ITHS Study Supports Policy Forum Article in AMA Journal of Ethics – ITHS News (December 2, 2015)