Study participants prefer less demanding consent

1. From an online survey, the majority of respondents preferred that written or oral consent be obtained from them before participating in research on medical practices (ROMP).

2. Of those who preferred giving written or oral consent, a majority were willing to give an easier form of consent rather than not allow the research to be conducted.

Evidence Rating Level: 2 (Good)

Study Rundown: Recently, the U.S. Office for Human Research Protections (OHRP) determined that all randomized studies comparing treatments must disclose the risks of each treatment to the study participants. However, such disclosure is usually not required if said treatments are chosen by the participants and their physicians. To examine the preferences of these disclosures, this survey evaluated opinions on both risk and informed consent practices associated with research on medical practices (ROMP). The results show a majority of respondents perceive hypothetical studies involving treatment randomization to be of higher risk than a study that involves a medical record review. Additionally, a vast majority support ROMP, but also would have researchers obtain their written or oral informed consent before performing any ROMP, including medical record reviews. If obtaining written or oral consent proved unfeasible, most respondents would give consent via a less involved method rather than halt the research. This study was limited in that the survey asked about hypothetical situations and was unable to account for nonresponse bias. Overall, the findings suggest that patients may prefer less-restrictive informed consent guidelines.

Click to read the study in the Annals of Internal Medicine

Relevant Reading: Research on medical practices and the ethics of disclosure

In-Depth [cross-sectional study]: This study used an online survey with informational videos about ROMP to poll both members of an online research panel and random Internet users about their attitudes toward the risk and informed consent procedures involved in ROMP. The survey asked users about the risk associated with three hypothetical research scenarios. The first was a medical record review that compared outcomes of three medications used to treat hypertension, the second was an unblinded, randomized study comparing the three medications, and the third was a randomized study comparing three medications for a more serious condition associated with an increase in stroke risk. A large portion of respondents preferred to give written consent for all three scenarios (51%, 47.2% and 52.4%, respectively). If written or oral consent was not possible, a majority of those who initially preferred written consent would rather receive general information than have the research study canceled (69.1%, 64.9%, and 65.7%, respectively).

Image: PD

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