When you decide to participate in a research study, what do you think the reserachers should inform you about?
Imagine that you have been diagnosed with depression. You see an ad in the local newspaper that a research group is studying a new drug for the treatment of depression and is recruiting people like yourself to participate. The study will investigate how effective the drug is at treating depression and will also look at whether the drug has any negative side effects.
Suppose the new drug is made by a small biotechnology company. The researcher owns a substantial portion of the stocks of the company. The value of the company's stocks can rapidly go up or down by large amounts depending on whether the drug is seen to be safe and effective for treating depression.
How important is it for you to know about the researcher's stock investment in the company before you consent to be in this study?
Do you think that the researcher should be required to tell you about his stock investment in the company before you are asked to participate?
Which option best reflects what you would do, given the researcher's stock investment in the drug company?How important is it for you to know about the researcher's stock investment in the company before you consent to be in this study?
- Extremely important.
- Very important
- Somewhat important
- Not very important
- Not at all important
Do you think that the researcher should be required to tell you about his stock investment in the company before you are asked to participate?
- Yes
- No
Which option best reflects what you would do, given the researcher's stock investment in the drug company?
- I would not participate in this study.
- I'm not sure
- I would still consider participating in this study
First, a little background:
The scenario you read and the questions you just answered were similar to ones that were asked to participants who have actually been diagnosed with depression. Also, individuals with coronary heart disease and breast cancer were given scenarios in which the researcher was said to be studying drugs that treated these health conditions. In the actual study, participants read seven scenarios, each having to do with a researcher's or university's personal financial investment in the drug being investigated. For instance, other scenarios included the university medical centre owning stocks of the drug company, the researcher receiving a lump sum of money per person enrolled in the study, and the drug company paying for the study.
Why were those questions important to ask?
Much of clinical research depends on patient volunteers to serve as research subjects. Patients must rely on the trustworthiness of the researchers who recruit them to help them decide whether to enroll in the study. This is especially true since benefit from participation can be uncertain. If an investigator or institution does not disclose that they have personal financial connections to the drug being studied, this could potentially undermine the trust of the participants. At the time that this study was submitted, there were no federal requirements on investigators or their institutions to disclose such financial conflicts of interest to potential research participants. This may continue to be the case in the future.
What can we say based on this study?
This study found two important trends: (1) Most potential research participants desired to be informed (and believed this should be required) regarding financial conflicts of interest in research, and yet (2) most still wanted to participate in such research. A clear majority still wanted to participate even in the most controversial scenario, which was the one you read on the previous screen. From these findings, then, it seems that the current practice of non-disclosure of financial conflicts of interest do not conform to the values and wishes of potential patient volunteers. It is not clear, however, whether disclosure, management, or elimination of financial conflicts of interest is the best solution. This study should not be taken to mean that only disclosure is required.