There are a few authors that have looked at SDM in the research context. A very nice paper is from the May 2020 V 22 n. 5 article (https://doi.org/10.1001/amajethics.2020.365) in the AMA Journal of Ethics. The authors make modifications to the approach in clinical ethics noting differences in the primary stakeholders' interest. Investigators are interested in furthering the knowledge of an intervention. The Investigator may have some monetary and/or prestige interest in performing the study. That disclosure allows the subject to assess the potential for bias in the investigator. There is also the point of equipoise in the research. Take the case of an intervention. We do not know if it is better, the same, or worse than current standard of care or even placebo. Still there are reasons to participate and many people do. They may get a new therapy that will help them. Others wish to promote knowledge. For others in Phase I it might be to make some money. To accommodate these other goals requires a modification about what to disclose. You already know some of these. We need to disclose the burden on the patient/subject in terms of time, assessments, and so on. It is also a good idea to explain why the study is important and what questions it hopes to answer. They would certainly have relevance to patients who wish to extend knowledge. I think the better we do this the more likely recruitment becomes easier. Viewing the patient as a partner in research surely will engage them more in the process.
There are no studies that I could locate searching PubMed for shared decision making in clinical research. There is plenty out there though on comprehension of documents in informed consent. Let draw out areas where I see significant differences. Whether these differences amount to anything is yet another question.
As pointed out previously, there are other players in the research context. IRBs or Ethics Committee are one. Their obligation is to oversee the sites (typically) and make sure the study design and process at the site is ethically satisfactory. To accomplish this, they review the protocols which is the roadmap for the study. It includes the purpose of the study. This informs the Ethics Committee if the risk to the patient is worth the study question. The procedures described in the protocol should not pose unnecessary risks to the patients. The Ethics Committee is the gatekeeper for this.
The Ethics Committee also reviews the consent form and all manner of communications for the patient/subject. These items have their own challenges. The Committees do a good job ensuring that there is a lot of information for the patient to review. The research on informed consent would indicate a more mixed review on improving the information and how easily it can be digested. Twenty-page consent forms with Privacy information become tedious much like the licensing agreements at the end of a software app.
It should be noted that the Ethics Committee is under no obligation to observe the consent process though they may do so. I have not in my experience experienced this either directly or indirectly. I would be interested to know if any Ethics Committees perform this activity.
What are we to make of this new player in the consent process? It seems to be quite helpful in ensuring that enough information is conveyed to the patient. It supplies some guardrails to the process. It does seem more restrictive than in the clinical practice process where information could be highlighted that is relevant to the patient/subject and the patient's goals. Perhaps the fact that we are only offering a way of participating in furtherance of knowledge makes the decision process far simpler. The patient/subject either values that or not. The rest is an even bet in terms of therapy.
The major problem with informed consent in clinical practice was figuring what information to convey to individual patients. A myriad of options typically. Each option had its pros and cons. With clinical research there are usually 2 or 3 options. The reasons to participate or not revolve around either altruistic motives, desperation, or the hope for some marginal gain. I sense this might require less soul searching on the part of the patient/subject.
Comentários