As many clinical research professionals know, proper delegation of authority is critical to maintaining ethical and compliant study conduct. Managing a research team requires a solid understanding of how best to delegate tasks and responsibilities, particularly when the team members have mixed training and levels of experience. However, even with a good amount of management and delegation experience, knowing when to assign a task to a staff member isn’t always straightforward.
There are some tasks that fall into a gray area of delegation of authority, such as informed consent, that require additional consideration before being assigned to non-principal investigators. The process of obtaining consent from individuals to participate in a clinical trial, specifically, is quite the ethical minefield; and whether or not this task (or parts of this task) should be delegated can be unclear.
What’s different about informed consent?
One reason informed consent is a gray area for delegation of authority is because, according to federal regulations, there is some information that can be communicated to potential participants by qualified staff members (non-principal investigators) to support informed consent. But, it is not admissible for support staff to communicate information regarding the potential impacts of study participation to an individual’s well-being.
Ultimately, the decision to delegate permissible elements of informed consent is a risk-benefit comparison—does delegating this task put the potential participant at risk?
Why is it a talking point?
Informed consent has made headlines in recent weeks for this very reason. Some states have ruled that physicians, not their delegates, are now required to obtain consent from patients for “…administering an experimental medication or device” (40 P.S. § 1303.504).
This ruling could considerably influence how physicians in these states obtain consent from patients. While it is still unclear how these laws could impact the research industry, they are more restrictive than other federal regulations and could affect processes at some sites. Non-PI research staff will no longer be allowed to communicate the logistical, non-risk-based information to support informed consent.
What could this mean?
The potential benefit of this ruling is that it could standardize the informed consent process, effectively moving it out of the delegation of authority gray area. However, this law could also lead to complications with physician time and effort allocation, among other concerns. Delegating non-risk associated communications to support staff allows the physician to focus their efforts on other research functions; this ruling could require them to allot more time to consenting patients than they would have otherwise.
Want to know more?
Watch the free, on-demand recording of Wendy and Mariette’s presentation, “Best Practices for Ethical and Compliant Delegation of Authority at Your Research Institution” for more information and tips on managing the oversight of your clinical trial operations.