Is informed consent needed for post-market patient registry?

Question:

Is it possible that a post-market patient registry that collects patient experience with the use of a medical device would not need informed consent? The study does not involve collection of specimens. Does the Food and Drug Administration (FDA) require informed consent for this kind of registry study? If an informed consent is needed, can it be administered online?
– VP, Medical Device Company

Answer:

If you are contacting the subjects and asking them questions about their experience, you could do online consent with a waiver of the signature requirement. On the other hand, if you are obtaining the information without actual subject contact, e.g., doing a medical chart review, a waiver of consent may be granted by the IRB. 

Under current FDA regulations, a waiver of the requirement for informed consent is narrowly limited to emergency research or certain life-threatening situations. The authority of the IRB to waive informed consent for certain kinds of FDA regulated minimal risk research is based on a 2017 guidance from the agency. 

In this 2017 guidance document, FDA noted that allowing a waiver of informed consent for certain FDA-regulated minimal risk research would facilitate investigators’ ability to conduct studies “that are important to addressing significant public health needs without compromising the rights, safety, or welfare of human subjects.”  The FDA subsequently published a proposed rule to align its requirements on informed consent waivers with those of the Common Rule. Under the Common Rule, informed consent may be waived for minimal risk research that meets certain criteria.

The guidance goes on to say that until FDA promulgates these regulations, they do not intend to object to an IRB waiving the requirements to obtain informed consent when the IRB finds and documents that the following (Common Rule) criteria are met:

1. The research involves no more than minimal risk.
2. The waiver or alteration will not adversely affect the rights and welfare of the subjects;
3. The research could not practicably be carried out without the waiver or alteration;
4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

This is the FDA’s way of allowing “enforcement discretion” until the regulations are changed and catch up with their decision to allow waivers of consent.  So, it is possible that an IRB would allow a waiver if your research meets these criteria.