The COVID-2019 pandemic has disrupted clinical research programs and associated clinical trials worldwide. Research institutions struggle with issues such as how to address imminent needs such as dealing with changing protocols, slowing patient enrollment, and the need for accelerated IRB reviews. As the FDA issued recent guidance, a prestigious New England-based law firm discusses issues for research centers and sponsors to consider during the pandemic.
Who is Verrill?
Verrill Dana LLP is a prestigious New England-based regional law firm.
What are some key Issues to consider? The authors in the JDSupra-based article suggest research centers and sponsors consider the following:
- Evaluate whether to suspend some research studies
- Identify reporting obligations in the event of a suspension (e.g. FDA, Clinicaltrials.gov, etc.)
- Addressing immediate hazard to research participants without prior IRB review and approval (discuss with IRBs what changes to research may be merited)
- Offer clear, concise communication in regard to study communication points of contact
- Re-review by the IRB or changes to informed consent (are risks of the study altered based on COVID-19?
- Changes to informed consent must be communicated—determine the best approach
- Does the changes associated with the crisis impact the results of the study?
Moreover, the attorney authors introduce new challenges associated with COVID-19 to clinical research studies:
- Based on the changes and proposed updates does the activity still fall under research and/or clinical investigation under the Common Rule?
- If the study changes it must be determined if the research or clinical investigation fits in a category for which a Secretarial or FDA waiver of certain regulatory requirements has been granted or for which the regulations permit exceptions.
- IRB review required and expertise with SARS-CoV-2/COVID-19 may be required
- Suggest the creation of a COVID-19 special IRB panel
- Ensure the ongoing enforcement of ethical principles and regulatory requirements despite acceptance (and need for) speedy reviews
The Verrill team discuss expanded access as well as other activities from testing and the development of new tests, vaccines and treatments.
Call to Action: Check out the JDSupra article authored by this group of attorneys. For clinical investigational sites or sponsors, Verrill offers a wealth of knowledge on clinical research rules and regulations.