August 9, 2022
For the Record- August 9, 2022: Impact of Dobbs v. Jackson on Research, Minor Change to Elements of Consent for Device Clinical Trials
In this Issue:
- Impact of Dobbs v. Jackson on Research
- Minor Change to Elements of Consent for Device Clinical Trials
- Slower Turnaround Times in August
Impact of Dobbs v. Jackson on Research
On June 24, 2022, the US Supreme Court issued a ruling on the Dobbs v. Jackson Women’s Health Organization case. The case concerned the constitutionality of a 2018 Mississippi state law that banned most abortion operations after 15 weeks of pregnancy. In its ruling the court determined that the US Constitution does not confer a right to abortion and overruled prior precedents established under Roe v. Wade and Planned Parenthood of Southeastern Pennsylvania v. Casey. The authority to regulate abortion was returned to the individual states.
Several states have existing laws that ban or restrict abortion. Other states passed ‘trigger laws’ that would ban or restrict abortion if Roe v. Wade were overturned. Information regarding the current legal status of abortion for individual states may be found here.
The impact to research involving abortion is varied and depends on several factors. Possible implications include:
- Limits or bans on fetal tissue collection (e.g., in states with abortion bans)
- Privacy and data confidentiality issues, including risk of legal harm for study participants (e.g., survey study collecting identifiable data on abortion history in states where it is now illegal to have one)
There may be other implications. This is an evolving situation that is likely to change over the coming months and years. We advise researchers working in this area to consider the impact on their individual studies and consult with HSD (206-543-0098 or firstname.lastname@example.org) if there are any questions.
Minor Change to Elements of Consent for Device Clinical Trials
Language in consent forms about the source of funding for device clinical trials is no longer required for studies with IDE letters issued after 2015. HSD’s template consent form and reference document for studies reviewed by non-UW IRBs have been revised to reflect this. Already approved consent materials do not have to be revised.
Up until now, HSD’s consent requirements for device clinical trials have been based on those of Noridian, the Medicare Administrative Contractor (MAC) for UW. They were intended to facilitate obtaining approval of Medicare coverage for investigational device studies from Noridian. In January 2015, the Centers for Medicare and Medicaid Services (CMS) took over the review and approval of coverage for investigational device studies from the regional MACs. CMS does not have consent language requirements and instead only requires documentation of IRB approval.
Studies with IDE letters issued prior to 2015 must still follow Noridian’s requirements, including its consent requirements. The study team is responsible for ensuring these elements are included in the consent materials.
If you have questions regarding what requirements your study is subject to, contact UW Medicine Compliance at email@example.com.
Slower Turnaround Times in August
Many HSD staff are taking time off this summer. While we will ensure that there is adequate coverage, we anticipate that turnaround times will be slower in August. We appreciate your patience and understanding. To minimize the impact to your research, we encourage you to ensure your applications are complete and submitted as early as possible. For any externally imposed urgent deadlines, please be sure to call these out in your submission so we can prioritize accordingly.