NEWSLETTER

SUMMER 2020

Gina Exception update and information

You’ve all probably heard the term GINA in relation to research that includes genetic testing, but what is GINA? GINA stands for ‘Genetic Information Non-Disclosure Act’ and was approved by the U.S. congress and passed into law in 2008 mainly in response to three factors: 1) The exponential growth in the field of genetic sequencing technology, 2) Decreasing costs of said technology that made genetic sequencing feasible for use in clinical care, and 3) Fears of genetic information being used for the purpose of discrimination, either by employers or health/life insurance companies. The legislation basically makes it illegal to make decisions about employment or insurance premiums based on genetic information, and forbids an insurance company from requiring a member to submit to genetic testing.

Since CHR does genetic testing as part of research and Kaiser provides health insurance , we are in the trusted position of having genetic information and providing insurance. To manage this potential conflict of interest, we comply with additional reporting requirements. Each KP region’s IRB is required to notify Program Office/KFRI no less than 60 days prior to the first genetic test being initiated on an individual project so KFRI can file the information with the appropriate federal agencies. Study teams can help by making it clear in their IRB application what kind of genetic testing, if any, will be done for the study.

ClinicalTrials.gov Enforcement Update

The FDA recently finalized a guidance document on the use of civil money penalties for non-compliance with ClinicalTrials.gov registration and reporting requirements.  While these requirements have been in effect for several years, the FDA has not yet exercised its legal authority to fine researchers or sponsors who are out of compliance. Public watchdog organizations have criticized the FDA for its lack of enforcement, and this guidance signals that the pattern may change.

The FDA plans to identify ClinicalTrials.gov non-compliance through routine audits and inspections as well as consumer complaints. If non-compliance is discovered, the party responsible for registration and reporting (“Responsible Party”) will be notified and given 30 days to come into compliance. If the issue is not remediated within that time, the FDA will consider further regulatory action, including potential civil money penalties.  The guidance indicates that the FDA will focus its enforcement efforts on higher-risk studies and studies with a pattern of non-compliance, either with ClinicalTrials.gov requirements or in other areas.

The best way to protect KP from FDA enforcement action and fines for ClinicalTrials.gov non-compliance is to ensure that studies for which you are a Responsible Party are registered and updated in a timely, accurate, and complete manner. Please review our policy, NWRC.RIM.06 – Clinical Trial Registration and Reporting, for details about the requirements.


Resource Roundup

As we enter the 65th month of 2020, Septobruary, it’s easy to lose track of all the new resources being released by the CHR IRB. Here’s a quick recap of the new resources added to the website in the last quarter:

  • IRBNet Modification Quick Guide (new) – Provides a crash course of creating and submitting a modification package in IRBNet.
  • Establishing IRB Reliance at KPNW IRB (new) – Outlines the process for having external sites rely on KPNW IRB or having KPNW rely on another IRB.
  • IRB Submission Guide (updated) – Details signature permission and document requirements for a variety of package types.
  • Service Level Expectations (new) – Outlines what you can expect from the IRB in terms of turn- around times, deadlines, and IRB workflow.
  • Top 10 Tips for Speedy IRB Review (new) – Distilled from the over 50 years of combined regulatory experience of your RSPO staff, here are our best tips for facilitating a quick IRB review process.

Policy Updates

  • NWRC.SEC.02 – Physically Moving Research-Related Data:  No substantive changes.  Updated links, references, and acronyms.
  • NWRC.PRIV.02, HIPAA Privacy Rule Authorization: Revised to remove redundancies with national and regional policies and to clarify the Research Compliance Department’s role and authority in reviewing HIPAA authorizations, prep-to-research assurances, and decedent research assurances.
  • NWRC.RIM.05, Researcher Training: Procedures clarified to state that CITI refresher courses may be taken instead of repeating the original course.

Mark Mac’s Media Corner

Y’all know I like to keep it topical…but I can do light too. This month’s media corner features a 50-minute treatise on that most treasured of bathroom accoutrements: SOAP! One of my favorite podcasts, Stuff You Should Know has finally given the fluff and fold treatment to this ubiquitous yet inscrutable substance. Click here to experience this squeaky clean episode.

Mark Mac’s Contest Corner

We’re trying something new this quarter and hope you’ll play along. Answer the below questions by replying to mark.j.mcnamara@kpchr.org with the answers to the below questions. All submissions that get both answers correct will be entered into a drawing for this beautiful 5” cherry wood bowl [crowd oos and aahs].

Questions: (1) What anesthesiologist-turned-researcher authored the 1966 New England Journal of Medicine article that took the scientific community to task for 22 published incidences of ethical malpractice in human subjects research, and (2) what was the title of the published article?