Informed consent in research is an essential requirement for safeguarding participants, but research teams often fall short in this area. The new standard for informed consent, backed by recent FDA and OHRP draft guidance, is clear, compliant, and patient-centric. If you are looking for strategies that align with these principles, our white paper is a great place to start.
Download your copy to explore:
- The evolution of informed consent document complexity, from 338 words on average from 1987-1990 compared to 1,087 words in 2005-2007 and as long as 8,333 words in 2020
- What FDA & OHRP joint guidance on key information means for your trials
- A deep dive into the top three IRB informed consent requirements: information, comprehension, and voluntariness
- Strategies to make informed consent in research more patient-centric, including tips for considering health literacy and making the most of clinical trial technology