Erin Rothwell, "Investigator’s Role for Innovative Consent Methods with Biospecimen Research"
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The document discusses the complexities of informed consent in biospecimen research, emphasizing the need for transparency, trust, and accountability from investigators. It highlights that broad consent is often misunderstood by participants, raising concerns about their comprehension and the ethical implications of research practices. Recommendations include enhancing communication methods, establishing an investigator commitment oath, and promoting respect for donors to improve public trust and safeguard biospecimen research.
![Awareness and Accountability
with Oath
• Unsure about improving trust
• Investigator accountability
– Too many [investigators] have done things wrong
and that is just the ones we know about
– Not vouch for other investigator behavior
– To drop the hammer on questionable behavior
• Promotes respect of donations among
investigators
– Investigators do not appreciate the donation](https://image.slidesharecdn.com/rothwell-151117155428-lva1-app6891/85/Erin-Rothwell-Investigator-s-Role-for-Innovative-Consent-Methods-with-Biospecimen-Research-17-320.jpg)
![Quotes Questioning Oath
• An oath would raise suspicious
• [Investigators are] trying to do the right
thing
• Another hoop to jump through](https://image.slidesharecdn.com/rothwell-151117155428-lva1-app6891/85/Erin-Rothwell-Investigator-s-Role-for-Innovative-Consent-Methods-with-Biospecimen-Research-18-320.jpg)
Erin Rothwell, "Investigator’s Role for Innovative Consent Methods with Biospecimen Research"
- 1. Investigator’s Role with Consent for Biospecimen Research Erin Rothwell, PhD
- 2. NPRM • Broad consent for future, unlimited research • Increase investigator independence • Surprising, less attention given to: – Transparency – Trust – Partnership – (Grady et al., 2015)
- 3. Federal Regulations • Broad consent for future purposes – NIH Genomic Data Sharing Policies – HIPPA 2013 amendment • For the most part, minimal risk research • However, informed consent is not engaged in a meaningful manner
- 4. Informed Consent • Informed consent is the cornerstone for the ethical conduct of research – Yet, it is seriously flawed • Clinical informed consent for study specific research over 45 year period (Falagas etal., 2009) • 54% understood aims • 50% understood randomization and risks • 47% knew participation was voluntary • 44% knew they could withdrawal • 57% understood the benefits
- 5. Promote Comprehension • Multimedia • Simplified paper based forms • Teach Back • Comprehension quizzes
- 6. Challenges to Broad Consent • Clinical Setting – Not the best time – Conflicting consent choices • Limited Public Knowledge about Research (Rothwell et al., 2012; Botkin et al., 2014) • Unknown future research uses
- 7. Participant Comprehension • Should continue, but if we are concerned with – Public Trust – Improving safeguards/confidentiality – Partnership • Should we focus on the investigator’s responsibilities’ too?
- 8. Commitment Letter/Oath • FDA has required an Investigator Commitment Letter for decades (www.fda.gov) • I agree to conduct the study(ies) in accordance with the relevant, current protocol(s) and will only make changes in a protocol after notifying the sponsor, except when necessary to protect the safety, rights, or welfare of subjects • I agree to personally conduct or supervise the described investigation(s). • I agree to inform any patients, or any persons used as controls, that the drugs are being used for investigational purposes and I will ensure that the requirements relating to obtaining informed consent in 21 CFR Part 50 and institutional review board (IRB) review and approval in 21 CFR Part 56 are met.
- 9. Questions • What can improve safeguards of biospecimen research? • What can improve confidentiality? • What can improve privacy? • What can help with public trust? • What can help build partnerships?
- 10. Culture of Investigator Research with Biospecimens • Communicating to research subjects about how investigators are committed to responsibly use biospecimens may help promote transparency and trust with research subjects.
- 11. Methods • Purpose – Broad consent – Oath/Commitment letter • Qualitative Descriptive Interviews (n =18) – Intermountain West
- 12. Methods • Conducting in person and over the telephone • Interviews ranged from 15-50 minutes • September 2015 • Notes and written summaries uploaded into Atlas.ti (Fasick, 2001;Halcomb & Davidson,2006)
- 13. Results • moving purpose of consent; • awareness and accountability; • gray areas; • comparisons to clinical care; and • components of investigator oath.
- 14. Moving Purpose of Consent • Changing interpretations of IRBs – We wrote in our consent form ‘researching genes’ and few years later they did not think that included ‘sequencing genes.’ • Hard to comprehend “unlimited” – Its scary because it’s unlimited, how do you communicate that • Difficulties of practical implementation in the clinical setting
- 15. Moving Purpose of Consent • Gives the option to say no or seek more information – Is broad consent trust in the regulatory process? Is it trust in the investigator? Or is just to give the option to say no?
- 16. Awareness and Accountability with Oath • Gives awareness to research subjects and investigators – It will bring awareness so I guess that helps with trust • Tells research subjects you are doing this for the right reason – Have to let them know you are doing this for the right reasons
- 17. Awareness and Accountability with Oath • Unsure about improving trust • Investigator accountability – Too many [investigators] have done things wrong and that is just the ones we know about – Not vouch for other investigator behavior – To drop the hammer on questionable behavior • Promotes respect of donations among investigators – Investigators do not appreciate the donation
- 18. Quotes Questioning Oath • An oath would raise suspicious • [Investigators are] trying to do the right thing • Another hoop to jump through
- 19. Gray Areas • No definitive right or wrong answers – There are such grey areas with research with biospecimens. – PhDs have no oath so they have to do what they think or hope is right • Investigator independence – A lot of independence – Integrity of the investigator is essential
- 20. Gray Areas • Rapid changes in genomics and technology – Fluid is the definition of investigator research – Need to stop and think about each case individually the next time you use them
- 21. Comparisons to Clinical Care • Different but similar to clinical care – Dealing with DNA not patients – I’m not a physician, I’m a researcher. • Their research may have implications for individual health – An investigator might have to wait five years to see the outcomes of their research but it might still yield life saving information • Lack a relationship with research subject
- 22. Components of an Oath • Transparency • Awareness about the importance • Respect to research subjects/donors • Communication practices • Safeguards • Risks/Benefits/Examples
- 23. General Conclusions • Investigator oath well received • Transparency trust • Accountability trust • Changing nature of biospecimen research – From broad societal impact to also include individual impact • Changing perception of research by the public • Efforts to promote research subjects’ comprehension should continue
- 24. Investigator Oath • Do you really think an oath will work? • Can it hurt? • Should participants be aware of the oath? • Is there another approach? • Example of HIPPA – Could we apply lessons learned?
- 26. FDA Investigator Commitment Letter • I agree to conduct the study(ies) in accordance with the relevant, current protocol(s) and will only make changes in a protocol after notifying the sponsor, except when necessary to protect the safety, rights, or welfare of subjects • I agree to personally conduct or supervise the described investigation(s). • I agree to inform any patients, or any persons used as controls, that the drugs are being used for investigational purposes and I will ensure that the requirements relating to obtaining informed consent in 21 CFR Part 50 and institutional review board (IRB) review and approval in 21 CFR Part 56 are met. • I agree to report to the sponsor adverse experiences that occur in the course of the investigation(s) in accordance with 21 CFR 312.64. I have read and understand the information in the investigator’s brochure, including the potential risks and side effects of the drug.
- 27. FDA Investigator Commitment Letter continued • I agree to ensure that all associates, colleagues, and employees assisting in the conduct of the study(ies) are informed about their obligations in meeting the above commitments. • I agree to maintain adequate and accurate records in accordance with 21 CFR 312.62 and to make those records available for inspection in accordance with 21 CFR 312.68. • I will ensure that an IRB that complies with the requirements of 21 CFR Part 56 will be responsible for the initial and continuing review and approval of the clinical investigation. I also agree to promptly report to the IRB all changes in the research activity and all unanticipated problems involving risks to human subjects or others. Additionally, I will not make any changes in the research without IRB approval, except where necessary to eliminate apparent immediate hazards to human subjects. • I agree to comply with all other requirements regarding the obligations of clinical investigators and all other pertinent requirements in 21 CFR Part 312.
- 28. Transparency and Awareness: • to respect your donation to science by allowing use of your biospecimen in research. • to respect your biospecimen as a limited resource and use it wisely and carefully. • to be open and transparent about research with your biospecimen.
- 29. Respect to Donors/ Investigator Promises • to appreciate the your donation for research and science in general. • to use the biospecimen in thoughtful and well-designed research in order to improve the well being of our society and health. • to use the biospecimen only in research that is well designed and intended to have a benefit to society. • to remember this is a donation from a person and not just data. • to conduct research with this donation to improve health and prevent disease. • to respect that all achievements in health and science are the result of previous work of others who have conducted beneficial and thoughtful research and to try to continue to build upon this knowledge for the health care of our society.
- 30. Communication • to acknowledge that although research is to improve health in general, there may be times when it impacts your individual health. • to publish results for other investigators to learn and build upon for future research.
- 31. Safeguards • to adhere to all privacy, ethical and confidential safeguards that are in place for this research. • to seek approval for my research from appropriate institutional, ethics, or governing committees before beginning research
- 32. Risks and Benefits/Example of Importance • to remember that there are some risks with this donation and to seek to minimize these risks • to not release the biospecimen donation to anyone who does not have appropriate approval and who would not adhere to the ethical standards in this oath. • 16. to seek help when needed if I am unsure about the integrity of the research or the welfare of the donors.