Informed Consent & issues surrounding it .pdf
- 1. Issues Surrounding Informed Consent to Research with Substance Abusing Participants _________, Ph.D.
- 2. Overview • This presentation will: • Provide a brief history of informed consent • Review the primary tenets of informed consent • Discuss ways in which the informed consent process may be compromised among substance abusers
- 3. Introduction • Many important medical and behavioral advancements required research on humans • Frequently conducted with marginal and highly vulnerable populations • Revelations of unethical investigations heightened public awareness of the potential for research misconduct
- 4. Nazi Medical Experiments (1942-1945) • Experimental Surgery - Ravensbrook • Sterilization Research - Auschwitz • Typhus Experiments - Buchenwald • Poison Experiments - Buchenwald • Sea Water Experiments - Dachau • High Altitude Experiments - Dachau • Hypothermia Experiments - Dachau
- 5. Tuskegee Syphilis Experiment (1932-1972) • Longest non-therapeutic experiment on human beings in medical history • U.S. Public Health Service (PHS) • 399 black men in the late stages of syphilis • Never told what disease they were suffering from or of its seriousness • 28 died directly of syphilis, 100 of complications, 40 wives infected, & 19 of their children born with congenital syphilis
- 6. Nuremberg Code • Adopted by UN General Assembly in 1948 • First international document to provide guidelines on research ethics • Made voluntary consent a requirement in clinical research studies • Emphasized that consent can be voluntary only if participants: • 1) are able to consent • 2) are free from coercion • 3) comprehend all risks and benefits
- 7. Helsinki Declaration • Established in 1964 at the 18th World Medical Assembly in Helsinki, Finland • World Medical Association adopted a set of principles to guide physicians on ethical considerations related to biomedical research • Emphasized the distinction between medical care that directly benefits the patient and research which may have no direct benefit
- 8. Belmont Report (1979) • National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research • Set forth three principles underlying ethical conduct of research: • Respect for Persons • Recognizing autonomy and dignity • Beneficence • Protection from harm by maximizing benefits and minimizing risks • Justice • Fair distribution of benefits and burdens
- 9. Basic Principles of Informed Consent • Intelligent • Must be capable of understanding • Knowing • Must be understood and retained • Voluntary • Must be autonomous
- 10. Vulnerabilities • Intrinsic • Attributes of the individual that limit capacity or freedoms • Extrinsic • Situational factors that may limit capacity or freedoms • Relational • Occur as a result of the a relationship with another individual or group
- 11. Intelligence • Refers to one’s intrinsic capacity to understand, appreciate, and express a choice • May be compromised in substance abusers due to a host of factors • Severe neurological effects of chronic drug use • Traumatic brain injury
- 12. Knowingness • Refers to one’s accurate understanding and appreciation of the study and their involvement • Substance abusers may experience impaired attention, cognition, or recall as a result of: • Acute intoxication or withdrawal • Long term effects of drug use on the brain • Developmental and environmental factors • Limited education, poor nutrition, and comorbid health and mental health problems
- 13. Consent recall • Rounsaville et al. (2008) • Examined consent recall among marijuana users • Presented consent information and tested participants on recall • 55% correctly answered all four multiple choice questions • Kiluk et al. (2010) • Immediate recall related to intelligence, attention, educational attainment
- 14. Consent recall • Festinger, Dugosh et al., 2007 • Examined consent recall among substance abusing offenders • Tested delayed (2 week post-consent) recall of consent information
- 15. Consent recall Question (# of items) % Totally Correct % Partially Correct Mean % Correct (SD) Purpose of study (2) 0 16 8 (19) Duration of participation (1) 72 N/A 70 (46) Compensation (7) 2 96 40 (26) Group assignment (1) 69 N/A 68 (47) Random assignment (1) 58 N/A 56 (50) Potential benefits (4) 0 46 15 (19) Potential risks (3) 0 25 8 (18) Declining participation (1) 90 N/A 88 (32) Study rights and protections (5) 0 0 0 (0) HIPAA (3) 0 4 2 (9)
- 16. Consent recall Question (# of items) % Totally Correct % Partially Correct Mean % Correct (SD) Purpose of study (2) 0 16 8 (19) Duration of participation (1) 72 N/A 70 (46) Compensation (7) 2 96 40 (26) Group assignment (1) 69 N/A 68 (47) Random assignment (1) 58 N/A 56 (50) Potential benefits (4) 0 46 15 (19) Potential risks (3) 0 25 8 (18) Declining participation (1) 90 N/A 88 (32) Study rights and protections (5) 0 0 0 (0) HIPAA (3) 0 4 2 (9)
- 17. Consent recall • Overall, clients recalled only 34% of information on average just two weeks post-consent • Replicated in several subsequent trials (Festinger, Dugosh, et al., 2009, 2011) • Delayed recall related to intelligence, reading level, memory, and attention
- 18. Researcher perceptions of understanding (Dugosh, Festinger, et al., 2014) • Conducted web-based survey to evaluate NIDA- and NIAAA-funded researchers’ perceptions about consent recall (n = 233) 48% 15% 37% Type of research Behavioral Biomedical Both 20% 8% 66% 11% Prisoners Pregnant women Low SES Cognitively impaired Special Populations
- 19. Researcher perceptions of understanding (Dugosh, Festinger, et al., 2014) 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Very Important Somewhat Important Somwhat Unimportant Not Important How important is it for participants to remember their consent information throughout the course of a study?
- 20. Researcher perceptions of understanding (Dugosh, Festinger, et al., 2014) 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Methods and Procedures Safeguards and Protections Risks Benefits How important is it for participants to remember the following areas covered in the consent process? Very Important Somewhat Important Somwhat Unimportant Not Important
- 21. Researcher perceptions of understanding (Dugosh, Festinger, et al., 2014) 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Methods and Procedures Safeguards and Protections Risks Benefits How well do you think participants remember information in each of the following areas? Completely Moderately Slightly Not at all
- 22. Voluntariness • Participation free from coercion and undue influence • Substance abusers often have certain situational factors that may interfere with their ability to make autonomous decisions • Often recruited from settings that are implicitly coercive (e.g., inpatient units, detoxification facilities, prisons) • May perceive, correctly or incorrectly, that cooperation is essential for their well being
- 23. Drug Court Participants (Dugosh, Festinger, et al., 2014) Item Not at all A little More than a little A lot I felt like I was talked into entering the study 91% (124) 9% (12) 1% (1) -- It was entirely my choice to enter the study (reverse scored) 93% (128) 6% (8) 1% (1) -- I thought it would look bad to my case manager if I did not enter the study 89% (122) 9% (12) 2% (3) I felt the judge would like it if I entered the study 50% (68) 26% (36) 7% (9) 18%(24) I entered the study even though I did not want to 94% (129) 5% (7) 1% (1) -- I felt that I could not say ‘no’ to entering the study 88% (120) 6% (8) 4% (6) 2% (3) I felt that entering the study would help my court case 57% (78) 23% (31) 11% (15) 10% (13) I thought it would look bad to my counselor if I did not enter the study 87% (119) 8% (11) 4% (5) 1% (2) I felt that I could not say no to being in the study because of the money 69% (94) 18% (24) 7% (10) 7% (9) I entered the study because I though it would please my attorney 96% (132) 2% (3) 1% (1) 1% (1) It would have created problems with my family if I chose not to participate 98% (134) 2% (3) -- -- It would have created problems between me and other people in the program if I chose not to participate 99% (136) 1% (1) -- --
- 24. Prisoners receiving MMT Dugosh, Festinger, et al., (2013)
- 25. Voluntariness and payment • Widely held belief that providing monetary incentives to substance abusers is an undue influence • Lower SES, lower educational attainment • Address this by providing gift card payments, non- monetary goods and services
- 26. Conclusions • Substance abusers present unique challenges related to informed consent to research • Problems may be magnified in genetics research • Fortunately, there are empirically-validated techniques and tools available to help improve informed consent among substance using participants