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Treatment Research Institute

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Presentation on theme: "Treatment Research Institute"— Presentation transcript:

1 Treatment Research Institute
Issues Surrounding Informed Consent to Research with Substance Abusing Participants Karen L. Dugosh, Ph.D. Treatment Research Institute Philadelphia, PA ©Treatment Research Institute, 2012

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 After the Belmont Report was established, DHHS and FDA revised their regulations for studies that involved human participants and informed consent emerged as the cornerstone for human subject protections

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 20% did not understand that participation was voluntary

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 2 weeks later

15 Consent recall Question (# of items) % Totally Correct
% Partially Correct Mean % Correct (SD) Purpose of study (2) 16 8 (19) Duration of participation (1) 72 N/A 70 (46) Compensation (7) 2 96 40 (26) Group assignment (1) 69 68 (47) Random assignment (1) 58 56 (50) Potential benefits (4) 46 15 (19) Potential risks (3) 25 8 (18) Declining participation (1) 90 88 (32) Study rights and protections (5) 0 (0) HIPAA (3) 4 2 (9) 2 weeks later

16 Consent recall Question (# of items) % Totally Correct
% Partially Correct Mean % Correct (SD) Purpose of study (2) 16 8 (19) Duration of participation (1) 72 N/A 70 (46) Compensation (7) 2 96 40 (26) Group assignment (1) 69 68 (47) Random assignment (1) 58 56 (50) Potential benefits (4) 46 15 (19) Potential risks (3) 25 8 (18) Declining participation (1) 90 88 (32) Study rights and protections (5) 0 (0) HIPAA (3) 4 2 (9) 2 weeks later

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 2 weeks later

18 Researcher perceptions of understanding (Dugosh, Festinger, et al
Conducted web-based survey to evaluate NIDA- and NIAAA-funded researchers’ perceptions about consent recall (n = 233) 2 weeks later

19 Researcher perceptions of understanding (Dugosh, Festinger, et al
2 weeks later

20 Researcher perceptions of understanding (Dugosh, Festinger, et al
2 weeks later

21 Researcher perceptions of understanding (Dugosh, Festinger, et al
2 weeks later

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) I thought it would look bad to my case manager if I did not enter the study 89% (122) 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) I felt that I could not say ‘no’ to entering the study 88% (120) 4% (6) 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) I entered the study because I though it would please my attorney 96% (132) It would have created problems with my family if I chose not to participate 98% (134) It would have created problems between me and other people in the program if I chose not to participate 99% (136)

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


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