1 Foundations of Research Research ethics Research Ethics: The Tuskegee Study The Common Rule The Belmont Report Research Ethics: The Tuskegee Study The Common Rule The Belmont Report Dr. David J. McKirnan, University of Illinois at Chicago, Psychology; 2 Foundations of Research Research questions, hypotheses & designs The Tuskegee Study The Common Rule The Belmont Report Dr. David J McKirnan, Certificate of 25 years completion in the Tuskegee Study. Image: U.S. Public Health Service. 3 Foundations of Research Tuskegee & the Natural History of Syphilis Tuskegee study of the Natural history of untreated syphilis. Dr. David J McKirnan, Led to many ethical standards in place today. Began Institutional Review Board structure Eunice Rivers, Tuskegee Study Coordinator, with study investigators Image: U.S. Public Health Service 4 Foundations of Research Tuskegee & the Natural History of Syphilis Tuskegee began as a treatment trial. Became a Natural history of untreated syphilis Natural History studies Monitor disease progression, viz: Dr. David J McKirnan, Natural progression in morbidity & mortality Individual differences in progression Variables that confer vulnerability / resistance to disease progression. Data on African-American syphilis progression were limited Systematic Northern European data 5 Foundations of Research Tuskegee & the Natural History of Syphilis Tuskegee addressed a serious public health problem: 1920s 30s Syphilis prevalence in poor, rural Black men was extremely high; 25% of African-American employees at a private Alabama company tested positive for syphilis Prevalence in 5 Alabama counties ranged from 35% to 40%. For context, today an Incidence of 5% = syphilis outbreak. At study outset treatments were only marginally effective Mercury was one of the earliest treatments, used extensively in Europe from the Renaissance to the 1940s "A night in the arms of Venus leads to a lifetime on Mercury. The arsenic-derived drug Salvarsan was the treatment of choice in 1930.Salvarsan One folk treatment actually consisted of drinking kerosene (!). 6 Foundations of Research Tuskegee & the Natural History of Syphilis 1928 1930: Tuskegee is begun as a prevalence and treatment study Funding: The Public Health Service ( PHS, predecessor to the CDC) The Rosenwald Fund (An African-American development fund). Participants: primarily poor, uneducated, African-Americans. Stage 1: Prevalence study 7,000 10,000 people tested; Syphilis prevalence = 36% Stage 2: Treatment trial Salvarson & Mercury; Penicillin not yet used in general medicine. 1,200 treated by Thus, the eventual observational study was not even a true natural history: treatment was provided in the early stages. 7 Foundations of Research Tuskegee & the Natural History of Syphilis 1931: The Depression slashes funding The treatment arm of the study is defunded. Rosenwald fund pulls out of the study Neither the PHS nor the State of Alabama have funds to continue the study. Men still followed by the Tuskegee Institute European data showed most syphilis symptoms to be physical rather than neurological. Tuskegee Investigators hypothesized that symptoms among African-Americans would be predominantly neurological. Since no coherent theory would predict this, it is a classic example of scientific racism. European data showed most syphilis symptoms to be physical rather than neurological. Tuskegee Investigators hypothesized that symptoms among African-Americans would be predominantly neurological. Since no coherent theory would predict this, it is a classic example of scientific racism. 8 Foundations of Research Tuskegee & the Natural History of Syphilis 1932: PHS funds the continuation of the Natural History study. Participants: 600 poor, African-American sharecroppers 399 participants had syphilis at study outset. Participants told they are simply receiving medical treatment, not that they are in a research study Incentives for participation: medical care, meals, burial insurance. Infected men not told they had syphilis. Cohort is recruited and maintained by local African- American Nurse, Miss Evers Nurse Evers cultivates personal relationships with participants, and drives them to their medical visits. 9 Foundations of Research Tuskegee & the Natural History of Syphilis 1945: Penicillin becomes generally available. Alexander Fleming identified Penicillin in The treatment potential recognized in Large scale production begun by the U.S. War Production Board (WPB) in 1943, to treat venereal disease. Tuskegee participants not informed that treatment is available One rationalization was that penicillin may not be effective for longer-standing syphilis. There was no clear theoretical rationale for this assumption The assumption later proved false was not tested by giving the Tuskegee men treatment. Treatment was given only when the study was stopped. Image: U.S. Public Health Service 10 Foundations of Research Tuskegee & the Natural History of Syphilis 1950s s; Multiple papers published in Medical Journals describe the study. Few or no ethical questions posed to PHS or the journals Dr. David J McKirnan, 11 Foundations of Research Tuskegee & the Natural History of Syphilis 1965: Dr. Irwin Schatz sends a letter to PHS (Then CDC) I am utterly astounded by the fact that physicians allow patients with a potentially fatal disease to remain untreated when effective therapy is available. CDC files the letter, noting it was the first such letter received. No reply was written. Peter Buxton Image: U.S. Public Health Service 1966: Dr. Peter Buxtun writes CDC after reviewing published articles on Tuskegee Buxtun invited to CDC to discuss the study. CDC does not change its policy or stop the study. 1968: Buxtun again writes CDC Committee formed to investigate the study. CDC again does not change policy or stop the study. 12 Foundations of Research Tuskegee & the Natural History of Syphilis 1972: Buxtun discusses the study with a reporter from the Associate Press. Jean Heller writes an explosive columns for the Washington Star (now Washington Post) and New York Times. 1972: Secretary of Health & Human Welfare (now Health & Human Services) convenes a panel in response to the Washington Star report, not from communication from CDC. Describes himself as shocked and horrified. 1972: Sen. Ted Kennedy begins congressional hearings. Congress hears about the study for the first time, despite 40 years of government funding for it. The study ends and remaining participants given penicillin. 13 Foundations of Research Tuskegee & the Natural History of Syphilis Dr. David J McKirnan, 1975; Class action suit brought by surviving members of the cohort. 1980s; HIV / AIDS re-invokes prospect of unethical research or treatment Incidence of HIV infections skewed toward African- Americans & other minorities Search for vaccines & treatments raises the prospects of racist or unequal treatment. 1997; Presidential apology Bill Clinton apologizes to the 8 remaining cohort members. 14 Foundations of Research Core ethical issues in Tuskegee No informed consent Key issue: Research was presented as Clinical care Refusal of treatment not informed when Penicillin became available Coercive enrollment & retention Deception: Patients unaware they were in a research study Exploitation: Primary incentive was burial $, which would require lifetime participation Co-opted population members: Local African-American Medical Personnel were key players on the research and study team. Dr. David J McKirnan, personal relationships with Nurse Evers vulnerability of uneducated, poor men with a disease 15 Foundations of Research Ethical Principles stemming from Tuskegee aftermath: Include participants of all races & both genders in study cohorts Barring a compelling reason to exclude groups. Members of the target population included on research team & design boards Note: African-Americans were on the research and outreach teams in Tuskegee Facilitate access to an intervention to the entire population Dr. David J McKirnan, Cannot withhold Standard of Care. Standard of Care shifted during the Tuskegee study from Salvarson to penicillin but study procedures did not. Research must contribute to population being studied Communicate research results Develop applied programs or interventions 16 Foundations of Research Ethics procedures stemming from Tuskegee Dr. David J McKirnan, Informed consent Non-coercive enrollment & retention Led to the 1979 Belmont Report Indirectly to core elements of the Common Rule. Ethical review & monitoring Led to establishment of the Federal Office for Human Research Protections (OHRP) Led to laws requiring Institutional Review Boards (IRBs) All Federally funded research must be reviewed and monitored by a local IRB Most institutions (e.g., UIC) require IRB approval of all research, federally funded or not. 17 Foundations of Research Psychology 242, Dr. McKirnan European data showed most syphilis symptoms to be physical rather than neurological. Tuskegee Investigators hypothesized that symptoms among African-Americans would be predominantly neurological. This is an example of: A = Expanding a hypothesis to a new study B = A change in theory C = Scientific racism D = Tailoring a hypothesis to a specific culture Click 18 Foundations of Research Click Dr. David J McKirnan, The Belmont Report mandates that in field or clinical research members of the study population be included in the investigative team. This is to ensure that the procedures are sensitive to participants concerns. What happened with this in the Tuskegee study? A = The study did not employ African-American personnel, so the study was insensitive to that group. B = There were African-American personnel, but they had no real role in the research. C = The study employed two key African-American personnel; an investigator and the outreach worker, and that prevented the worse of the ethical problems. D = The study employed two key African-American personnel, but they actually facilitated the unethical study. 19 Foundations of Research Psychology 242, Dr. McKirnan Which of these was not an unethical feature of the study: A = Syphilis was not that important a health threat to the population under study. B = A lack of informed consent C = Coercive enrollment and retention practices D = Refusal of effective treatment Click 20 Foundations of Research Psychology 242, Dr. McKirnan Which of these was not an unethical feature of the study: A = Participants were not given their diagnosis. B = There was no institutional ethical review. C = The study did not contribute to the population being studied. D = Members of the target population were not included in the research team. Click 21 Foundations of REsearch Tuskegee Study: Overview SUMMARY Tuskegee study begin as a potentially valuable trial of treatment outcomes Begun and should have remained a natural history of participants response to treatment. Had the virtue of being conducted by a local institution Tuskegee Institute with African-American Investigators & staff. Became a wholly unethical no-treatment history. Based on spurious and racist scientific reasoning about differences between Africans and Caucasians Investigators took advantage of participants economic and social vulnerability to exploit and harm them. Note: Tuskegee participants were not actually given syphilis; they were not given treatment. Tuskegee led to many of our research norms and institutional controls. 22 Foundations of Research Research questions, hypotheses & designs Dr. David J McKirnan, The Tuskegee Study The Common Rule: Core criteria for ethical research The Belmont Report and the Informed Consent document Still from the Milgram Study on obedience 23 Foundations of Research Dr. David J McKirnan The Common Rule Minimize risks Risks must be reasonable Recruit participants equitably Informed consent Document consent Monitor for safety Protect vulnerable participants & maintain confidentiality The Common Rule criteria for Human Subjects Protection 24 Foundations of Research Risks should not exceed those of everyday behavior. Core issue: The Common Rule Minimize risks Reasonable risks Equitable recruitment Informed consent Document consent Data monitoring for safety Protect vulnerable participants & maintain confidentiality Minimization of risks Potential harms from research: Withholding care Loss of time, money, change in self-perception Direct: Tuskegee-like Indirect:Clinical trials, wait-list designs Use of deception in experimental manipulation Is the informed consent valid? Possible embarrassment or negative self-perception Erode trust & confidence in social science Dr. David J McKirnan 25 Foundations of Research Potential harms, cont. Psychological harm Physical harm Cold War radiation experiments, Army psychoactive drug research Drug trials in prison populations Some forms of Animal research Direct: Indirect: Behavior induced by the experiment: Experimental conditions that encourage risk, alcohol & drug use, smoking The Common Rule Minimize risks Reasonable risks Equitable recruitment Informed consent Document consent Data monitoring for safety Protect vulnerable participants & maintain confidentiality Dr. David J McKirnan Experiments that induce anxiety or other negative moods The Zimbardo or Milgram studies led participants to believe they were capable of harming others Loss of confidentiality or privacy Discomfort or pain Changed self-perception Embarrassment 26 Foundations of Research Dr. David J McKirnan, Social or political harm Portraying social groups in a negative light, e.g.: IQ among lower socio-economic status or minority participants Pathologizing GLBT or other populations Ignoring or discounting some groups: e.g., women or minorities in clinical research Potential harms, cont. The Common Rule Minimize risks Reasonable risks Equitable recruitment Informed consent Document consent Data monitoring for safety Protect vulnerable participants & maintain confidentiality Factors that make researchers vulnerable to research harm: Financial pressure for study results Publication & grant pressure Simple bias or prejudice Lack of institutional controls Active Institutional Review Board Study monitors 27 Foundations of Research Harm to Participants, cont. Prevention of research harms : Independent & rigorous Institutional Review Board [IRB] Diversity among investigators, research centers Study monitoring The Common Rule Minimize risks Reasonable risks Equitable recruitment Informed consent Document consent Data monitoring for safety Protect vulnerable participants & maintain confidentiality Careful pilot testing & monitoring of study manipulations Informed consent and debriefing to: a) fully inform participants about the study b) eliminate any imposed state 28 Foundations of Research Reasonableness of risks Whether a risk to participants is reasonable rests on a Cost benefit analysis Does the study present risks greater than every-day life? How much greater, for how long? Are they justified by the likely knowledge to be gained? Core issue: The Common Rule Minimize risks Reasonable risks Equitable recruitment Informed consent Document consent Data monitoring for safety Protect vulnerable participants & maintain confidentiality Dr. David J McKirnan Potentially harmful research may be justified if it provides invaluable data, e.g.: Milgram obedience studies Zimbardo prison experiment Intrusive animal studies Studies that pay people to take medical or behavioral risks 29 Foundations of Research Reasonableness of risks Dr. David J McKirnan, The Zimbardo Prison Study subjected college students to real stress but provided invaluable data about how social roles and the physical setting affects behavior. Weighing risks against potential benefits is difficult and complex We lack a scientific metric for evaluating degrees of potential harm. The benefits of research are rarely guaranteed. Research that presents little harm may be unjustified if it will not provide useful data: Research always requires time, effort, potential embarrassment Research that is trivial or incompetent may be inherently unethical for those reasons. Often research that has great scientific or applied benefit has no direct benefit for the study participants. 30 Foundations of Research Reasonableness of risk Causes of unreasonable research risk: The Costs of participation may not be fully understood by investigator Benefits may be overstated or not framed in terms of target population. Publication & grant pressure to recruit participants at any cost. Prevention: Independent & rigorous Institutional Review Board [IRB]. The Common Rule Minimize risks Reasonable risks Equitable recruitment Informed consent Document consent Data monitoring for safety Protect vulnerable participants & maintain confidentiality Dr. David J McKirnan An advisory board of people from the target population (CAB or Community Advisory Board). Pilot testing to assess the actual risks of the research. 31 Foundations of Research Participant Recruitment People potentially affected by research must: Have the opportunity to join the study Have the opportunity to withdraw once enrolled Not be coerced or deceived into enrollment Equitable recruitment: How do we ensure that all social groups are represented? Some groups are less likely to enlist than are others; How much should Investigators try to overcome peoples reluctance to join a study? At what point does that become coercive? Some groups drug abusers, those in poverty will respond to even a small monetary incentive to join even high risk studies. Is offering a monetary incentive to those individuals coercive? Are they treated inequitably by not being offered money? The Common Rule Minimize risks Reasonable risks Equitable recruitment Informed consent Document consent Data monitoring for safety Protect vulnerable participants & maintain confidentiality Dr. David J McKirnan 32 Foundations of Research Coercive payments or incentives; Culturally or socio-economically coercive. Potential loss of benefits, such as recruitment in a medical setting. Deceptive descriptions of experiment Ability to comprehend protocol & provide informed consent; Children, elderly, developmentally delayed, mentally ill Highly complex or long-term research protocols Prevention: Local IRB & Funders requirements for equitable representation. Participant Recruitment The Common Rule Minimize risks Reasonable risks Equitable recruitment Informed consent Document consent Data monitoring for safety Protect vulnerable participants & maintain confidentiality Potential problems in recruitment: Arbitrary bias in sampling Excluding or only including groups for reasons unrelated to the research protocol (I,e, convenience, or ease of recruitment). Using highly unrepresentative samples (e.g., reliance on college students in social / behavioral research). 33 Foundations of Research Informed consent Key elements of the Informed Consent document: Purpose & procedures of the study. Why the participant was recruited. Study requirements and duration. Possible risks or harms, The study is voluntary & the participant can withdraw at any time. Any potential benefits or costs of participation. Who to contact for information / concerns, including the IRB. Written signature. How do we know the participant understood? Administer consent quiz, or personal interview. How to document consent? For studies where participants are anonymous the IRB can waive written consent. The Common Rule Minimize risks Reasonable risks Equitable recruitment Informed consent Document consent Data monitoring for safety Protect vulnerable participants & maintain confidentiality Dr. David J McKirnan 34 Foundations of Research Informed consent Dr. David J McKirnan, Deception in experiments: How do we provide informed consent if the participant cannot know the hypothesis? The study must present no risks of harm The participant must be thoroughly debriefed after the study. Deception can erode trust & confidence in social science The consent document is one of the most closely examined issued in IRB ethical reviews. The Common Rule Minimize risks Reasonable risks Equitable recruitment Informed consent Document consent Data monitoring for safety Protect vulnerable participants & maintain confidentiality 35 Foundations of Research Data and clinical trial monitoring Two key elements of Research Monitoring: Monitoring of clinical trials Studies of a new drug or treatment Behavioral intervention studies Participants are followed over time with multiple study visits. Data Safety Monitoring Boards Independent bodies that oversee data collection and analyses Dr. David J McKirnan, The Common Rule Minimize risks Reasonable risks Equitable recruitment Informed consent Document consent Monitor for safety Protect vulnerable participants & maintain confidentiality 36 Foundations of Research Data and clinical trial monitoring Investigators in clinical trials are required to monitor and report any health or safety adverse events Trial related due to a feature of the trial protocol E.g., heart complications during trials of weight loss drugs Can be deemphasized or ignored in trials testing products Often ignored in behavioral intervention studies Non-Trial related; e.g., deaths during longitudinal study of injection drug users Trial-related Serious Adverse Events may require a protocol change or may stop the study. Dr. David J McKirnan, The Common Rule Minimize risks Reasonable risks Equitable recruitment Informed consent Document consent Monitor for safety Protect vulnerable participants & maintain confidentiality Monitoring for safety: Trial monitoring Data Safety Monitoring Board Monitoring for safety: Trial monitoring Data Safety Monitoring Board 37 Foundations of Research Fen-Phen; a case study of failed trial Monitoring Dr. David J McKirnan, The Common Rule Minimize risks Reasonable risks Equitable recruitment Informed consent Document consent Monitor for safety Protect vulnerable participants & maintain confidentiality 1992; Physicians begin prescribing a combination of Fenflouramine and Phentermine (Fen-Phen) for obesity, with no FDA approval. 1996; After clinical trials by the manufacturer the FDA approves Redux, a Fen-Phen drug. The manufacturer reported 4 cases of severe cardiac effects during trial monitoring, despite 41 having actually occurred. The Food and Drug Administration bypassed staff who had concerns, and approved the drug without a black box warning. Large Pharmaceutical Companies can have substantial influence in FDA decisions Wyeth spends $52 million promoting the drug, garnering $300 million in annual sales. Time Magazine notes Fen-Phen as the hot new diet drug, but raises safety questions. 1997; 30 year-old woman dies of cardiac event after taking Fen-Phen for a month ; Mayo clinic finds multiple cases of cardiac problems in women taking Fen-Phen FDA receives 144 Adverse Event reports; 30% of patients taking Fen- Phen show cardiac abnormalities. Fen-Phen pulled from market. 2003; Forbes Magazine reports 153,000 law suits against Wyeth, who pays out $13 billion in settlements. Click for a PBS Frontline documentary on Fen-Phen Click for a PBS Frontline documentary on Fen-Phen 38 Foundations of Research Data and clinical trial monitoring The DSMB monitors: Trial integrity; is the research protocol being followed correctly. Stopping rules for research risks or positive findings Data integrity: Ensures that data are collected in a valid fashion Guards the data against unblinding of participants or investigators; The DSMB is entrusted with all the codes for experimental groups and unblinds participants and investigators only when the trial is over. Dr. David J McKirnan, The Common Rule Minimize risks Reasonable risks Equitable recruitment Informed consent Document consent Monitor for safety Protect vulnerable participants & maintain confidentiality Monitoring for safety: Trial monitoring Data Safety Monitoring Board Monitoring for safety: Trial monitoring Data Safety Monitoring Board 39 Foundations of Research The Womens Health Initiative; a case study of stopping rules for a clinical trial. The Common Rule Minimize risks Reasonable risks Equitable recruitment Informed consent Document consent Monitor for safety Protect vulnerable participants & maintain confidentiality 1980s-90s: Millions of women use Hormone Replacement Therapy of estrogen plus progestin (E+P) to relive menopausal symptoms. 1991: NIH begins a study after observational data suggest that women using hormones have lower rates of heart disease. 2002: The E+P part of the Initiative is stopped early after women show higher rates of heart attack, stroke and breast cancer. Millions of women abandon hormones overnight. 2004: The study of estrogen only is stopped one year early: women taking estrogen show fewer breast cancers and only small increased risk of stroke. Both arms of the study were stopped early: The first trial because the DSMB detected adverse effects of E+P therapy The second because estrogen showed strong enough positive results that the control women were all put on therapy. 40 Foundations of Research How sensitive should scientists be to political or social pressures around their research, e.g., sexual behavior stem cells gun risks Thought questions: Monitoring for safety How do we separate self-interest & political pressure from science? The Common Rule Minimize risks Reasonable risks Equitable recruitment Informed consent Document consent Monitor for safety Protect vulnerable participants & maintain confidentiality How much does military or corporate (pharmaceuticals, tobacco..) funding for research distort scientific findings? climate change evolution economics & social policy Dr. David J McKirnan Are scientists responsible for the social impact of their findings? E.g., negative portrayal of social out-groups The use of empirically validated techniques for unethical practices 41 Foundations of Research Vulnerability to coercion in research Cognitive : The capacity to think about and provide informed consent for participation; Children, older adults Dementia or cognitive limitations, mentally ill, drug users. The Common Rule Minimize risks Reasonable risks Equitable recruitment Informed consent Document consent Monitor for safety Protect vulnerable participants & confidentiality Dr. David J McKirnan What makes someone vulnerable to coercion in research? What is coercion in research? Enrollment: Joining a study that a reasonable person would see as harmful or exploitive Continued participation : Not recognizing harm or exploitation that emerges once the research begins Recognizing harms but not having the psychological or physical capacity to withdraw. 42 Foundations of Research Vulnerability to coercion in research The Common Rule Minimize risks Reasonable risks Equitable recruitment Informed consent Document consent Monitor for safety Protect vulnerable participants & confidentiality Dr. David J McKirnan What makes someone vulnerable to coercion in research? Authority : liable to authorities who have a vested interest in your participation. Prisoners Medical patients, students via Dual Role Patients / students may feel obligated to participate in a study conducted by their physician / Professor Deferential: participation due to deferential attitudes or cultural pressure rather than actual willingness. Medical: selected due to serious health-related condition for which there are no satisfactory remedies. Poor / disadvantaged: lacking important social goods money or health care provided via research participation. 43 Foundations of Research Case study of unethical use of scientifically based techniques. The American Psychological Assn. endorsed Psychologists serving as interrogators at Guantnamo Bay until September 15, American Psychiatric & Medical Associations refused to endorse interrogations Interrogations linked to torture & unlawful detention As helping professions they are prohibited from this As a research organization APA declared itself exempt from ethical standards of helpers If research-based techniques are used, does APA as a research organization have an ethical responsibility? Dr. David J McKirnan After years of boycotts and protests, APA finally altered its stance and accepted the do no harm ethical stance of helping professions. 44 Foundations of Research Bonus section: Ethics and the research industry There is substantial pressure and temptation for data faking Career advancement and funding requires finding positive results Experiments must work to be published Dr. David J McKirnan Drug licensing, marketing diagnostic devices or behavioral interventions all require positive findings. The varieties of research fraud Simple faking of data; Deitrik Stapel successfully faked 20 years of data (click image & below for the story) He was aided by trust and lack of strong oversight in the research industry.lack of strong oversight Cherry Picking results; publishing only those that work. Drug companies would selectively submit only successful trials to the FDA FDA now requires submission and access to all drug trials Selective choice of variables: Large data sets contain multiple variables, Investigators can cheat by analyzing those that show positive results. 45 Foundations of Research Psychology 242, Dr. McKirnan How do we determine whether a research risk is reasonable A = A cost benefit analysis B = No risk is acceptable C = The Research Investigator decides if the study is too risky D = Risk cannot exceed what riskier people in society face anyway Click 46 Foundations of Research Psychology 242, Dr. McKirnan Which of these is most important as a cause of research harms, or data that are inaccurate or actually fraudulent? A = Science attracts ethically questionable people B = Financial and professional pressure for positive research results C = A lack of clear methods for many research areas D = It is not possible to monitor a study once it is underway Click 47 Foundations of Research Psychology 242, Dr. McKirnan I want to recruit poor people for a study of an experimental vaccine. To ensure I get enough people to take the vaccine I offer $200 dollars for each of five study visits. Is this ethical? A = Yes, taking an experimental drug is risky and people should be paid well. B = No, the researchers do not know if the vaccine works yet. C = Yes, as long as they are told whether they are getting the real drug or the placebo. D = No, that rate of compensation for poor people is coercive. Click 48 Foundations of Research Psychology 242, Dr. McKirnan Are experiments using deception ethical? A = Yes, as long as the investigator things the results may be important. B = No, participants cannot give informed consent if they do not know what the experiment is about. C = Yes, as long as there is IRB review and systematic debriefing after the study. D = No, IRBs will not sanction deception in research. Click 49 Foundations of REsearch Tuskegee Study: Overview SUMMARY The Common Rule: core guidelines Minimize risks Risks must be reasonable Recruit participants equitably Informed / Document consent Monitor for safety Protect vulnerable participants & maintain confidentiality Larger institutions have key roles in maintaining ethical behavior Institutional Review Boards (IRBs) Organizations such as the APA can behave in clearly unethical fashion The research industry directly presses for questionable, mediocre or fraudulent research. 50 Foundations of Research The Tuskegee Study The Common Rule: Core criteria for ethical research The Belmont Report and the Informed Consent document Research questions, hypotheses & designs Dr. David J McKirnan 51 Foundations of Research Belmont Report (CITI training) 1. Respect For Persons Right to exercise autonomy & make informed choices. 2. Beneficence Minimization of risk & maximization of social / individual benefit How much information should participants get from a blinded, randomized trial? See ethics of clinical trialsethics of clinical trials 3. Justice Research should not unduly involve groups unlikely to benefit from subsequent applications. Include participants of all races & both genders Members of target population on design & research team Research & researchers contribute to study population studied Communicate research results & develop programs/ interventions Dr. David J McKirnan 52 Foundations of Research The informed consent document Why am I being asked to participate in this research?..who is being recruited or selected? Why is this research being done? Overview Box: What is the purpose of this research? What procedures are involved? What are the potential risks and discomforts? Are there benefits to taking part in this research? What other options are there?...What happens if I decline participation? procedures, purposes, potential risks & benefits, potential outcomes. Brief descriptions.. Dr. David J McKirnan 53 Foundations of Research Informed consent elements, 2 Will I be told about new information that may affect my decision to participate? What about privacy and confidentiality? What if I am injured as a result of my participation? What are the costs for participating in this research?...e.g., for services, etc. Will I be reimbursed for any of my expenses for participation in this research? Can I withdraw or be removed from the study? Who should I contact if I have questions? Signature of participant or legally authorized representative Dr. David J McKirnan