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Course Hero has millions of student submitted documents similar to the one below including study guides, practice problems, reference materials, practice exams, textbook help and tutor support.
signed Digitally by Jeannine Blackwell DN: cn=Jeannine Blackwell, c=US, o=University of Kentucky, ou=Graduate School, email=jeannine. email@example.com Date: 2007.10.05 10:36:59 -04'00'
University of Kentucky
Department of Behavioral Science Research Ethics & Dilemmas Time: Location: Instructor: TBD COMOB 104 TK Logan, Ph.D. Professor Department of Behavioral Science Center on Drug and Alcohol Research Ph. 257-8248 Email: firstname.lastname@example.org Office hours: By appointment
Course Description and Objectives
This class will utilize case studies for debate, class participation, and papers to help students gain skills to recognize and resolve research dilemmas. Objectives of this class include: (1) understand basic elements of ethical dilemmas; (2) to understand basic ethical theories and frameworks for solving ethical dilemmas; (3) to examine ethical dilemmas within a behavioral or medical science research context; and, (4) to examine ways of eliminating bias and promoting objectivity in a behavioral or medical science research context.
Section I: Overview What is ethics? What are ethical dilemmas? Code of ethics Research code of ethics Principles and biases of decision making Framework for resolving dilemmas Section II: Use of human research subjects Risk/benefit ratio Recruitment Informed consent/coercion Privacy and confidentiality Section III: Ethical considerations of study design and samples Methodology and samples Clinical research studies Randomization Control groups Placebos 1
Section IV: Vulnerable populations Prisoners Mentally challenged Pregnant women Children Elderly Section V: Conducting research in different cultures Cultural sensitivity International research Section VI: Misconduct in research Misrepresentation of data Sloppiness/arrogance Plagiarism Misappropriation Interference Whistleblowers Section VII: Conflicts, funding, and ownership Conflicts of interest Funding Ownership of data and results Patents, copyrights, and Intellectual property Section VIII: Eliminating bias and promoting objectivity Scientific integrity: Individual and organizational factors Peer review process Personal and professional biases Overconfidence Responsible mentorship Research on ethics TOPIC Section I: Overview Section II: Use of human research subjects Section III: Ethical considerations of study design and samples Section IV: Vulnerable populations Section V: Conducting research in different cultures Section VI: Misconduct in research Section VII: Conflicts, funding, and ownership Section VIII: Eliminating bias and promoting objectivity Student project presentations WEEKS 1-6 7-8 9 10 11 12 13 14-15 16
IV. Course Requirements and Grading
Papers: Papers will comprise 40% of the grade. Papers will track the students intellectual progress through the class. Students will be assigned papers based either on specific readings or on specific topics. Each class will begin with a review of student papers and responses/thoughts by the class. An example of class readings for each section is attached to this syllabus, but is subject to change for a variety of reasons (e.g., student interest, updated articles, expansion of a particular topic at the request of students). Class Participation: Class participation will comprise 30% of the grades. Students are expected to participate in all class discussions fully. This class is not a lecture class but rather an experiential learning process. This will include discussion of papers, all assigned readings, and class content. Projects: Project papers and presentations will comprise 30% of the class grades. Projects will be determined by students based on their particular area of interest but will be subject to approval by course instructor. Writing projects are all expected to be typed, readable and professional. Grading will be based on content as well as writing ability. Presentation of projects will also be included in the grade. Example projects may include developing a case study, writing a paper for publication focused on ethical research issues, or reviewing an ethical theory of decision making framework that was not discussed in detail in the class. Although these are examples, the determination of a project is open to facilitate student learning, application, and creativity with this content area.
ATTENDANCE As this is a graduate level course, you are expected to attend class and be prepared to discuss the required readings. If you have a university excused absence you should notify the instructor prior to the class, when possible. Each unexcused absences will result in 5% reduction in the final grade for the course.
Sample student reading list which is subject to change. Section I: Overview 1. Scenario exercise and the human subjects certification required by IRB (two options) 2. Readings and assignments due as noted below. Charo A. (1999, June 25). Human subjects have it worse then guinea pigs. The Chronicle of Higher Education, Retrieved July 6, 2006 from the World Wide Web: http://www.physics.ohiostate.edu/~perry/p596/Assign/topics/humansubjects.html Spotts, P. (2005, Dec 22). Laboratory ethics: What makes some scientists cheat?Questionable stem-cell research in South Korea case may be the latest in a series of ethical lapses in 2005. The Christian Science Monitor, p. 2. Gitlin, J. (2006). More science fraud. ARS Technica Journals, 1, 19, 2578. Retrieved July 5, 2006, from the World Wide Web: http://arstechnica.com/journals/science.ars/2006/1/19/2578 Encourage ethics in the laboratory. (2006, Feb. 21). The Christian Science Monitor, p.8. Mellgren, D. (2006). Commission says researcher guilty of fraud. Washingtons News, Traffic & Weather. Retrieved July 5, 2006 from the World Wide Web: http://www.wtop.com Pincock, S. (2006, Jan. 16). Lancet study faked. The Scientist: Magazine of the Life Sciences. Annas, G. (1996). Questing for grails: Duplicity, betrayal and self-deception in postmodern medical research. Journal of Contemporary Health Law & Policy, Spring. Smith, M. (2003). Moral foundations in research with human participants. In A. Kazdin (Ed.), Methodological issues & strategies in clinical research (pp. 771-778). Washington, DC: A.P.A. Sieber, J. (1998). Planning ethically responsible research. In L.Bickman & D. Rob (Eds.), Handbook of applied social research methods (pp. 127-156). Thousand Oaks, CA: Sage Publications. The Nuremberg code. Retrieved July 27, 2006 from the World Wide Web: http://www.hhs.gov/ohrp/references/nurcode.htm Declaration of Helsinki 1964 (1996). British Medical Journal, 7070(313). *World Medical Association of Declaration of Helsinki The Belmont Report. Retrieved July 27, 2006 from the World Wide Web: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm Cohen, J. Brief overview of the common rule. http://asgraduate.richmond.edu/Overview_Rule.pdf NSF (National Science Foundation). (2006). Frequently asked questions and vignettes. Retrieved from the World Wide Web at: www.nsf.gov/bfa/dias/policy/hsfaqs.jsp#c (2/6/2007). Frequently asked questions (faqs) and answers. Retrieved from the World Wide Web at: http://www.research.uky.edu/ori/ When do activities involving human subjects need institutional review board (IRB) review and approval? Retrieved from the World Wide Web at: http://www.research.uky.edu/ori/ Issues to be addressed when conducting exempt review: University of Kentucky educational resource. Retrieved from the World Wide Web at: http://www.research.uky.edu/ori/ University of Kentucky: Assessing the research risk. Retrieved from the World Wide Web at: http://www.research.uky.edu/ori/ University of Kentucky human research protection program comprehensive plan. Retrieved from the World Wide Web at: http://www.research.uky.edu/ori/ 5
University of Kentucky office of research integrity and institutional review board standard operating procedures. Retrieved from the World Wide Web at: http://www.research.uky.edu/ori/ HIPAA instructions for all IRB applications. Retrieved from the World Wide Web at: http://www.research.uky.edu/ori/ Guterman, L. Federal privacy rules may hamper medical research, study finds. (2005 May 25). The Chronicle of Higher Education. Artnak, K. & Benson, M. (2005). Evaluating HIPAA compliance: A guide for researchers, privacy boards, and IRBs. Nursing Outlook, 53, 79-87. Shalowitz, D. & Wendler, D. (2006). Informed consent for research and authorization under the health insurance portability and accountability act privacy rule: An integrated approach. Annals of Internal Medicine, 144(9), 685-688. Frequently asked questions on certificates of confidentiality. Retrieved from the World Wide Web at: http://grants.nih.gov/grants/policy/coc/faqs.htm Could reality shows become reality experiments? (2005, March). The Observer, 18(3). Lynn, M. & Nelson, D. (2005). Common (mis)perceptions about IRB review of human subjects research. Nursing Science Quarterly, 16(3), 264-270. Oakes, J. (2002). Risks and wrongs in social science research. Evaluation Review, 26(5), 443-479. Mueller, J. & Furedy, J. (2001, Sept.). Reviewing for risk: Whats the evidence that it works?. Observer, 14(7). Azar, B. (2002). Ethics at the cost of research?. Monitor on Psychology, 33(2), 38-40. Gunsalus, C. (2003). Human subject regulations: Whom are we protecting from what, and why? Working to align incentives with ethical goals. Professional Ethics Report. 16(2), 1-3. Fitzgerald, M. (2004). Big basket or mission creep. Professional Ethics Report 17(2), 1-3. Sieber, J., Plattner, S., & Rubin, P. (2002). How (not) to regulate social and behavioral research. Professional Ethics Report. 15(2), 1-4. U.S. halts research on humans at Duke University cant ensure safety, probers find. (1999, May 12). Washington Post. Spiegel, P. & Koocher, G. (2006). What scientists want from their research ethics committee. Journal of Empirical Research on Human Research Ethics, January, 67-82. Kapp, M. (2006). Ethical and legal issues in research involving human subjects: do you want a piece of me?. Journal of Clinical Pathology, 59, 335-339. Resnik, D. (1998). The ethics of science: An introduction. Specifically, Chapter 4: Standards of ethical conduct in science (53-73). New York, NY: Rutledge. Thought paper due for each article: Martinson et al. (2006) and De Vries et al. (2006). Rachels, J. (2003). The utilitarian approach. In The Elements of Moral Philosophy (pp. 91101). New York, NY: McGraw-Hill Publications. Rachels, J. (2003). The debate over utilitarianism. In The Elements of Moral Philosophy (pp. 102-116). New York, NY: McGraw-Hill Publications. Rachels, J. (2003). Are there absolute moral rules? In The Elements of Moral Philosophy (pp. 117-129). New York, NY: McGraw-Hill Publications. Rachels, J. (2003). Kant and respect for persons. In The Elements of Moral Philosophy (pp. 130-140). New York, NY: McGraw-Hill Publications. Rachels, J. (2003). The ethics of virtue. In The Elements of Moral Philosophy (pp. 173190). New York, NY: McGraw-Hill Publications.
De Vries, R., Anderson, M., & Martinson, B. (2006). Normal Misbehavior: Scientists Talk about the Ethics of Research. Journal of Empirical Research on Human Research Ethics, March, 4350. Martinson, B., Anderson, M., Crain, A., & De Vries, R. (2006). Scientists perceptions of organizational justice and self-reported misbehaviors. Journal of Empirical Research on Human Research Ethics 51-66. Paper with interviews of three people. IRB applications. 1) Design a fictional study that would meet exempt criteria, justifying why it would meet this criteria and including all pertinent information.; 2) Design a fictional study that would meet expedited criteria, justifying why it would meet this criteria and including all pertinent information. 3) Describe a study that would meet full review criteria. This study will be one that you will fill out all the paper work. Section II: Use of human research subjects Risk/Benefit Ratio Cody, R. (2006). Anticipating risk for human subjects participating in clinical research: Application of failure mode and effects analysis. Cancer Investigation, 24, 209-214. Kopelman, L. (2004). What conditions justify risky nontherapeutic or no benefit pediatric studies: A sliding scale analysis. International and Comparative Health Law and Ethics, Winter, 749-758. Wendler, D. (2005). Protecting subjects who cannot give consent: Toward a better standard for minimal risks. Hastings Center Report, Sept-Oct. Ernst, A., & Fish, S. (2005). Exception from informed consent: Viewpoint of institutional review boards-balancing risks to subjects, community consultation, and future directions. Academic Emergency Medicine, 12, 1050-1055. Resnik, D. & Sharp, R. (2006). Protecting third parties in human subjects research. IRB: Ethics and Human Research, 28, 1-7. Martin, D., Meslin, E., Kohut, N., & Singer, P. (1995). The incommensurability of research risks and benefits: Practical help for research ethics committees. IRB: Ethics and Human Research, 17, 8-10. Informed Consent/ Coercion Weiss, R. (1998, February 9). Fertility innovation or exploitation?. The Washington Post, pp. A1. Menikoff, J. (2004). The involuntary research subject. Cambridge Quarterly of Healthcare Ethics, 13, 338-345. Wager, E., Tooley, P., Emanuel, M., & Wood, S. (1995). How to do it: Get patients consent to enter clinical trials. British Medical Journal, 311, 734-737. Titus, S., & Keane, M. (1996). Do you understand?: An ethical assessment of researchers description of the consenting process. The Journal of Clinical Ethics, 7,60-68. Sieber, J. (1994). Voluntary informed consent and debriefing. In D. Barnbaum & M. Byron (Eds.), Research Ethics: Text and Readings (pp. 102-107). Upper Saddle River, NJ: Prentice-Hall. Willis, G. (2006). Cognitive interviewing as a tool for improving the informed consent process. The Journal of Empirical Research on Human Research Ethics, February, 9-24.
Verheggen, F., Jonkers, R., & Kok, G. (1996). Patients perceptions on informed consent and the quality of information disclosure in clinical trials. Patient Education and Counseling, 29, 137153. Nelson, K., Garcia, R., Brown, J., Mangione, C., Louis, T., Keeler, E., & Cretin, S. (2002). Do patient consent procedures affect participation rates in health services research?. Medical Care, 40, 283-288. Adamson, J., Cockayne, S., Puffer, S., & Torgerson, D. (2006). Review of randomized trials using the post-randomised consent (Zelens) design. Contemporary Clinical Trials, 27, 305-319. Mann, T. (1994). Informed consent for psychological research: Do subjects comprehend consent forms and understand their legal rights?. Psychological Science, 5, 140-143. Marshall, P. (2006). Informed consent in international health research. The Journal of Empirical Research on Human Research Ethics, February 25-42. Singer, E., Thurn, D., & Miller, E. (1995). Confidentiality assurances and response: A quantitative review of the experimental literature. Public Opinion Quarterly, 59, 66-77. Guterman, L. (2006, June 16). Guinea pigs in the ER: Researchers debate the ethics and logistics of performing emergency research without patients consent. The Chronicle of Higher Education, Retrieved July 7, 2006 from the World Wide Web: http://chronicle.com Dougherty, A. (2006). Letter to the editor: In defense of the PolyHeme trial. The American Journal of Bioethics, 6, W56. Japsen, B. (2006, April 3). Blood substitute draws praise, fire: Ethicists, lawmakers question consent process, but 1 man credits PolyHeme with saving his life. Chicago Tribune,p.1. No-consent treatments authorized: U.S. moves to ease Nuremburg code. (1996, November 5). Chicago Tribune, p. 14. Kipnis, K., King, N., & Nelson, R. (2006). Trials and errors: Barriers to oversight of research conducted under the emergency research consent waiver. IRB: Ethics & Human Research, March-April. Kalra, D., Gertz, R., Singleton, P., & Inskip, H. (2006). Confidentiality of personal health information used for research. British Medical Journal, 333,196-198. Murff, H., Pichert, J., Byrne, D., Hedstrom, C., Black, M., Churchill, L., & Speroff, T. General clinical research center staff nurse perceptions and behaviors regarding informed consent: Results of a national survey. IRB: Ethics and Human Research, 28, 8-12.
Payments to research subjects Grady, C. (2005). Payment of clinical research subjects. The Journal of Clinical Investigation, 115, 1681-1687. Bentley, J., & Thacker, P. (2004). The influence of risk and monetary payment on the research participation decision making process. Journal of Medical Ethics, 30, 293-298. Festinger, D., Marlowe, D., Croft, J., Dugosh, K., Mastro, N., Lee, P., DeMatteo, D., & Patapis, N. (2004). Do research payments precipitate drug use or coerce participation?. Drug and Alcohol Dependence, 78, 275-281. Grady, C., Dickert, N., Jawetz, T., Gensler, G., & Emanuel, E. (2005). An analysis of U.S. practices of paying research participants. Contemporary Clinical Trials, 26, 365-375. Singer, E., Van Hoewyk, J., Gebler, N., Raghunathan, T., & McGonagle, K. (1999). The effect of incentives on response rates in interviewer-mediated surveys. Journal of Official Statistics, 15, 217-230. Dickert, N., & Grady, C. (1999). Whats the price of a research subject? Approaches to payment for research participation. The New England Journal of Medicine, 341, 198-203. 8
Singer, E., Groves, R., & Corning, A. (1999). Differential incentives: Beliefs about practices, perceptions of equity, and effects on survey participation. Public Opinion Quarterly, 63, 251-260. Deren, S., Stephens, R., Davis, W., Feucht, T., & Tortu, S. (1994). The impact of providing incentives for attendance at AIDS prevention sessions. Public Health Reports, 109,Public Health Reports, 109, 548-554. Grady, C. (2001). Money for research participation: Does it jeprodize informed consent?. The American Journal of Bioethics, 1, 40-44. Latterman, J., & Merz, J. (2001). How much are subjects paid to participate in research?. The American Journal of Bioethics, 1, 45-48. Resnik, D. (2001). Research participation and financial inducements. The American Journal of Bioethics, 1, 54-56. Menikoff, J. (2001). Just compensation: Paying research subjects relative to the risks they bear. The American Journal of Bioethics, 1, 56-58. Ashcroft, R. (2001). Money, consent, and exploitation in research. The American Journal of Bioethics, 1, 62-63. Heath, E. (2001). On considering (what I might do for) money. The American Journal of Bioethics, 1, 63-64. Anderson, J., & Weijer, C. (2001). The research subject as entrepreneur. The American Journal of Bioethics, 1, 67-69. Sugarman, J., Kass, N., Goodman, S., Perentesis, P., Fernandes, P., & Faden, R. What patients say about medical research. IRB: A Review of Human Subjects Research, 20,1-7. Recruitment/ Retention Jairath, N., Ulrich, C., & Ley, C. (2005). Ethical considerations in the recruitment of research subjects from hospitalized, cardiovascular patient populations. Journal of Cardiovascular Nursing, 20, 56-61. Miller, K., McKeever, P., & Coyte, P. (2003). Recruitment issues in healthcare research: The situation in home care. Health and Social Care in the Community, 11, 111-123. Sadler, G., Peterson, M., Wasserman, L., Mills, P., Malcarne, V., Rock, C., Ancoli-israel, S., Moore, A., Weldon, R., Garcia, T., & Kolodner, R. (2005). Recruiting research participants at community education sites. Journal of Cancer Education, 20, 235-239. Lindsay, J. (2005). Getting the numbers: The unacknowledged work in recruiting for survey research. Field Methods, 17,119-128. Cox, K., & Mcgarry, J. (2002). Why patients dont take part in cancer clinical trials: An overview of the literature. European Journal for Cancer Care, 12, 114-122. Kaiser, M., & Hays, B. (2005). Recruiting and enrolling pregnant adolescents for research. Issues in Comprehensive Pediatric Nursing, 29, 45-52. Leak, G. (1981). Student perception of coercion and value from participation in psychological research. Teaching of Psychology, 8, 147-149. Section III: Ethical considerations of study design and samples Study Design and Ethical Behavior Brainard, J. (2004 September 17). Privacy concerns spur plan to revise questionnaire for medical school graduates. The Chronicle of Higher Education, Retrieved September 17, 2004 from the World Wide Web: http://chronicle.com MacQueen, K., & Buehler, J. (2004). Ethics, practice, and research in public health. Health Policy and Ethics Forum, 94, 928-931. 9
Fairchild, A., & Bayer, R. (2004). Ethics and the conduct of public health surveillance. Science, 303, 631-632. Coen, A., Patrick, D., & Shern, D. (1996). Minimizing attrition in longitudinal studies of special populations: An integrated management approach. Evaluation and Program Planning, 19, 309-319. Stefancic, A., Schaefer-McDaniel, N., Davis, A., & Tsemberis, S. (2004). Maximizing follow-up of adults with histories of homelessness and psychiatric disabilities. Evaluation and Program Planning, 27, 433-442. Shaver, F. (2005). Sex work research: Methodological and ethical challenges. Journal of Interpersonal Violence, 20, 296-319. Weiss, R. (1998 August 1). Volunteers at risk in medical studies complex research projects strain system of safeguards. The Washington Post, p. A01. Sugarman, J., Kass, N., Goodman, S., Perentesis, P., Fernandes, P., & Faden, R. (1998). What patients say about medical research. IRB: A Review of Human Subjects Research, 20, 1-7. Rosnow, R., & Rosenthal, R. (Eds.). (1997). People Studying People: Artifacts and Ethics in Behavioral Research (pp. 113-131). U.S.A.: W.H. Freeman and Company. Marshall, P. (2003). Human subjects protections, institutional review boards, and cultural anthropological research. Anthropological Quarterly, 76, 269-285. Research/ Clinical Intervention Emanuel, E., Wendler, D., & Grady, C. (2000). What makes clinical research ethical?. Journal of the American Medical Association, 283, 2701-2711. Alpert, J., Biggs, M., Davis, L., Shores-Wilson, K., Harlan, W., Schneider, G., Ford, A., Farabaugh, A., Stegman, D., Ritz, A., Husain, M., Macleod, L., Wisniewski, S., & Rush, A. (2005). Enrolling research subjects from clinical practice: Ethical and procedural issues in the sequenced treatment alternatives to relieve depression (STAR*D) trial. Psychiatry Research, 141, 193-200. Roberts, L., & Dunn, L. (2003). Ethical considerations in caring for women with substance use disorders. Obstetrics and Gynecology Clinics of North America, 30, 559-582. West, W. (2002). Some ethical dilemmas in counseling and counseling research. British Journal of Guidance & Counseling, 30, 261-268. Bekker, L., Jaspan, H., McIntyre, J., Wood, R., & Gray, G. (2005). Adolescents and HIV vaccine trials: What are the clinical trial site issues?. Journal of International Association of Physicians in AIDS Care, 4, 93-97. Stolberg, S. (1999 November 28). The biotech death of Jesse Gelsinger. The New York Times. Kong, W. (2005). Legitimate requests and indecent proposals: Matters of justice in the ethical assessment of phase I trials involving competent patients. Journal of Medical Ethics, 31, 205208. Sugarman, J., & McKenna W. (2003). Ethical hurdles for translational research. Radiation Research, 160, 1-4. Jansen, L. (2006). The problem with optimism in clinical trials. IRB: Ethics and Human Research, 28, 15-19. Placebos Street, L., & Luoma, J. (2002). Control groups in psychosocial intervention research: Ethical and methodological issues. Ethics & Behavior, 12, 1-30. Freedman, B. (1992). A response to a purported ethical difficulty with randomized clinical trials involving cancer patients. The Journal of Clinical Ethics, 3, 231-234. 10
Hellman, S., & Hellman, D. (1991). Of mice but not men: Problems of the randomized clinical trial. The New England Journal of Medicine, 22, 1585-1589. Feder, L. (1998). Using random assignment in social science settings. Professional Ethics Report, 11. Krause, M., & Howard, K. (2003). What random assignment does and does not do. Journal of Clinical Psychology, 59, 751-766. Mudur, G. (2006). Indian study sparks debate on the use of placebo in psychiatry trials. British Medical Journal, 332, 566. Khanna, S., Vieta, E., Lyons, B., Grossman, F., Eerdekens, M., & Kramer, M. (2005). Risperidone in the treatment of acute mania: Double-blind, placebo-controlled study. British Journal of Psychiatry, 187, 229-234. J., Storosum, Wohlfarth, T., Gispen-de-Wied, C., Linszen, D., Gersons, B., Zwieten, B., & Brink, W. (2005). Suicide risk in placebo-controlled trials of treatment for acute manic episode and prevention of manic-depressive episode. American Journal of Psychiatry, 162, 799-802. Hoffman, S. (2001). The use of placebos in clinical trials: Responsible research or unethical practice?. Connecticut Law Review, 33. Linde, M., May, A., Limmroth, V., & Dahlof, C. (2003). Ethical aspects of placebo in migraine research. Cephalalgia, 23, 491-495. Hrobjartsson, A., & Gotzsche, P. (2001). Is the placebo powerless?. An analysis of clinical trials comparing placebo with no treatment. New England Journal of Medicine, 21, 1594-1632. Walsh, T., Seidman, S., Sysko, R., & Gould, M. (2002). Placebo response in studies of major depression. Journal of the American Medical Association, 287, 1840-1847. Polgar, S., & Ng, J. (2005). Ethics, methodology and the use of placebo controls in surgical trials. Brain Research Bulletin, 67, 290-297. Spigt, M., Knipschild, P., Schayck, C., & Knottnerus, J. (2005). The validity and ethics of giving placebo in a randomized nonpharmacologic trial was evaluated. Journal of Clinical Epidemiology, 58, 350-356. Orentlicher, D. (2001). Placebo-controlled trials of new drugs: ethical considerations. Diabetes Care, 24, 771-72. Traumatic Research Walker, E., Newman, E., Koss, M., & Bernstein, D. (1997). Does the study of victimization revictimize the victims?. General Hospital Psychiatry, 19, 403-410. Newman, E., Walker, E., & Gefland, A. (1999). Assessing the ethical costs and benefits of trauma-focused research. General Hospital Psychiatry, 21, 187-196. Ruzek, J., & Zatzick, D. (2000). Ethical considerations in research participation among acutely injured trauma survivors: An empirical investigation. General Hospital Psychiatry, 22, 2736. Tusher, C., Smith, S., & Cook, S. (2005). The ethics of violence research. The Community Psychologist, 65-67. Langford, D. (2000). Developing a safety protocol in qualitative research involving battered women. Qualitative Health Research, 10, 133-142. Griffin, M., Resick, P., Waldrop, A., & Mechanic, M. (2003). Participation in trauma research: Is there evidence of harm?. Journal of Traumatic Stress, 16, 221-227. Newman, E., Kaloupek, D., Keane, T., & Folstein, S. (1997). Ethical issues in trauma research. In G. Kaufman, & J. Jasinski (Eds.), Out of the Darkness; Contemporary Perspectives on Family Violence (pp. 271-281). Thousand Oaks, CA: Sage Publications. Collogan, L., Tuma, F., Sewell, R., Borja, S., & Fleischman, A. (2004). Ethical issues pertaining to research in the aftermath of disaster. Journal of Traumatic Stress, 17, 363-372. 11
Kilpatrick, D. (2004). The ethics of disaster research: A special section. Journal of Traumatic Stress, 17, 361-362. Newman, E., & Kaloupek. (2004). The risks and benefits of participating in trauma-focused research studies. Journal of Traumatic Stress, 17, 383-394. Interviewer / Researcher Safety Fisk, D., Rakfelt, J., Heffernan, K., & Rowe, M. (1999). Outreach workers experiences in a homeless outreach project: Issues of boundaries, ethics, and staff safety. Psychiatric Quarterly, 70, 231-246. Russell, C., Porter, M., & Touchard, D. (2001). Studying dangerous places: Safety and its construction as a factor in field research. Journal of Applied Health and Behavior, 3, 15-23. Urquiza, A., Wyatt, G., & Jones, B. (1997). Clinical interviewing with trauma victims: Managing interviewer risk. Journal of Interpersonal Violence, 12, 759-772. Williams, T., Dunlap, E., Johnson, B., & Hamid, A. (1992). Personal safety in dangerous places. Journal of Contemporary Ethnography, 21, 343-374. Huff, J. (1997). The sexual harassment of researchers by research subjects. In M. Schwartz (Ed.), Researching Sexual Violence Against Women: Methodological and Personal Perspectives ( pp.115-127). Thousand Oaks, CA: Sage Publications. Gwiasda, V., Taluc, N., & Popkin, S. (1997). Data collection in dangerous neighborhoods: Lessons from a survey of public housing residents in Chicago. Evaluation Review, 21, 77-93. Hilton, T. (2006). Staff members are human subjects, too. Journal of Substance Abuse Treatment, 31, 9-15. Section IV: Vulnerable populations Children Olds, S. (2003). Informed-consent issues with adolescent health behavior research. American Journal of Health and Behavior, 27, S248-S263. Frissell, K., McCarthy, D., Amico, E., Metrik, J., Ellingstad, T., & Brown, S. (2004). Impact of consent procedures on reported levels of adolescent alcohol use. Psychology of Addictive Behaviors, 18, 307-315. Meaux, J., & Bell, P. (2001). Balancing recruitment and protection: Children as research subjects. Issues in Comprehensive Pediatric Nursing, 24, 241-251. Meade, M., & Slesnick, N. (2002). Ethical considerations for research and treatment with runaway and homeless adolescents. The Journal of Psychology, 136, 449-463. Moolchan, E., & Mermelstein, R. (2002). Research on tobacco use among teenagers: Ethical challenges. Journal of Adolescent Health, 30, 409-417. Larsen, K., & Larsen, H. (2003). Ethical issues in youth surveys: Potentials for conducting a national questionnaire study on adolescent schoolchildrens sexual experiences with adults. Adolescent Health, 93, 1878-1882. Vitiello, B. (2003). Ethical considerations in psychopharmacological research involving children and adolescents. Psychopharmacology, 171, 86-91. Rohling, J., Arata, C., OBrien, N., Bowers, D., & Klibert, J. (2006). Sensitive research with adolescents: Just how upsetting are self-report surveys anyway? Violence and Victims, 21, 425444.
Mental Illness National Bioethics Advisory Committee. (1998). Moving ahead in research involving persons with mental disorders: Summary and recommendations. Retrieved from the World Wide Web: http://www.georgetown.edu/research/nrcbl/nbac/capacity/Moving.htm Rosenstein, D., & Miller, F. (2003). Ethical considerations in psychopharmacological research involving decisionally impaired subjects. Psychopharmacology, 171, 92-97. Wendler, D., Martinez, R., Fairclough, D., Sunderland, T., & Emanuel, E. (2002). Views of potential subjects toward proposed regulations for clinical research with adults unable to consent. American Journal of Psychiatry, 159, 585-591. Davies, B. (2005). Coercion or collaboration? Nurses doing research with people who have severe mental health problems. Journal of Psychiatric and Mental Health Nursing, 12, 106-111. DuVal, G. (2004). Ethics in psychiatric research: Study design issues. Cancer Journal of Psychiatry, 49, 55-59. Prisoners Hayes, M. (2006). Prisoners and autonomy: Implications for the informed consent process with vulnerable populations. Journal of Forensic Nursing, 2, 84-89. Brainard, J. (2006 July 17). Report calls for easing rules on research involving prisoners, but adding some protections. The Washington Post. Urbina, I. (2006, August 13). Panel suggests using inmates in drug trials. The New York Times, (p. 1). Elderly Kim, S., Appelbaum, P., Jeste, D., & Olin, J. (2004). Proxy and surrogate consent in geriatric neuropsychiatric research: Update and recommendations. American Journal of Psychiatry, 161, 797806. Bayer, A., & Fish, M. (2003). The doctors duty to the elderly patient in clinical trials. Drugs Aging, 20, 1087-1097. Fitten, J. (1993). The ethics of conducting research with older psychiatric patients. International Journal of Geriatric Psychiatry, 8, 33-39. Chronically Ill Karlawish, J. (2003). Conducting research that involves subjects at the end of life who are unable to give consent. Journal of Pain and Symptom Management, 25, S14-S24. Disaster Research Levine, C. (2004). The concept of vulnerability in disaster research. Journal of Traumatic Stress, 17, 395-402. Rosenstein, D. (2004). Decision-making capacity and disaster research. Journal of Traumatic Stress, 17, 373-381. Pregnant Women Kornblum, A. (1994). Trial and error: Should pregnant women be research subjects? Environmental Health Perspectives, 102. Poverty Dickens, B., & Cook, R. (2003). Challenges of ethical research in resource-poor settings. International Journal of Gynecology and Obstetrics, 80, 79-86. 13
Section V: Conducting research in different cultures Recruiting Minorities Weiss, R. (2005 December 6). Study debunks that blacks are wary of medical research minorities are willing to volunteer but often are not asked. The Washington Post, (p. A3). Silvestre, A., Hylton, J., Johnson, L., Houston, C., Witt, M., Jacobson, L., & Ostrow, D. (2006). Recruiting minority men who have sex with men for HIV research: Results from a 4-city campaign. Public Health Matters, 96, 1020-1027. Dancy, B., Wilbur, J., Talashek, M., Bonner, G., & Boyd, C. (2004). Community-based research: Barriers to recruitment of African Americans. Nursing Outlook, 52, 234-240. Sterling, Y., & Peterson, J. (1999). Challenges of recruiting minority populations for research. Journal for Specialists in Pediatric Nursing, 4, 172-174. Wiemann, C., Chacko, M., Tucker, J., Velasquez, M., Smith, P., DiClemente, R., & Sternberg, K. (2005). Enhancing recruitment and retention of minority young women in communitybased clinical research. Journal of Pediatric Adolescent Gynecology, 18, 403-407. Miskimen, T., Marin, H., & Escobar, J. (2003). Psychopharmacological research ethics: Special issues affecting US ethnic minorities. Psychopharmacology, 171, 98-104. Parrado, E., McQuiston, C., & Flippen, C. (2005). Participatory survey research: Integrating community collaboration and quantitative methods for the study of gender and HIV risks among Hispanic migrants. Sociological Methods & Research, 34, 204-239. Fontes, L. (1997). Conducting ethical cross-cultural research on family violence. In G. Kantor & J. Jasinski (Eds.), Out of the Darkness. Thousand Oaks, CA: Sage Publications. International Research Matthews, C., Guttmacher, S., Flisher, A., Mtshizana, Y., Hani, A., & Zwarenstein, M. (2005). Written parental consent in school-based HIV/AIDS prevention research. Research and Practice, 95, 1266-1269. Shapiro, H., & Meslin, E. (2001). Ethical issues in the design and conduct of clinical trials in developing countries. New England Journal of Medicine, 345, 139-142. LaFraniere, S., Flaherty, M., & Stephens, J. (2000 December 19). The dilemma: Submit to suffer uninformed consent is rising ethic of the drug test boom. The Washington Post, (p. A1). Consenting adults? Not necessarily. (2005). Nature, 435, 138-139. Kolata, G. (2004 March 5). Companies facing ethical issue as drugs are tested overseas. The New York Times, (p.1). Jones, K. (2006 May 18). A flawed approach to drug testing. The Washington Post, (p. A22). Mills, E., Singh, S., Singh, J., Orbinski, J., Warren, M., & Upshur, R. (2005). Designing research in vulnerable populations: Lessons from HIV prevention trials that stopped early. British Medical Journal, 331,1403-1406. Ballantyne, A. (2005). HIV international clinical research: Exploitation and risk. Bioethics, 19, 476-491. Pace, C., Emanuel, E., Chuenyam, T., Duncombe, C., Bebchuk, J., Wendler, D., Tavel, J., McNay, L., Phanuphak, P., Forster, H., & Grady, C. (2005). The quality of informed consent in a clinical research study in Thailand. IRB:Ethics & Human Research, Jan, 9-17. Wendler, D., Emanuel, E., & Lie, R. (2004). The standard of care debate: Can research in developing countries be both ethical and responsive to those countries health needs? American Journal of Public Health, 94, 923-928.
Jewkes, R., Watts, C., Abrahams, N., Kekana, L., & Moreno, C. (2000). Ethical and methodological issues in conducting research on gender based violence in Southern Africa. Reproductive Health Matters, 8, 93-103. U.S. Department of Health and Human Services. (2007). International Compilation of Human Subject Research Protections. Washington D.C., WA: Office for Human Research Protections, U.S. Department of Health and Human Services. Section VI: Misconduct in research Fraud / Misconduct Smallwood, S. (2002, October 25). Crossing the line: A heroin researcher partakes and pays the price. Retrieved from the World Wide Web at: www.chronicle.com Matthews, R. (2005). No way to treat a patient; Tens of thousands of people have been subjected to unnecessary drug trials. New Scientist, July, p.19. Herman, R. (1994, April 19). Research fraud breaks chain of trust investigation interrupts ongoing studies. The Washington Post, (p. Z6). Boyes, R. (2000, August 17). Fakers and copycats give academic research a bad name. The Times, (p. 19). Gardenier, J. (2003). Best statistical practices to promote research integrity. Professional Ethics Report, 16, 1-2. Three federal agencies seek information about Yales grant accounting practices Yale pledges full cooperation. (2006, August 21). Yale University office of Public Affairs, Retrieved July 7, 2006 from the World Wide Web: www.yale.edu/opa/newsr/06-07-03-01.all.html. Murray, M. (1987). A long disputed paper goes to press. Science News, 131, 52-53. Stewart, W., & Feder, N. (1987). the integrity of the scientific literature. Nature, 325, 207214. Braunwald, E. (1987). On analyzing scientific fraud. Nature, 325, 215-216. Cowen, R. (1987, January 27). Critics fault flaws in some scientific research studies. Christian Science Monitor, (p. 19). Monastersky, R. (2005). Scientific misbehavior is rampant, study of 3,000 researchers finds. Chronicle of Higher Education, 51, A11. Martinson, B., Anderson, M., & Vries, R. (2005). Scientists behaving badly. Nature, 435, 737-738. Dean, C. (2005, June 14). Mundane misdeeds skew findings, researchers say. The New York Times, (p.6). Guterman, L. (2006, April 21). Sense of injustice can lead scientists to act unethically, study finds. The Chronicle of Higher Education, Retrieved April 8, 2006 from the World Wide Web: http://chronicle.com Chan, A., Hrobjartsson, A., Haahr, M., Gotzsche, P., & Altman, D. (2004). Empirical evidence for selective reporting of outcomes in randomized trials. Journal of the American Medical Association, 291, 2457-2465. Sudbo, J., Lippman, S., Sagen, M., Flatner, N., Ristimaki, A., Sudbo, A., Mao, L., Zhou, X., Kidal, W., Evenson, J., Reith, A., & Dannenber, A. (2005). Non-steroidal anti-inflammatory drugs and the risk of oral cancer: A nested case-control study. The Lancet, 366, 1359-1366. Forsman, B. (1999). An ethical analysis of the phenomenon of misconduct in research. Acta Oncologica, 38, 107-110. Tomkowiak, J., & Gunderson, A. (2004). To IRB or not to IRB?. Academic Medicine, 79, 628-632. 15
Manier, J. (1999, August 28). UIC suspended from doing most human research federal panel says some test subjects not fully informed. Chicago Tribune, (p. 1). A.P. (2001, August 31). Report on a research death faults review board. The New York Times, (p. 16). Levine, S., & Weiss, R. (2001, July 20). Hopkins told to halt trials funded by the U.S. death of medical volunteer prompted federal directive. The Washington Post, (p. A1). Glick, M. (2006). Scientific fraud-real consequences. Journal of the American Dental Association, 137, 428-430. Bonetta, L. (2006). The aftermath of scientific fraud. Cell, 124, 873-875. Ehringhaus, S., Ciechanover, A., Hulse, R., Pascal, C., & Goodman, S. (2006). Nobel round table discussion 2: Conflicts of interest, scientific misconduct, fair sharing, and intellectual property in an interdisciplinary/ inter-institutional consortium. Society for Experimental Biology and Medicine, 1535, 1240-1254. Whistle Blowing Thomas, P. (1995, September 15). FBI lab audit finds some discrepancies misconduct allegations are not corroborated. The Washington Post, (p. A3). Sprague, R. (1993). Whistleblowing: A very unpleasant avocation. Ethics & Behavior, 3, 103-133. Lenzer, J. (2005). What can we learn from medical whistleblowers?. PLoS Medicine, 2, 0583-0586. Lennane, K. (1993). Whistleblowing: A health issue. British Medical Journal, 307, 667670. Section VII: Conflicts, funding, and ownership Peer Review Sox, H., & Rennie, D. (2006). Research misconduct, retraction, and cleansing the medical literature: Lessons from the Poehlman case. Annals of Internal Medicine, 144, 609-613. Kotchen, T., Lindquist, T., Malik, K., & Ehrenfeld, E. (2004). NIH peer review of grant applications for clinical research. Journal of the American Medical Association, 291, 836-843. Marris, E. (2006). Should journals police scientific fraud. Nature,439, 520-521. Altman, L. (2006, May 2). For sciences gatekeepers, a credibility gap. The New York Times. Roediger, H. (2005). The greatest literature never published. The Academic Observer, 18, 37-40. Glenn, D. (2004, October 20). Scholar sends sham papers to social-work journals to show weakness of peer review. The Chronicle of Higher Education, Retrieved October 20, 2006 from the World Wide Web: http://chronicle.com Epstein, W. (2004). Confirmational response bias and the quality of the editorial processes among American social work journals. Research on Social Work Practice, 14, 450-458. Epstein, W. (1990). Confirmational response bias among social work journals. Science, Technology, & Human Values, 15, 9-38. Giles, J. (2006). Journals submit to scrutiny of their peer-review process. Nature, 439, 252. Marris, E. (2006). Doctor admits Lancet study is fiction. Nature, 439, 248. Lee, K., Boyd, E., Leduc, J., Bacchetti, P., & Bero, L. (2006). Predictors of publication: Characteristics of submitted manuscripts associated with acceptance at major biomedical journals. Medical Journal of Australia, 184, 621-626. 16
Olson, C., Rennie, D., Cook, D., Dickersin, K., Flanagin, A., Hogan, J., Zhu, Q., Reiling, J., Pace, B. (2002). Publication bias in editorial decision making. Journal of the American Medical Association, 287, 2825-2828. Monastersky, R. (2006, November 29). Science journal must develop stronger safeguards against fraud, panel says. The Chronicle of Higher Education, Retrieved November 29, 2006 from the World Wide Web: http://chronicle.com Authorship Grieger, M. (2005). Authorship: An ethical dilemma of science. Sao Paulo Medical Journal, 123, 242-246. Newman, A., & Jones, R. (2006). Authorship of research papers: Ethical and professional issues for short-term researchers. Journal of Medical Ethics, 32, 420-423. Pederson, T. (2006). Author, author burning bright; author, author are you right?. The FASEB Journal, 600. Guterman, L. (2004, December 2). Lead author removes name from disputed Columbia U. study linking pregnancy and prayer. The Chronicle of Higher Education, Retrieved December 2, 2006 from the World Wide Web: http://chronicle.com Pignatelli, B., Maisonneuve, H., & Chapuis, F. (2005). Authorship ignorance: views of researchers in French clinical settings. Journal of Medical Ethics, 31, 578-581. Dingfelder, S. (2006). Get the credit you deserve. gradPSYCH, 4, 42-44. Winnerman, L. (2006). Prevention on paper. gradPSYCH, 4, 46-52. Conflict of Interest Tanner, L. (2006). JAMA says docs misled over industry ties. Chron.com, Retrieved July 25, 2006 from the World Wide Web: www.chron.com Kim, S., Millard, R., Nisbet, P., Cox, C., & Caine, E. (2004). Potential research participants views regarding researcher and institutional financial conflicts of interest. Journal of Medical Ethics, 30, 73-79. Boyd, E., Cho, M., & Bero, L. (2003). Financial conflict-of-interest policies in clinical research: Issues for clinical investigators. Academic Medicine, 78, 769-774. Willman, D. (2006, July 16). NIH scientists work at drug consultant doubted. The Lexington Herald Leader, (p. A10). Gillis, J. (2002, June 30). Patients werent told of stake in cancer drug. The Washington Post. OHarrow, R. (2000, August 16). Companies influence on medical studies is feared. The Washington Post, (p. A1). Hilts, P. (2000, August 16). U.S. weighs rule changes on conflicts in drug study. The New York Times, (p. 28). Brown, D. (1993, September 7). In medical research, physicians loyalties sometimes conflict. The Washington Post, (p. a8). Stelfox, H., Chua, G., ORourke, K., & Detsky, A. (2006). Conflict of interest in the debate over calcium-channel antagonists. The New England Journal of Medicine, 338, 101-106. Puttagunta, P., Caulfield, T., & Griener, G. (2002). Conflict of interest in clinical research: Direct payment to the investigators for finding human subjects and health information. Health Law Review, 10, 30-32. Spence, D. (2006). Research for profit. British Medical Journal, 332, 1155-1156. Lewis, D., Michels, R., Pine, D., Schultz, S., Tamminga, C., & Freedman, R. (2006). Free lunch?. American Journal of Psychiatry, 163, 569-70. 17
Lewis, D., Michels, R., Pine, D., Schultz, S., Tamminga, C., & Freedman, R. (2006). Conflict of interest. American Journal of Psychiatry, 163, 571-73. Freedman, R., Lewis, D., Michels, R., Pine, D., Schultz, S., Tamminga C., Patterson, S., McIntyre, J., Goldman, H., Yudofsky, S., Hales, R., Rapaport, M., Hales, D., Krajeski, J., Kupfer, D., Badaracco, & M., Scully, J. Conflict of interest, round 2. American Journal of Psychiatry, 163, 1481-83. Campbell, E., Weissman, J., Vogeli, C., Clarridge, B., Abraham, M., Marder, J., & Koski, G. (2006). Financial relationships between institutional review board members and industry. The New England Journal of Medicine, 355, 2321-9. Plagiarism Mclemee, S. (2004, September 14). Plagiarism by design? MIT press seeks recompense from McGraw-Hill for copying in architecture book. The Chronicle of Higher Education, Retrieved September 14, 2004 from the World Wide Web: http://chronicle.com Associated Press. (1988, November 29). Harvard professor quits in plagiarism case. Chicago Tribune, (p. 8). Ortiz, B. (2005, July 15). Jury in UK plagiarism trial set to return. The Lexington Herald Leader. Specter, M. (1988, November 29). Plagiarism scandal at Harvard prominent medical school professor resigns. The Washington Post, (p. a1). Giles, J. (2005). Taking the cheats. Nature, 436, 258-259. Cyranoski, D. (2006). Your cheatin heart. Nature Medicine, 12, 490. Winter, E. (2006). Plagiarism. Journal of Sports Sciences, 24, 113. Ownership Guterman, L. (2006, September 1). Digging into the roots of research ethics: How a Canadian ethnobiologist became a champion of research that advances the lot of indigenous peoples. Retrieved from the World Wide Web at: www.chronicle.com Siegelman, P. (2002). Towards an integrated theory of intellectual property. Virginia Law Review, 88, 1455-1528. Section VIII: Eliminating bias and promoting objectivity Preventing Misconduct Williams, W. (2004). Blissfully incompetent. Psychological Science in the Public Interest, 5, i-ii. Dunning, D., Heath, C., & Suls, J. (2004). Flawed self-assessment. Psychological Science in the Public Interest, 5, 69-106. Nylenna, M., & Simonsen, S. (2006). Scientific misconduct: A new approach to prevention. The Lancet, 367, 1882-1884. Steinberg, J. (2002). Misconduct of others: Prevention techniques for researchers. American Psychological Society, 15, 39-40. Moody, L., & McMillan, S. (2002). Maintaining data integrity in randomized clinical trials. Nursing Research, 51, 129-133. Begg, C., Cho, M., Eastwood, S., Horton, R., Moher, D., Olkin, I., Pitkin, R., Rennie, D., Schulz, K., Simel, D., & Stroup, D. (1996). Improving the quality of reporting of randomized controlled trials. The Journal of the American Medical Association, 276, 637-9. Murray, B. (2002). Research fraud neednt happen at all. Monitor on Psychology, February, 27-28. 18
Executive Summary. (2002). Integrity in Scientific Research: Creating an Environment That Promotes Responsible Conduct (pp. 1-15). Washington, D.C.: The National Academies Press. Marincola, F. (2003). Translational medicine: a two-way road. Journal of Translational Medicine, 1. Berk, R., Berg, J., Mortimer, R., Walton-Moss, B., & Yeo, T. (2005). Measuring the effectiveness of faculty mentoring relationships. Academic Medicine, 80, 66-71. Bird, S. (1996). The role of science professionals in teaching responsible research conduct. Bioscience, 46, 783-86. Benatar, S. (2002). Reflections and recommendations on research ethics in developing countries. Social Science and Medicine, 54, 1131-1141. Sieber, J. (2004). Empirical research on research ethics. Ethics and Behavior, 14, 397-412. Tancredi, L. (1995). The limits of empirical studies on research ethics. Ethics and Behavior, 5, 217-36.