1. Responsible Conduct of Research in the Health Sciences Dr. Peggy Valentine Professor and Associate Dean Division of Allied Health Sciences

2. What is meant by responsible conduct of research? It involves the ethical responsibilities of those engaged in research It ensures protection of the rights and interests of study participants Researchers are obligated to avoid misconduct

3. What are examples of misconduct? Fabrication, falsification or plagiarism in proposing, performing, or reviewing research, or in reporting the results

4. Why is research important in the health sciences? To reduce human suffering To validate social or scientific theories To dispel ignorance To improve understanding of human behavior

5. The focus of this presentation In this presentation, I will use HIV/AIDS as a paradigm in highlighting important issues that face researchers.

6. (VOA photo - N. Colombant) The HIV/AIDS Pandemic and Research

7. Guiding Ethical Principles Respect for human dignity Respect for informed consent Respect for vulnerable persons Respect for privacy and confidentiality Respect for inclusion Minimize harm Maximize benefit

8. Human Dignity ….What makes a person a person, rather more than merely an individual, is a spiritual capacity: the capacity to reflect and choose, to be imaginative and creative, to be an originating source of action (Michael Novak, 1999)

9. Informed Consent Official statement developed by the researcher that informs study participants of the purpose and scope of the study Basic elements: purpose, description of procedures, disclosure of risks or discomforts, how confidentiality will be ensured, right of refusal, benefits, signatures, name of institution and telephone number of investigator

10. Confidentiality The need to take utmost care with patient confidentiality is a paramount consideration in HIV-related research. There is a potential for discrimination and stigmatization. Mail should not be sent to an individual's address or phone calls made that could identify them as possibly being HIV-positive. Family or friends may not be aware of the health status.

11. Confidentiality, cont’d. In cases where identifying information on research participants needs to be kept for research purposes (for example, longitudinal studies) it should be stored separately from collected data Participants should be informed of confidentiality procedures and also the risks, however remote, that there are some circumstances where researchers may be required to report on data, for example if subpoenaed in court.

12. Be Careful A person's HIV status may be illegally revealed to pharmacists, police officers, doctors, school officials, or other authority figures. Most states already protect medical privacy, and a new federal law provides more protection http://www.aclu.org/HIVAIDS/HIVAIDSlist.cfm?c=88 http://www.aclu.org/HIVAIDS/HIVAIDSlist.cfm?c=88 Issue: HIV names reporting

13. Researchers should be aware of the potential of being placed in situations where mandatory reporting of behaviors to authorities is required (i.e.. Illegal drug use, child abuse)

14. Other Considerations Involvement of the community (community participatory research) Human rights and discrimination Legal issues

15. Involving the Community Researchers wishing to recruit HIV- positive people to their studies should consult the affected communities before starting the project. This may involve discussions with People Living with HIV/AIDS organizations or AIDS Councils about the nature of the research.

16. Cameroon AIDS Research Sparks Controversy By Nico Colombant, Abidjan, 26 January 2005 A Yaounde-based activist for a non- governmental organization dealing with ethics and AIDS, Calice Talom, says everything started badly when participants were rushed to sign a consent form in English most of them probably didn't understand.

17. Dan Heller's Photos, Arusha, Tanzania Respect for vulnerable persons

18. Vulnerable Persons Diminished decision-making capacity Diminished competency Children Institutionalized Avoid abuse, exploitation, discrimination

19. Whistleblower Says U.S. Bungled AIDS Study Tuesday, January 04, 2005 Federal officials involved in a U.S.- funded study in Uganda endangered the lives of hundreds of patients testing an AIDS drug because of careless and negligent research practices, a government whistleblower said Tuesday. (WebMD)

20. Whistleblower, cont’d. Fishbein told NIH's AIDS research chief in 2003 that the Uganda study should not be resumed. The agency had stopped the research for 15 months after auditors, medical experts and others disclosed problems with the project. (Problem with liver failure in the study participants) The concerns were dismissed, and the clinics reopened.

21. Inclusion Fairness and equity Fair methods, standards and procedures for reviewing research protocols No segment of the population should be unfairly burdened with the harms of research Do not neglect nor discriminate against those who may benefit from research advances

22. "Women Don't Get AIDS, They Just Die From It..” http://fubini.swarthmore.edu/~WS30/WS30F1998/moriah3-intro.html Women have not been involved in the clinical trials which test the safety and efficacy of HIV/AIDS drugs. Latest advances are denied to women because harm to their potential offspring is feared (but unstudied). Drugs tested only on men are more dangerous for women, the dosages may need to be different HIV/AIDS research that has been done on women has almost exclusively focused on vertical or perinatal (i.e., during birth) transmission Barrier to women participating in studies include the location, gender of study primary investigator, the availability of child/family care, and transportation to the site

23. Balancing Harm and Benefit Remember the rights of participants in a study Duty to avoid, prevent or minimize harm Maximize the benefits for participants, society and the advancement of knowledge

24. Lawsuit Filed Over Woman Who Died in AIDS Drug Trial Wednesday, December 29, 2004 The family of a pregnant woman who died while taking experimental AIDS drugs to protect her baby from getting the disease is suing the doctors, drug makers and hospitals involved in the study for $10 million. http://www.foxnews.com/story http://www.foxnews.com/story

25. Flawed AIDS Drug Study Exposes NIH Misconduct Thursday, February 03, 2005; By Jonathan M. Fishbein “Scientists are pressured to produce results at the expense of regulations whose purpose is to protect the safety, rights and welfare of study subjects, not to mention the preservation of scientific integrity”

26. Concluding Remarks Respect human dignity Follow guiding ethical principles Avoid careless and negligent research practices Involve the community you are studying