1. Research Ethics Anne J. Davis, RN, PhD, DSc (hon), FAAN

2. Brief History of Research Ethics Research using human subjects has occurred for many years. General assumption that those doing research would be ethical. There was no clear understanding or agreement on what “ being ethical ” in research meant. In the 20th century there were several situations that led the international community of scientists to formalize the Ethics of Research. Research using human subjects has occurred for many years. General assumption that those doing research would be ethical. There was no clear understanding or agreement on what “ being ethical ” in research meant. In the 20th century there were several situations that led the international community of scientists to formalize the Ethics of Research.

3. The German medical community was one of the best educated and medically advanced medical communities in the west and perhaps in the world during the 19th and 20th centuries. The German medical community was one of the best educated and medically advanced medical communities in the west and perhaps in the world during the 19th and 20th centuries. In Asia, Japan joined Germany and declared war on much of Asia before being defeated. On Dec 7, 1941, the Japanese bombed Pearl Harbor, Hawaii which was part of the USA. This event brought the USA into WW2. In Asia, Japan joined Germany and declared war on much of Asia before being defeated. On Dec 7, 1941, the Japanese bombed Pearl Harbor, Hawaii which was part of the USA. This event brought the USA into WW2.

4. The USA is the only country to date that has used the atomic bomb and the Japanese are the only people who have had this bomb dropped on them. The ethics of this action taken by the USA has been discussed and written about extensively and is still under discussion. The USA is the only country to date that has used the atomic bomb and the Japanese are the only people who have had this bomb dropped on them. The ethics of this action taken by the USA has been discussed and written about extensively and is still under discussion.

5. During this war, Germany had concentration camps in which they put people they thought were non-human such as homosexuals, Jews, gypsies, and the mentally ill. During this war, Germany had concentration camps in which they put people they thought were non-human such as homosexuals, Jews, gypsies, and the mentally ill. The German medical community did experimentation on these groups. Such experimentations were not considered good science later and did great harm to these “ non-people ” including killing some of them. The German medical community did experimentation on these groups. Such experimentations were not considered good science later and did great harm to these “ non-people ” including killing some of them.

6. At the war trials in Nuremberg, Germany much of this was openly discussed and led the international scientific/medical community to re-think their position on research ethics. Out of this experience came The World Medical Association Helsinki Declaration of 1964 and other such documents detailing research ethics principles. At the war trials in Nuremberg, Germany much of this was openly discussed and led the international scientific/medical community to re-think their position on research ethics. Out of this experience came The World Medical Association Helsinki Declaration of 1964 and other such documents detailing research ethics principles. We know less about Japan medical experimental during WW2 but we do know it occurred. Only recently have some younger Japanese begun to openly deal with this ethical issue. Such openness is not always welcomed by older Japanese. We know less about Japan medical experimental during WW2 but we do know it occurred. Only recently have some younger Japanese begun to openly deal with this ethical issue. Such openness is not always welcomed by older Japanese.

7. We also know more about Nazi doctors than we know about Nazi nurses. A German nurse, Hilde Steepe, before her untimely death, did research on German nurses during WW2 and found some of them very caring as they killed patients by giving them poison. Among other ideas, such behavior raises the question: What do we care about? What are the underlying values of our caring? Other German nurses helped civilian prisoners escape. We also know more about Nazi doctors than we know about Nazi nurses. A German nurse, Hilde Steepe, before her untimely death, did research on German nurses during WW2 and found some of them very caring as they killed patients by giving them poison. Among other ideas, such behavior raises the question: What do we care about? What are the underlying values of our caring? Other German nurses helped civilian prisoners escape.

8. In the USA, we had a famous violation of research ethics. During the early part of the 20th century poor Black men who had syphilis were in a research study funded by the USA government. At that time, there was no effective treatment for this disease. As this research continues into the early 1970s, there was treatment for syphilis but these men did not receive it. When the news of this reached the public there was outrage about this unethical use of human research subjects. There was a nurse involved in this and a play was written with her as a main character. In the USA, we had a famous violation of research ethics. During the early part of the 20th century poor Black men who had syphilis were in a research study funded by the USA government. At that time, there was no effective treatment for this disease. As this research continues into the early 1970s, there was treatment for syphilis but these men did not receive it. When the news of this reached the public there was outrage about this unethical use of human research subjects. There was a nurse involved in this and a play was written with her as a main character.

9. This briefly is some history and explains how we have come to have more open ethical requirements about research with humans. This briefly is some history and explains how we have come to have more open ethical requirements about research with humans. I have not discussed the ethics of research with non-human animals but that is an important topic. I have not discussed the ethics of research with non-human animals but that is an important topic. Also I have not mentioned the ethics of auto-experimentation or conducting research on one ’ s self. Also I have not mentioned the ethics of auto-experimentation or conducting research on one ’ s self.

10. Informed consent Ethical principles involved are: Ethical principles involved are: Person ’ s autonomy, Person ’ s autonomy, Do no harm, Do no harm, Do good, Do good, Truth telling Truth telling Person being asked to participate in research needs to be free from coercion and have freedom of choice. Should be able to say no freely if wishes to. Should understand that if enters the research, can withdraw later if wishes to. Person being asked to participate in research needs to be free from coercion and have freedom of choice. Should be able to say no freely if wishes to. Should understand that if enters the research, can withdraw later if wishes to.

11. Notions of Rights and Obligations- We have a right to participate or to refuse to participate in research We have a right to participate or to refuse to participate in research Do we have an obligation to participate in research? Do we have an obligation to participate in research? Yes? No? Why? Yes? No? Why?

12. Vulnerable populations in research children, healthy children in control group with some possible risk children, healthy children in control group with some possible risk very elderly people very elderly people people whose first language is not same as researcher people whose first language is not same as researcher prisoners prisoners mentally ill mentally ill mentally retarded mentally retarded dying patients dying patients

13. Questions about the Informed Consent process Who gives informed consent? Competent Adults Who gives informed consent? Competent Adults What do we mean by competent? What do we mean by competent? Who is an adult? Who is an adult? If one of these cannot give informed consent, who should speak in the best interest of the person being asked to participate in research? If one of these cannot give informed consent, who should speak in the best interest of the person being asked to participate in research? What is Best Interest? How do we determine? What is Best Interest? How do we determine?

14. Risk and Benefit Research is not always for the benefit of the person in the research. We assume that treatment is beneficial for the patient but research may not be. It may be beneficial for others or for science or the researcher. What do we tell the potential research subject? Research is not always for the benefit of the person in the research. We assume that treatment is beneficial for the patient but research may not be. It may be beneficial for others or for science or the researcher. What do we tell the potential research subject? How do we measure risk? What risk? Physical, psychological, social? How do we measure risk? What risk? Physical, psychological, social? Should we tell about a risk that is extremely remote and not apt to happen? Should we tell about a risk that is extremely remote and not apt to happen? Is it possible to relate too much information? How much information is enough? Is it possible to relate too much information? How much information is enough?

15. Institutional Review Board (IRB) In the USA, there is a law that says that any institution where research with human subjects is conducted and that receives national government research money must have an IRB. In the USA, there is a law that says that any institution where research with human subjects is conducted and that receives national government research money must have an IRB. There is a possible conflict of interest for some IRB members who value science and also value human rights and informed consent. These 2 values can conflict with each other. There is a possible conflict of interest for some IRB members who value science and also value human rights and informed consent. These 2 values can conflict with each other.

16. Role of the Nurse in Research of Other People Do clinical nurses have a role in the research of other people? Do clinical nurses have a role in the research of other people? If so, what is that role? If so, what is that role? Do nurses have ethical responsibilities in other people ’ s research? Do nurses have ethical responsibilities in other people ’ s research? If so, what ethical responsibility? If not, why not? If so, what ethical responsibility? If not, why not?

17. Role of the Nurse in Clinical Trials The communications about the ethics of clinical trials are often between Research Ethics Committee (IRB) and the Principle Investigator (PI) but in the USA, the nurse actually gets informed consent and manages much of the research data collection. Recently at the American Society of Bioethics and Humanities annual meeting, a nurse gave a paper on this important topic. The communications about the ethics of clinical trials are often between Research Ethics Committee (IRB) and the Principle Investigator (PI) but in the USA, the nurse actually gets informed consent and manages much of the research data collection. Recently at the American Society of Bioethics and Humanities annual meeting, a nurse gave a paper on this important topic.

18. A Possible Problem with the Formal Organization of Research Ethics? Will this formal organization of research ethics trivialize the ethics? Will researchers think, I do not have to worry about this; the IRB will take care of the ethical issues. Will this formal organization of research ethics trivialize the ethics? Will researchers think, I do not have to worry about this; the IRB will take care of the ethical issues. Important to know that in the USA, researcher cannot obtain research funds or get results of research published unless can show approval by the IRB in his/her institution. Important to know that in the USA, researcher cannot obtain research funds or get results of research published unless can show approval by the IRB in his/her institution.

19. Some Remaining Difficulties in Research EthicsSome Remaining Difficulties in Research Ethics a. The IRB has limitations because it must believe the researcher that he/she will do what the proposal says regarding informed consent. Members must assume that the researcher will in fact give the person the Informed Consent paper explaining the research and possible risks and benefits and that there is no requirement to be a human subject. a. The IRB has limitations because it must believe the researcher that he/she will do what the proposal says regarding informed consent. Members must assume that the researcher will in fact give the person the Informed Consent paper explaining the research and possible risks and benefits and that there is no requirement to be a human subject. But the IRB does not know if this really does happen. But the IRB does not know if this really does happen. The IRB is not a police committee checking up on researchers ’ behavior. I would not want the IRB to police scientists. The IRB is not a police committee checking up on researchers ’ behavior. I would not want the IRB to police scientists.

20. Some researchers do violate research ethics. We had in the USA a famous case of a junior scientist making up findings which were not true. This study could not be repeated by other scientists and get the same results. Both the junior scientist and his supervisor were in trouble and after this event, could not receive funds for research. Some researchers do violate research ethics. We had in the USA a famous case of a junior scientist making up findings which were not true. This study could not be repeated by other scientists and get the same results. Both the junior scientist and his supervisor were in trouble and after this event, could not receive funds for research. Qualitative Research is often less controlled than quantitative research. Could there be ethical issues arising from this situation? Qualitative Research is often less controlled than quantitative research. Could there be ethical issues arising from this situation?

21. THANK YOU for your attention.