Research EthicsResearch Ethics

Anne J. Davis, RN, PhD, DSc (hoAnne J. Davis, RN, PhD, DSc (hon), FAANn), FAAN

Brief History of Research EthicsBrief History of Research Ethics

• Research using human subjects has occurreResearch using human subjects has occurred for many years. General assumption that td for many years. General assumption that those doing research would be ethical. Therhose doing research would be ethical. There was no clear understanding or agreement e was no clear understanding or agreement on what “being ethical” in research meanon what “being ethical” in research meant. In the 20th century there were several situt. In the 20th century there were several situations that led the international community ations that led the international community of scientists to formalize the Ethics of Reseaof scientists to formalize the Ethics of Research.rch.

• The German medical community was oThe German medical community was one of the best educated and medically ne of the best educated and medically advanced medical communities in the advanced medical communities in the west and perhaps in the world during twest and perhaps in the world during the 19th and 20th centuries.he 19th and 20th centuries.

• In Asia, Japan joined Germany and decIn Asia, Japan joined Germany and declared war on much of Asia before being lared war on much of Asia before being defeated. On Dec 7, 1941, the Japanesdefeated. On Dec 7, 1941, the Japanese bombed Pearl Harbor , Hawaii which e bombed Pearl Harbor , Hawaii which was part of the USA. This event broughwas part of the USA. This event brought the USA into WW2. t the USA into WW2.

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

• During this war, Germany had concentrDuring this war, Germany had concentration camps in which they put people tation camps in which they put people they thought were non-human such as hey thought were non-human such as homosexuals, Jews, gypsies, and the mhomosexuals, Jews, gypsies, and the mentally ill.entally ill.

• The German medical community did exThe German medical community did experimentation on these groups. Such eperimentation on these groups. Such experimentations were not considered gxperimentations were not considered good science later and did great harm tood science later and did great harm to these “non-people” including killino these “non-people” including killing some of them. g some of them.

• At the war trials in Nuremberg, Germany mucAt the war trials in Nuremberg, Germany much of this was openly discussed and led the inth of this was openly discussed and led the international scientific/medical community to rernational scientific/medical community to re-think their position on research ethics. Out e-think their position on research ethics. Out of this experience came The World Medical Aof this experience came The World Medical Association Helsinki Declaration of 1964 and ossociation Helsinki Declaration of 1964 and other such documents detailing research ethither such documents detailing research ethics principles.cs principles.

• We know less about Japan medical experimeWe know less about Japan medical experimental during WW2 but we do know it occurred. ntal during WW2 but we do know it occurred. Only recently have some younger Japanese Only recently have some younger Japanese begun to openly deal with this ethical issue. begun to openly deal with this ethical issue. Such openness is not always welcomed by olSuch openness is not always welcomed by older Japanese.der Japanese.

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

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

• This briefly is some history and explainThis briefly is some history and explains how we have come to have more opes how we have come to have more open ethical requirements about research n ethical requirements about research with humans.with humans.

• I have not discussed the ethics of reseaI have not discussed the ethics of research with non-human animals but that irch with non-human animals but that is an important topic.s an important topic.

• Also I have not mentioned the ethics of Also I have not mentioned the ethics of auto-experimentation or conducting reauto-experimentation or conducting research on one’s self.search on one’s self.

Informed consentInformed 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 tellingTruth telling• Person being asked to participate in Person being asked to participate in

research needs to be free from coercion research needs to be free from coercion and have freedom of choice. Should be and have freedom of choice. Should be able to say no freely if wishes to. Should able to say no freely if wishes to. Should understand that if enters the research, can understand that if enters the research, can withdraw later if wishes to. withdraw later if wishes to.

Notions of Rights and ObligationNotions of Rights and Obligationss--• We have a right to participate or to refusWe have a right to participate or to refus

e to participate in researche to participate in research• Do we have an obligation to participate iDo we have an obligation to participate i

n research?n research?• Yes? No? Why? Yes? No? Why?

Vulnerable populations in researcVulnerable populations in researchh

• children, healthy children in control group witchildren, healthy children in control group with some possible riskh some possible risk

• very elderly peoplevery elderly people• people whose first language is not same as respeople whose first language is not same as res

earcherearcher• prisonersprisoners• mentally illmentally ill• mentally retardedmentally retarded• dying patientsdying patients

Questions about the Informed CoQuestions about the Informed Consent processnsent process• Who gives informed consent? Competent AduWho gives informed consent? Competent Adu

ltslts• 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, If one of these cannot give informed consent,

who should speak in the best interest of the pwho should speak in the best interest of the person being asked to participate in research?erson being asked to participate in research?

• What is Best Interest? How do we determine?What is Best Interest? How do we determine?

Risk and BenefitRisk and Benefit

• Research is not always for the benefit of the person in Research is not always for the benefit of the person in the research. We assume that treatment is beneficial fthe research. We assume that treatment is beneficial for the patient but research may not be. It may be beneor the patient but research may not be. It may be beneficial for others or for science or the researcher. What ficial for others or for science or the researcher. What do we tell the potential research subject?do we tell the potential research subject?

• How do we measure risk? What risk? Physical, psycholHow do we measure risk? What risk? Physical, psychological, social?ogical, social?

• Should we tell about a risk that is extremely remote aShould we tell about a risk that is extremely remote and not apt to happen?nd not apt to happen?

• Is it possible to relate too much information? How muIs it possible to relate too much information? How much information is enough? ch information is enough?

Institutional Review Board (IRInstitutional Review Board (IRB)B)• In the USA, there is a law that says that any insIn the USA, there is a law that says that any ins

titution where research with human subjects ititution where research with human subjects is conducted and that receives national governs conducted and that receives national government research money must have an IRB. ment research money must have an IRB.

• There is a possible conflict of interest for some There is a possible conflict of interest for some IRB members who value science and also valuIRB members who value science and also value human rights and informed consent. These 2 e human rights and informed consent. These 2 values can conflict with each other.values can conflict with each other.

Role of the Nurse in Research of ORole of the Nurse in Research of Other Peoplether People• Do clinical nurses have a role in the resDo clinical nurses have a role in the res

earch of other people?earch of other people?• If so, what is that role? If so, what is that role? • Do nurses have ethical responsibilities Do nurses have ethical responsibilities

in other people’s research?in other people’s research?• If so, what ethical responsibility? If not, If so, what ethical responsibility? If not,

why not?why not?

Role of the Nurse in Clinical TrialsRole of the Nurse in Clinical Trials

• The communications about the ethics of clinicThe communications about the ethics of clinical trials are often between Research Ethics Coal trials are often between Research Ethics Committee (IRB) and the Principle Investigator (Pmmittee (IRB) and the Principle Investigator (PI) but in the USA, the nurse actually gets inforI) but in the USA, the nurse actually gets informed consent and manages much of the researmed consent and manages much of the research data collection. Recently at the American Sch data collection. Recently at the American Society of Bioethics and Humanities annual meociety of Bioethics and Humanities annual meeting, a nurse gave a paper on this important teting, a nurse gave a paper on this important topic. opic.

A Possible Problem with the FormA Possible Problem with the Formal Organization of Research Ethics?al Organization of Research Ethics?• Will this formal organization of research ethics Will this formal organization of research ethics

trivialize the ethics? Will researchers think, I dtrivialize the ethics? Will researchers think, I do not have to worry about this; the IRB will tako not have to worry about this; the IRB will take care of the ethical issues.e care of the ethical issues.

• Important to know that in the USA, researcher Important to know that in the USA, researcher cannot obtain research funds or get results of cannot obtain research funds or get results of research published unless can show approval research published unless can show approval by the IRB in his/her institution.by the IRB in his/her institution.

Some Remaining Difficulties in ReSome Remaining Difficulties in Research EthicsSome Remaining Diffsearch EthicsSome Remaining Difficulties in Research Ethicsiculties in Research Ethics• a. The IRB has limitations because it must believe a. The IRB has limitations because it must believe

the researcher that he/she will do what the proposal the researcher that he/she will do what the proposal says regarding informed consent. Members must says regarding informed consent. Members must assume that the researcher will in fact give the assume that the researcher will in fact give the person the Informed Consent paper explaining the person the Informed Consent paper explaining the research and possible risks and benefits and that research and possible risks and benefits and that there is no requirement to be a human subject.there is no requirement to be a human subject.

But the IRB does not know if this really does But the IRB does not know if this really does happen.happen.

• The IRB is not a police committee checking up on The IRB is not a police committee checking up on researchers’ behavior. I would not want the IRB to researchers’ behavior. I would not want the IRB to police scientists. police scientists.

• Some researchers do violate research ethics. Some researchers do violate research ethics. We had in the USA a famous case of a junior sciWe had in the USA a famous case of a junior scientist making up findings which were not true. entist making up findings which were not true. This study could not be repeated by other scieThis study could not be repeated by other scientists and get the same results. Both the junior ntists and get the same results. Both the junior scientist and his supervisor were in trouble anscientist and his supervisor were in trouble and after this event, could not receive funds for rd after this event, could not receive funds for research. esearch.

• Qualitative Research is often less controlled thQualitative Research is often less controlled than quantitative research. Could there be ethican quantitative research. Could there be ethical issues arising from this situation? al issues arising from this situation?

THANK YOU for your attention.THANK YOU for your attention.