A Little History Nuremberg Doctors’ Trial ( ) 23 Nazi Physicians tried for research killing on prisoners. Carrying out experiments to develop a secret way to sterilize large populations. Developing a vaccine for typhus by exposing prisoners Nuremburg Code - 1st internationally recognized code of research ethics.

History Tuskegee Syphilis Study ( ) Tuskegee Syphilis Study done to determine the natural history of untreated latent syphilis 400 black males - death rate twice as high as control no informed consent, When penicillin became available, they were not informed or treated Study continued until press reports in 1972.

Jewish Chronic Disease Hospital Study Injection of live cancer cells into chronically ill patients to develop information on the nature of the human transplant rejection process. Researchers said consent was given orally but not documented. Patients weren’t told they would receive cancer cells because it would frighten the patients unnecessarily.

Willowbrook hepatitis studies Institution for “mentally defective persons” Infecting retarded children with hepatitis (fed feces) “They’ll get hepatitis anyhow. Better under controlled conditions.” To study the natural course of hepatitis Vaccine studies. Mid 1950’s to early ‘70s.

The Birth of Human Subjects Protection The Nuremberg Code, 1947 The Belmont Report, 1979, written in response to the expos é of both the Tuskegee Syphilis Study and U.S. human radiation experiments World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects (1964,75, 83,89, 96,2000, 2002) WHO International Ethical Guidelines for Biomedical Research Involving Human Subjects

Nuremburg Code Requires voluntary consent. Experiments must be rational. Experiments must be based on animal studies and knowledge of the disease. Experiments should avoid suffering. No experiment should involve excessive risks, except in those studies where physical. experimental physicians also serve as subjects.

Nuremburg Code Degree of risks should be determined by importance of the problem. Precautions should be taken to avoid against even remote possibilities of injury, disability, or death Experiment should be conducted only by scientifically qualified persons. Subjects should be able to end experiment at any time. The scientist in charge must be prepared to terminate the experiment at any stage, if they believe the experiment is likely to result in injury, disability, or death to the subject.

The Three Belmont Principals Beneficence Freedom from harm: exposing participants to experiences that result in serious or permanent harm is unacceptable e.g. first test the new drugs on animal or tissue. Freedom from exploitation: participants should be assured that the information they give will not be used against them. Benefit from research: any personal or social benefits should be clearly mentioned. Researcher must maximize possible benefits. Benefits to participants must outweigh the risks

The Three Belmont Principals Respect for persons The right to self-determination: it means that subjects has the right to voluntary decide whether or not to participate in the study, and the right not to be punished as a result of failing to participate. The right to full disclosure: full disclosure means that the researcher has fully described the nature of the study, the right to refuse to participate and to withdraw. Informed consent Treat individuals as capable of making decisions Refrain from making choices for participants Participants must feel free to volunteer; no coercion Protecting those not capable of making their own decisions

The Three Belmont Principals Justice The right to fair treatment: this includes the right for fair selection, fair treatment, and fair access to clarify information. The right to privacy: subject should be assured that any information collected during the study should be kept in strict confidence. This could be through anonymity or other confidentiality procedures. Anonymity: occurs when ever the researcher can’t link a subject with the information for that subject. A promise of confidentiality: it means that any information from the subject should not be publicly reported or being accessed to somebody other than the researcher.

World Medical Association Declaration of Helsinki (1964) Voluntary participation with consent in writing. Design described in written protocol. Review by an independent committee. Responsible scientific publication. Protection of vulnerable populations.

Justification of Research in Humans Impossible to reach the important conclusions without studying humans. Human physiology, because animals often are not the same. Epidemiological studies, because they depend on human susceptibilities and human interactions Agents for treating humans because animal experiments don ’ t predict results

Research Ethics All researchers, even students, have a responsibility to conduct ethical research. Participants in research studies should know and understand their rights and responsibilities. Ethical considerations are part of the design of the research project.

Researcher Ethical responsibility Researcher has two broad ethical responsibilities Scientific responsibility for following established guidelines and conducting research that will yield knowledge. The researcher ’ s relationship to participants as it affects collection, interpretation, and reporting of data.

Ethical Questions in Planning Research What are the benefits of this study? How will the consent of participants be gained? How will confidentiality/anonymity be handled? Are the participants appropriate for the study? Are there potential physical or psychological harms? How will the researcher’s role affect the study? Is the research design valid? Is researcher capable of conducting the study?

Elements of Informed Consent Subject status Subject purpose Type of data Nature of the commitment Sponsorship Subject selection Procedures Potential risk or costs Potential benefits Confidentiality pledge Voluntary consent Right to withdraw Alternatives Contact information

Gaza Health Research Center Consent Form Interviewer’s Comment: _______________________________________________________________ Time Interview Started: Hour: …………………. |___| Minute:……………….. Hello, my name is ………………………………. and I am working with the Gaza Health Research Center. We are doing a research on reproductive health. You have been randomly selected to participate in this study. We would like to ask you some questions about your reproductive health. The interview includes sensitive and intimate questions. This interview will probably take about 15 minutes. If you do not have time to do the interview right now, we can arrange to come back at a later time. Your participation in this interview is voluntary. You can refuse to answer any questions or series of questions if you choose. However, I would like to assure you that all that is said during the interview will be strictly confidential and that the information collected from you will be used only in scientific reports without any mention of your name. Information gathered from the study will be used to improve programs that promote the well-being of women. So we hope you will give accurate answers. In case you want to know more about this study, or in the event that any harm will arise from asking our questions, we refer you to see Dr. Abu El-Abed at his offices at Nursing Collage, Tel: Signature of person obtaining consent Date Thank you for your cooperation

Study title: The Needs of Family Members of Critically Ill Adults Investigator: Ahmed Mohammed, R.N. Mr. Mohammed is a registered nurse studying the emotional and social needs of family members of patients in the Intensive Care Units (Research purpose). Although the study will not benefit you directly, it will provide information that might enable nurses to identify members’ needs and assist family members with those needs (potential benefits). The study and its procedures have been approved by the appropriate people and review by the Helsinki Committee (Helsinki approval). The study procedures involve no foreseeable risks or harm to you or your family (potential risks). The procedures include: (1) responding to a questionnaire about the needs of family members of critically ill patients and (2) completing a demographic data sheet (explanation of procedures). Participation in this study will take approximately 20 minutes(time commitment). You are free to ask any questions about the study or about being a subject and you may call Mr. Mohammed at (999) (work) or (999) (home) if you have further questions (offer to answer questions). Your participation in this study is voluntary; you are under no obligation to participate (voluntary consent) You have the right to withdraw at any time and the care of your family member and your relationship with the health care team will not be affected (option to withdraw). The study data will be coded so they will not be linked to your name. your identity will not be revealed while the study is being conducted or when the study is reported or published. All study data will be collected by Mr. Mohammed, stored in a secure place, and not shared with any other person without your permission (assurance of anonymity and confidentiality). I have read this consent and voluntarily consent to participate in this study Subject’s Signature Date

Ethical evaluation of the research process 1.Problem statement: Consideration of religious & cultural beliefs. Literature review: 2. Literature review: Academic honesty ( plagiarism). Primary source Objectivity.

Ethical evaluation of the research process 3. Research design Coercion to obtain consent. Deception of subjects by Placebo. Concealed observation. Violation of confidentiality. Invasion of privacy. Exploit subjects. Risk & harm exposure.

4. Analysis, reporting & dissemination of results: Honesty. Confidentiality. Share findings Not disseminating the results. 5. Administrative & personnel: Misuse of funds or equipment. Ethical evaluation of the research process

Possible Research Risks Physical Harm. Confidentiality. (leaking information about a participant) Invasion on Privacy. (conducting part of a study in a public setting) Emotional/Psychological.

How to Reduce Risks Have an informed consent form Use code numbers instead of names to identify people Destroy raw data when study is over

Scientific Misconduct Basically, there are three major types of scientific misconduct fabrication; Inventing or making up data falsification; includes the selective omission/deletion/suppression of conflicting data without scientific or statistical justification. plagiarism; the theft of another's work

Vulnerable subjects Children under 13 yrs old Mentally or emotionally disabled people Mental retardation Mental illness Unconsciousness Physically disabled people Deaf subjects Physical impairment preventing them from writing Pregnant women Institutionalized people