ETHICS OF HEALTH RESEARCH By; Dr. Heba Shehto

ETHICS OF HEALTH RESEARCH By; Dr. Heba Shehto. undergraduate i I J —midiiine> ata• -—:æpärticipants material.

Objectives Understand modern research ethics: terminology and historical background Describe the principles and processes of informed consent for research Understand patient safety in research and benefit vs. risk considerations Understand the importance of privacy and confidentiality in research and methods of their assurance Describe the rights and obligations of the investigator, the sponsor, and the patient Appreciate the delicate balance between clinical care and clinical research Describe the contents of the research protocol and related documents Understand issues of research governance: Institutional Review Board/Research Ethics Committee (IRB/REC), Nuremberg, Helsinki, good clinical practice (GCP), and Saudi research regulations Describe the ethics of research publication and how to prevent violations 10. Describe the types, and the prevention, of conflict of interest in research and publication..

Terminology and definitions.

A clinical trial: is an investigation of the pharmacological properties, adverse effects, safety, and efficacy of a product. An investigational product: is a pharmaceutical form of an active ingredient being tested in a clinical trial. An Institutional Review Board (IRB) is an independent body responsible for review, approval, and monitoring of ongoing research projects, in order to protect patient safety and rights, and assure the public of human subject protection . An investigator: is a qualified person who is responsible for conducting research..

A sponsor: is the company (usually pharmaceutical) that will fund the study. Review : is a strict and systematic process of assessing a research project regarding its scientific advantage, its validity, the reliability of the research methodology, qualification of the investigators, research subject rights and safety, and other ethical considerations. A reviewer: is a person with specialist knowledge in a field of medicine, health care, and research methodology asked to review a research project and recommend to IRB its approval, modification, or rejection..

Exempt review مستثنى من المراجعة : is for research that has no interventions and carries no risk to humans . Expedited review مراجعة سريعة : is for research that has minimal risk for humans. Full review: is for research that involves human intervention and carries potential risk . It has to be reviewed and approved by the full IRB . Informed consent form (ICF): refers to background information and signature forms used to obtain informed consent. An Investigator Brochure (IB): contains scientific information about the investigational product. An adverse event: is an untoward symptom or sign after use of the investigational product. It may be described as adverse or as serious..

WHY ARE RESEARCH ETHICS IMPORTANT.

WHY ARE RESEARCH ETHICS IMPORTANT. Modern medical practice is evidence-based . Evidence is derived from research . A practitioner who engages in research tends to practice better medicine , not only because of the new evidence that is available to him/her, but because of the intellectual stimulation التحفيز الفكري provided by research activities. Even clinicians who are not engaged in research cannot escape being affected because there are usually many active research protocols in their hospital . Reading and understanding medical textbooks and research papers requires knowledge and understanding of research terminology and techniques. It is impossible to escape research ethics, and every practitioner is expected to know at least some of the fundamentals ..

ETHICAL , LEGAL AND POLICY ISSUES.

Background: terminology and history: Modern research ethics owes its origins to horrifying violations committed by the Germans and the Japanese in the Second World War (1939-1945), when they carried out cruel experiments on prisoners of war and other victims without consent. The Nazi doctors involved in the cruel experiments were tried at Nuremberg in Germany, and at the conclusion of the trials the Nuremberg declaration set out 10 principles to be followed in human research. These principles were updated in the Helsinki declaration of 1964 and its subsequent amendments. In the US, the Belmont Report of 1979 restated similar principles. In 1996, the International Conference on Harmonization published Good Clinical Practice (GCP) guidelines that are followed by clinical researchers worldwide..

Patient's Wald No. 2 Auschwitz. A Prisoner Subject.

High altitude experiments were performed to test how long pilots would survive after being ejected from their planes. Prisoners were put into low-pressure tanks with little oxygen. Many of those who did not die immediately were put under water until they died. Autopsies followed..

he Nuremberg Trial (1946) • The individuals who conducted Nazi experiments during VW•J- II were tried separately from other war criminals because of their professional status as physicians and the horrendous (404) and unique nature of their crimes. •They were found guilty of murder, torture and other atrocities..

The Declaration Of Helsinki The well-being of the subject should take precedence OVER the interests of science and societv. Physician should obtain the subject's freely given informed consent in writing Ethical review committee approval 0 is a must..

The Belmont Report Belmont: village within the Town of Amity which is in Allegany County, New York, USA. In 1974, the National Commission for the Protection of Human Subiects of Biomedical and Behavioural Research was established. In 1978, it submitted The Belmont Report that sets the fundamental ethical principles : 1. Respect for persons 2. Beneficence 3. Justice.

The GCP guidelines are based on the Helsinki declaration and have two main objectives: Protect the subject/patient. Ensure credible and accurate data. Patient protection is assured by informed consent, as well as independent review and approval of the research protocol ..

What does GCP Cover? e Design e Conduct e Performance e Monitoring Auditing e Analysis.

Informed consent for research Following full disclosure of the study details to enable the subject to make an informed decision, he or she must voluntarily and freely agree to participate in the study. The information given to the subject: Must be in writing. Must have been approved by the IRB/REC. The subject must be given time to ask questions . The consent form must be signed by the subject, dated , and witnessed . The subject must be given a copy of the consent form..

The following information must be included in the consent information: Purpose of the trial, that the treatments/procedures are for research, Procedures involved, Expected benefits , Expected risks /inconveniences, Alternative treatments and procedures, Compensation for trial injury, freedom of the subject to withdraw from the study without having to give reasons, Confidentiality , subject's permission for direct access to his/her records, A person to contact in case of injury or questions, duration of the study, and number of subjects involved..

Informed consent….. cont … Special precautions have to be taken to make sure that interests of vulnerable subjects are protected because they may not be able to exercise their full autonomy due to certain constraints. Vulnerable subjects include Minors Mental patients Incapacitated persons for whom consent is by their legal representative. Students Junior employees are also vulnerable because they may consent to research under duress. In exceptional circumstances , research can be carried out without consent ( IRB/RECs examine the situation very carefully before approving research without consent). In the emergency room , and the research is necessary for improving service delivery. In some types of psychological research, seeking consent may bias the respondent..

Patient safety: Benefit vs. risk considerations.

Patient safety: Benefit vs. risk considerations Approval of a study depends benefits and risks . Subjects participating in the study may benefit from the new treatment. Some subjects in the control arm may receive no benefits ; in these cases, we have to consider the study's benefit to the community . The benefits of the study, whether individual or communal, have to be considered against the risk that the study subject faces . All studies plan to minimize this risk. It is, however, not possible to envisage (Imagine) all risks in advance, so we need systems of ensuring patient safety. Patient safety is ensured by monitoring and reporting adverse events ..

Patient safety: Benefit vs. risk considerations ….CONT. Potential adverse events are defined in the protocol and are reported on the CRF ( Case Report Form). An adverse drug reaction: is any bad and unintended response to the investigational product. Serious adverse events have to be reported to IRB/REC and the sponsor. Death and life-threatening conditions are reported within 7 days . Others have to be reported within 15 days. IRB/REC will investigate the report, and may make decisions on suspending or stopping the study. The consideration of benefit vs. risk is undertaken by IRBs/RECs but it seems that this is not done in a systematic way. It may be necessary to use techniques used in other disciplines, such as decision-making sciences ..

Privacy and confidentiality: The study subject has rights to privacy and confidentiality. Study data should not be disclosed to any third parties. Even within the study team , data should be disclosed on a need-to-know basis. To protect confidentiality , study documents should be locked up or should be saved on password- protected computers. The sponsor has no right to access patient notes ..

Rights and obligations: Investigator, sponsor, and patient The investigator Must be qualified to undertake the study by education, training, and experience. Main responsibilities are commanding adequate human and other resources for the study, Providing medical care for the study subjects, Dealing with the IRB/REC, Making sure that all study procedures conform تتفق to the protocol , Assuring that all study subjects gave free and voluntary informed consent, Keeping all the study records , Accounting for the investigational product, Providing progress and final reports ..

The main responsibilities of the sponsor: Provide the investigational product , Funding of the study, and Follow-up and monitoring. The patient has the responsibility to: Comply with study procedures Report any adverse events promptly..

The balance between clinical care and clinical research The clinician investigator faces the dilemma of prioritizing between research and patient care, which is a difficult task . Why ? Investigator may violate the doctor's duty to treat in pursuit السعي وراء of science. Lack of good research may lead to poor clinical care. This dilemma may manifest as the conflict between the role of the doctor (to ensure the best interests of the patient) and the role of the researcher (to produce knowledge that may not immediately benefit the patient). The primary role of the doctor is to treat the patient. Research is a secondary role, and should never be allowed to interfere with patient care and patient safety..

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The main document in research is the protocol . It must be a comprehensive شامل and detailed guide to conducting the research. It must contain the research background (based on a literature review); general and specific objectives of the research; eligibility criteria; outcome measures; sampling and randomization details, including whether the sample size is adequate to detect a difference with sufficient power; and the intervention proposed. The case report form (CRF) is an important study document. It must be constructed in such a way that it captures data correctly. Special precautions are needed to ensure the security of electronic CRFs. The case report form (CRF) is a paper or electronic questionnaire specifically used in clinical trial research.

Review governance الحكم.

Review governance : IRB/REC , GCP , Saudi research regulations IRB/REC : is an independent مستقل body, whose main function is to protect the safety, welfare, and rights of the patient. Their responsibilities It reviews and approves the research protocol and all trial documents, Making sure that the investigators are qualified The risk-benefit ratio is favorable . It also has to monitor the way that the study is conducted, to make sure that it adheres to the protocol ..

Research Ethics Committee (REC) Institutional Review Board (IRB).

Their members Its members must be drawn from a range of disciplines, and there must be some members who are non-scientists and some not affiliated to the institution ليس تابع . The members must not have any relation to the investigator or the sponsor ; any members with a potential conflict of interest in a particular study must withdraw from the meeting. The IRB/REC must also review financial arrangements to make sure there are no unethical payments and conflicts of interests. IRB/REC also monitors and investigates safety reports and reports of adverse events . It can suspend or stop a study if it feels that patient safety is compromised ..

A regulatory body is usually a governmental entity that carries out inspections to make sure that the study follows the guidelines . In Saudi Arabia, the Monitoring/Compliance Office of the National Bioethics Commission undertakes this function . IRB/REC and regulatory bodies follow specific ethical and legal guidelines and regulations in their work. The regulations in Saudi Arabia were published in the Umm al Qura Gazette as Research Ethics Regulations No 4402 of 1420, Research ethics by laws No 4403 of 1433. The Helsinki Declaration and its amendments , and the ICH-GCP regulations are also followed..

The main principles of ICH –GCP ( The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use & ( good clinical practice) focus on : Patient protection; a favorable risk benefit ratio, Safety and welfare of the patient are placed before scientific interests. The study must be carried out according to a protocol approved by an ethical committee, Researchers must be qualified, Informed consent must be obtained, Patient safety must be assured, Patient confidentiality must be obtained, there must be Compensation for study related injury, Products used must conform to Good Manufacturing Principles (GMP), Systems must exist to ensure quality..

Ethics of research publication Several ethical violations can occur regarding publication of research results. Researchers tend to submit positive findings for publication and suppress negative ones. In a few cases, these decisions may involve a conflict of interest when the researcher succumbs يستسلم to pressure from the sponsor. Other problems involve authorship and plagiarism , but these are common to all other types of scientific publication..

Conflict of Interest (COI) issues: تضارب المصالح DEF. COI situations occur when the sponsor of the study influences reported outcomes to make them favorable to the new investigational product. The investigator, consciously or unconsciously, may produce results favorable to the sponsor, and receive financial or other rewards for this. In some cases, the investigator may not seek material rewards, but may want promotion and recognition ..

Conflict of Interest (COI) issues …CONT. COI issues also arise in the peer review ( evaluation of scientific, academic, or professional work by others working in the same field) process, when research reports are submitted for publication. Many institutions have developed detailed COI guidelines, which are constantly updated as new loopholes ثغرات are found. The best protection against COI is full disclosure of such interests at all levels of the research process: IRB/REC must disclose their interests, and authors must disclose their interests when they submit work for publication. Knowledge of research ethics guidelines will help the clinician investigator undertake ethical research..

What About Ethics of Aninval Experirnentation (Research)?.

THANKYOU ACT ETHICALLY AND CARRY ON.