Informed consent as an essential component in the ethics of biomedical research الموافقة المستبصرة كعنصر أساسى فى أخلاقيات البحث الحيوى الطبى د. عدنان ابراهيم الهندى PhD in Medical Parasitology الاربعاء 6/24/ اليوم الدراسى والذى تعقده شؤون البحث العلمى فى الجامعة الاسلامية بعنوان " اخلاقيات البحث العلمى “

6/24/2016 2

Outline - Definition -Criteria -Reasons for Informed consent The History and Importance of Informed Consent in Clinical Trials -Elements of Informed Consent -Informed Consent practice among postgraduate students (Biological Sciences Programme) Gaza Strip 6/24/2016 3

- Informed consent: Voluntary agreement given by a person or a patients' responsible (a parent) for participation in a study, immunization program, treatment regimen, invasive procedure, etc., after being informed of the purpose, methods, procedures, benefits, and risks. Informed consent is the process of communication between a patient and physician that results in the patient’s authorization or agreement to undergo a specific medical intervention [AMA 1998]. For both ethical and legal reasons, patients must be given enough information to be fully informed before deciding to undergo a major treatment, and this informed consent must be documented in writing. 4

Criteria The essential criteria of informed consent are that the subject has both knowledge and comprehension فهم, that consent is freely given without duress اكراه or under influence, and that the right of withdrawal at any time is clearly communicated to the patient. (Geneva: CIOMS/WHO 1991) and International Ethical Guidelines for Biomedical Research Involving Human Subjects (Geneva: CIOMS/WHO 1993). 6/24/2016 5

Reasons for Informed consent Informed consent is designed to protect individuals participating in clinical research trials. An individual interested in participating in a medical research trial will receive a document that contains information about the benefits and risk of the trial, the research procedures and the reasons for the research. 6/24/2016 6

- The participant should be able to review the document with doctors and ask questions about things they do not understand. -Official consent to participate in the trial is given when this document is signed, with the researcher and the participant retaining a copy. However, the process of informed consent should not end there. -The researchers are obligated to keep the participant updated and answer any questions the participant has. Informed consent does not obligate the participant to finish the trial. A participant has the right to leave the trial at any time during the study. 6/24/2016 7

The History and Importance of Informed Consent in Clinical Trials: - The twentieth century was a time of many scientific advances, especially in the field of medicine. - Doctors were able to use advancing technology to understand more about the human body and the many diseases that attack it. - During the twentieth century, a great many medicines and vaccines were developed that were able to almost entirely eradicate diseases such as small pox and polio. These advances required years of research and testing. 6/24/2016 8

During World War II, doctors in Nazi Germany were conducting horrifying research on prisoners in concentration camps. This research was done on involuntary participants who usually died as a result of the experiments. After the war, many of these doctors were tried at the Nuremberg trials for their crimes. The International community was shocked by the revelations كشف of their research. As a result of the trial, the Nuremberg Code was created in This international document was one of the earliest to address ethics in medical research. It stated that voluntary consent was mandatory for any clinical research. 9

- Voluntary consent meant that the participants were able to consent موافقة, were not being coerced اكراه to do the study and understood the risks and benefits involved. The Code was adopted by the United Nations in However, there were many unethical clinical research trials being done during World War II in America and Britain. President Franklin Roosevelt created an Office of Scientific Research and Development to combat diseases such as dysentery, influenza and malaria, diseases that commonly affect soldiers. One of the research teams created a potential vaccine for dysentery. - 6/24/

-To test it the researchers used orphans and mentally retarded individuals in institutions. The orphans developed dangerously high fevers, thus proving that the vaccine did not work. -Penicillin, the wonder drug of the century, was tested on prisoners to find the most effective dosage. 6/24/

Many medical advancements came from World War II, the US government sought to continue this trend by creating the National Institutes of Health, which provided funds for experimentation. These funds were given with no stipulations شروط about the rights of the experiments participants. In the period of time between the NIH funded 2,000 research projects, and none of them used informed consent. During this same period of time a drug called thalidomide was being developed. This drug was supposed to prevent miscarriages. The head of the Food and Drug Administration did not want to approve the drug for use because she was unsatisfied with test results. 6/24/

However, 200,000 American women were given the drug without knowing that it had no been approved. These women were essentially taking part in a drug trial without knowing it. They were not warned of the risks. The result was that many babies of women taking this drug were born with extreme birth defects عيوب خلقية شديدة. This caused a huge scandal. Congress passed an amendment تعديل to the Food, Drug and Cosmetic Act that required doctors to tell patients if they were taking a trial drug. 6/24/

One major event that caused this was an article written by Henry Beecher that appeared in the June 16, 1966 issue of the New England Journal of Medicine. This article exposed many clinical research trials that had been funded 22 examples of unethical research.. One of the examples was that mentally retarded children at a state school were infected with hepatitis virus. The researcher who carried out this experiment eventual became head of the pediatrics department at New York University. 6/24/

One of the major events that brought the issue of obtaining informed consent to the public was the revelation of the Tuskegee Syphilis Study. The study was conducted by the United States Public Health Service. The Tuskegee study began in 1932 and continued till 1972, when it was revealed to the public. The purpose of the study was to examine the long term affects of syphilis. The subjects of the study were 400 African American males, who were primarily poor sharecroppers. These men all had syphilis, but were unaware of it. They were also unaware of the true nature of the experiment. 6/24/

- The most horrifying aspect of the experiment was in the 1950 penicillin was proved to be effective at curing syphilis. The researchers did not treat the men syphilis and even prevented other doctors who saw the participants from treating the syphilis. As many as one hundred men may have died from complications from their untreated syphilis. The study was revealed in 1972 by a researcher who had worked on the project. His newspaper article shocked the country and caused the project to be shut down. In 1997 President Clinton formally apologized for the study. 6/24/

The many revelations of unethical medical research in the 1960s and 1970s led Congress to pass the National Research act which created. The commissions final report the National Commission for the Protection of Human Subjects in Biomedical and Behavioral research and recommendations is known as the Belmont report. The intent was to create a cohesive set of guidelines for conducting ethical research. The commission felt that medical advancement should not require a loss of human rights. The commission reaffirmed the role of the Institutional Review Boards that had been created in the 1960s. 6/24/

The Belmont Report also expanded the definition of informed consent, making sure that participants were kept informed throughout the experiment and more fully understand risks and benefits. It also stated that individuals with a lower capacity for making decisions, such as children, the elderly and the developmentally disabled needed to be protected. The US departments of Health and Human Services and the FDA revised their research rules based on this report. 6/24/

Obstacles of informed consent -Language is an issue in securing informed consent. -Literacy. -Autonomy: الاستقلالية الذاتية personal choice, decision- making. -Disclosure: When life-treatening condition such as cancer is diagnosed the custom in most parts of the world is to tell the relatives rather than the patient. 6/24/

The Informed Consent Process with Children - Children are persons who have not attained the legal age for consent to treatments or procedures involved in research. -When children are involved in a research activity it is necessary to obtain their assent and the permission of their parents.. Assent ا لمصادقة is defined as a child's affirmative agreement to participate in research. - This gives a child the opportunity to decide if they want to take part, and to decline if they are not interested. 6/24/

- The assent procedure should reflect a reasonable effort to enable the child to understand, to the degree they are capable, what their participation in research would involve. Parental Permission In addition to obtaining the assent of a child participant, it is necessary to have parental permission. This gives a parent or guardian the opportunity to learn about the study, ask questions, and agree or decline their child’s participation in the research study. 6/24/

- Elements of Informed Consent Valid informed consent incorporates five elements: 1. Voluntarism requires that the patient be free from “coercion اكراه and from unfair persuasions and inducements. 2. Capacity can be defined as the patient’s ability to make health care decisions. 3. Disclosure involves providing the patient with the information needed to understand a procedure]. This information includes the nature and purpose of the treatment, as well as its risks, potential benefits, and available alternatives. 6/24/

4. Understanding requires that the patient comprehend the information given and appreciate its relevance to her individual situation. 5. Decision refers to the patient’s authorization allowing a physician to execute the proposed treatment. Consent forms facilitate and document this authorization but should be seen as secondary to the process through which the patient and the physician discuss and negotiate the proposed treatment. 6/24/

Table 1. Different variables with informed consent 6/24/ %No.Variable Sex Males Females Type of the research Biological Medical Did the research included informed consent Yes No

6/24/ %No.Informed consent type 9.52 None Oral Written The participant in the research 9.52 None Child Adult 4.81 Both In case the participant is an adult who signed the form 194 None The patient itself 9.52 One of his relatives

6/24/ The patient was informed about the objectives of the research Yes 4.81 No 9.52 No answer Did the participant received full explanation about the research Yes No 9.52 No answer Who had take the sample from the patient The researcher The physician 9.52 No answer

Table 2. Sample size 6/24/

Table 3. The number of the refused cases in the research 6/24/

Recommendations - التاكيد على استعمال الموافقة المستنيرة فى البحوث الصحية، الطبية والبيولوجية. - أعطاء شرح شامل عن اهداف البحث وتفصيلاته للمريض واهله او اقاربه. - احترام راى الذين رفضوا الاشتراك فى الدراسة. - 6/24/

References Accessed Dein, S.; Bhui, K. (2005) Issues concerning informed consent for medical research among non- westernized ethnic minority patients in the UK J R Soc Med.96: Accessed http:// - Accessed Accessed /24/

اشكركم لحسن استماعكم 6/24/