ASPEK ETIKA DAN HUKUM PENELITIAN Oleh Sofwan Dahlan

OVERVIEW In 1932, the study began. Patients were examined; those with syphilis were admitted. The PHS prevented other doctors from administering treatment. During world war II, some of the study participants were drafted and were found to have syphilis during their draft medical exams. The PHS asked the draft boards to exclude these men from treatment requirements. And the draft boards agreed to this request. In 1943, penicillin began to be use to treat syphilis. The patients in the Tuskegee study were excluded from this treatment.

In 1972, Peter Buxton, a PHS employee, told J In 1972, Peter Buxton, a PHS employee, told J. Heller, a reporter from the Associated Press, about the study. Publicity and the resulting public outcry brought the study to a halt. In 1973, congressional hearings about the study resulted in new regulations about medical experi-ments on human beings. Also in 1973, a class action lawsuit was brought against the researchers. This lawsuit was settled in 1974 with a 10 million dollars payment. As part of the settlement, all participants were given free lifetime medical care.

In 1997, President Clinton formally appologized to all of the study participants and their families. He said the study was “deeply, profoundly, moral- ly wrong”. The 11 remaining survivors of the study witnessed the appology at the White House.

HOROR STORY An unethical research was conducted on African-American men from 1932 to 1972 US and had a major impact on ethics in medical research. Researchers followed a total of 600 African-Ameri-can men. A control group of 201 men did not have syphilis and 399 men did have the desease. The study participants were told there being evaluated for “bad blood”. Even when penicillin was available in the 1940’, the afflicted men were not offered treatment for the sake of continuing the study. The study exemflifies racism, physician paternalism, abuse of the vulnerable.

NONCONSENSUAL RESEARH In 1932, a doctor at the Rockefeller Institute for Medical Investigations injected Puerto Rican citizens with cancer cells; at least 13 of patients died of the desease. In 1940, prisoners in Chicago were injected with the life malaria virus in order to evaluate new treatments for the desease. In September 1950, the US Army sprayed the serratia bacteria over San Frasisco. This was a test to see how vulnerable a city would be to a biological attack. Some people developed drug-resistant bacterial infections and one man died.

In New York City in 1966, the US Army spread the bacteria Bacillus subtilis variant niger through the subway system. Millions of American citizens were unknowingly exposed. In Los Angeles in 1990, thousands of Hispanic African-American babies were injected with an experimental measles vaccine that was not licensed for use at that time. Parents weren’t told it was experimental. In 2001, the Federal Office of Human Research Protection suspended John Hopkins’ research license after they discovered that the hospital failed to tell patients that the drug hexamethonium was experimental and toxic. Patient died after ......

MEDICAL RESEARCH Medical research has saved countless live in the past century. To advance medical treatments, rigorous and ethical clinical studies must conducted. How can we ensure that these studies provide the most good to the greatest number of patients? How can we protect clinical subjects while they are part of study?

ETHICAL CLINICAL STUDY Ethical clinical studies are important, not only to protect the patients participating in them, but to make sure that medicine and medical advances are trusted and respected. What happens when a trial ends early? How can we prevent problems with medical research in the future?

GUIDING PRINCIPLES Human dignity must be preserved and respected at all time. Risks to human being must be minimized with establish methods and design --- nonmaleficence. The benefits of the study must be maximiz-ed ----- beneficence. Selection of the research must be randomized ---- principle of justice. All participants must be fully informed about the research and they must freely consent to the study’s parameters ------ autonomy.

Privacy and confidentility of the participants must be protected ------ autonomy. Participant safety and health must be continuously monitored. If researchers find that the study’s risks outweigh the benefits at any point, the study must be discontinued and the results published. Any participants who may be especially vulnerable, such as children, pregnant women, prisoners, or the disabled, must be rigorously protected.

Freedom from discrimination. Freedom from torture and cruel. HUMAN RIGHTS (FUNDAMENTAL OF ETHICAL PRINCIPLES) The right to life. Freedom from discrimination. Freedom from torture and cruel. Freedom from inhuman or degrading treatment. Freedom of opinion and expression. The right to equal access to public services. The right to medical care.

PRECAUTIONARY PRINCIPLE There are two broad classes:  the Strong Precautionary Principle: Take no action unless you are certain that it will do no harm.  the Weak Precautionary Principle: Lack of full certainty is not justification for preventing an action that might be harmful. Both types are problematic, although the latter considerably less so than the former. (International Consumers for Civil Society)

CRITICISMS OF STRONG PP  Preventing (or attempting to prevent) some action that might lead to the death of a human beings may itself result in the death of all human beings.  Demanding that a technology should not be admitted untill it has been proved to be harmless is equivalent to requiring an infinitely high standard of proof --- which can never be achieved.  The notion that regulations should be based on the presumption that there is no safe dose for any chemical that exhibits harmful properties at some dose has been widely refuted.  Applied generally, the strong precautionary principle would end civilization. (International Consumers for Civil Society)

DEFINITION Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Clinical research involves the scientific investigation of the etiology, prevention, diagnosis or treatment of human disease using human subjects, human populations or materials of human origin. Included in the definition are studies that utilize tissues or pathogens only if they can be linked to a patient.

1. Patient-Oriented Research: This type of research involves a particular person or group of people or uses materials from humans. Studies of mechanisms of human disease. Studies of therapies or interventions for disease. Clinical trials. Studies to develop new technology related to disease.

Epidemiological & Behavioral Studies: These types of studies examine the distribution of disease, the factors that affect health, and how people make health-related decisions. Outcomes & Health Services Research: These studies seek to identify the most effective and most efficient interventions, treatments, and services.

CLINICAL TRIAL Clinical trials can help: prevent illnesses by testing a vaccine;  detect or diagnose illnesses by testing a scan or blood test;  treat illnesses by testing a new medicine;  find out how best to provide psychological support;   find out how people can control their symptoms or improve their quality of life by testing how a particular diet affects a condition.

BIOMEDICAL CLINICAL TRIALS Biomedical clinical trials of experimental drug, treatment, device or behavioral intervention may proceed through four phases: Phase I clinical trials test a new biomedical intervention in a small group of people (e.g., 20-80) for the first time to evaluate safety (to determine a safe dosage range and to identify side effects). Phase II clinical trials study the biomedical or behavioral intervention in a larger group of people (several hundred) to determine efficacy and to further evaluate its safety.

Phase III studies investigate the efficacy of the biomedical or behavioral intervention in large groups of human subjects (from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions as well as to monitor adverse effects, and to collect information that will allow the intervention to be used safely. Phase IV studies are conducted after the intervention has been marketed. These studies are designed to monitor effectiveness of the approved intervention in the general population and to collect information about any adverse effects associated with widespread use.

Before a clinical trial of a new medicine can begin, all of the following need to be in place: The science the research is based on must be reviewed by experts.  The researchers must secure funding. An organization, such as a hospital or research institute, must agree to provide a home base for the trial. Needs to review and approve the trial and issue a clinical trial authorisation. A recognised ethics committee must review the trial and allow it to proceed. 

TRIALS OF OTHER TREATMENTS Researchers and others are expected to work within a framework of ethical and scien-tific standards. This applies to all health and social research.  It includes: promoting good practice. reducing adverse incidents and ensuring lessons are learned. preventing poor performance and miscon-duct.

INTRODUCTION TO MEDICAL RESEARCH Medical research is a valuable tool that has deve-loped many effective drugs and treatments to treat disease and reduce suffering in the past 100 years. Some of the major benefit of research include: Vaccine for measles, polio, and HPV vaccine. Insulin treatments for diabetes. Medications for high blood pressure and high cholesterol. Heart interventions such as bypass surgery and defibrillation. Improved treatments for HIV and AIDS. Increasingly successful treatments for cancer.

FOR USING PATIENT as a research study: The will have advance medical technology. Physician may prolong patient’s lives. There is a great benefit to society. AGAINST USING PATIENT as a research study: The treatment may pose risks to the patient. Patients should not be use like tools. The patient – physician relationship may suffer.

HOW TRIALS ARE REGULATED Conditions include: Anyone taking part in a trial must have a full understanding of the objectives of the research and any risks and potential in-conveniences they may experience when taking part. This information will be given to them at a meeting with a member of the research team. A point of contact must be provided so that patients can obtain more information about the trial.

BASIC PRICIPLES (HELSINKI) Biomedical research subject must confirm to generally accepted scientific principles and should be based on adequated performed laboratory and animal experimen-tation and on a thorough knowledge of scientific literature. The design and performance of each experimental procedure involving human subjects should be clearly in an experimental protocol which should be transmitted to a specially independent commite for consideration, comment and guidance. Biomedical research involving human subjects should be conducted only by scientifically qualified persons and under the supervision of clinically competence medical person. The responsibilty for human subject must always rest with a medically qualified person and never rest on the subject of the research, even though the subject has given his or her consent.

Biomedical research involving human subjects cannot legimately be carried out unless the importance of the objective is proportion to the inherent risk to the subject. Every biomedical research project human subjects should be preceded by careful assessment of predectable risks in comparison with forseeble benefits to the subject or to others. Concern for the interests of the subject must always prevail over the interests of science and society. The right to the research subject to safeguard his or her integrity must always be respected. Every precaution shoulde be taken to respect the privacy of the subject and to minimize the impact of the study on the subject’s physical and mental integrity and on the personality of the subject.

Doctor should obtain from engaging in research projects involving human subject unless they are satisfied that the hazards involve are believed to be predictable. Doctors should cease any investigation if the hazard are found to outweight the potential benefits. In the publication of the results of his or her research, the doctor is obliged to preserved the accuracy of the results. Reports of experimentation not in accordance with the principles laid down in this declaration should not be accepted for publication. In any research on human beings, each potential subject must be adequately inform of the aims, methods, anticipated benefits and potential hazards of the study and the discomfort it may entail. He or she should be informed that he or she is at liberty to abstain for participation in the study and that he or she is free to withdraw his or her consent to participation at any time.

When obtained informed consent for the research project the doctor should be particulary cautions if the subject is in a dependent relationship to him or her or may may consent under durres. In that case the informed consent should be obtained by a doctor who is not enganged investigation and who is completely independent of this official relationship. In case of legal incompetence, informed consent should be obtained from the legal guardian in accordance with national legislation. Where physical or mental incapacity make it impossible to obtain informed consent or when the subject is aminor, permission from the responsible relative replaces that of the subject in accordance with national legislation. The research protocol should always contain a statement of the ethical consideration involved and should indicate that the principles inunsiated in the present declaration are coplied with.

THERAPEUTIC BIOMEDICAL RESEARCH In treatment of the sick person, the doctor must be free to use a new diagnostic and therapeutic measure, if in his or her judgment is offers hope of saving life, restablishing or aleviating suffering. The potential benefits, hazards, and discomfort of a new methods should be weighed against the advantages of the best current diagnostic and therapeutic methods. In any medical study, every patient - including those of control group, if any - should be assured of the best proven diagnostic and therapeutic method. The refusal of the patient .............................

4. The refusal of the patient to participate in a study must never interfere with the doctor patient relationship. The doctor considers is essential not to obtain informed consent, the specific reasons for this proposal should be stated in the experimental protocol for transmission to the independent committee (1, 2). The doctor can combine medical research with professional care, the objective being the aquisi-tion of new medical knowledge, only to the extent that medical research is justified by its potential diagnostic or therapeutic value for the patient.

NON-THERAPEUTIC BIOMEDICAL RESEARCH In the purely scientific application of medical research carried out on a human being, it is the duty of the doctor to remain the protector of the life and health of that person on whom biomedical research is being carried out. The subject should be voluteer – either healthy persons or patients for whom the experimental design is notrelated to the patient’s illness. The investigator or the investigating team should discontinue the research if in his / her or their judgment it may, if continued, be harmful to the individual.

4. In research on man, the interest of science and society should never take precedence over consideration related to the well being of the subject.

NURENBERG CODE The voluntary consent of the human subject is absolutely essential. The experiment should be such as to yield fruitful result for the good of society, unprocurable by other means or methods of study and not random and unnecessary in natur. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the desease or other problem under study that the anticipated re-sult will justify the performance of the experiment. The experiment should be so conducted as to avoid or unnecessary physical and mental suffering and injury.

No experiment should be conducted where there is an a priory reason to believe that death or disabling injury will occure; except, perhaps, in those experiments where the experimental physicians also serve as subjects. Th degree of risk to be taken should never ex-ceed that determined by the humanitarian importance of the problem to be solved by the experiment. Proper preparations should be made and adequate facilities provided to protect the experi-mental subject againts even remove possibilities of injury.

The experiment should be conducted only by scientically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage the experiment. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of experiment seem to him to be impossible.

10. During course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the excercise of the good faith, superior skill, and careful judgement requir-ed of him that a continuation of the experimental is likely to result in injury, disability or death to the experimental subject. .

NURENBERG CODE IS SUMMERIZED IN FIVE POINTS Medical research on human subjects requires the voluntary consent of study subjects. Consent must be obtained freely through the subject’s own volition, not through coercion, deception, or intimidation. It must be obtained after the patient has sufficient knowledge of the objectives, methods, and foreseeable risks of the research. Studies are justifiable only when experiment on animals have been performed.

Benefits of the study findings outweigh the fore-seeable risks in in terms of their contribution to society. Subjects can suspend treatment at the own will at any time during the study.

ANIMAL RESEARCH Through animal research, medicine has developed: Immunizations for polio, diphteria, mumps, and hepatitis. Biomedical advances in cancer research, including bone marrow transplants. Pacemakers. Artifical joints. Development of insulin and antibiotics. Organ transplants. Treatment for glaucoma.

PROTOCOL Trials follow a set of rules, known as a protocol, to ensure that they are as safe as possible, that they measure the right things in the right way and that the results are meaningful. A full protocol should be available to anyone who is considering taking part in a trial and wants to see it.

PENELITIAN KESEHATAN Penelitian dan pengembangan kesehatan merupakan salah satu sumber daya kesehat-an yang sangat besar arti dan manfaatnya untuk mendukung pembangunan kesehatan; Untuk kepentingan pembangunan kesehatan guna meningkatkan kemampuan nasional, maka penelitian dan pengembangan kesehat-an dan penerapannya perlu ditata dan dimantapkan pengelolaannya;

DEFINISI YURIDIS Penelitian dan pengembangan kesehatan adalah kegiatan ilmiah yang dilakukan menurut metode sistematik utk menemukan informasi ilmiah dan/atau teknologi yang baru, membuktikan kebenaran atau ketidakbenaran hipotesis sehingga dapat dirumuskan teori atau suatu proses gejala alam dan/atau sosial di bidang kesehatan, dan dilanjutkan dengan menguji penerapannya untuk tujuan praktis di bidang kesehatan.

KEWAJIBAN PENYELENGGARA Penyelenggara penelitian & pengembangan kesehatan berkewajiban menjaga kerahasiaan identitas dan data kesehatan pribadi atau keluarga atau masyarakat yang bersangkutan. Manusia, keluarga, atau masyarakat ybs berhak setiap waktu mengakhiri/menghentikan keterlibatannya dalam penelitian dan pengembangan kesehatan.

HAK SUBJEK PENELITIAN Manusia, keluarga, dan masyarakat ybs berhak mendapat informasi lebih dahulu dari penyelenggara penelitian mengenai: tujuan penelitian dan pengembangan kesehatan serta penggunaan hasilnya; jaminan kerahasiaan tentang identitas dan data pribadi; c. metode yang digunakan; d. risiko yang mungkin timbul; e. hal lain yang perlu diketahui oleh ybs.

INFORMED CONSENT Penelitian kesehatan terhadap manusia hanya dpt dilakukan atas written consent ybs. Persetujuan tertulis dapat pula dilakukan oleh orang tua atau ahli warisnya bila orang itu: a. tidak mampu melakukan tindakan hukum; b. keadaan kesehatannya tdk memungkinkan; c. telah meninggal dunia; Persetujuan tertulis diberikan kepala keluarga yang bersangkutan dan terhadap masyarakat dalam wilayah tertentu oleh Bupati / Walikota.

Penelitian kesehatan terhadap: anak hanya dapat dilakukan dalam rangka peningkatan derajat kesehatan anak-anak; wanita hamil atau menyusui hanya dapat dilakukan dalam rangka pembenaran masalah kehamilan, persalinan, atau peningkatan derajat kesehatannya; penderita penyakit jiwa / lemah ingatan hanya dapat dilakukan dalam rangka mengetahui sebab terjadinya penyakit jiwa atau lemah ingatan, pengobatan atau reha- bilitasi sosialnya.

PENGIRIMAN SPESIMEN Penyelenggara penelitian dapat: mengirim spesimen ke lembaga penelitian di luar negeri utk penelitian lebih mendalam sepanjang hal tersebut tidak mampu dilaksanakan di dalam negeri; memasukkan spesimen dari luar negeri untuk keperluan penelitian kesehatan. Syarat dan tata cara pengiriman spesimen ke atau dari luar negeri ditetapkan oleh Menteri.

Pasal 14 (1) Manusia, keluarga, atau masyarakat berhak atas ganti rugi apabila pelaksanaan penelitian dan pengembangan kesehatan terhadapnya mengakibatkan terganggunya kesehatan, cacat atau kematian yang terjadi karena kesalahan atau kelalaian penyelenggara penelitian dan pengembangan kesehatan. (2) Tuntutan ganti rugi sebagaimana dimaksud dalam ayat (1) dilaksanakan sesuai dengan peraturan perundang-undangan yang ber- laku.

Pasal 15 (1) Penerapan hasil penelitian dan pengembangan kesehatan pada tubuh manusia hanya dapat dilakukan setelah sebelumnya diterapkan pada hewan percobaan. (2) Pelaksanaan penerapan hasil sebagaimana dimaksud dalam ayat (1) hanya dilaksanakan apabila dapat dipertanggungjawabkan dari segi kesehatan dan keselamatan jiwa manusia. Ketentuan lebih lanjut mengenai tahapan dan tata cara penerapan hasil penelitian dan pengembang-an kesehatan sebagaimana dimaksud dalam Pasal 6 ayat (1) ditetapkan oleh Menteri setelah mendapat pertimbangan dari Ketua Lembaga Ilmu Pengetahuan Indonesia. .

Pasal 19 Barang siapa dengan sengaja melakukan penelitian dan pengembangan kesehatan dan penerapannya terhadap manusia, keluarga, atau masyarakat tanpa memperhatikan norma yang berlaku dalam masyarakat serta kesehatan dan keselamatan yg bersangkutan sebagaimana dimaksud dalam Pasal 5 ayat (2) dan Pasal 9, dipidana berdasarkan keten-tuan Pasal 81 ayat (2) Undangundang Nomor 23 Tahun 1992 tentang kesehatan.

Terima Kasih Sampai Jumpa