Presentation on theme: "INFORMED CONSENT IN BIO-MEDICAL RESEARCH INVOLVING HUMAN PARTICIPANTS Selina khatun MPH, Mphil Lecturer(Anatomy Department) MMC."— Presentation transcript:
INFORMED CONSENT IN BIO-MEDICAL RESEARCH INVOLVING HUMAN PARTICIPANTS Selina khatun MPH, Mphil Lecturer(Anatomy Department) MMC
INFORMED CONSENT Concept and Importance Historical Background Obtaining Informed Consent: Elements for Informed Consent Essential Information for prospective participants. Procedure Exceptions Informed Consent Form
CONCEPT OF INFORMED COSENT ˚ Medical advances should not require some people to sacrifice their health and rights for the good of all. ˚ Informed consent is a process which is designed to empower the individual to make a voluntary informed decision regarding participation in the research. ˚ Voluntary consent means that the participants were able to consent, were not being coerced to do the study and understood the risks and benefit involved.
Informed Consent ˚ Informed consent is a key instrument in protecting the right. ˚ Procurement of consent ensures human dignity of the participants and also shows respect for them. ˚ Informed consent is one of the primary ethical principles governing human subject research. ˚ Informed consent assures that prospective research subjects will understand the nature of the research and can knowledgeably and voluntarily decide whether or not to participate
Informed Consent ˚ The fundamental ethical duty of respect for persons requires that we do not act against a person’s wishes, and thus genuine consent to participate in research must be obtained.
Informed Consent ˚ Why get informed consent? -Respect for person; Autonomy - Justice
Informed Consent ˚ Importance of Informed Consent. -Informed Consent is the first and longest of the 10 principles in the Nuremberg code. -Informed Consent is included in every guidelines on Research Ethics. -Informed Consent is one of the 8 requirements for clinical research.
Informed Consent ˚ Informed Consent allows individuals: -To determine whether participating in research fits with their values and interests. -To decide whether to contribute to this specific research project. -To protect themselves from risks. -To decide whether they can fulfill the requirements necessary for the research.
HISTORICAL BACKGROUND OF INFORMED CONSENT Early References Prussian Minister of Interior, tuberculin for the treatment of tuberculosis must not be used against a person’s will Dr. Albert Neisser was fined by the Royal disciplinary court of Prussia for not seeking patient’s consent for his experimental studies of vaccination for Syphilis Sir Willium Osler endorsed the necessity of informed consent in medical research.
1931- Health Department regulations of German Reich stated that both human experimentation and the use of novel treatment required consent in a clear and undebatable manner.
World war-II and unethical clinical trials done by US Health Services gave birth of Bio- ethics. Creation of IRB and notion of Informed Consent.
-During World War –II -In Nazis Concentration camp and in America and Britain -President F. Roosevelt-Office of Scientific research to combat Dyscentry, Influenza, Malaria -Use orphan, mentally retarded, psychotic patients -Penicillin to prisoners to settle the dose. -Attitude was different -NIH- funds for experimentation, No right for participants.
NIH funded 2000 research projects, none of them use informed consent -Thalidomide- Birth defects -Amendment to FD and cosmetic acts. -June 16 th,1966. Henry Beecher- NEJM, describe 22 examples done on vulnerable group. -IRB(1960)+ FDA -Tuskegee Syphilis study :President Clinton apologized
-( ) -National Research Act -National Commission for protection of research participants in Biomedical and Behavioral Research ,Belmont Report
Belmont Report º Expanded the definition of Informed consent. º Participants-kept informed throughout the experiment, º Understand risks and benefits. º Protection of vulnerable group.