1. INFORMED CONSENT IN BIO-MEDICAL RESEARCH INVOLVING HUMAN PARTICIPANTS Selina khatun MPH, Mphil Lecturer(Anatomy Department) MMC

2. INFORMED CONSENT  Concept and Importance  Historical Background  Obtaining Informed Consent: Elements for Informed Consent Essential Information for prospective participants.  Procedure  Exceptions  Informed Consent Form

3. 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.

4. 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

5. 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.

6. Informed Consent ˚ Why get informed consent? -Respect for person; Autonomy - Justice

7. 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.

8. 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.

9. HISTORICAL BACKGROUND OF INFORMED CONSENT Early References 1891- Prussian Minister of Interior, tuberculin for the treatment of tuberculosis must not be used against a person’s will. 1898- 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. 1907- Sir Willium Osler endorsed the necessity of informed consent in medical research.

10. 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.

11. 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.

12. -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.

13. -1945-1966 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 1932-1972 -1997:President Clinton apologized

14. -(1960-1970) -National Research Act -National Commission for protection of research participants in Biomedical and Behavioral Research. -1979,Belmont Report

15. 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.