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INFORMED CONSENT IN BIO-MEDICAL RESEARCH INVOLVING HUMAN PARTICIPANTS Selina khatun MPH, Mphil Lecturer(Anatomy Departme

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

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INFORMED CONSENT IN BIO-MEDICAL RESEARCH INVOLVING HUMAN PARTICIPANTS Selina khatun MPH, Mphil Lecturer(Anatomy Departme

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  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 16th,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.

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