INFORMED CONSENT IN BIOMEDICAL RESEARCH INVOLVING HUMAN PARTICIPANTS

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 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.

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 Bioethics. 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.

- 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

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

Belmont Report º Expanded the definition of Informed º Participants-kept experiment, informed º Understand risks and benefits. º Protection of vulnerable group. consent. throughout the