ACRP CCRC Exam with Questions and Answers

ACRP CCRC Exam with Questions and Answers The _________ has developed the Declaration of Helsinki (DoH): ANSWER World Medical Association; as a statement of ethical principles to provide guidance to physicians and other participats in medical research involving human subjects. (DoH) It is the duty of ________________ in medical research to protect the life, health, privacy and dignity of the human subject. ANSWER the physician (DoH) In medical research, societal/scientific interest should always be prioritized after: ANSWER prioritization of the subject's health and well being (DoH) The primary purpose of medical research involving human subjects is to: 2 part answer... ANSWER 1) improve prophylactic, diagnostic and therapeutic procedures 2) improve the understanding of the aetiology and pathogenesis of disease (DoH) The _________________________________ must be independent of the investigator, the sponsor or any other kind of undue influence. ANSWER Institutional Review Board/Committee (DoH) The physician should cease any investigation if: ANSWER the risks are found to outweigh the potential benefits. (DoH) What is obtained in the place of 'consent' when the subject is deemed legally incompetent (such as a child)? ANSWER 1) obtain the subject's assent 2) obtain the subject's legally authorized representative's consent