Ohrp - Study guides, Class notes & Summaries

What procedures must be described in an agreement called an "assurance of compliance" with OHRP? - ANSWER-procedures in place that ensure that subjects will be protected in a manner commensurate with the Common Rule, including review by an independent committee comparable to an IRB. A professor at Big State University proposes to study attitudes about obesity in Chile by giving subjects in Chile surveys to complete. Which is a question that the Big State University IRB should ask the resear...

1. Which of the following are the three principles discussed in the Belmont Report? - Respect for Persons, Beneficence, Justice 2. The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that: - Persons with diminished autonomy are entitled to protection. 3. Which of the following is an example of how the principle of beneficence can be applied to a study employing huma...

1. Which of the following are the three principles discussed in the Belmont Report? - Answer-Respect for Persons, Beneficence, Justice 2. The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that: - Answer-Persons with diminished autonomy are entitled to protection. 3. Which of the following is an example of how the principle of beneficence can be applied to a study ...

What procedures must be described in an agreement called an "assurance of compliance" with OHRP? - Procedures in place that ensure that subjects will be protected in a manner commensurate with the Common Rule, including review by an independent committee comparable to an IRB. A researcher proposes to conduct a study at a foreign site that has been determined to be exempt from the federal regulations by institutional policy. According to federal regulations, is review required at the fore...

Informed Consent -Answer A statement that the study involves research. Explanation of purpose of research. Expected duration of subject's participation. Procedures to be followed. Identification of experimental procedures. Reasonably foreseeable risks or discomforts. Benefits to subject or to others expected. Statement describing confidentiality of records identifying the subject. Disclosure of alternative procedures and treatment. Explanation of Compensation for Injury. Who to contact with...

A sponsor who determines and unanticipated AE presents unreasonable risk, termination shall occur within _____ working days and not later than ___ working days after sponsor first received notice of effect Correct Answer 5, 15 IRB determinations for emergency situations are to be retained by IRB for at least ___ years after completion of clinical investigation Correct Answer 3 Al IRB records need to be kept for ____ years follow completion of research Correct Answer 3 FDA will provide w...

What procedures must be described in an agreement called an "assurance of compliance" with OHRP? - Answer-Procedures in place that ensure that subjects will be protected in a manner commensurate with the Common Rule, including review by an independent committee comparable to an IRB. A researcher proposes to conduct a study at a foreign site that has been determined to be exempt from the federal regulations by institutional policy. According to federal regulations, is review required at the...

CITI –Social & Behavioral Research, Exam Review Questions and answers, rated A+ What procedures must be described in an agreement called an "assurance of compliance" with OHRP? - -Procedures in place that ensure that subjects will be protected in a manner commensurate with the Common Rule, including review by an independent committee comparable to an IRB. A researcher proposes to conduct a study at a foreign site that has been determined to be exempt from the federal regulations b...

CIP Exam Practice Questions With Verified Answers Minimal Risk - ANS The probability of harm or discomfort...not greater...than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations. The Belmont Principles - ANS Respect for persons, beneficence, and justice IRB - ANS An administrative body composed of scientists and nonscientists established to protect the rights and welfare of human research subjects recruited to part...

What procedures must be described in an agreement called an "assurance of compliance" with OHRP? - ANSWER Procedures in place that ensure that subjects will be protected in a manner commensurate with the Common Rule, including review by an independent committee comparable to an IRB. A researcher proposes to conduct a study at a foreign site that has been determined to be exempt from the federal regulations by institutional policy. According to federal regulations, is review required at the ...