What information should be provided to an IRB for review at the initiation of a study? Choose the best response.

After the IRB reviews and approves your protocol, informed consent, and associated documents, you should receive:

To document that the research participant has voluntarily agreed to participate in the study, the research participant must:A. Pass a test of comprehension.B. Meet with the institution's Institutional Review Board (IRB).C. Sign and date the Informed Consent Form.D. All of the above.

Question 1A student is conducting a research project that involves the use of a survey. The survey asks subjects about their highest level of education, political affiliation, and views on various social issues. The student will not collect identifiable information. This study would be subject to which type of review? Determination for Exemption Not Human Subjects Convened Review Expedited ReviewQuestion 2Under the U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) regulations, what is the Institutional Review Board (IRB) charged with? Select all that apply.Select all correct answers. Reviewing subject recruitment materials and strategies. Assuring that researchers follow all applicable institutional policies and federal regulations related to research with human subjects. Reviewing manuscripts prior to submission for publication. Protecting the rights and welfare of human subjects. Conducting inquiries into scientific misconduct.Question 3A student plans on interviewing 15 principals in neighboring high schools. The student plans to collect data about the personal experiences the principals have had with disruptive students, including the types of disciplinary actions that were taken (including decisions they may have personally made) and their feelings or thoughts regarding whether those actions were appropriate. The research data collected could have an impact on the principals’ careers. The student will collect identifiers. This study would be subject to which type of review? Convened Review Determination for Exemption Expedited Review Not Human SubjectsQuestion 4In the U.S., the first federal regulations for human subjects research began in 1991 with the codification of the ________. Nuremberg Code Belmont Report Common Rule Declaration of HelsinkiQuestion 5Where could student researchers and/or student subjects find additional resources regarding the IRB approval process? Select all that apply.Select all correct answers. IRB Office Export Control Office Faculty Advisor/Research Mentor The Student Union

When is it necessary to obtain IRB approval for a user study?Group of answer choiceswhen conducting online or mail studieswhen using data from a publicly available source like a newspaper or magazinewhen the results are used only in a class but won't be publishedwhen the data obtained is about individuals who are not livingall of these require IRB approval

Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB: Is not required unless additional risks have been identified. Is limited to review of unanticipated problems. Must be conducted by a convened IRB. Must occur within 12 months of the approval date.