CITI Exam Info Modules 1-3 Questions and Answers Rated A

CITI Exam Info Modules 1-3 Questions and Answers Rated A Research "A systematic investigation including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge." Intent matters. - Defined by federal regulations at 45 CFR 46.102 (Protection of Human Subjects 2009) Human subject a "living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information." Interventions (w/human subjects in research) Include physical procedures through which data are gathered, such as (1) measuring brain function to supplement paper and pencil inquiries into the development of language, and (2) behavioral interventions such as experimental education programs or unproven psychosocial therapies. They also include manipulation of the subject or the subject's environment performed for research purposes, for example, studies investigating the effect of music on memory. IDENTIFIABLE PRIVATE INFORMATION "Information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place" and "Information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a school record)" FERPA Family Education Rights and Privacy Act HIPAA Health Insurance Portability and Accountability Act CFR Code of Federal Regulations 45 CFR 46 The United States (U.S.) Department of Health and Human Services (HHS) regulations Subpart A of 45 CFR 46 Often referred to as the Common Rule The Common Rule Document that directs researchers to consider privacy and confidentiality when conducting research. The federal regulations for protecting research subjects. An "assurance" An assurance identifies the regulations for protecting research subjects that the institution will abide by and the ethical principles it will adopt. Every institution conducting research with federal support is required to enter into an agreement called an "assurance." IRB A review committee established to ensure that the rights and welfare of human research subjects are protected. Must have at least five members, diverse Expedited Review Expedited reviewers cannot disapprove a research plan. If an expediting reviewer thinks a research plan is not approvable, the plan must be submitted to the IRB for review. Continuing Review Continuing review must be conducted at intervals appropriate to the degree of risk, but not less than once per year... Federal regulations permit expedited review procedures to be used for continuing review if the initial review was expedited and no new risks were identified. It also may be used when the initial review was conducted by an IRB under some circumstances, such as (1) when during the initial review the IRB determined that the research involves no more than minimal risk and no additional risks have been identified, or (2) the remaining activities are limited to data analysis. The IRB or the expediting reviewer(s) must determine that all the requirements for initial review continue to be satisfied. (OHRP) Office for Human Research Protections Subparts B, C, and D Subpart B: Pregnant women, human fetuses, and neonates Subpart C: Prisoners Subpart D: Children