Board Authority and Composition Purpose The purpose is to describe the authority, composition and administration of the Institutional Review Board (IRB). Definitions A nonscientist is an IRB member whose training, background, and occupation would incline him/her to ...
General Data Protection Regulation Purpose The purpose is to outline the policy and procedures for compliance with the European Union (EU) and Economic Area鈥檚 (EEU) General Data Protection Regulation, which became effective May 25, 2018. Policy | Special Categories | Consent | Inadvertent Activation | Penalties | Data Breach Reporting | Procedures Definitions Anonymized Data is data in which there are no identifiable persons, i.e., all personal identifies have been removed. Controller is a ...
Informed Consent and Assent Purpose The purpose is to outline the policies and procedures for the informed consent and child assent of human subjects (participants) in research. General Requirements | Basic Elements | Additional Elements | Waiver or Alteration | Documentation | Waiver of Documentation Parent/Guardian Permission and Child Assent | Posting of Clinical Trial Consent Form to Federal Website | Screening/Determining Eligibility Definitions Assent is an agreement to participate in...
Reproductive Risk in Clinical Research Purpose The purpose is to describe the policies and procedure related to reproductive risk in clinical research. Policies No reference to contraception may be used in the informed consent form or any other materials shared with human subjects participating in research. If reproductive risks have been identified in a proposed study, the following language is required in the informed consent form: Avoidance of Pregnancy: The medicines and procedures used...
Deception or Incomplete Disclosure Purpose The purpose is to outline the policy and procedures for deception or incomplete disclosure used in human research. Definitions Deception is an intentional misleading of others through misrepresentation or falsehood. In research, it may happen when an investigator provides subjects (participants) with false information in order to obtain unbiased results in social or behavioral research. Some examples are: 鈼 The investigator provides the subjects ...
Mandatory Reporting Purpose The purpose is to outline the policies and procedures for mandatory reporting to the Institutional Review Board (IRB) or Exempt Review Committee (ERC) concerning human research. Definitions An adverse event (AE) is any untoward or unfavorable occurrence in a human subject, including any abnormal sign (e.g., abnormal physical exam or lab finding), symptom, or disease, temporally associated with the subject鈥檚 participation in the research, whether or not considered ...
INSTITUTIONAL REVIEW BOARD POLICY Application Process and Deadlines Purpose The purpose is to outline the policies and procedures for the application process to the Institutional Review Board (IRB) or Exempt Review Committee (ERC) and appropriate deadlines for each. Policies All research involving human subjects (participants) must be submitted for review and approval via a web-based submission and management system, IRBNet, at irbnet.org. In the system, three boards exist, each with its own ...
Separation of Principal Investigators Purpose The purpose is to outline the policy and procedures for separation of faculty, staff or students who serve as the Principal Investigator (PI) for research involving human subjects. Definitions Employees or agents are individuals who: (1) act on behalf of the institution; (2) exercise institutional authority or responsibility; or (3) perform institutionally designated activities. They may include staff, students, contractors, and volunteers. ...
Expedited Review Purpose The purpose is to outline the policy and procedures for expedited review of research involving human subjects. Policy | Prohibited from Expedited Review | Expedited Categories | Minor Changes to Approved Research | Procedures Definitions Expedited is a classification of human subject research review which is performed outside of convened, monthly meetings of the Institutional Review Board (IRB) and is permitted by Federal regulations at 45 CFR 46.110 for certain non-...
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