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 ...
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....
Revisions to Approved Research Purpose The purpose is to outline the policy and procedure for revisions to approved human research. Definition Revisions to research are changes requested by the Principal Investigator (PI) or funding sponsor to a previously approved project. Modifications/Amendments are changes or additional information requested by the Institutional Review Board (IRB) or Exempt Review Committee (ERC) to any part of a research application or supplementary materials after ...
Full Review Purpose The purpose is to outline the policies and procedures for full review of research involving human subjects. Definitions Full review is a method of human subject research review required in the Code of ...
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...
Incentives in Research Purpose The purpose is to describe the policies for incentives or other rewards used in research involving human subjects. Definitions Children are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the ...
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 ...
International Research Purpose The purpose is to outline the policy and procedures for International research. Definition General Data Protection Regulation (GDPR) is a European law which establishes data protections for privacy and ...
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 ...
Mandatory Training Purpose The purpose is to outline the policies and procedures for mandatory educational training in human research. Definitions | Chart of Courses | Additional Courses | International Research | Professional Services | Unaffiliated Investigators | Policies | Procedures ...
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