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 ...
Non-English Speaking Participants Purpose The purpose is to outline the policies and procedures for non-English speaking participants involved in research. Definitions Interpreters work live with research participants. They verbally convey (in another ...
General Data Protection Regulation Purpose The purpose is to outline the policy and procedures for compliance with the European Union (EU) and Economic Area’s (EEU) General Data Protection Regulation, which became effective May 25, 2018. Policy | Special Categories | ...
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