ACIRB范围 & 权威

The scope and authority of the ACIRB is based on federal IRB guidelines as well as on state of Iowa code, UnityPoint 健康 policy and 澳门网上博彩下载 institutional policy.

ACIRB 权威 - According to Federal Regulations, is as follows:

  • Approve research/projects
  •  Disapprove research/projects
  • Modify research/projects
  • Conduct continuing reviews
  • 观察/验证变化
  • Suspend or terminate approval
  • Observe the consent process and the research/project procedures
  • Audit research/project records for compliance

The minimum federal requirements for research involving human subjects include several aspects the ACIRB is responsible for reviewing. 像这样, applications for review by the ACIRB must include, 至少, information that allows the ACIRB to assess the following:

Risk and anticipated benefit analysis

  • Identification and assessment of risks and anticipated benefits
  • Determination that risks are minimized
  • Determination that risks are reasonable given the potential benefits

知情同意

  • Informed consent process and documentation

同意

  • The affirmative agreement of minors or of individuals who are unable to make their own decisions to participate in the project
  • 同意 process and documentation

科目选择

  • Equitable selection in terms of ethnicity, race, and gender
  • Benefits will be distributed fairly among the community's populations
  • Additional safeguards are provided for any vulnerable populations susceptible to pressure to participate

保障措施

  • Ensure that individual privacy is not invaded during subject 招聘
  • 确认, 维护, and monitoring that procedures are in place to assure confidentiality of the information collected during the project

Collection, storage and analysis of data

  • Confirmation that there are plans to keep data secure during collection, storage and analysis

Research design/methods

  • Verification that design and methods are appropriate and scientifically valid and therefore, justify exposing subjects to risks that may be encountered during the project

Additional information

  • If vulnerable populations are included as subjects, 识别, 招聘, and safeguards must be built into the proposal

The ACIRB must also review:

  • The qualification of the principal investigator and collaborators on the project
  • A complete description of the proposed project
  • Compliance with applicable federal and state laws/regulations, and of institutional policy
  • 任何要求(e).g., clinical brochures/investigator protocols) necessary for FDA-regulated research
  • Funding requirements/expectations

When regulations are not followed, the ACIRB may implement any or all of the following consequences:

  • Suspension of the research/project
  • Suspension of all a PI's research/projects
  • Require that the PI may not use data or publish results
  • Notify sponsors, regulatory agencies, and funding agencies of noncompliance
  • Debarment by FDA from using investigational products
  • Render the PI unable to receive funding from federal grants
  • Provide additional monitoring and oversight by the ACIRB and/or third-party monitoring of project activities
  • Termination of employment
  • 吊销许可证
  • Immediate shut-down of ALL research at an organization

Please note these are not theoretical consequences. Some or all of these consequences have occurred at sites where human subjects research was conducted improperly or without IRB approval.