Allen College Institutional Review Board (ACIRB) | Print |  E-mail

 

Welcome to the Allen College Institutional Review Board (ACIRB) website.  The ACIRB's role is to review projects and studies to confirm that they meet federal, state, and institutional standards from an ethical, legal, and moral standpoint.

We are committed to the highest standards of research and of protecting the rights and welfare of participants involved in any proposed project or study.  We review projects, oversee compliance and research integrity, and provide guidance and access to training for faculty, staff, and students on research regulations and compliance topics.

Important Links

Click here to access Forms & Templates
Click here for Procedure to Submit a Protocol for ACIRB Review

About ACIRB
Definitions
What Requires Review?
Timeline for Reviews
Required Training
ACIRB Meeting Schedule
ACIRB Members
FAQs

Scope and Authority of the ACIRB

The scope and authority of the ACIRB is based on federal IRB guidelines as well as on state of Iowa code, UnityPoint Health policy, and Allen College institutional policy.

ACIRB authority, according to federal regulations, is as follows:

  • Approve research/project
  • Disapprove research/project
  • Modify research/project
  • Conduct continuing reviews
  • Observe/verify changes
  • Suspend or terminate approval
  • Observe the consent process and the research/project procedures
  • Audit research/project records for compliance

The minimum federal requirements for projects involving human subjects participation include several aspects that the ACIRB is responsible for reviewing.  As such, applications for review by the ACIRB must include, at a minimum, 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 in relation to potential benefits

Informed consent

  • Informed consent process and documentation

Assent

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

Selection of subjects

  • 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

Safeguards

  • Ensure that individual privacy is not invaded during subject recruitment
  • Confirming, maintaining, 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, then identification, recruitment, 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
  • Any requirements (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 project
  • Suspension of all of a PI's 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
  • Loss of licenses
  • Immediate shut-down of ALL research at an organization

Please note that 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.

 
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