Human Subjects Research: Policy & Process

Policy | Stamp Policy | Process | Reporting Adverse Events


Policy

Union University, in accordance with its Multiple Project Assurance (MPA) filed with the Department of Health and Human Services, and 45 CFR part 46 establishes the Institutional Review Board for the Protection of Human Subjects (IRB).

Charge of the Committee

The IRB is responsible for reviewing research involving human subjects to ensure that such research is consistent with the principles of :

  1. respect for persons,
  2. beneficence, and
  3. justice, as set forth in the Belmont Report (1979).
Additionally, the IRB follows all applicable Federal, state, and university regulations. These include but are not limited to 45 CFR Part 46, 21 CFR parts 50 and 56 and the Union University Multiple Project Assurance (MPA) for research involving human subjects.

Scope of Review

All research involving human subjects must be submitted for review and approved by the IRB before it is initiated. The IRB reviews all research using human subjects regardless of funding source and regardless of whether the investigator is faculty, staff or student. Failure to comply with University policy may result in penalties (see Non-Compliance).

Definition of Human Subject

"Human subject" means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. (Title 45 CFR 46.102(f)).

Definition of Research

"Research" means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. (Title 45 CFR 46.102(d)).

Non Compliance

In accordance with 45 CFR 46, the IRB is required to report all instances of non-compliance to the federal Office for Protection from Research Risks, Washington, DC.

Additionally, non-compliance with this policy by faculty/staff members may result in one or more of the following:

Non-compliance with this policy by students may jeopardize awarding of the degree being sought.


Stamp Policy

Any application approved for research using human subjects will require that the approved consent form include a stamp from the IRB giving the protocol number and the date approved. This will ensure that the correct, approved version is being used. It will also serve as a reminder of when the protocol must be reviewed again.


Process

The Principal Investigator determines that research will involve human subjects. The PI completes and submits an application to the Institutional Review Board (IRB) at irb@uu.edu who then determines what level of review is needed (exempt, expedited, full) and initiates the appropriate review process for that level. The Institutional Review Board communicates the results of the review to the PI (exemption, approval, recommendations, etc).

PI provides progress report at the time of continuing review, which is due at intervals no less often than 12 months.

The IRB Office maintains record of all protocol approvals, disapprovals, continuing reviews, and other actions of the IRB, as well as Federal and institutional written policies and procedures.

Union University assures compliance of Federal regulations by all collaborators in human subject research.

The IRB shall report to appropriate University and federal government officials:

  1. any unanticipated problems involving risks to subjects or serious or continuing noncompliance with IRB requirements and
  2. any suspension or termination of IRB approval of research.

Communication:

  1. Investigators: The IRB Chair, IRB members, and the IRB Compliance Officer communicate with investigators concerning review procedures, Federal and University policies, assistance with application, etc.
  2. IRB members: IRB Chair discusses proposed policy changes and implementation with IRB members, and the IRB Compliance Officer schedules meetings, forwards applications for review, and lists recommendations and suggested modifications.
  3. University personnel: Department Chairs instruct faculty about University policy as it relates to the IRB. The IRB Chair and its members are available to discuss any details of policies and procedures.
  4. Subjects: Investigators must be available to discuss any concerns the subjects in their research may have. The consent form must include a contact phone number of the investigator, as well as the IRB Chair. The Chair is available to discuss any concerns about the subjects' rights as subjects.

Training:

  1. Investigators: The IRB Chair and its members are available to discuss any details of policy, procedure, suggestions, etc. that an investigator might have. Faculty advisors are available to discuss policy with their students who might be conducting research.
  2. IRB members: Copies of Federal regulations and guidelines and other resources are housed in the IRB Office. The IRB Chair also provides guidance to the IRB.
  3. University personnel: The IRB Chair and its members are available to discuss any details of policy, procedure, suggestions, etc.
  4. IRB Tutorial for Researchers

Reporting Adverse Events
New findings are unexpected problems whose nature, severity, and frequency are not described in the information provided to the IRB or to participants. Examples include unexpected complications in a subject, missteps in the consent documentation, or breaches of confidentiality. Adverse events should be reported to the IRB within 10 working days using the Adverse Events Form. Sometimes a study must be suspended to ensure subjects' safety.

The report of the event should discuss:

These reports usually receive expedited review, but in some cases the full IRB is involved.

The University's policies on adverse events are based on Food and Drug Administration regulations. According to the FDA, a "serious adverse drug experience" with respect to human clinical experience includes "any experience that suggests a significant hazard, contraindication, side effect, or precaution," including "any experience that is fatal or life-threatening, is permanently disabling, requires inpatient hospitalization, or is a congenital anomaly, cancer, or overdose." An "unexpected adverse experience" is any adverse experience whose nature, severity, and frequency of risk are not described in the information provided for IRB review or in the consent form. (See 21 CFR 312.32 [4-1-92])