Since September, 1999, the Bureau has carried out a program of routine quality audits of human research projects. For those who would like to know what to expect if their project is chosen for an audit, Funeka Sihlali, the Bureau's Research Quality Coordinator, has prepared this explanation.

The Research Quality Coordinator implements, coordinates and monitors the quality assurance programs for all human research overseen by Cook County Bureau of Health Services Scientific Committees (IRBs). The coordinator is also an ex-officio member of the Cook County Hospital/Bureau IRB. One of the coordinator's responsibilities is to audit research projects. About 10% to 15% of our active research projects are chosen at random for routine audit each year.

Audits and Continuing Review

Most researchers know that Institutional Review Boards must approve and oversee all human research. They may not know, however, one duty of the IRB is "continuing review" of ongoing research to assure that the rights and welfare of human subjects are protected. The various federal agencies that regulate research have somewhat different standards for what constitutes continuing review. For instance, one of the federal rules for FDA regulated research (21 CFR 56.108) states that "an IRB shall conduct continuing review of research covered by these regulations at intervals appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or have a third party observe the consent process and the research". Historically, most research institutions have implemented this and similar rules by way of written reports submitted least yearly as part of the renewal process (in the Bureau we do this by way of Progress Reports). Efforts by IRBs or institutions to gather information in person about ongoing research have usually been limited to high-risk situations or when there is reason to believe a problem exists.

Numerous observers have expressed concerns that this system for continuing review does not provide enough information to assure that research is being carried out as planned. Worse, it means that a project could be operating with serious deficiencies for an entire year, or until there is a complaint, before the IRB or institutional officials have a chance to find out about it.

For these reasons, more and more institutions have adopted some form of research auditing. The purpose of audits is to give support to researchers and to educate them when necessary, to reinforce measures designed to protect the welfare of research participants, and to promote good clinical practice. Audits are not meant to be punitive exercises. As anxiety-provoking as an audit may be, the goal is to provide an opportunity to educate and to correct myths or incorrect assumptions about how to carry out good research. In this way poor practices can be corrected before irreversible problems are created or participant welfare is compromised.

The Audit Process

If an audit is "for cause" – that is, the audit is carried out in response to a complaint or an allegation of serious noncompliance – there will be a very small window for negotiating a time to carry out the audit. In most cases the audit will take place as soon as possible. On the other hand, when it is a routine "at random"audit, it will be scheduled at a convenient time within two weeks of your receiving the audit notification.

All routine audits are preceded by a written notice to the principal investigator and a request to make an appointment for the audit. If your project is chosen for an audit, you are expected to be responsive to this notice, to cooperate fully with the auditor and to provide her with an appropriate area on site in which to work.

During an audit, the following methods may be used:

1) Interview with the Principal Investigator or contact person ( a person listed as an investigator who has oversight responsibilities for the project). This is done to assess the progress and direction of the study and to clarify any misunderstandings.

2) Review of the Regulatory Binder and its contents. The Regulatory Binder is the binder or file in which you keep all the documents pertaining to your regulatory responsibilities for this project. It should include:

• The complete current protocol, including copies of study documents associated with the protocol (e.g., Case Report Forms, investigator's brochure);
• The currently approved consent form;
• All correspondence with the IRB;
• The complete current list of investigators and copies of their c.v.'s;

The Regulatory Binder will be inspected to verify that this information corresponds to the documents on file with and approved by the IRB.

3) Inspection of the research data, materials and documentation. This will be done to:

• Monitor the accessibility and confidentiality of the records;
• Verify the accuracy and completeness of the information;
• Check the source documentation;
• If an investigational new drug is used:
Check the storage of the medication;
Monitor its use, timing and inventory accountability.

4) Evaluate the informed consent process. Research staff will be interviewed, completed consent forms will be inspected, and at times subjects will be interviewed or a consent process will be observed. This is done to:

• Evaluate the adequacy of the process;
• Validate dates and signatures;
• Check that all required elements of consent are present;
• Review the circumstances in which consent is obtained;
• Review any compensation offered.

5) Review adherence to the protocol. Research records will be reviewed to:

• Check the validity of the inclusion and exclusion criteria used;
• Confirm laboratory results (verified with hard copy lab reports);
• Check for unapproved concomitant medications or the possibility of simultaneous investigational drugs.

6) Review staffing for the project. This will be done to:

• Monitor delegation of responsibility;
• Evaluate the competency and training of the personnel;
• Find out if the project is adequately staffed.

If you have any questions about the audit process, please contact the Research Qulaity Coordinator at 312-572-3506.

Back to top