The Human Research Routine Review & Education Program is a joint collaboration between Human Research Compliance and the Joint Clinical Trials Office Quality Assurance Unit (JCTO QAU). Through routine review and educational initiatives, the program intends to provide reasonable assurance of the integrity of all human research, improve human research protections, and identify quality improvement areas.
Goals of the Program
The purpose of the Advisory Committee is to provide oversight of the Human Research Routine Review & Education Program and its impact on the Weill Cornell Human Research Protections Program and associated educational initiatives.
Membership shall be representative of the Weill Cornell research community and include voting members who are physicians, IRB members, study and regulatory coordinators, and non-voting members, such as audit team members from the Human Research Compliance Office and the Joint Clinical Trials Office Quality Assurance Unit.
Q: What is the purpose of the Human Research Routine Review & Education Program?
A: The purpose of the program is to review how research is conducted, and to detect, correct and prevent potential and existing problems, through Routine Reviews and For‐Cause audits. There are several objectives of the program. They include:
Q: What is the difference between a Routine Review and a For‐Cause audit?
A: Routine Reviews are not-for-cause, initiated by the review team, and are equally distributed among types of research, taking into account criteria that include:
Written reports detailing the findings of a Routine Review are only shared with the PI, research team and Routine Review team, unless a finding indicates possible serious or continuing noncompliance, or a possible unanticipated problem involving risks to subjects or others, in which case the report is also shared with the IRB.
For‐Cause audits are those that are requested by the IRB, Department Chair, the Institutional Official, Research Integrity Officer, or Executive Leadership, and may be conducted in response to any of the following:
Written reports detailing the findings of a For‐Cause audit are always shared with the IRB.
Apart from how they are initiated, and to whom the written reports with findings are disseminated, For‐Cause audits and Routine Reviews are the same.
Q: How are studies selected for a Routine Review?
A: All active research studies approved by the WCM IRB are eligible to be reviewed. Protocols from all tiers of risk (minimal risk and greater‐than‐minimal risk) will be reviewed, however, higher risk studies will be the focus of more reviews than those considered to be lower risk.
Protocols will be randomly selected for Routine Review from within each tier of risk, but in a controlled manner so that repeated reviews of the same group within short periods of time are avoided, unless previous reviews have revealed problems.
Q: I have an upcoming inspection from the FDA. Can I request assistance from the Routine Review team?
A: Yes. You may request assistance with preparation for an external audit by the FDA or other regulatory body by emailing email@example.com.
Q: How far in advance will I be notified if one of my studies is scheduled to undergo a Routine Review or For-Cause audit?
A: For‐Cause audits may be unscheduled and/or occur without prior notice, whereas for a Routine Review our team will work with the Principal Investigator to arrange scheduling.
Q: How long will the Routine Review or For-Cause audit take?
A: Depending of the scope of the evaluation, the Routine Review or For-Cause audit may take anywhere from a few hours to several days.
Q: How can I prepare?
A: Once a date has been finalized, the Principal Investigator and study team will receive a plan that outlines the scope of the audit or Routine Review. Based on this information, one should take steps to make all needed documentation accessible to the Routine Review team, including anything residing on a departmental share drive, by granting any electronic permissions necessary. Private space should also be secured by the Principal Investigator or designee for the Routine Review team to be able to examine all records on the agreed upon dates. At least one study team member who can answer Routine Review team questions should be made available for the duration of the review. Investigators can also complete an Investigator Routine Review Preparation Checklist.
Q: What happens during a For‐Cause audit or Routine Review?
A: A given audit or Routine Review involves interviews and comprehensive regulatory and participant documentation review.
The PI is always interviewed twice – once to start the audit/Routine Review and a second time to discuss findings – and members of the study team and/or participants are interviewed as needed. The PI’s first interview occurs at the beginning of the audit/Routine Review, whereas the PI exit interview occurs within 3 days of completion of the evaluation.
The Routine Review team will evaluate regulatory documentation, including IRB documentation, study team credentials and participant documentation, such as informed consent(s), assent(s), and medical record, in detail. During this time, a member of the study team able to answer questions should be made available.
When applicable, the Routine Review team will also tour the research facility to verify control, storage, and accountability of investigational new test articles and/or to confirm availability of related research equipment.
The Routine Review team may also view the study team conducting the informed consent process.
Q: What topics will be covered during the initial Principal Investigator interview?
A: The Principal Investigator will meet with one or more members of the Routine Review team for a 30‐minute PI interview about topics such as:
Q: What topics will be covered during an interview with a member of the study team?
A: The interview is a discussion guided by the individual’s role on the protocol and may include:
Q: What and how much documentation will be evaluated during the For‐Cause audit or Routine Review?
A: The Routine Review team will evaluate regulatory documentation, including IRB documentation, study team credentials and participant documentation in detail. This may require arranging for Routine Review team access to any systems used internally such as a folder on a department share drive, a REDCap project, or other system used by the study team. The plan received by the PI and study team prior to the evaluation will indicate how many participant charts will be reviewed.
Q: What specific documentation will be evaluated?
A: For all audits, regulatory documentation, including but not limited to:
A review of study team credentials and training such as:
A review of participant source documentation, consisting of the following:
Q: My study was just evaluated. How long will it take before I receive a report?
A: A written report is issued by the Routine Review team detailing the findings, including corrective actions, within 3 weeks of the exit interview.
Q: Who else sees the written report?
A: In the case of Routine Reviews, only the PI, research team, and Routine Review team see the report, unless findings indicate possible serious or continuing noncompliance, or a possible unanticipated problem involving risks to subjects or others, in which case the report is shared with the IRB. Otherwise, the report stays with the PI, research team, and Routine Review team.
In the case of a For‐Cause audit, at a minimum, the IRB, Assistant Dean of Human Research Compliance, Associate Dean of Clinical Research, department chair, and division chief will also view the report. Other relevant and key stakeholders may view it as necessary.
Q: How much time do I have to respond to the written report?
A: The Principal Investigator has 21 days to implement corrective actions and respond in writing. If an extension is needed to complete any corrective actions, the request, including how many additional days are needed, must be sent to firstname.lastname@example.org. The extension is not to exceed an additional 21 days.
Q: What if my protocol is out of compliance with state or local regulations, WCM policies, and/or the IRB‐approved protocol?
A: If this occurs, the Principal Investigator is required to implement a corrective action plan commensurate with the degree of noncompliance. In some cases, the written report you receive will guide you as to what corrective actions might best fit your circumstances in the opinion of the Human Research Routine Review & Education Program. If this happens, the principal investigator can choose to follow these prescribed corrective actions or implement his or her own. In either case, corrective actions must be detailed in the principal investigator’s response to the written report so that, in the case of a For‐Cause audit, they can be presented to the IRB by the audit team at a convened meeting.
Q: What is the role of the IRB in the For‐Cause audit or Routine Review process?
A: The IRB is not involved in the Routine Review process, unless findings indicate possible serious or continuing noncompliance, or a possible unanticipated problem involving risks to subjects or others, in which case the report is shared with the IRB. In the case of a For‐Cause audit, findings are always shared with the IRB.
Once the IRB is briefed on the findings and corrective actions implemented by the principal investigator, it may determine that a given finding constitutes serious or continuing noncompliance, or an unanticipated problem involving risks to subjects or others, in which case the finding will need to be reported to the Health and Human Services Office of Human Research Protections (OHRP) and/or the United States Food and Drug Administration (FDA), the sponsor, and funding agency in accordance with IRB responsibilities as dictated by federal regulations 45CFR46.103(b)(5)(ii) and 21CFR56.108(b)(2), respectively.
Whether or not the IRB determines serious or continuing noncompliance, or an unanticipated problem involving risks to subjects or others, has occurred, it will issue a determination letter, which is distributed to the Principal Investigator, Assistant Dean of Human Research Compliance, Associate Dean of Clinical Research, Department Chair, and Division Chief.
As part of the determination letter, the IRB may issue corrective actions in addition to ones prescribed in the written report or selected as appropriate by the principal investigator, such as:
The IRB also determines, when a Principal Investigator appeals an audit finding, whether the finding was accurate or not accurate.
Q: How do I appeal a For-Cause audit finding?
A: If you disagree with the accuracy of a For‐Cause audit finding, notify email@example.com of the request to appeal with a signed memo 2 weeks prior to the IRB meeting at which the findings are to be discussed. The audit findings and appeal will both be presented at an IRB meeting by the audit team.
Q: What if, after I appeal a For‐Cause audit finding, the IRB determines the audit finding should stand?
A: If this occurs, the PI has 7 days from the date of notification to provide and implement a corrective and preventative action plan.
Q: What if, after I appeal a For‐Cause audit finding, the IRB determines the audit finding was not accurate?
A: If this occurs, the PI is not required to complete corrective actions, and, if appropriate, an amended written report will be issued.