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JHM IRB Routine Monitoring Visits
The Office of Human Subjects Research was expanded in 2004 to include a Compliance Group. This group consists of the Regulatory Team and Monitoring Staff. The Monitoring Staff conduct monitoring visits of research protocols approved by the JHM IRB 1-6 and JHM ACH IRB. The visits primarily are intended to ensure the conduct of approved research at Johns Hopkins proceeds according to the approved protocol. Routine visits will be conducted periodically.
The purpose of a monitoring visit is to:
- Assess adherence to Federal Regulations
- Assess adherence to IRB Guidelines
- Determine that the rights and safety of human subjects have been properly protected
- Provide education to investigators
Protocols are selected for routine visits by performing a query of the IRB database.
What information will be reviewed during the visit?
- Investigator’s office protocol file
- Informed Consent document for each consented subject
- Inclusion/exclusion criteria
- Study procedures as approved by the IRB
- Occurrence and reporting of events and protocol deviations
What should be done if the study team identifies problems when preparing for the visit?
If you identify errors or omissions while preparing for the visit notify the IRB Compliance staff for guidance. The most frequent advice that is given if an error or omission is detected is to document the occurrence of the event and place a signed dated memo regarding the event in the research file. A report describing this event should also be submitted to the IRB along with a plan of corrective action that will be taken to eliminate future occurrence of the problem.
Does the Principal Investigator (PI) need to be present during the entire visit?
No. The PI will be asked to meet with the Monitoring Staff at the beginning of the visit for a brief interview (about 15-20 minutes). The PI, or the PI’s research staff, will be asked to be available by pager or to check in periodically to answer questions that may arise. The PI will be asked to meet with the Monitoring Staff at the end of the visit to review the findings, clarify any misunderstandings, and discuss corrective actions for any deviations noted during the visit.
How many research participant records will be reviewed during the visit?
Routine Visit: A review of 10-30% of total participants consented will be performed. If there are less than 4 participants enrolled, a review of all research participant records will be performed. If no participants were consented a review of the protocol binder will be performed.
Prior to the visit, the PI will be asked to provide a list of study participants (initials or ID numbers only) along with the date of informed consent.
What information/documents should be available for the visit?
The PI will be asked to have the following information available for the visit:
- Informed consent document(s)
- Participant’s research records
- Source documentation
- Regulatory binder
What is source documentation?
Source documentation is the collection of physician notes, laboratory results, or diagnostic test results that confirm subject eligibility. These documents are placed in the participant’s research record.
What consent documentation problems are frequently identified during a visit?
- Consent forms not dated by the subject, investigator, and/or consent designee
- Use of a consent form that is not the most current
- Consent form signed by a consent designee not authorized by the IRB
- Failure to have interior elements signed/dated by the participant
What other types of problems could be identified during a visit?
- Modifications to the protocol (i.e. a change in study procedure) without the approval of the IRB
- Extemporaneous modifications to the informed consent document (i.e. a change made to the consent document by the investigator) without the approval of the IRB
- Lost or missing consent forms
- Failure to report events or deviations
- Consent forms signed after the implementation of research procedures
- Deficient documentation of eligibility assessments
The final visit report will list actionable findings, as well as areas in which deficiencies were identified. In cases where problems are noted, the investigator has the opportunity to respond to recommendations of the monitor or to provide clarifications or to develop a plan of corrective action to eliminate the potential for future problems.
The final visit report will be provided to the PI. The JHM IRB responsible for study oversight will review the report at a convened meeting if substantial issues were raised during the monitoring visit.