Brief Overview of Researcher Responsibilities
Responsibilities of the Investigator During the conduct of Human Research
- Do not start Human Research activities until you have the final IRB approval letter.
- Personally conduct or supervise the Human Research.
- Conduct the Human Research in accordance with the relevant current protocol as approved by the IRB.
- When required by the IRB, ensure that consent or permission is obtained in accordance with the relevant current protocol as approved by the IRB.
- Do not modify the Human Research without prior IRB review and approval unless necessary to eliminate apparent immediate hazards to participants. If this occurs, notify the IRB of the event immediately.
- Protect the rights, safety, and welfare of subjects involved in the research.
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Submit to the IRB:
- Proposed modifications.
- A continuing review application as requested in the approval letter. Please note that applications must be received at the specified time prior to expiration of the approval. Failure to submit the application by the specified date may result in a lapse of approval. Implications of a lapse in approval are noted in “How do I submit a continuing review?”
- A PI Termination/Final Report application to close out Human Research.
- Report the occurrence of any “Reportable New Information” to the IRB within 5 business days of your knowledge of their occurrence. The kinds of reportable new information and events that must be promptly reported to the IRB are described in the Investigator Manual.
- Do not accept or provide payments to professionals in exchange for referrals of potential participants (“finder’s fees.”)
- Do not accept payments designed to accelerate recruitment that were tied to the rate or timing of enrollment (“bonus payments.”)
- Maintain signed and dated consent documents for three years after completion of the research. Maintain signed and dated HIPAA authorizations and consent documents that include HIPAA authorizations for six years after completion of the research (if written consent and HIPAA are required).
- For FDA-regulated research involving investigational drugs, comply with the following FDA regulations: 21 CFR §312.7, §312.57, §312.59, §312.60, §312.61, §312.64, §312.66, §312.68, and §312.69.
- For FDA-regulated research involving investigational devices, comply with the following FDA regulations: 21 CFR §812.7, §812.100 and §812.110, §812.145, and §812.150.
- For research involving clinical trials, comply with the International Council on Harmonization – Good Clinical Practice Guidelines (E6) Section 4.
- For VA Human Research:
- Flag the medical record when required by the IRB.
- Inform the pharmacy service of the IRB’s and Research and Development Committee’s approval through Form 10-1223.
- Provide the pharmacy with a signed copy of Form 10-1086 to document each participant’s consent to participate in the study.
- Inform the Chief, Pharmacy Service, and the Research and Development Committee when a study involving investigational drugs had been terminated.
- Maintain a record of the research in the participant’s medical chart.
- Prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the Human Research on each individual administered the investigational drug or device, or employed as a control in the Human Research. Case histories include:
- Case report forms
- Supporting data including, for example, signed and dated consent forms and medical records including, for example, progress notes of the physician, the individual’s hospital chart(s), and the nurses’ notes.
- Documentation that informed consent was obtained prior to participation in the Human Research.
- Maintain signed and dated consent documents for five years after completion of the research.
- Where applicable, maintain a record of participant enrollment statistics by ethnic group, so that this information can be reported to the IRB at the time of continuing review.
