Do not start Human Research activities until you have the final IRB approval letter.
Do not start Human Research activities until you have obtained all other required institutional approvals, including approvals of departments or divisions that require approval before commencing research that involves their resources.
Ensure that there are adequate resources to carry out the research safely, including, but not limited to, sufficient investigator time, appropriately qualified research team members, equipment, and space.
Ensure that Research Staff continue to remain qualified (e.g., including but not limited to appropriate training, education, expertise, credentials, protocol requirements, and, when relevant, privileges) to perform procedures and duties assigned to them for the duration of the study.
Delegate responsibilities to Research Staff by staff experience, training, and qualifications.
Assure that all research procedures are performed with appropriate supervision and only by individuals who are licensed, trained, or otherwise qualified to perform them in the state of Illinois and according to institutional policies.
Monitor the research study and perform quality assurance activities to ensure that participants are protected, and that data are reliable.
Update the IRB office with any changes to the list of study personnel.
Update the IRB office with any changes to investigative sites.
Personally conduct or supervise the Human Research.
Conduct the Human Research following the current protocol as approved by the IRB.
When required by the IRB, ensure that you or your designee obtains consent or permission following the 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.
Protect the rights, safety, and welfare of participants involved in the research.
Make arrangements to oversee the research and protect participants if you become temporarily unavailable to conduct or oversee the research personally.
If unavailable to provide sufficient oversight, as when on a leave of absence, arrange for another IRB-approved investigator on the study to assume direct responsibility, or notify the IRB of alternate arrangements.
Obtain the legally and ethically effective informed consent of research participants according to the plan approved by the IRB.
Ensure that only qualified Research Staff obtain informed consent.
Submit an updated disclosure of financial interests within thirty (30) days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new financial interest.
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 tied to the rate or timing of enrollment (“bonus payments”).
See additional requirements of various federal agencies in Appendix A. These represent additional requirements and do not override the baseline requirements of this section.
Engage in routine post-approval monitoring activities and directed reviews (for-cause audits).
If the study is a clinical trial supported by a Common Rule agency, you must post one IRB-approved version of a consent form used to enroll participants on a public federal website designated for posting such consent forms. You must post the form after you close recruitment and no later than sixty (60) days after the last study visit. Please contact the study sponsor with any questions.
The supporting Federal department or agency may permit or require redactions to the information posted if certain information should not be made publicly available on a Federal website (e.g., confidential commercial information). Contact the Federal department or agency supporting the clinical trial for a formal determination.
Contact the supporting Federal department or agency sponsor with any other questions regarding consent form posting obligations.