Conducting the Protocol

Conducting the Protocol

Conducting the Protocol

No Modifications Without Prior IRB Approval

In most cases, no protocol, consent process, or consent form may be changed without prior approval from the IRB, except to eliminate an apparent, immediate hazard to one or more subjects. Also, the investigator is responsible for updating information about his or her research contacts with the OIRB. For more information, see the sections on Continuing Review & Approval and Project Revisions & Amendments.

Notify OIRB of all Reportable Problems

The Principal Investigator must report promptly to the IRB and sponsor any clinical trial research-related injuries to human participants or any unanticipated problems involving risks to human subjects or others, at UAB, multi-center trial safety reports from other participating sites, as well as DSMB reports. The IRB may require that any research project that has been associated with unexpected serious harm to the participants be terminated. If the research involves an investigational new drug or device, the Investigator must report such incidents to the Sponsor and/or the FDA as well as the IRB. See the section on Reporting Research-Related Problems for definitions and reporting guidelines.

Provide OIRB with Copies of All Monitoring Reports

Investigators are required to submit a copy of any and all internal and external monitoring reports within 2 weeks of receiving them. Such reports include those generated by

  • A clinical research organization,
  • A data safety monitor (e.g., DSMB, DSMC)
  • An internal monitoring process.

Participant Withdrawal from Research--Guidance for Investigators

When a participant withdraws from a research study, the data collected on the participant up to that point remains part of the study’s database and cannot be removed. The Investigator may ask the participant who wishes to withdraw if they would agree to provide continued follow-up and further data collection subsequent to their withdrawal from the interventional portion, such as that for clinical outcome information obtained through a chart review and would need an addendum consent form addressing the maintenance of privacy and confidentiality of the participant’s information if this type of situation was not addressed in the original informed consent. The IRB must approve this type of addendum consent form prior to its use.

If the participant withdraws from the research study and does not consent to continued follow-up, the investigator cannot access the participants’ medical record or other confidential records for purposes related to the research study. An investigator may; however; review the records prior to the withdrawal and consult public records, such as those establishing survival status.

Guidebook Topics