Human Subjects Research - Institutional Review Boards - IRBs
Ongoing Submissions including following:
- Continuing Review
- Change in PI or Key Personnel
- Safety and Deviation Reporting
- Protocol Closure
It is the policy of the IRB to review human research appropriate to the degree of risk involved, but not less than once per year. “Higher risk” research (as determined by the Committees on Human Research – hereafter “Committee”) may require more frequent reviews. The purpose of continuing review is to determine:
- whether the risks to subjects continue to be minimized and reasonable in relation to the anticipated benefits;
- whether the selection of subjects continues to be equitable;
- whether the informed consent continues to be appropriate;
- changes in key personnel and whether mandatory training is complete;
- whether there continue to be:
- adequate provisions for monitoring the data collected to ensure the safety of the subjects, when appropriate;
- adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data, when appropriate; and
- appropriate safeguards for vulnerable populations.
All research protocols (except protocols determined by the Committee to qualify for exempt status) must undergo continuing review at least once a year, unless all research activity, including data analysis, has been completed.
The Research Coordinator will receive a reminder notice approximately three months in advance that continuing review is due. Two additional reminders will be sent with the last copied to the PI. It is important that the continuing review come in for review with sufficient time to review prior to its expiration. All work must cease if the protocol approval expires.
The IRB recognizes that research is a continuous process and that changes in the conduct of a study and/or changes to the consent document are necessary. However, no changes to an approved protocol should be implemented until the Committee has reviewed and approved the changes. This includes, but is not limited to,
- scientific changes, new research questions and or methods
- subject recruitment methods
- consent form changes
- treatment changes
- amendments to the sponsor’s master protocol
- as well as changes or additions in study sites, investigators, or key personnel
Major modifications/amendments potentially affecting the risk/benefit ratio are reviewed through the full committee review process, minor modifications not affecting the risk to subjects may be reviewed through the expedited review process.Amendment Review Forms
The primary reason it is important that the IRB be aware of who is conducting the research, is to ensure those key personnel have completed the required training in Human Subjects Research. Therefore, it is required that the investigator notify the IRB office when there is a change in PI or any additions or deletions to research staff participating in a protocol.Key Personnel Review Forms
The IRB is required under 45 CFR part 46 to submit to the Office for Human Research Protections (OHRP) any unanticipated problems involving risk to subjects or others (UAPs).
[21 CFR 56.108 (b)(1) & 45 CFR 46.103(b)(5)(i)].
OHRP considers UAPs, in general, to include any incident, experience, or outcome that meets all the following criteria:
- unexpected (in terms of nature (type of event), severity (extent of harmfulness), or frequency (number of like events higher than anticipated) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;
- related or possibly related to participation in the research (possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and
- suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
Safety Review Forms
Investigators have the responsibility to formally close a study with current IRB approval once it is completed or discontinued. Among other reasons for closing out a study, this informs the IRB on the conduct and outcomes of the study, including any risks or problems that may have arisen since the last study renewal and which may need to be disclosed to the study participants or others.Do not close-out a study if any of the following six conditions apply. Such studies must remain active and continue to receive ongoing IRB review and approval.
- Enrollment ongoing
- Research-related interventions and/or follow-up ongoing
- Subject follow-up ongoing
- Biological specimens containing personally identifiable information are being maintained in a repository that has been approved as part of this study or upon which analysis or research is ongoing. If, however, specimens have been transferred to a separate repository that has ongoing IRB approval, the study may be closed.
- Primary data analysis or manuscript preparation that involves the use or access to personally identifiable information ongoing.
- If there is an external study sponsor and the sponsor has not provided permission to close the study with the IRB.
You must close out a protocol utilizing a Request for Continuing Review form.
Last modified February 06 2014 09:14 AM