January 2019

1. When is continuing review required?
2. When is continuing review NOT required by regulation.
3. Can the IRB require continuing review where not required by regulation?
4. When continuing review is required, how is the approval period set by a JHM IRB?
5. How and when should a continuing review application be submitted?
6. What action may be taken on a continuing review application?
7. What happens if approval expires before continuing review is conducted?
8. What are the requirements for reporting on study progress if a formal continuing review is not required?

1. When is continuing review required?

Research approved by a JHM IRB may continue only for the time period set by the IRB.  For certain research studies, these periods are controlled, in part, by the DHHS and FDA regulations for human subject research.  Where a formal continuing review is required either by regulation or through a determination of the JHM IRB, the maximum approval period is one year minus one day.  In these cases, in order to conduct research for more than one year, a continuing review process is mandatory.

2. When is continuing review NOT required by regulation?

Under the Revised Common Rule, continuing review is no longer a regulatory requirement for the following types of research [studies initially approved on or after 1/21/2019]

1. Research that was eligible for expedited review at the time of initial approval,
2. Exempt research conditioned on limited IRB review,
3. Research that has completed all interventions and now only includes analyzing data, even if the analysis involves identifiable biospecimens or information,
4. Research where all study-related interventions are completed and the remaining study activities only include accessing follow-up clinical data from clinical care procedures.

These exceptions to the requirement for continuing review do not apply to FDA-regulated research.

3. Can the IRB require continuing review where not required by regulation?

For studies where continuing review is not required by regulation the IRB may determine continuing review is required provided the rationale for this determination is documented as part of the IRB review process.

4. When continuing review is required, how is the approval period set by a JHM IRB?

When continuing review is required, either by regulation or by IRB determination, the IRB may approve research for a defined time period of not more than one year minus one day.  The IRB may approve a project for a period of less than one year, limit the number of study participants, or require monthly or six-month reports.  The IRB approval automatically expires at the time or event set by the IRB.  The IRB will consider the risks posed by the study intervention, what type of safety monitoring is provided in the protocol, and any other factors which affect the health and welfare of the study participants when establishing the time period for continuing review. 

5. How and when should a continuing review application be submitted?

The continuing review application should be submitted by the PI no later than 6 weeks prior to the expiration of the study.   In eIRB, submit a Further Study Action, Continuing Review Application. The application must include substantive information about the progress of the study, the number and type of participants consented since the last approval, a summary of protocol events and deviations (if any),  report of subject complaints (if any), if there was significant, relevant, literature published since the last approval, and a summary of the literature. Any changes proposed along with the Continuing Review Application must be submitted in a separate Change in Research Further Study Action in eIRB.

6. What action may be taken on a continuing review application?

The JHM IRB may act on a continuing review application in one of four ways:

1. The continuing review application may be approved;
2. The continuing review may be approved with administrative changes that must be completed by the PI;
3. The continuing review application may be tabled pending submission of clarifications or revisions; or
4. The continuing review application may be disapproved.
5. For studies reviewed under the Revised Common Rule where there is no regulatory requirement for continuing review, the JHM IRB may determine that continuing review is still required or may determine continuing review is not required. If the JHM IRB determines that no further continuing review is required it may determine that a progress report must be submitted at an interval of 1, 2 or 3 years or may establish that no progress report is required.

Written notification of the action is provided to the PI.   In cases where a continuing review application is disapproved, the IRB will provide its rationale for the action taken.  The investigator may request an appearance before the IRB to present arguments for reversal of the decision or propose a change in the protocol based on the advice and counsel of the IRB.

7. What happens if approval expires before continuing review is conducted?

Approval automatically expires if a continuing review application is not submitted for IRB review prior to the expiration date.  If a continuing review application is submitted and IRB review is not scheduled before the approval date expires, all research activity must stop until the review occurs. The IRBs have the authority to allow continued participation of subjects in research for which IRB approval has lapsed while the continuing review process occurs if there is an overriding safety concern or ethical issues that indicates it is in the best interest of the participants to continue. In such cases where participants may continue in the research, all other activity must stop until the IRB completes the review process. If approval lapses, the IRBs do not have the authority to allow new enrollment while the continuing review process is conducted.

8. What are the requirements for reporting on study progress if a formal continuing review is not required?

Where continuing review is not required by regulation or a determination of the JHM IRB the JHM IRB may require submission of a progress report at periodic intervals or not require additional reporting on the study’s progress. At the time of initial approval, the IRB will determine what type of reporting is required and will specify the interval for submission in the approval notice. If a progress report is required, the JHM IRB may set the interval for reporting at one, two or three years. Future reporting requirements will be assessed during each review and may be changed at any time. Progress reports must be submitted in eIRB using the progress report Further Study Action.

Regardless of the requirement set by the IRB for reporting study progress (continuing review,  progress report, or no reoccurring report of progress), investigators still must inform the IRB of any changes to the protocol and inform the IRB of reportable events.