Submitting a Progress Report

Progress Report

Where continuing review is not required by regulation or a determination of the Rutgers IRB the Rutgers 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 Rutgers 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 Submit Continuation Report function. HSPP will also increase post-approval monitoring to ensure that study activities are carrying on as described in the protocol. Eligible studies will be required to submit a progress report instead of a Continue Review Report. This information will be noted on your IRB Approval Letter.

Continuing Review

Research approved by a Rutgers 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 Rutgers 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.

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] (Note: a periodic Progress Report may still be required. (See *NEW information section below.)

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.

The IRB Can Require A CR When Not Required By The Regulations

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.

The Rutgers IRB has determined that the following studies are still required to undergo continuing review even when considered eligible under the Revised Common Rule:

1. Research which requires annual review by a fully convened Board;
2. Research which is subject to the US Food and Drug Administration (FDA) oversight or by another sponsor that requires continuing review per sponsor contract;
3. Research involving the Department of Veterans Affairs (VA);
4. Research that is federally funded was approved prior to the implementation date of January 21, 2019 and has not transitioned to the revised Common Rule;
5. Research subject to the discretion of the HSPP or an IRB that may involve the following:
   1. Student-led research;
   2. Research involving non-Rutgers investigators;
   3. Research conducted internationally;
   4. Research including particularly vulnerable populations;
   5. Research involving additional regulatory oversight, such as a conflict of interest (COI) management plan;
   6. Research amendment or incident report revealing new findings that require additional oversight;
   7. Investigator has had previous serious non-compliance or a pattern of non-serious non-compliance;

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. 

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 approval process is pending.

The Rutgers 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 Rutgers IRB may determine that continuing review is still required or may determine continuing review is not required. If the Rutgers IRB determines that no further continuing review is required it may determine that a status report must be submitted at an interval of 1, 2 or 3 years or may establish that no status 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.

Submit your Continuing Review by the PI, no later than 6 weeks prior to the expiration of the study. In eIRB, submit a 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 a Modification in eIRB.

To submit a Progress  Report, enter your study in eIRB and select "Submit Progress Report". This must be submitted and approved prior the the expiration of your study.

Submission Methods

For current eIRB studies, submit your request using eIRB.

For current paper studies, complete a paper form with any other applicable documents and emaill your modification submission to the IRB. 

Overview

Federal Regulations and University Policy Mandate

If approval for continuation is not granted prior to the expiration date of the protocol, all recruitment, subject enrollment, and other research related activities (e.g. study visits, chart reviews, data analysis using subject identifiable data, manuscript development, etc.) must stop.

Currently enrolled subjects should continue to receive treatment and follow‐up that is in their best interest.

Failure to submit timely requests for continuing review demonstrates non‐compliance with federal regulations and institutional policy and is reportable to the FDA, OHRP, and the study sponsor (when applicable).

Continued non‐compliance affects the investigator's standing with the IRB and may prohibit the investigator from conducting future research at the University.

IRB Office Requirements

• In order to prevent non‐compliance due to an expired protocol, an investigator must submit his/her Continuing Review Application or Final Study Report to the IRB office
• At least 4 weeks in advance of the expiration date of IRB approval for minimal risk (expedited) protocols
• At least 8 weeks in advance of the expiration date of IRB approval for greater than minimal risk (full board) protocols
• If non‐compliance occurs due to an expired protocol, then the investigator must submit the Expired Study Report Form with his/her Continuing Review Application or the Closure Form with his/her Final Study Report. Both forms require the investigator to provide a detailed corrective action plan.

Corrective Action Plan for Expired Protocols

A corrective action plan describes how a delayed submission resulting in an expired protocol will be prevented from occurring in the future and what changes in procedure are being implemented to prevent protocol approvals from expiring in the future.

Below are three examples of acceptable corrective action plans:

Example #1

• My system/procedure to track deadlines will be by placing the dates in my calendar and in the calendar of the co‐investigators and other study personnel.
• The visual tool, with an available alarm, is the Outlook calendar that we will be using.
• My plan for maintaining calendar notifications for expiring protocols will be to set an alarm in the calendar which will notify us of expiration dates. The calendar will be backed up on the departmental server in case the local drive fails.

Example #2
The study’s coordinator is going to construct a well‐organized e‐file system for every study under the PI’s name. The folder will be located on the PI’s shared drive and will be organized by protocol. There will be subfolders within each protocol’s folder, organized in chronological order, for each of the continuing reviews, amendments, etc. This system will provide anyone new to the study, such as new research fellows, with easy access to the status of all studies under this PI and the most current IRB documents. Additionally, the coordinator is going to develop a spreadsheet for all protocols under the PI. The spreadsheet will be updated as needed and will serve as a quick reference for when continuing reviews need to be compiled and submitted.

Example #3
Upon receiving approval from the IRB:

• I will complete corrections to the final chapter of the project. At the time of suspending the project all of the research was completed. My faculty advisor had only reviewed the data that I compiled and only made recommendations for corrections to the written report.
• I will complete those corrections to the written report and then give my faculty advisor a weekly progress update on Fridays.
• My faculty advisor and co‐investigator will review my final written report.
• I will schedule a weekly meeting in person with my faculty advisor to review her recommendations to the final document.
• I plan to present the findings and submit the paper for publication. The results of this study will provide evidence based information to the ongoing discussion among stakeholders as they attempt to provide enhanced healthcare for foster children in the State of New Jersey.
• I will submit a Final Study Report/Study Closure Form to the IRB at least 4 weeks before my IRB approval expires after my paper has been accepted for publication or presentation and no additional analysis of the data will be done. If further data analysis is needed before my paper is accepted, then I will submit a Continuing Review Application to the IRB at least 4 weeks before my IRB approval expires.

Please note that exact duplication of these examples in place of an original corrective action plan will not be accepted by the IRB and will be returned to the investigator to be revised and then resubmitted to the IRB.

Notifications

1. All investigators shall receive via email and/or hard copy notices of pending expiration ofhis/her research study approximately 90, 60, 30 days prior to the expiration date.
2. Within 30 days of expiration a letter will be sent via email and/or hard copy to the PI, all co-investigators, and the Department Chair from the Campus-IRB Director notifying them ofthe expiration.
3. Within 30 to 60 days of expiration a letter will be sent by the Campus IRB Director to the IRB Chair and Executive Director, HSPP notifying them that the study is being referred to the Executive IRB committee. A copy of this letter will be sent to the PI, and the Depart Chair, or the Research Dean if the PI is a Dept Chair. This letter will include the dead line for submission of required documents and the Executive Committee meeting date at whichthe protocol will be reviewed. The date of the meeting to which investigators will bereferred will be identified by determining the next deadline that provides the PI will at least 15 business days to respond.
   1. Investigators who do not submit an application for continuation or closure prior totheir expiration date will be referred to the Executive Committee. The study will be reviewed by the Executive Committee for continuation or closure at the request of the principal investigator if it is received by the meeting deadline. The study will be referred for administrative termination if no application is received by the meeting deadline.
   2. Investigator submit a continuation or closure request prior to expiration, but whose protocols expire during the review process:
      1. Before assignment to an Executive Committee meeting date, a careful review of the study file will be conducted to access the timeliness of submission, the turn-around time of IRB reviews, and the amount of time IRB staff have taken to provide comments and/or other necessary materials and guidance to the investigators.
      2. In case where expiration of the protocol is due to IRB reviewer turn-around and/or IRB staff time, the protocol will not be assigned an Executive Committee review date. The file will be reviewed again for inclusion on an Executive Committee agenda in the following month if the study status is still at that time “Expired.” No notice will be generated.
      3. In cases where expiration of the protocol is due to the principal investigator’s failure to submit a response to an IRB debriefing memorandum, a notice of referral to the Executive Committee will be generated and accompanied by a copy of the outstanding debriefing memorandum. If the principal investigator does not respond to the debriefing memorandum prior to the submission deadline, the protocol will be included on the Executive Committee agenda for administrative termination. If the principal investigator responds to the debriefing memorandum prior to the submission deadline, the protocol will be included on the Executive Committee agenda for closure or continuation at the request of the principal investigator.
      4. Investigators who have left the institution: Following administrative closure of protocols of investigators who have been found to have left the institution, notification of the closure and referral for future follow-up will be made to the appropriate school research dean.

Any exception to these procedures will be made through special permission by the IRB Chair and/or Director.

Executive IRB Committee Actions

The Executive IRB shall take action based on the following Categories of Expired Protocols:

• Category 1: Unfunded minimal risk protocols – no submission of continuation application.
  • Protocols in this category may be voted upon as a group.
  • Protocols will be administratively closed.
  • Investigator is placed on probation.

• Category 2: Funded minimal risk protocols – no submission of continuation application.
  • Protocols in this category may be voted upon as a group.
  • Protocols will be administratively closed.
  • Sponsors will be notified of protocol status.
  • Investigator is placed on probation.

• Category 3: Unfunded greater than minimal risk protocols – no submission of continuation application.
  • Protocols in this category will be voted upon individually.
  • All these studies present greater than minimal risk to participants, the Executive Committee of the IRB will make a determination as to whether a for-cause audit will be required.
  • Investigator is placed on probation.

• Category 4: Funded greater than minimal risk protocols – no submission of continuation application.
  • Protocols in this category will be voted upon individually.
  • As these studies present greater than minimal risk to participants, the Executive Committee of the IRB will make a determination as to whether a for-cause audit will be required.
  • Sponsors will be notified of protocol status.
  • Investigator is placed on probation.

• Category 5: Unfunded minimal risk protocols with submission of continuation application.
  • Protocols in this category will be voted upon as a group.
  • Principal Investigators will be issued a warning letter requiring that they submit a response to the IRB addressing all outstanding issues within 15 days of notice.
  • Failure to provide adequate response by the stated deadline will result inadministrative closure.
  • Investigator is placed on probation.

• Category 6: Funded minimal risk protocols with submission of continuation applications.
  • Protocols in this category will be voted upon as a group.
  • Principal Investigators will be issued a warning letter requiring that they submit aresponse to the IRB addressing all outstanding issues within 15 days of notice.
  • Failure to provide adequate response by the stated deadline will result inadministrative closure.
  • Sponsor will be notified of protocol status.
  • Investigator is placed on probation.

• Category 7: Unfunded greater than minimal risk protocols with submission of continuation application.
  • Protocols in this category will be voted upon individually.
  • Principal Investigators will be issued a warning letter requiring that they submit a response to the IRB addressing all outstanding issues within 15 days of notice.
  • All these studies present greater than minimal risk to participants, the Executive Committee of the IRB will also make a determination as to whether a for-cause audit will be required.
  • Investigator is placed on probation.

• Category 8: Funded greater than minimal risk protocols with submission of continuation application.
  • Protocols in this category will be voted upon individually.
  • Principal Investigators will be issued a warning letter requiring that they submit aresponse to the IRB addressing all outstanding issues within 15 days of notice.
  • All these studies present greater than minimal risk to participants, the Executive Committee of the IRB will also make a determination as to whether a for-cause audit will be required.
  • Sponsors will be notified of protocol status.
  • Investigator is placed on probation.

Continuing non-compliance: An investigator who has been brought before the Executive IRB more than once for expired protocols will be considered for a determination of continuing non-compliance, subject to reporting to OHRP.

Exceptions may be granted by the IRB Executive Committee on a case by case basis.

Designation of Investigator-on-Probation

• Implications of designation as Investigator-on-probation:
  • Investigators-on-probation may not submit new protocols for review to Rutgers IRB or Western IRB, nor can they be added as study personnel to other existing or new protocol submissions.
  • Investigators-on-probation may submit review requests for continuation of other protocols.
  • IRB members who are determined to be investigators-on-probation may be suspended from membership on the IRB until they have complied with the conditions set forth to return to good-standing.
• Steps investigators-on-probation must take to regain good standing.
  • Investigators-on-probation must present a final report for each study that has been administratively closed by the Executive Committee of the IRB.
  • Investigators-on-probation must present a detailed corrective action plan addressing the reasons why protocols were allowed to fall out of review and explaining what steps will be taken to prevent future occurrences.
  • Once administratively closed by the IRB, Principal Investigators may not resume study activity on that protocol. The protocol must be submitted and reviewed as a new submission, and new approval granted prior to the initiation or continuation of research activities.