SOP #20 Continuing Review of Approved Research

Owner: Vice President of Academic Affairs
Author: CSS IRB
Contact: irb@css.edu
Policy Number: 20
Effective Date: 10/8/2021

 

1. Policy

The CSS IRB requires that human subject research activities be reviewed in accordance with federal regulations (CFR 45 §46.109 (e) (f)) and at intervals appropriate to the degree of risk.

OHRP CONTINUING REVIEW GUIDANCE

Under the revised Common Rule, continuing review is not required for:

  • Research that is eligible for expedited review.
  • Exempt research conditioned on limited IRB review.
  • Research that has completed all interventions and now only includes analyzing data, even if the information or biospecimens are identifiable.
  • Research that has completed all interventions and now only includes accessing follow-up clinical data from clinical care procedures.

Importantly, the IRB can override this default and still choose to require continuing review, as long as the IRB documents the decision and the rationale for this decision.

[Refer to 45 CFR 46.109(f), 46.110, and 46.115(a)(8) of the revised Common Rule.]

2. Purpose

The IRB conducts continuing review of approved research at intervals appropriate to the degree of risk. Federal regulations require an IRB to conduct substantive and meaningful continuing review of human subjects research that is within the jurisdiction of the IRB. This SOP outlines the criteria for continuing review, and investigator and IRB responsibilities.

3. Research Approved Following 2018 Revised Common Rule Requirements

As of January 21, 2019, research meeting the following criteria does not require continuing review, unless the IRB specifically documents that continuing review is required:

  • Per IRB determination, the research presents no greater than minimal risk to subjects, OR
  • The research has progressed to the point that it involves only data analysis or accessing follow-up data from procedures that subjects would undergo as part of clinical care, and
    • The research does not include FDA regulated components.

Nevertheless, the IRB may determine that research meeting the above criteria is required to undergo continuing review, for example:

  • The research involves regulatory oversight that must be monitored, such as Conflict of Interest.  (See, CSS IRB SOP #36 Conflict of Interest (COI) and COI Disclosure for IRB Members.)
  • The PI or other research personnel have had serious non-compliance (See, CSS IRB SOP #30 Non-Compliance with Human Subjects Research Policies/ Guide and Report Form), or
  • A pattern of non-serious non-compliance in their research practice (reviewed on a case by case basis).

In such cases, the IRB will specifically document that continuing review is required for the research, including the justification for requiring continuing review.

When continuing review is not required, investigators continue to be responsible for submitting to the IRB any adverse events, compliance issues, and modifications for the life of the research, and for notifying the IRB of the completion of the research using the Closure Form within IRBNet.

4. Procedure If Continuing Review is Required

A. Investigator Responsibilities

For multi-year research, the principal investigator is responsible for submitting a continuing review application, if appropriate,  through IRBNet with sufficient time prior to the expiration of the current IRB approval so that there will be no lapse in the study approval. Allow at least one month for a full committee continuing review and two weeks for an expedited continuing review.

Submission Requirements.

Submit the Continuing Review via IRBNet - IRBNet will direct the PI through the process. In order to determine the status of the study, the following will be available for the IRB members to review:

  1. Materials maintained within the study workspace in the electronic IRBNet system including but not limited to:
    1. Current and previous versions of IRB-approved consent document(s).
    2. Current and previous versions of the IRB-approved protocol including any previously-approved amendments to the research.
    3. All unanticipated problems related to the research involving risks tosubjects or others including Serious Adverse Events and major protocol deviations that required prompt reporting.
    4. All amendments to the study.
    5. A list of all current study personnel.
  2. Continuing Review Submission and supporting documents (e.g. monitoring reports).

B. Possible Outcomes of Continuing Review

As an outcome of continuing review, the IRB may take any appropriate action allowed under the review process.

Additionally, the IRB may also take any of the following actions:

  • Require revision of the protocol, consent or other approved materials consistent with the current status of the study and any change in regulatory requirements.
  • Suspend or terminate approval of the research.
  • Impose special conditions or relax conditions previously imposed on the research protocol.

C. Expedited Review for Renewal

For a protocol that qualifies for expedited review  where continuing review is required, the continuing review may also be conducted using expedited procedures.  (See, CSS IRB SOP #11, Expedited Review Procedure and Checklist.)

Continuing review of research previously approved by the convened IRB may be reviewed via expedited review where no subjects have been enrolled and no additional risk to subjects have been identified.

When conducting research under an expedited review procedure, the IRB conducts the review using the same criteria used to grant initial approval, as listed in CSS IRB SOP #27 Initial Review and CSS IRB SOP #12, Criteria For IRB Approval Of Research.

If the review indicates that there has been a change to either the risks or benefits, the study may be referred for Full Board review.

D. Status or Progress Report

IRBNet will ask for information regarding the status or progress of the research during the last year. The information will include but is not limited to:

  • The number of participants accrued.
  • The number of withdrawals and the reasons for withdrawals.
  • Unanticipated problems including complaints about the research.
  • Amendments to the research.
  • Any relevant recent literature, any interim findings, any relevant multi-center trial reports if applicable.
  • An assessment by the researcher of the current risk-potential benefit based on study results to date.

E. Amendments to the Protocol

Changes to the protocol or study documents may be submitted at the same time as the continuing review. An investigator must not implement proposed modifications until the changes are reviewed and approved by the IRB.

F. Avoiding Lapses in Approval

If an IRB approval expires, All Research Activities Involving Human Subjects Must Stop! These activities include subject contact, data collection and data analysis. The only exception to this requirement is for activities that are needed for participant safety. Contact the CSS IRB to discuss this possibility. No new subjects may be enrolled.

In cases of the need for continuing study activities for participant safety, the information that the IRB needs to allow this exception is included in the Continuing Review Application. The IRB determines on a case-by-case basis whether treatment may continue for currently enrolled subjects. The IRB will notify the investigator if it is permissible under federal guidelines to continue limited research activities.

If project activities occur or continue after the expiration date, the investigator is out of compliance with both federal regulations and CSS policy. The IRB cannot grant retroactive approval for work done after the expiration date. Even if the continuing review application has been submitted to the IRB, all activities must stop until approval is granted.

The application for continuing review will ask for details about any lapses and will also ask for a corrective action plan to ensure such lapses do not occur in the future.  (See, CSS IRB SOP #30 Non-compliance With Human Subjects Research Policies/Guide and Report Form).

5. IRB Reviewer Responsibilities

A. Review Criteria

Continuing review of research, if appropriate, must be substantive and meaningful. The criteria for continuing review are the same as those for initial review. Therefore, the IRB (or the Chair or his/her designee for protocols reviewed using expedited review procedures) must determine that all the following requirements are satisfied:

  • Risks to subjects continue to be minimized and reasonable in relation to anticipated benefits;
  • Selection of subjects continues to be equitable;
  • Informed consent is sought or waived in accordance with 45 CFR 46.116 as well as 21 CFR 50.25 for FDA-regulated research.  (See, CSS IRB SOP #16, Informed Consent w Checklist and Templates and CSS IRB SOP #15, Waiver or Alteration of Consent Waiver Request Form Reviewer Checklist)
  • Informed consent will be documented, or documentation waived in accordance with 45 CFR 46.117 and 21 CFR 50.27 for FDA-regulated research. (See, CSS IRB SOP #18, Waiver of Documentation of Consent.)
  • The research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects, when appropriate; o There are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data, when appropriate, and o Appropriate safeguards for vulnerable subjects are provided. o If multi-site research, the study management of information relevant to protection of subjects is adequate.

B. Review of Recruitment, Screening and Consent Documents:

When reviewing the recruitment, screening and/or consent documents, the IRB will ensure the following:

  • The currently approved or proposed documents are complete, accurately reflect the information in the study application, and meet all the regulatory and College criteria for approval.

Any new findings that may relate to the subject’s willingness to continue participation are provided to the subject in an updated informed consent form or addendum to the informed consent form.

C. Determining Appropriate Interval for Continuing Review

The IRB will determine which projects require review more often than annually in order to ensure the continued protection of the rights and welfare of the research subjects. The IRB considers the following factors, along with any other factors deemed relevant by the IRB, in determining the frequency of review:

  • the nature of the study,
  • the degree of risk involved, and
  • the vulnerability of the study subject population.

The IRB will communicate to the investigator in writing any determinations of a requirement for review more often than annually and indicate this in the minutes for the meeting.

6. Verification from Other Sources

The IRB will determine which projects need verification from sources other than the investigators that no material changes have occurred since the prior IRB review on a case-by-case basis.

7. Continuing Review Reminders and Notices

  • As a courtesy, IRBNet sends out continuing review reminders before studies expire. A notice of expiration is issued on the date of expiration of each study.
  • Investigators are advised to complete the Continuing Review Application via IRBNet and submit the required accompanying documentation within thirty days from the date of expiration.
  • It is ultimately the investigator’s responsibility to submit a continuing review application and to allow sufficient time for the review and re-approval process to be completed before the current approval expires.
  • The expiration date listed on the Approval Notice and within IRBNet is the last date on which research activities may occur.

Resources

45 CFR § 46.109(e)

45 CFR § 46.109(f)OHRP Guidance – Revised Common Rule Q and A’s

https://www.hhs.gov/ohrp/education-and-outreach/revised-common-rule/revised-common-rule-q-anda/index.html

Children’s Hospital of Philadelphia Continuing Review of Approved Research

https://irb.research.chop.edu/sites/default/files/documents/irbsop404_cr_012219.pdf UCLA Guidance: IRB Review Type – Continuing Review http://ora.research.ucla.edu/OHRPP/Documents/Policy/4/Continuing_Review.pdf

This is a new policy per the 2018 Common Rule Requirements.

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