Review outcomes

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• Provisional option with request for further information

  The Committee may decide that a final opinion cannot be issued until further information or clarification has been received from the applicant.

  The time in which the REC have to issue an opinion is suspended until this further information has been provided, by the Chief Investigator, in full and meeting the REC’s requirements.

  Additional information should be provided within 1 month. If the REC has not received a response in 2 months, the application will be withdrawn.

• Provisional opinion pending consultation with referee

  The committee may decide that a final opinion cannot be issued until further advice has been sought from a referee. It should indicate a provisional opinion but not make a formal request for further information at this stage.

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• Favourable opinion with standard conditions

  The REC has formed a favourable opinion and standard conditions must be met before the start of the study. These are:

  • management permission or approval from the host organisations
  • regulatory approval must be obtained if required
  • clinical trials must be registered on a publicly accessible database.

• Favourable opinion with additional conditions

  The REC has formed a favourable opinion however conditions, other than standard conditions, must be met before the start of the study. This will depend on the study but for example:

  • minor adjustments to study or participant documents
  • completion of training such as GCP
  • clarifying data security measures
  • evidencing insurance cover.

  These conditions must not be to the effect that they would require further ethical consideration by the REC. If your study requires PBPP approval, the REC should not set PBPP approval as a condition of a favourable opinion. 

• Unfavourable opinion

  A REC may give an unfavourable opinion. This means that they have found significant issue with your study or application that cannot be addressed through revisions or provision of additional information.

  The REC must describe the reasons for their decision and any options available for further review.

• Informal guidance

  A REC may give informal and non-binding guidance as part of their review. This will be distinct from any conditions attached to an opinion.

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• Challenging an opinion, request or condition

  It is possible to challenge an opinion, request or condition set by the REC and the REC can vary their opinion in light of new information or resolution of an error or misunderstanding. This may, for example, be where it is not reasonably practicable to comply with the changes requested by the REC.

  A CI or sponsor can request a variation of opinion by writing to the Chair of REC, copied to the Head of Approvals Support. This process is described in sections 3.49-3.54 of the REC Standard Operating Procedures.

  An applicant may appeal against the decision of the REC and seek a second opinion from another REC. The appeal process, and other options following an unfavourable opinion, are detailed in Section 8 of the REC Standard Operating Procedures.

• Meeting conditions

  The Chief Investigator or Sponsor must notify the REC in writing when conditions have been met and provide copies of final documents for reference. The REC should acknowledge receipt within 5 working days and confirm whether conditions have been met.

• Confirmation of favourable opinion

  You will receive confirmation from the REC of their favourable opinion and that any conditions have been met. This is in the form of an email and letter giving a REC reference number. All communications relating to the RECs opinion will also be sent to the study sponsor.

  The RECs favourable opinion does not equate to approval to begin your research. You must first obtain:

  • R&D approval - R&D should have already received your documents via IRAS, however, they may still wish to confirm details or put in place an agreement
  • University ethics approval.

  Only once all approvals are in hand can you begin your study.

  For more on what's required once you've obtained approval, see the once you have approval page.