Research Ethics Review Program

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• Full Review

  • This process is undertaken for any studies that require medical intervention. It entails having two Committee members conduct an initial review of the study and subsequently, is reviewed by the entire Committee at the next scheduled meeting. Following the meeting, the Investigator is advised of any issues that require resolution prior to approval being granted.
  • Please see the “Check List for Submission of Research Study for Review” for a list of the requirements for submission of a study for Full Review.

• Expedited Review

  • Research activities involving no more than minimal risk may be reviewed by the Research Ethics Review Committee Chair through the Expedited Review procedure. Investigators may request that their study receive an expedited Review however, the Research Ethics Review Committee will make the final determination.
  • If, upon review by the Chair the study does not meet the criteria for Expedited Review, the Investigator will be notified by fax and mail that a full review is required.
  • The following would not normally be eligible for Expedited Review:
    • Genetic studies
    • Studies that involve medical intervention

  Examples of research studies that may be eligible for Expedited Review include:

  1. Collection of excreta and external secretions including sweat, urine, uncannulated saliva, placenta removed at delivery and amniotic fluid at time of rupture of the membrane prior to or during labor. 
  2. Recording of data from subjects 18 years of age or older using non-invasive procedures routinely employed in clinical practice.
     1. This includes the use of physical sensors that are applied either to the surface of the body or at a distance and do not involve input of matter or significant amounts of energy into the subject or an invasion of the subject’s privacy.
     2. It also includes such procedures as weighing, testing sensory acuity, electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, diagnostic echography, and electroretinography.
     3. It does not include exposure to electromagnetic radiation outside the visible range (for example: xrays, microwaves).
  3. Collection of blood samples by venipuncture, in amounts not exceeding 450 milliliters in an eight week period and no more often than two times per week, from subjects 18 years of age or older and who are in good health and not pregnant.
  4. Moderate exercise by healthy volunteers.
  5. The study of existing data, documents, records, pathological specimens, or diagnostic specimens.

  • Following review, the Investigator is advised of any issues that require resolution prior to approval being granted.
  • Please see the “Check List for Submission of Research Study for Review” for a list of the requirements for submission of a study for Expedited Review.

• Reciprocal Review

  • The College of Physicians and Surgeons of Alberta has signed a reciprocity agreement with the Alberta Cancer Board, the Governors of the University of Calgary, and the Calgary Health Region to share information relating to each of their respective Research Ethics Boards’ review of research studies. This avoids duplication of the review of the same research study by another party.
  • It is the responsibility of the Investigator to determine whether a study has been submitted to one of these Research Ethics Boards in Alberta. The Chair of the Research Ethics Review Committee of the College of Physicians and Surgeons reserves the right to subject the proposed submission to a full Committee review.
  • Please see the “Check List for Submission of Research Study for Review” for a list of the requirements for submission of a study for Reciprocal Review.

• Multi-centre Studies

  • The first application received at the College by an investigator applying for review of a study by the Research Ethics Review Committee (whether Full, Expedited or Reciprocal) is designated “Lead Investigator” by the RERC Administrator.
  • If/when subsequent applications are received from investigators at other sites in Alberta for the same research study, these investigators are designated “Additional Investigators”. These are the Committee’s terms and it is understood that there is a Qualified Investigator for each site.
  • The submission by the “Lead Investigator” is reviewed following the appropriate process (Full, Expedited or Reciprocal).
  • Upon approval of the study for the “Lead Investigator”, the “Additional Investigators” (for whom application forms have been received) are contacted and requested to submit any material that has not yet been provided as well as a copy of the approved version of the informed consent form on their letterhead (the most recently reviewed informed consent form is designated as the approved version and the version date on the bottom of the consent form is the approval date).
  • It is the responsibility of the “Additional Investigator” to obtain a copy of the approved version of the informed consent from the Sponsor. It must be placed on the investigator’s letterhead and their name and contact information must be inserted in the appropriate places. The approved version date must be in the footer of the document. The Investigator may choose to have an additional date (called a “site version date”) to reflect the date the consent was submitted from their site.
  • Upon receipt of the requested information, the application will be reviewed and the investigator will be notified of the outcome of that review. Please see the “Check List for Submission of Research Study for Review– Multi-centre Studies” for a list of the requirements for these submissions. Please note that an investigator may also submit an application prior to the study being approved for the “Lead Investigator”.

• Extension Studies

  • The Research Ethics Review Committee (RERC) has developed the following guidelines to assist in the submission of an Extension study.
    • No two Extension studies are alike, therefore, each will be considered individually.
  • The following information is intended to serve as a guide to assist you in meeting RERC requirements for Extension studies. Please refer to this information prior to each Extension study submission.
    • Definition:
      • An Extension study is one that requests:
        •  an extension of time to recruit additional subjects
        • an extension of time to collect more research data utilizing the approved original study protocol
        • an extension of time that also incorporates a change in procedures, dosages or testing for the subjects
        • “continuation phase” that was outlined in the submission of the original protocol but not completely documented 

  Procedures

  • If an Extension study is submitted with the original study protocol it will be reviewed by the full committee in the course of the original review and approved with the original protocol.
  • If an Extension study is submitted separately after RERC approval of the original protocol and it is only requesting an extension of time to allow for recruitment of additional subjects or to collect more data, then the review will be performed by the Chair.
  • If an Extension study is submitted separately after RERC approval of the original study protocol and incorporates changes or additions to the procedures, dosages and/or investigations, it will require separate review by the full committee.
  • Please note, Extension studies are not Amendments, therefore, all Extension studies do require a separate protocol number.

• Assessment Review

  • While in most cases it is clear whether a study protocol requires RERC review, there are situations where this determination is not so obvious.
  • Wherever possible, the Research Ethics Administrator will ask questions to help the investigator determine whether the proposal should be submitted to the RERC for review. 
  • Occasionally, to make a definitive determination, a preliminary assessment of the proposal by the RERC Administrator and/or the RERC Chair is required. The purpose of an Assessment is to make a definitive determination regarding requirement for submission of a proposal for RERC review.
  • The Assessment fee covers the cost of assessing a proposal and if appropriate, providing a letter that confirms research ethics approval is not required.
    • If the assessment determines that the proposal requires review and the study must be submitted to the RERC, the Assessment fee will be deducted from the normal cost of the service provided (e.g. Full Review or Expedited Review).