/ Biomedical UofS Research Ethics Board
Renewal Form
Secondary Use of Health Data or Biological Material

Please type in your responses, save a copy and email to . All parts of this form are required and must be filled out. Incomplete or handwritten forms will not be processed by the Research Ethics Office. Should you have questions, please contact us at 306-966-2975 or .

(Double click on boxes to check)

Use this form ONLYif your research involvessecondary use of existing health data or biological materials.

PART 1: Identification:

Bio #:

Study Title:

Principal Investigator or Supervisor:

Current Expiry Date: Click here to enter a date.

Sponsor: Funder:

List of current Student(s) with E-mail addresses:
If more than one, use tab at the end of the line (if you are using a word version that does not support this feature please use the return key to add additional lines). / N/A
Name: / Email:
Have there been any changes in Research Personnel?
(PI, Sub-investigators, students i.e. undergrad, grad, post-doc, resident)
If yes, please list below and specify add/remove:
If more than one, use tab at the end of the line (if you are using a word version that does not support this feature please use the return key to add additional lines). / Yes No
Add or Remove / Name
(first name, last name) / Specify PI, Sub-I or Student / Department / Email:
PART 2: Nature of the Study:
Secondary use of health data / Secondary use of biologicalmaterial
If biological materials were used, please specify type used:
PART 3: Current Status of the Study:(please mark all that apply)
Health Data/Biological Materials have not yet been obtained
Health Data/Biological Materials are still being collected
Health Data/Biological Material collection is complete. Remaining research activities are limited to data analysis of already collected data.
If the study is completed, please submit a study closure form
PART 4: Number of Biological Materials/Charts:(complete each line)
  1. Target/expected number of biological materials/charts:

  1. Number of biological materials/charts accessed to determine eligibility in this reporting period:

  1. Number of biological materials/charts obtained in this reporting period?

  1. Other, please explain:

PART 5: Study Design:
Have there been any changes to the study (study design or procedures) that have not already been reviewed and approved by the Bio-REB?
If yes, please submit an amendment. / Yes No
PART 6: Post-Approval Reporting:(for the last reporting period ONLY)
Reportable Unanticipated Problems:
Unanticipated Problems include any incident, experience or outcome (including an adverse event or breach of confidentiality) that meets ALL of the following criteria:
1)Unexpected in terms of nature, severity or frequency
2)Related or possibly related to participation in research
3)Suggests that research places research participants or others at a greater risk of harm than was previously known or recognized
  1. Were there any unanticipated problems that fit the reporting criteria?
/ Yes No
If yes, were they reported to the REB? / Yes No
If not reported to the REB please attach an Unanticipated Problem Report Form

2. Have there been any study participant complaints about the research in thelast reporting period? / Yes No
If yes, were they reported to the REB? / Yes No
If no, please describe:
3. Have any ethical concerns arisen related to the study in the last reporting period? / Yes No
If yes, were they reported to the REB? / Yes No
If no, please describe:
PART 7: Study Progress:(Required)
Provide a brief summary of study progress to date:
PART 8: Data Security and Storage:
Has data storage or security arrangements changed in any way in the last reporting period? / Yes No
If yes, please describe:

PART 9: DECLARATION BY PRINCIPAL INVESTIGATOR:

The submission of the Renewal Formfor this study, confirmsthat the Principal Investigator assumes full responsibility for the scientific and ethical conduct of this study and agrees to conduct this study in compliance with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2 2014), the Personal Health Information Protection Act (HIPA) and other relevant laws, regulations or guidelines, [e.g., Health Canada Part C, Division 5 of the Food and Drug Regulations, Part 4 of the Natural Health Products Regulations, Medical Devices Regulations, and ICH/GCP Consolidated Guideline E6].

Date the form was completed Click here to enter a date.
Name of Person who completed the form

If form submitted on behalf of the PI:

is authorized to prepare and submit this form on behalf of the Principal Investigator
Authorized person contact information:
Email: / Phone:

Please forward the form to the

Biomedical Annual Renewal Form For Secondary Use Research

June2015 Page 1 of 3