How to Apply for Ethics Review
Research Ethics Board How to Apply for Ethics Review 2013 Research Ethics Board Review Guide Document Index 1. RVH REB Web-site Home Page………………………………….... Page 2 2. Does My Research Require Ethics Review?................................. Page 3 3. What Kind of Review Does My Research Require?...................... Page 5 4. How to Apply……………………………………………………….…. Page 6 5. FAQ’s…………………………………………………………………… Page 8 6. General Application…………………………………………………… Page 10 7. Retrospective Chart Application……………………………………….. Page 29 8. Elements of Informed Consent ………………………………………… Page 39 9. Expedited Review Checklist………………………………………..…. Page 40 10. Full-Board Review Checklist……………………………………..…… Page 41 11. Privacy Tool/Checklist…………………………………………………. Page 42 12. Submission Guidelines……………………………………….…..……. Page 43 13. Informed Consent Generic Template for minimal risk studies…….. Page 44 Page 1 About the RVH Research Ethics Board 1. Does my research require ethics review? 2. What kind of review does my research require? 3. How to apply 4. Submission Guidelines Links: ADR/SAE Reporting CAREB SAE Reporting Guidance 2010 Educational Links & Training Manual FAQ's The RVH Research Ethics Board (REB), is a ten-member board that meets monthly and is composed of a variety of healthcare and community professionals, in accordance with its Terms of Reference. The REB is charged with safeguarding the interests, rights and wellbeing of patients who participate in Research Studies/Clinical Trials. This is achieved in three ways: 1. By reviewing for integrity, all proposed new Clinical Trials/Studies. 2. Review of all reported serious and unexpected adverse events; and 3. Review of all revised/amended documentation throughout the duration of the clinical trial. The REB adheres to the principles set out in: 1. 2. 3. 4. 5. 6. TPD/ICH Good Clinical Practice Guidelines The Tri-Council Policy Statement Personal Health Information Protection Act 2004 Food & Drug Regulations Schedule 1024 The Canadian Charter of Rights and Freedoms The Code of Federal Regulations Fee schedule Forms Research Ethics Certification: Educational Links Meeting Schedule Membership 1. CITI-Canada Good Clinical Practice; Responsible Conduct of Research; or Biomedical Research Ethics Education module(s) https://www.citiprogram.org/ Policies & Procedures 2. Panel for Research Ethics Tri-Council Policy Guidelines (2) Statement (TCPS2) on-line Certification http://tcps2core.ca/welcome Delegation of Signing Authority Protocol Violations Submission Deadlines Confidentiality Template Application Package Page 2 Does My Research Require Ethics Review? Generally, all research that involves human subjects requires review and approval by an REB. If you are uncertain whether REB review is required you must obtain the written opinion of the Chair of the REB as to whether the research should be subjected to prior ethics review and approval. The Chair of the REB will decide whether a given project: • • • Requires full REB review; Is eligible for delegated review (formerly known as an “expedited review”) Is exempt from REB review. Research proposals must be approved by the REB before you can begin the research The Tri-council Policy Statement (TCPS2) Guidelines set out the following requirements for ethics review: Article 2.1: The following requires ethics review and approval by an REB before the research commences: (a) Research involving living human participants; (b) Research involving human biological materials, as well as human embryos, fetuses, fetal tissue, reproductive materials and stem cells. This applies to materials derived from living and deceased individuals. Article 2.2: Research that relies exclusively on publicly available information does not require REB review when: (a) The information is legally accessible to the public and appropriately protected by law; or (b) The information is publicly accessible and there is no reasonable expectation of privacy. Article 2.3: REB review is not required for research involving the observation of people in public places where: (a) It does not involve any intervention staged by the researcher, or direct interaction with the individuals or groups; (b) Individuals or groups targeted for observation have no reasonable expectation of privacy; and (c) Any dissemination of research results does not allow identification of specific individuals. Article 2.4: REB review is not required for research that relies exclusively on secondary use of anonymous information, or anonymous human biological materials, so long as the process of data linkage or recording or dissemination of results does not generate identifiable information. Page 3 Article 2.5: Quality assurance and quality improvement studies, program evaluation activities, and performance reviews, or testing within normal educational requirements when used exclusively for assessment, management or improvement purposes, do not constitute research for the purposes of this Policy, and do not fall within the scope of REB review. In summary, human research is considered to include any of the following, if the researcher: • • • • • • • Will administer a drug, take a blood sample, do a test or perform any procedure, clinical, therapeutic, or otherwise, upon the person of himself/herself or someone else, for research rather than treatment Will ask people information whether by telephone, letter, survey, questionnaire or interview Will review information from patient charts (even their own patients' charts) for research rather than clinical purposes Will use material derived from people (tissue samples, blood, DNA) Will be using non-public records (e.g. not the telephone book) which contain identifying information about anyone either directly or indirectly Will use information previously gathered about anyone - secondary data analysis Will be observing anyone's responses or behaviour, either directly or indirectly If you cannot determine whether an intended investigation constitutes research (for instance, quality assurance studies do not constitute research), contact the Chair of the REB or the Ethics Coordinator or the Ethics Coordinator for assistance. Page 4 What Kind of Review Does My Research Require? FLOW-CHART Research Protocol Submitted to REB in accordance with PHIPA, TCPS & GCP Guidelines Expedited Review Minimal risk (TCPS C1) Non-therapeutic intervention 30 day turn-around Reviewed by 2 REB members i.e. Surveys, Chart Reviews, Questionnaires Disposition Full-board Review Not minimal risk (1.6 TCPS) 30 – 90 day turn-around Reviewed by all REB members at monthly full-board meeting Full-board review is the default requirement unless expedited review is authorized by Chair Disposition (a) Approved (a) Approved (b) Approved with Revisions (b) Approved with Revisions (c) Denied (c) Denied Page 5 How To Apply 1. New Studies for Initial Review 1. Print and read the “FAQs” form on the REB web-site. 2. Download and print “Expedited Review Check-list” or “Full-board Review Check-list” (as applicable). 3. Follow instructions on Check-list precisely, for assembling of documents for submission. 4. Download and print application package. Select either the General Application or the Retrospective Chart Review Application. 1 5. Fill out application form. Obtain all departmental impact signatures 6. To obtain Departmental Impact Signatures: Contact the Administrative Assistant of the Impacted Department(s). Arrange to provide a full set of study documents, including a completed Application Form, for signature by the Clinical and Administrative Directors of the department. The Administrative Assistant will contact you when sign-off has occurred. 7. Clinical Trials only: Download and print RVH Patient Information form and attach to hard-copies of Informed Consent Forms (as the last page). 8. Submission must be hard-copy, triplicate, bound with sturdy clips. 9. Send submission to: Ms. Romaine Miller Research Ethics Board Coordinator Room 3251 Royal Victoria Regional Health Centre 201 Georgian Drive Barrie, Ontario L4M 6M2 1 Note: Departmental Impact forms may also be required for Radiology, Pharmacy and Lab. These forms may be downloaded from our ‘Forms’ site. Page 6 2. Continuing Review 1. All Submissions for continuing review should be submitted in triplicate, collated, with a covering letter fully describing the nature of the submission, the documents attached and the type of review you are requesting. 2. Amended Documents must contain ‘tracked-changes’, a new date/version number in the footer and include a Summary of Changes, or they will be returned to the Investigator. 3. Submit to the REB as in (6) above. 3. Adverse Drug Reactions (ADR’s) - Reporting The RVH REB follows the CAREB 2010 Guidance on SAE/ADR reporting. 1. All ADR’s should be submitted in duplicate, collated, in accordance with GCP Section 4.11 reporting requirements: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guideld/ich/efficac/e6-eng.php#a4.11. Please also see the RVH REB Web-site. 2. A completed SAE Tracking Form should be completed and appended to the front of the reports. Page 7 FAQ’s Question 1. What forms do I need and how do I apply for ethics review? Response 1. Click here for instructions: http://www.rvh.on.ca/UserFiles/File/Research%20Ethics/FORM S1.doc and 2. http://www.rvh.on.ca/UserFiles/File/Research%20Ethics/HOW %20TO%20APPLY.doc 2. Can submissions be made electronically? No. 3. Is the submission dead-line for full-board review, flexible? Permission from the REB Chair must be obtained to apply postdeadline. 4. Who signs the Departmental Impact Section on the general application form? The Clinical and Administrative Directors of all departments impacted by the study must provide impact signatures, on the general application form. Forms are available on the home page. It is the researcher’s responsibility to obtain these signatures prior to applying. Submissions without impact signatures are considered ‘incomplete’ and will be returned to the researcher. 5. How long does ethics review take? Expedited review turn-around is usually less than 30 days. Fullboard review turn-around is between 30 – 90 days, depending upon the complexity of the study, the number of modifications required by the REB Review Letter and the time taken by the PI to respond to the REB Review Letter. RVH employees do not prepare ethics submissions. The researcher is responsible for all aspects of the submission. 6. I am an external researcher. What RVH Employee looks after obtaining departmental impact signatures and preparing/copying the forms and documents for ethics review? 7. I have REB approval from another board outside of this hospital, do I need to obtain research ethics review for my study here at RVH? Yes. All documents submitted to the original board must also be submitted to RVH, in accordance with our submission guidelines. 8. Is there a fee for REB Review? Fees are payable for industry studies. Please see Fee Schedule: http://www.rvh.on.ca/UserFiles/File/FEES%20June%202,%202009( 3).doc Page 8 9. I have questions regarding the research ethics process and/or the content of my submission. Who may I consult with? You may consult with the REB. The REB strongly encourages researchers to come forward with any questions they may have, prior to study submission and/or review. The REB is committed to providing education, guidance and leadership in the application of ethical principles to the conduct of research to investigators, staff and students The first point of contact is the REB Coordinator at ex. 43318. The REB Chair or his/her designate, is available by appointment, to assist with more complex issues. The Chair of the REB may also request a meeting with the researcher(s) to determine if or how the protocol can or should be modified to satisfy the concerns of the REB (see REB P&P’s). Page 9 Royal Victoria Regional Health Centre 201 Georgian Drive Barrie, ON L4M 6M2 General Research Application Instructions 1. This form is used to apply for initial REB review of most new research projects (except for studies listed in point 2) 2. Do not use this form for Chart reviews, Prospective databases, or Human tissue research. Specialized forms are available on our website. 3. Please answer all questions. If your application is incomplete it cannot be reviewed. Please see our website for information on “How to Apply, FAQs and Submission Guidelines”. 4. Researchers should submit their application should to: RVH Research Ethics Board c/o Romaine S. Miller, REB Coordinator 201 Georgian Drive, Barrie, ON L4M 6M2 705.728.9090 x 43318 millerr@rvh.on.ca Requirements: (3) Paper copies of your application and all supporting documents. One copy must have original signatures. (1) Electronic copy of your submission. The deadline for full-board review is 30 days prior to the next Full Board meeting. There is no deadline for Expedited Review of minimal risk studies. The REB meets on the third Wednesday of every month. Researchers can expect to receive the results of the review within 15 business days of the REB meeting. 5. CITI Canada Good Clinical Practice (GCP) and Tri-Council Policy (TCPS) Training Requirements – NEW Web-site: https://www.citiprogram.org/login.asp?strKeyID=003EA32F-ED44-4AAC-AB3D-BF65D2CC38BC13039371&language=english All local principal investigators (LPIs) involved in clinical trials, are now required to provide proof of GCP training when submitting an application to the RVH Research Ethics Board (effective January 1, 2014). Refer to Section 2 - Question 1. For all other (non-clinical trial) research, effective January 1, 2014, the LPI will be required to provide proof of completion of either the TCPS2: CORE (Course of Research Ethics http://tcps2core.ca/welcome ) online training or of CITI-Canada Biomedical training: https://www.citiprogram.org/login.asp?strKeyID=003EA32F-ED44-4AAC-AB3DBF65D2CC38BC-13039371&language=english Application for equivalency for both types of research may be made to the RVH REB until January 1, 2015. Page 10 RVH REB: General Research Application 1. General Information 1. Title of Study: 2. Keywords (list up to five): 3. What is your expected study period? Start: (m/d/y) End: (m/d/y) 4. Has this study undergone a formal scientific review? If yes, please attach the approval letter Yes No Yes No 5. Has this study been submitted to any other REB? If yes, please attach the approval letter (or relevant correspondence) 6. Has this study been denied approval by any other REB? If yes, please attach the REB letter Yes 7. Is this an industry sponsored study? If yes, who is the sponsor? 8. Is this an investigator-initiated study? 10. Is this a multi-site study? Yes No No Yes Yes No 9. Is this a student project? Resident/Fellow If yes, please specify: Yes No MD Post-doc PhD Master’s Undergrad No 11. Do you plan on conducting this study at RVH? Yes No 12. How will you make the results of this study public? Peer reviewed publication Clinical trial registry Report to participants (please explain): Other (please explain): Thesis Presentation 13. How would you explain this study to a lay person (max. 10 lines)? Page 11 RVH REB: General Research Application 2. Investigators 1. Who will serve as the Principal Investigator (PI) for this study? The PI cannot be a student. First: Last: Degree: Institution: Dept: Program: Address: City: Province: PC: Tel: Ext: Fax: Email: GCP/TCPS Training: Is this a Clinical Trial? Yes No . • If Yes, please complete the CITI-GCP Tutorial (https://www.citiprogram.org/) and indicate your Certificate # If you completed another accredited GCP training instead of the CITI-GCP tutorial, please append the program outline and completion certificate for the other training. • If No, please see the Instruction page regarding the upcoming requirement - effective January 1, 2013 - for the LPI to complete either the TCPS2: CORE (Course of Research Ethics) training or GCP training and append certificate. Yes No 2. Is the Principal Investigator (PI) of this study affiliated with RVH? If No, please complete this section. If this is a student project, please name one student as PI. First: Last: Degree: Institution: Dept: Program: Address: City: Province: Tel: Ext: Fax: Email: 3. Does this study have a Coordinator? If Yes, please complete this section First: Institution: Address: Tel: Ext: Yes Last: Dept: City: Fax: Student PC: No Degree: Program: Province: Email: Student PC: Yes No 4. Does this study have any Co-investigators? If Yes, please complete this section. To list additional researchers, please include a separate page with your paper submission Student First: Last: Degree: Institution: Dept: Program: Address: City: Province: PC: Tel: Ext: Fax: Email: First: Institution: Address: Tel: First: Institution: Address: Tel: First: Institution: Address: Tel: First: Institution: Address: Tel: Ext: Last: Dept: City: Fax: Degree: Program: Province: Email: Ext: Last: Dept: City: Fax: Degree: Program: Province: Email: Ext: Last: Dept: City: Fax: Degree: Program: Province: Email: Ext: Last: Dept: City: Fax: Degree: Program: Province: Email: Student PC: Student PC: Student PC: Student PC: Page 12 RVH REB: General Research Application 3. Description of Research Yes No 1. Is this a clinical trial? A clinical trial is “…any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc.” (WHO) Yes No 2. Is this an observational study? An observational study monitors change over time without introducing an intervention 3. Does this study include human tissue collection or analysis? Retrospective Prospective If yes, please specify: Yes No Yes No 4. Does this study include genetic testing? If yes, please attach a separate Genetic Consent form 5. Does this study require access to existing records? If yes, please specify the source: Health Records (specify): Electronic Database (specify): Outside Institution (specify): Other (specify): Yes No Yes No 6. Does this study involve qualitative methods? If yes, please specify: Questionnaire/Survey Focus Group Please attach a copy of all study questions and interview guides 7. Does this study involve any other types of research? If yes, please explain: Yes Interview Other (specify): No Page 13 RVH REB: General Research Application 4. Clinical Trials * If this is not a clinical trial, please go to section 6. 1. What type of clinical trial is this study? (Please check all that apply) Pilot Phase 1 Phase 2 Randomized Double Blind Single Blind Other (specify): Phase 3 Open Label Phase 4 2. Will this trial use an Active comparator? Yes No If yes, please justify that this treatment is standard care and that clinical equipoise exists (max 5 lines): Yes No 3. Will this trial use a Placebo control? Please see TCPS Section 7.4 for limits on the use of placebos If yes, please justify that a placebo is necessary and that clinical equipoise exists with respect to this treatment (max 5 lines): Please describe how you will reduce the risks to participants assigned to placebo (max 5 lines): 4. Does this trial involve a new investigational drug, device, or natural health product? Yes No 5. Does this trial involve a drug, device or natural health product used for an indication outside of the Health Canada Yes Notice of Compliance (NOC) or Drug Identification Number (DIN) application or Medical Device License? No Yes No 6. Does this trial require Health Canada approval? If yes, who submitted the Clinical Trial Application to Health Canada? LPI PI Sponsor (specify): Other (specify): 7. Have you received a No Objection Letter (NOL) from Health Canada? Yes The NOL must be submitted to the REB in conjunction with this application. 8. Has this study been registered on a clinical trial registry? Registry name: Registration number: All clinical trials must be registered before they begin Yes No No Page 14 RVH REB: General Research Application 5. Methodology * This section is intended to be a summary. Please submit a study protocol detailing the research that you plan to conduct. 1. What is the rationale for this study (i.e., why are you doing this study; max 5 lines)? 2. What are the objectives of this study (i.e., what do you hope to show; max 5 lines)? 3. Please specify your study design (e.g., RCT, cohort; max 5 lines): 4. Please specify your study population (e.g., diagnosis, age, gender; max 5 lines): 5. Please specify your study procedures (max 5 lines): 6. What is your primary outcome and how will it be measured (max 5 lines)? 7. What are your secondary outcomes and how will they be measured (max 5 lines)? 8. What is your sample size? Local: Total (for multi-site research): 9. How did you determine your sample size (max 5 lines)? 10. How will you analyze your data (max 5 lines)? Page 15 RVH REB: General Research Application 6. Study Interventions Yes No 1. Does this study involve any diagnostic testing? If yes, please specify: Imaging Lab Other (specify): Yes 2. Does this study involve any of the following interventions? If yes, check all that apply: Chemotherapy Drugs Radiotherapy Natural health product Gene therapy Cognitive/Behavioural therapy Other (specify): No Surgery Medical Device 3. Does this study require any drugs? Yes If yes, list all drugs identified in the protocol Investigational Generic Brand Yes No Yes No Yes No Yes No Yes No Yes No Observation Questionnaire/Survey Exercise Focus group Interview No Manufacturer Dose Freq Route Duration 7. Safety and Monitoring * All studies must be monitored to ensure participant safety and confidentiality, and to ensure the integrity of data collection and analysis. 1. How will you monitor the conduct of this study (max 5 lines)? If this is a minimal risk Undergraduate/Master’s study, the student’s Supervisor should serve as monitor. 2. Does this study have a formal steering committee? If yes, please explain: 3. Will an interim data analysis be done? If yes, please explain: Yes Yes No No 4. Will you use a data safety monitoring board (DSMB)? Yes No If yes, is it independent of the sponsor? Yes No Page 16 RVH REB: General Research Application 8. Risks and Benefits 1. What are the risks to participants in this study (e.g. pain, distress, privacy breach, social implication; max 5 lines)? 2. How will you minimize and manage the risks (max 5 lines)? 3. Will participants receive any other benefits from participating in this study (e.g. continued access to new drug)? No Yes If yes, please explain: 4. Will participants be reimbursed for study related expenses (e.g. parking)? If yes, please explain: 5. Will participants receive any compensation (e.g. money for time)? If yes, please explain: Yes Yes No No 6. How will the scientific community and society benefit from this study (max 5 lines)? 9. Participants Yes No 1. Does this study focus on any of these potentially vulnerable groups? If yes, check all that apply: People with cancer Children People with incurable disease Elderly people People in medical emergencies Aboriginal people (see TCPS2 Chapter 9) People in long-term care People in poverty People with mental health issues People in prison People who are unable to consent Other (specify): 2. Do you have any age, ethnic-specific groups, language, gender or race-related inclusion or exclusion criteria? No If yes, please explain: Yes Page 17 RVH REB: General Research Application 10. Recruitment 1. How do you plan to recruit participants? Investigators will approach their own patients/students Investigators will receive referrals from other Healthcare providers Decision support services (DSS) will prepare a list of potential participants. DSS signature required Advertising (e.g., poster, email, web-based). Please submit a copy of all advertisements Database of people who consented to future contact. Please explain: Direct approach (e.g. random digit dialing). Please explain: Educational records (e.g. information from Registrar). Please explain: Other (specify): Patients may not be approached by a researcher until someone in the patient’s circle of care has asked the patient if they are interested in hearing about a study. 2. Do you need to screen Personal Health Information (PHI) of patients to identify potential participants? Yes No If yes, please describe your screening process (max 5 lines): Researchers must destroy all information collected during screening in a secure manner, as soon as screening is complete. 3. Does your recruitment plan require you to contact potential participants by: Yes No Telephone Yes No Email Yes No Letter If yes, please attach a copy of all telephone scripts and correspondence Page18 RVH REB: General Research Application 11. Consent * Please see our website for Information/Consent Form requirements. 1. Will you be seeking written consent from participants (i.e. age 16+)? If yes, please attach a Consent form for Participants If no, please explain: Yes No 2. Will any participants be minors (i.e. age 0-15)? Yes No If yes, please attach a Consent form for Parents, and an Assent form for children age 7-15. Yes No 3. Will all participants be competent to consent? If no, please attach a Consent form for Substitute Decision Makers Yes No 4. Do you need to request a waiver of consent? Please see TCPS Section 2 for conditions under which consent can be altered or waived If yes, please explain: 5. Who will obtain consent to participate? 6. When and where will this be done? 7. Will any of the investigators have a position of authority or power over the participants? If yes, how will you manage and minimize any undue influence? Yes No 8. How will you ensure continuing consent during the study? 9. Will participants have the option to withdraw from this study? If yes, what do they have to do to withdraw? Yes No Page 19 RVH REB: General Research Application 12. Collection of Personal Information Categories of information (TCPS2) • Identifying information identifies a participant through direct identifiers (e.g. Full name, Medical record number) • Identifiable information could identify a participant through a combination of indirect identifiers (e.g. DOB plus address) • De-identified/coded information: identifiers are removed and replaced with a code; the code can be used to reidentify participants • Anonymized information: all identifiers are removed and no code is kept • Anonymous information: no identifiers were collected Personal Health Information (PHI) • The collection, use and disclosure of PHI are regulated by the Personal Health Information Protection Act (PHIPA) 2004. Researchers must comply with this legislation • Collection of participant SIN is prohibited, unless payments to participant exceed $500/yr (required for tax purposes) • PHI should be collected at the lowest level of identifiability possible (e.g. initials instead of a name, age instead of DOB) 1. Do you need to record any identifiers for this study? Yes If yes, check all that apply: Identifier Why is this necessary? Full name Initials Health card number Medical record number Address Full postal code Partial postal code Telephone number Email Physician Date of birth Age Other (specify): No 2. How will you record study data? Case report form. CRFs must not include direct identifiers. Please attach the first 2 data pages. Other (specify): Page 20 RVH REB: General Research Application 13. Storage and Protection of Information PHIPA requirements • Paper files with identifiable information must be kept in a locked cabinet within a locked office (but not at home) • Electronic files with identifiable information may be stored on a password protected computer on a secure network (i.e., virus protection, file backup, firewall) or they must be encrypted. • Electronic files with identifiable information may be stored on mobile devices (e.g. laptop, CD, USB, PDA), but only if there is no alternative method of storage; these files must be encrypted. • Identifying and/or identifiable PHI cannot be transmitted by email unless it is encrypted Coding • Identifying and/or identifiable PHI should be protected by a coding system • The code (study ID and identifiable PHI) must be isolated from study data and stored in a secure manner 1. Will you use a coding system to protect identifiable information? If No, please explain: Yes No 2. How will you store and protect the study code (or other data with identifiers)? Type of record Required protection Paper file Locked cabinet in locked institutional office Electronic file Password protected computer on a secure network Electronic file Encrypted (specify software used): AV tapes Locked cabinet in locked institutional office Location (i.e., bldg, room) 3. How will you store and protect data without identifiers? 4. Do you plan to anonymize the study data? Yes No If yes, when? You are required to destroy identifiers or links at the earliest possible time. 5. How long will you keep the study data? If this study requires Health Canada approval, records must be retained for 25 years. For all other studies the REB recommends 10 years. Sponsors and institutions may set other requirements. 6. What will you do with the study data after this period? Page 21 RVH REB: General Research Application 14. Transmission of Data 1. Does this study require you to send data outside of the institution where it is collected? If No, go to section 16 Yes No Yes No 2. Does this data include identifiers? If No, go to section 16 If yes, a data transfer agreement may be necessary (contact the RVH Research Ethics Coordinator x43318 to discuss) 3. Where will the data be sent? Data sent to the US is open to access by US Regulatory Bodies. Researchers must inform study participants of this possibility. 4. Please list the names and affiliations of persons outside of your research team who will have access to the identifiable data. Institutional Affiliation Name 5. How will the data be transmitted? Fax Email Encryption protocol must be attached Private Courier Delivery must be traceable Canada Xpresspost Regular mail may not be used Other (specify): 15. Secondary Use of Data 1. Will you link the locally collected data with any other data sets? If yes: Identify the dataset: Explain how the linkage will occur: Provide a list of data items contained in the dataset: 2. Will the data be entered into a database for future use? If yes, please specify: Where it will be stored? Who will be the custodian? Who will have access to the database? What security measures will be in place? Any secondary analysis must be approved by the REB. Yes Yes No No Page 22 RVH REB: General Research Application 16. Funding Yes No 1. Does this study require any financial or in-kind support? If No, go to section 18. If yes, please identify the sources (include all internal, external, public or private sources) Source Status Local Budget Applied Pending Received $ In-kind (specify): Applied Pending Received $ In-kind (specify): 2. Where will the funds be administered? Royal Victoria Regional Health Centre Total Budget $ $ Other (specify): 3. Will there be a signed contract/agreement with a study-related funding source? Yes No If yes, will it limit your access to the research data, or your right to publish the study results? Yes If yes, please explain: Agreements must be reviewed and signed by authorized institutional officials No 17. Conflict of Interest 1. Will any investigators, members of the research team, and/or their partners or immediate family members: Yes • Function as an advisor, employee, officer, director or consultant for a study-related sponsor or funding source? Yes • Have a direct or indirect financial interest (including patents or stocks) in the drug, device or technology employed in this research study? Yes • Receive any personal benefit (apart from fees for service) as a result of, or connected to this study? (e.g., remuneration, intellectual property rights, rights of employment, consultancies, board membership, share ownership, stock options, honorariums). No No No 2. If you answered yes to any of the above, please describe the conflict of interest: Please explain how you will manage the COI to ensure that participant rights and welfare are not affected: Page 23 RVH REB: General Research Application 18. Budget Summary • • • • • Please check all services required in your study and enter amounts where possible If you have a detailed study budget, please include it as a supporting document If you report your budget as cost per participant, please provide a list of services/costs per participant Payments to investigators should not exceed accepted standards (e.g., OHIP) Investigators may not accept any payments for enrolling participants Services A (Unit cost) B (# per participant) C (# of participants) = Subtotal X-ray Ultrasound Bone Scan CT Scan MRI/PET ECG Endoscopy Labs Pharmacy (e.g. drugs, fees) Medical Records (chart fee) Other (specify): Personnel Investigator (e.g. history, physical) Nurse/coordinator Other staff (specify): Participants Reimbursement (e.g. parking) Payment (e.g. money for time) Equipment (specify): Administration (specify): Other (specify): Industry Studies (add 30% overhead) Industry Studies (add $3000 REB fee) Total Page 24 RVH REB: General Research Application 19. Resource Authorization 1. Does your study impact or require resources from any of these areas? If yes, please obtain the necessary signatures. Area Decision Support Health Records Laboratory Services Laboratory Services Pharmacy Radiology/Diagnostic Imaging Radiology/Diagnostic Imaging Information Technology Surgical Services Surgical Services Oncology Oncology BCFHT BCFHT FMTU Other (specify): Name of Authorized Official Jonathan Wiersma Linda Long Dr. Russell Price Barbara LeMay Dr. Debra Merrill Dr. Scott Good Heather Gillis Dave Shortreed Dr. Peter Dauphinee Shawn Virtue Dr. Robert El-Maraghi Tracey Keighley-Clarke Dr. Brent Elsey Michael Feraday Dr. Stuart Murdoch Cost to Dept. Yes No Signature Page 25 RVH REB: General Research Application 20. Signatures 1. Confirmation of Responsibility: Local Principal Investigator • I assume full responsibility for the scientific and ethical conduct of the study as described in this REB application and submitted protocol. • I agree to conduct this study in compliance with the Tri-Council Policy Statement 2(TCPS2) and any other relevant regulations and guidelines. • I certify that all researchers and other personnel involved in this project at this institution are appropriately qualified and experienced or will undergo appropriate training to fulfill their role in this project. • I certify that any and all conflicts of interest have been declared • I have obtained all necessary resource utilization signatures, and all costs associated with the use of these resources have been declared. • On behalf of my research team, I recognize the importance of maintaining the confidentiality of all personal information, including personal health information, and the privacy of individuals with respect to that information. I will ensure that the personal information is used only as necessary, to fulfill the specific research objectives and related research questions described in this application and approved by the REB. This includes all conditions and restrictions imposed by the REB governing the use, security, disclosure, return or disposal of the research participants’ personal information. I agree to take any further steps required by the REB and/or the institution to ensure that the confidentiality and security of the personal information is maintained in accordance with the Personal Health Information Protection Act (PHIPA), its accompanying regulations and the TCPS2. Name of PI Signature Date (m/d/y) Name of site PI (if different from PI) Signature Date (m/d/y) Name of Supervisor (if PI is an Undergrad/Masters student) Signature Date (m/d/y) 2. Research Ethics Certificate of Completion attached? 3. Confirmation of PI Qualifications: CV attached? 4. Study Budget attached? Yes Yes Yes No No No • IMPACTED DEPARTMENTS INFORMED OF RESEARCH PROPOSAL (provide date and signature of Researcher): _______________________ Date ________________________________________________ RESEARCHER (Print Name) - Signature • Impact Analysis (page 1 of within Research Proposal Protocol) has been reviewed and approved by each specific department being impacted upon (provide date and signature): ________________________ Date ________________________________________________ RESEARCH A (Print name below) - Signature Page 26 RVH REB: General Research Application _______________________ Date Approved ________________________________________________ CHAIRPERSON – Research Ethics Board - Signature _______________________ Date Approved ________________________________________________ CHAIRPERSON - Medical Advisory Committee - Signature ________________________ Date Approved _______________________________________________ SECRETARY - Board of Directors - Signature Page 27 RVH REB: General Research Application 21. Supporting Documents • • • Please assign (or report) a version date for all supporting documents (this is how the REB tracks changes) Documents without a version date will be returned to you If this page is incomplete we cannot accept your application Document Protocol (Required) Consent forms Participant Parent Assent Genetic Other Clinical trial documents Investigator brochure Product monograph Health Canada NOL General documents GCP/TCPS Certificate REB correspondence Advertisement Telephone script Sample email Interview guide Questionnaire Case report form Other (specify) Version date (m/d/y) Comments Date: Control Number: Page 28 RESEARCH ETHICS BOARD (REB) APPLICATION FOR RETROSPECTIVE REVIEW OF MEDICAL CHARTS/HEALTH RECORDS COMPLETE ALL SECTIONS OF THE FORM AS REQUIRED, OTHERWISE IT WILL BE RETURNED. Complete the application in 10 point font. Handwritten submissions will not be processed. November 14, 2012 INSTRUCTIONS & GUIDELINES When do I use this form? ▼ IF RESEARCH, does it involve contacting patients? ▼ ▼ YES NO ▼ If YES…complete “General Research Application” form ▼ IF QUALITY ASSURANCE by Internal Depts. ▼ If NO...complete “Application for Retrospective Review” ▼ REB Review not Required Privacy Tutorial All Investigators conducting retrospective review of health records are encouraged to undertake retrospective chart review research ethics education prior to submission of this Application. We recommend the following brief webbased program at http://ethics.mcmaster.ca/chart/ Research Studies – submit the Application form, together with supporting documentation to: RVH Research Ethics Board Romaine S. Miller, REB Coordinator 201 Georgian Drive, Barrie, ON L4M 6M2 705.728.9090 x 43318 millerr@rvh.on.ca (DO NOT FAX). Applications normally undergo an expedited review process. Applications are reviewed by the Research Ethics Board. The Principal Investigator will receive an email/letter confirming REB approval. Page 29 RESEARCH ETHICS BOARD (REB) APPLICATION FOR RETROSPECTIVE REVIEW OF MEDICAL CHARTS/HEALTH RECORDS 1. (a) Is this a student project? Yes No 2. (a) Title of Study: (b) What is the purpose of the study, the objectives and the question(s) this study will answer? (Describe briefly) 3. (a) Principal Investigator: (Only one person can be designated as the PI. If more than one name is listed, the first name will be assigned the role of Local Principal Investigator. The Local Principal Investigator must have an appointment at the institution where this application is being submitted for review) Name & Degree(s) RVH Title or Position Clinical Program Hospital Affiliation Phone # Email * Privacy Tutorial: All Investigators (including students) conducting retrospective review of health records are encouraged to undergo training for privacy protection of human subjects prior to submission of this Application. This training may done by completing the brief web-based program at http://ethics.mcmaster.ca/chart/ (b) Funding Source (Name of sponsor/funding agency/industry partner – state full name): (c) Indicate location(s) where the study will be conducted: RVH – specify site: BCFHT OTHER (d) Was this study reviewed by another Research Ethics Board or Institution? If YES, please attach any other REB or institutional approvals. (e) Attached YES NO To follow Conflict of Interest: Will any investigators, members of the research team, and/or their partners or immediate family members: (i) Receive any personal benefit (for example, a financial benefit such as remuneration, intellectual property rights, rights of employment, consultancies, board membership, share ownership, stock options, etc.) as a result of, or connected to this study? YES NO (ii) If YES, please describe the benefits and explain how they will be managed to ensure that participant rights and welfare are not affected. (Do not include conference and travel expense coverage, possible academic promotion, or other benefits which are integral to the conduct of research generally). Attached Page 30 4. Individual(s) who will be reviewing/abstracting medical records/charts: Name and Degree(s) Staff Affiliation? (Specify RVH, BCFHT or None) Profession Precise Role on Project Email * Refer to Instructions. This field must be completed for all individuals. For tutorial: http://ethics.mcmaster.ca/chart/ 5. Additional individuals on the study team who will be given access to the collected data: Name and Degree(s) Staff Affiliation? (Specify RVH, BCFHT or None) Profession Precise Role on Project * Refer to Instructions. This field must be completed for all individuals. For tutorial: http://ethics.mcmaster.ca/chart/ 6. Risks and Benefits of the Proposed Study. (a) What are the anticipated public and scientific benefits of the study? (Describe briefly) (b) What are the possible harms/risks to patients and how will you manage the risks? (Describe briefly) 7. What patient information source are you accessing? Health Records/Clinic/Office Files? (Specify which) Electronic Database (Specify which) Outside Institution (Specify which) Other (Specify which) Please note: Clinical Connect and DI-R cannot be used for research purposes. 8. Identify if you require resources from the following: Health Records (retrieval of health records) Decision Support Services (to identify research population). Other (specify): Page 31 9. What type of data do you need? (a) Aggregate (i.e. you do not need to collect and use personal health information from individual medical charts/health records, e.g. you want to determine how many post-op wound infections occurred in patients with hip replacement surgery) If you require only aggregate data, indicate your search criteria (e.g. diagnoses, procedure, time period, other): (b) Identifiable data (i.e. you need to view individual medical charts/health records) If identifiable data, provide justification for a waiver of consent (Note: The REB may waive the requirement for subject consent and authorization if these criteria are met: (a) The objectives of the research can reasonably be accomplished without using the personal health information that is to be disclosed; (b) It is impossible or impracticable to carry out the research and to answer the research question properly, given the research design, if the prior consent of the participant is required; (c) The information is used in a manner that will ensure its privacy and confidentiality; (d) The lack of the participant’s consent is unlikely to adversely affect the welfare of the participant; and (e) The research involves no more than minimal risk to the participants – and no therapeutic intervention; Page 32 (c) If you require identifiable data, please “tick” the checkboxes to indicate what type of data you are collecting. Investigators should plan to collect personal data at the lowest level of identifiability necessary to achieve the study objectives. We recommend using only initials, and first 3 digits of postal code. Even a dataset without direct identifiers may present a risk of indirectly identifying data subjects if the dataset contains sufficient information about the individuals concerned. For advice, consult the CIHR Best Practice Guidelines for Protecting Privacy and Confidentiality: http://www.cihr-irsc.gc.ca/e/29072.html PERSONAL IDENTIFIERS (check all that apply) Υ How will this item be stored? Electroni Paper -cally Justify why each item is required Full Name Address Telephone Number Ontario Health Card Number Gender Initials Date of Birth (day/month/year) Age or year of birth Full Postal Code First 3 digits of Postal Code Email address Fax number Healthcare Provider Admission Date Discharge Date Service Date Medical Device Identifier Certificate/License number Vehicle Identification Medical Record Number Account Number Full face photograph OTHER (specify): OTHER (specify): (d) Please describe the reasonably foreseeable harms and benefits that may arise from the use of the personal health information and how you intend to address those harms. e.g., if PHI is inappropriately released consequences could include embarrassment, refusal of employment or insurance coverage, stigmatization of individuals/groups. 10. What is the minimum number of records required to achieve your study? 11. Data to be abstracted for the time period of (from when to when?): 12. Attach data collection form or list of fields to be abstracted. (Mandatory: Application will be returned if this information has not been included.) Page 33 13. Are any sensitive issues raised in this study which may require subject consent? (e.g. HIV status, mental health problem or diagnosis, subjects identifiable, e.g. pedigrees, other): YES NO If YES, justify not getting patient consent and specify additional safeguards for confidentiality: 14. Do you plan to link the locally collected data with any other data set(s) (e.g. OHIP, ICES, CIHI or census tract data)? YES NO If YES, indicate: (i) (ii) (iii) (iv) Why is it being linked ; Identify the data set ; Identify how the linkage will occur ; Provide a list of data items contained in it . 15. Indicate the steps to be taken to protect the information being collected. Please check all that apply. NOTE: If direct identifiers must be retained they should be isolated on a separate dedicated server/network without external access (i.e. research databases with patient information should not be housed on portable devices such as laptops or flashcards). PHYSICAL/PAPER Completed data forms will be stored in locked filing cabinets in secure location: Premises will be locked except when one or more of the individuals named under questions 4 or 5 are present: Access to premises will be controlled through the use of passcards, security clearances, etc… Other – specify: Physical location of records – specify name of organization, building, room number (e.g. Royal Υ Victoria Regional Health Centre, 4SC, Room 4501) TECHNICAL/ ELECTRONIC Computer security methods to prevent unauthorized access will be: De-identificaton Password Protection Encryption Virus protection Firewalls Other – specify: If data will be de-identified, indicate when (e.g. as soon as data collection is complete) and how (e.g. use of study ID or code number): If using encryption software, please identify name of software: Computers will be housed in a locked secure location – specify name of organization, building, : room number (e.g. Royal Victoria Regional Health Centre, 4SC, Room 4501) Identify owner of computer equipment being used for storage of data with identifiers: 16. (a) Will data be sent outside of the institution where it was collected and/or will you be receiving data from other sites (for example, in the case of a multi-site study where you are the coordinating site receiving data)? YES NO Page 34 If YES, explain why it is necessary to send/receive data outside of the institution where it was collected: (b)Data Transmission Transmission of data via: Fax - Security at the receptor site MUST be described: Email (Encryption protocol MUST be attached) Private Courier (Must be able to trace delivery) Canada Post Xpress-post or Priority Courier (Regular mail may NOT be used) Other – Specify: Sent? Rec’d? (c) Where will data be sent? (d) Specify the names and affiliations of persons outside of your study team (e.g. technical service providers, other researchers) who will have access to the data* (Data sent or received by the institution will require that the parties enter into an information transfer agreement before the data transfer takes place.): 17. Will the data be entered into an ongoing electronic database for future use in another study? (Please note: Any secondary analysis must be approved by the REB prior to implementation.) YES NO If YES, specify: (i) Where it will be stored: (ii) Who will be the custodian (i.e. the person responsible for data storage and integrity): (iii) Who will have access to it: (iv) Security measures: 18. (a) Specify how long you plan to keep the data. (Please note: You are required to destroy identifiers [or links] at the earliest possible time.) destroyed or irreversibly anonymized (i.e. the key identifying the link between data (b) Will data be and the individual’s identity is deleted)? NOTE: Any mishandling or unauthorized use of study data will lead to cancellation of REB approval for the study - Page 35 Confidentiality Agreement THE FOLLOWING REPRESENTS THE TERMS AND CONDITIONS UNDER WHICH THE HANDLING OF CONFIDENTIAL INFORMATION FOR THE PROJECT SHALL PROCEED. THESE TERMS AND CONDITIONS HAVE BEEN DRAFTED IN COMPLIANCE WITH THE PERSONAL HEALTH INFORMATION PROTECTION ACT AND OTHER PRIVACY LEGISLATION. 1. All information received or exchanged will be held in strict confidence. 2. Information will not be used for any purpose other than for the project for which it was provided. The information will be shared only with those individuals listed on this form, who are working directly on the project, except for authorized oversight of the study. 3. No attempt will be made to contact any individual to whom the information relates, directly or indirectly. 4. Information will be kept in a location that is physically secure and to which access is given only to the individual(s) listed on this form. 5. All direct identifiers will be segregated/stripped from clinical data; a unique study identifier (i.e. a randomly generated or meaningless ID number) will be assigned to each patient record; the Master list linking the ID with identifiable material will be stored in a separate computer file and/or physical location; and the Master list will be locked and password protected. 6. No information will be released outside the province of Ontario. 7. Data sent or received by the institution will require that the parties enter into an information transfer agreement before the data transfer takes place. 8. Policies and procedures on the retention and destruction of information must be in place by the party undertaking the project. 9. It is strongly recommended that members of the research team and any individual(s) listed below read the Personal Health Information Protection Act. Part IV, Sec 44. 10. Publication of confidential information requires adherence to the following principles: • The institution agrees to allow the publication of the information as it pertains to the project providing that the institution or its practices are not the main focus of the publication. • In cases where the publication focuses on the institution, the institution reserves the right to review and approve the use of this information prior to publication. • The institution will be acknowledged within any publication as providing the source information in the following fashion: “e.g. Royal Victoria Regional Health Centre. A copy of the publication will be given to the institution (e.g. Royal Victoria Regional Health Centre, Research Ethics Board Information which is lost or stolen must be reported to the Chief Privacy Officer of Royal Victoria Regional Health Centre). 11. A breach of institutional policy regarding access to information and protection of privacy may have serious consequences or be just cause for termination of my employment and/or affiliation with the institution. NOTE: Any mishandling or unauthorized use of study data will lead to cancellation of REB approval for the study, Page 36 12. Any changes to this research plan will be submitted to the REB for approval prior to proceeding, including any change in persons given access to the data. The undersigned hereby agree to these terms and conditions governing the handling of confidential information, and commits him/herself to these terms and conditions: _________________________________________________ _______________________________ Signature of the Principal Investigator Date -ANDSignatures of all study team members and individuals reviewing medical records/charts: Print Name Signature Date Signed Page 37 Signature Page • IMPACTED DEPARTMENTS INFORMED OF RESEARCH PROPOSAL (provide date and signature of Researcher): _______________________ Date ________________________________________________ RESEARCHER (Print Name) - Signature • Impact Analysis (page 1 of within Research Proposal Protocol) has been reviewed and approved by each specific department being impacted upon (provide date and signature): ________________________ Date ________________________________________________ RESEARCH ASSOCIATE (Print name below) - Signature • RESEARCH PROPOSAL PROTOCOL APPROVED BY DIRECTORS OF THE DEPARTMENT _______________________ Date ________________________________________________ CHIEF PRIVACY OFFICER & MANAGER, HEALTH RECORDS Linda Long Date CLINICAL DIRECTOR (if applicable) - Signature RESEARCH PROPOSAL PROTOCOL reviewed and approved by: (provide date and signature) _______________________ Date Approved ________________________________________________ CHAIRPERSON – Research Ethics Board - Signature _______________________ Date Approved ________________________________________________ CHAIRPERSON - Medical Advisory Committee - Signature ________________________ Date Approved _______________________________________________ SECRETARY - Board of Directors - Signature Page 38 Elements Of Informed Consent – GCP Guidelines The researcher should provide any person who is to give informed consent with the following information as 1 indicated in the Guideline for GCP and the TCPS : • • • • • • • • • • • • • • • • • • • • • • • • • 1 2 The identity of the researcher. That the trial involves research. The purpose of the trial. The trial treatment(s) and the probability for random assignment to each treatment. The trial procedures to be followed, including all invasive procedures. The subject’s responsibilities. Those aspects of the trial that are experimental. The reasonably foreseeable risks or inconveniences to the subject and, when applicable, to an embryo, fetus, or nursing infant. The reasonably expected benefits. When there is no intended clinical benefit to the subject, the subject should be made aware of this. The alternative procedure(s) or course(s) of treatment that may be available to the subject and their important potential benefits and risks. A description of the likely consequences of non-participation if the research is therapeutic. An assurance that exemplary care will be taken to safeguard the subject. The compensation and/or treatment available to the subject in the event of trial-related injury. The anticipated prorated payment, if any, to the subject for participating in the trial. The anticipated expenses, if any, to the subject for participating in the trial. That the subject’s participation in the trial is voluntary and that the subject may choose not to participate or withdraw from the trial, at any time, without penalty or loss of benefits to which the subject is otherwise entitled. If there are practical limitations to withdrawal, for example removal of a surgically implanted device, these should be stated. That the monitor(s), the auditor(s), the RVH REB, and the regulatory authority(ies) will be granted direct access to the subject’s original medical records for verification of clinical trial procedures and/or data, without violating the confidentiality of the subject, to the extent permitted by the applicable laws and regulations and that, by signing a written informed consent form, the subject or the subjects’ legally acceptable representative is authorizing such access. That records identifying the subject will be kept confidential and, to the extent permitted by the applicable laws and/or regulations, will not be made publicly available. If the results of the trial are published, the subject’s identity will remain confidential. A description of how the data will be stored and/or when it will be destroyed. That the subject or the subject’s legally acceptable representative will be informed in a timely manner if information becomes available that may be relevant to the subjects’ willingness to continue participation in the trial. The person(s) to contact for further information regarding the trial and the rights of trial subjects, as well as a telephone number. The person to contact in the event of trial-related injury, as well as a contact number. The foreseeable circumstances and/or reasons under which the subject’s participation in the trial may be terminated; The expected duration of the subject’s participation in the trial; and 2 The approximate number of subjects involved in the trial Section 4.8.10 GCP Guidelines Section 4.8.10 GCP Guidelines Page 39 Expedited Review Checklist All information on how to submit study documents to the Research Ethics Board (REB), for expedited review is posted on the REB web-site (access through the RVH home-page). All applicants are encouraged to review this web-site prior submitting an application. We look forward to receiving your documentation for review, however, with the advent of the new privacy regulations as defined by PHIPA, there has been a tremendous increase in the number and type of studies that now must be reviewed by the REB, therefore please note that all essential components of the Study must be submitted accurately – and in their entirety - on the first occasion of their submission, otherwise the option for expedited review will not be available. Please Note: All Documentation is to be submitted in Triplicate, collated into separate sets and stapled or clipped with sturdy, well-anchored clips. Incomplete or illegible submissions may be returned to the investigator without review. Covering Letter with brief description: and - If waiver of consent is being sought, please clearly state the grounds under PHIPA/TCPS, relied upon - RVH Confidentiality Agreement (Section 44 PHIPA) General Application form or Retrospective Chart Review form (as applicable) completed and signed (including departmental Impact signatures) Study Protocol/Research Plan/Amendment (must address all points in the Privacy Tool Checklist) Investigator’s Brochure/Product Monograph (if applicable) Survey* (if any) In triplicate Informed Consent* (If any) Previous REB Approval (if any) Pictures/Graphs/Flow Charts etc. (if any) C.V.’S Researchers/Research Associates Study Budget or Cost Analysis Completed Privacy Checklist All other relevant documentation Page 40 Full-Board Review Checklist All information on how to submit a Study to the Research Ethics Board (REB), for full-board review is posted on the REB web-site (access through the RVH home-page). All applicants are encouraged to review this web-site prior submitting an application. We look forward to receiving your Study for review, however, with the advent of the new privacy regulations as defined by PHIPA, there has been a tremendous increase in the number and type of studies that now must be reviewed by the REB, therefore please note that all essential components of the Study must be submitted accurately – and in their entirety - on the first occasion of their submission, otherwise the submission may be placed on the REB Agenda for the following month. Please Note: All Documentation is to be submitted in Triplicate, collated into separate sets and stapled or clipped with sturdy, well-anchored clips. Incomplete or illegible submissions may be returned to the investigator without review. Covering Letter with brief description of Study General Application Form or Retrospective Chart Review Form (as applicable) Study Protocol/Research Plan (must address all points contained in the Privacy Tool Checklist) Health Canada No Objection Letter (if applicable) Unsigned copy of the Clinical Trial Agreement (if applicable) Investigator’s Brochure/Product Monograph (if applicable) Survey* (if any) In triplicate Informed Consent* (If any) Previous REB Approval (if any) Pictures/Graphs/Flow Charts etc. (if any) C.V.’S Researchers/Research Associates Study Budget or Cost Analysis Completed Privacy Checklist Unsigned Copy of Draft Clinical Trial Agreement (if applicable) All other relevant documentation Page 41 Privacy Tool/Checklist The research plan must describe: The name, affiliation, roles and qualifications of everyone working on the research and accessing personal health information Adequate justification for disclosing personal health information to these persons The nature of the research The particular research objectives and related research questions The duration of the research The anticipated public and scientific benefit of the research The required personal health information The sources of the personal health information The use of personal health information, including details on information linkage (if any) Adequate justification for using the personal health information Adequate justification for linking the personal health information Adequate consent process/form OR adequate justification for proceeding without consent The reasonably foreseeable harms and benefits of the information use Adequate explanation of how foreseeable harms will be addressed Adequate privacy and security safeguards How long the information will remain identifiable and why How and when the information will be destroyed or returned to source Details on research funding Details on whether the researcher has applied for other research ethics board approval and its response or the status of the application Details on the researcher’s conflicts of interest Details on any additional matters the law or ethical guidelines and conventions may require Page 42 RVH Research Ethics Board SUBMISSION GUIDELINES Send Submissions to: Ms. Romaine Miller Research Ethics Board Coordinator, Rm 3251 Royal Victoria Regional Health Centre 201 Georgian Drive Barrie, Ontario L4M 6M2 Attention: Dr. Laura Crook, REB Chair New Protocols: Covering letter Prepare in accordance with Full-board or Expedited Review Checklist Submit in triplicate Send e-copy of Informed Consent SAE Reporting: Submit in duplicate Submit completed SAE Tracking Form Continuing Review: Submit in Duplicate Include e-copy of Revised Consent(s) Annual Re-Approval or Study Closure Submit in duplicate Use “Annual Re-Approval/ Study Closure Form It is the Researcher’s responsibility to apply for - and obtain – Annual Re-approval. A failure to do so may result in study closure. Page 43 [Enter Logo(s)] INFORMED CONSENT FOR PARTICIPATION IN RESEARCH ACTIVITIES PROJECT TITLE: [ENTER TITLE] PRINCIPAL INVESTIGATOR: [Enter name] ASSOCIATE INVESTIGATORS: [Enter name] INTRODUCTION: You are being asked to take part in a research study being sponsored/conducted [enter researcher or sponsor’s name], because [enter reason]. Participation in this research is entirely voluntary. Before making a decision to participate in this study it is important that you read and understand the following explanation of the proposed study procedures, why it is being done, and what it will involve. It includes details we think you need to know in order to decide if you wish to take part in this study. The following information describes the purpose, procedures, benefits, discomforts, risks and precautions associated with this study. It also describes your right to refuse to participate or withdraw from the study at any time. In order to decide whether you wish to participate in this research study, you should understand enough about its risks and benefits to be able to make an informed decision. If you decide to take part in the study, it is important that you are completely truthful about your health history and any medications you are taking. This will help prevent unnecessary harm to you. This is known as the informed consent process. Please ask the study staff or principal investigator to explain any words you don't understand before signing this consent form. Make sure all your questions have been answered to your satisfaction before signing this document. PURPOSE OF THE RESEARCH: The purpose of this research study is to [Enter Purpose in lay terms] DESCRIPTION OF THE RESEARCH: [Describe research in lay terms] RISKS OF STUDY PARTICIPATION There are [enter risks]/[no risks] associated with the [observational data] involved in this study. Page 44 BENEFITS OF STUDY PARTICIPATION [Describe benefits in lay terms] WITHDRAWAL FROM THE STUDY Participation in any research study is voluntary. If you choose not to participate you will continue to have access to customary care at the Royal Victoria Hospital. If you decide to participate in this study you can change your mind at any time without giving a reason, and you may withdraw from the study at any time without any effect on the care you will receive at Royal Victoria Hospital. [Describe what must be done for the study participant to withdraw] COMPENSATION Your participation is voluntary and no compensation will be provided to you as a result of your participation. RESEARCH PARTICIPANT’S RIGHTS: The investigator, [enter name], is available to answer any questions my may have about your participation in this study [enter contact info]. Should you have any questions or concerns regarding your rights as a participant in this study, you may contact The Research Ethics Board Chair at the Royal Victoria Hospital, Barrie at 705-728-9090 ext. 43318. Your participation in this study is strictly voluntary. You may refuse to participate or you may discontinue participation at any time during the study without penalty or loss of benefits to which you are otherwise entitled. Your participation may be stopped by the study doctor without regard to your consent for any reason whatsoever. ETHICAL CONSIDERATIONS: [Enter here] CONFIDENTIALITY All data collected will be kept strictly confidential in locked offices at [enter address]. A code of initials will identify all documents. Electronic data will be stored on [enter the storage medium giving details re encryption and methods of transmission – if any]. Names or initials in any report of the completed study will not identify you. However, information may be shared with authorized members of the study, as well as members of the data-coordinating centre [Enter institution, if any]. The information might also be inspected by Canada’s HPB and/or other appropriate governmental agencies, and/or the Research Ethics Board at Royal Victoria Hospital. Study data will be retained for a period of [enter period] and be destroyed at that end of that period by means of [enter method of destruction]. By signing the written informed consent, you agree with these possible actions. Your name or any material identifying you as a study participant will not be released without your written permissions, except if such release is required by law. WHAT YOU WILL NEED TO BRING TO YOUR APPOINTMENT: [Enter information, if applicable] Page 45 SCHEDULE “A” Signatures You will be given a copy of this consent form after it has been signed and dated by you and the study staff. My signature on this consent form means the following: • The study has been fully explained to me, I have been given the chance to discuss it and all of my questions have been answered to my satisfaction, • I have read each page of this consent form, • I am aware of what is required of me as a participant in the study, • I am aware of the risks to me of participating in the study, • I allow access to my personal health information and study data as explained in this consent form, and • I voluntarily consent to take part in this study. Name of Participant (Print) Signature of Participant Date (yyyy-Mmm-dd) Person Obtaining Informed Consent: My signature below signifies that I have explained the nature and purpose of the study and the risks involved to the study participant, and I have answered all questions to the best of my ability. Name of Person Obtaining Informed Consent (print) Signature of Person Obtaining Informed Consent Date (yyyy-Mmm-dd) Investigator: (signature should be obtained prior to randomization or enrollment) My signature below signifies that the study has been reviewed with the study participant by me and/or by my delegated staff and I have answered the participant’s questions to the best of my ability. My signature may be affixed at a later date, as I may not be present at the time the participant’s signature is obtained. Signature of Investigator Date (yyyy-Mmm-dd) YES NO Was the participant assisted during the consent process? If YES, please check the relevant box and complete the signature space below: F The consent form was read to the participant. The person signing below attests that the study as set out in this form was accurately explained to, and appeared to be understood by the participant. F The person signing below acted as a translator for the participant during the consent process. Language: ____________________________ Name (print) Signature Date (yyyy-Mmm-dd) Page 46
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