Research Ethics Office Children’s Treatment Centre, Main Floor 41 Ramsey Lake Road, Sudbury, ON P3N 1H5 t: 705-523-7100, ext. 2409 [email protected] RESEARCH ETHICS BOARD APPLICATION FOR AN EXPEDITED/DELEGATED REVIEW
1.1 Project Title
1.2 Anticipated Project Dates Start Date End Date 1.3 Principal or Lead Investigator at this site (if a student project, the supervisor should be listed as the Principal Investigator (PI)) Name s
s Street Address e r
d City, Postal d A Code g n i l i a M
Telephone Email NOTE: As of January 1, 2013, all PI’s (or in the case of a student project, the student) must complete the Tri-Council Policy Statement (TCPS 2) on-line tutorial: www.pre.ethics.gc.ca/eng/education/tutorial-didacticiel/ Please enclose a copy of your certificate with your application. 1.4 Is this a student or resident project? I.e. Is completion of this research a YES requirement for a course, degree etc. NO If yes, name of student: 1.5 List all local co-investigators and collaborators. Name Title/Position Email
1.6 Will the research utilize: YES NO
Patient contact Patient records HSN staff HSN resources 1.7 Type of research activity Chart or record review / data collection Select all that apply Survey, interview, questionnaire, focus group Other (specify) 1.8 All REB correspondence should be sent to: Name Mailing Address Email
Toll free / Sans frais www.hsnsudbury.ca 1.866.469.0822 Delegated Review – REB Application Revised January 2013
SECTION 2 PROJECT DESCRIPTION Complete each section where indicated. Do not direct the reviewer to ‘SEE ATTACHED’. Your protocol will be RETURNED UNREVIEWED if the project description information is incomplete, illegible or improperly filled out. 2.1 Provide a brief overview of the proposed describing the population and purpose. e.g. Charts of patients less than 3 months of age presenting to the HSN Emergency Department with a rash will be reviewed to examine possible seasonal variations. NOTE in addition to the REB submission form a full description of the study must be submitted e.g. Protocol, research proposal, outline of study, which must have a date and a version number.
2.2 Background, Justification & Objectives and Hypotheses: Provide a clear statement of the purpose and objectives of the research (i.e. Why is the research being done?)
2.3 Methodology - Describe the study design or data collection process and describe in detail what will be done to the participants and/or their data. 2.4 Number of local subjects or records SECTION 3 RESEARCH PARTICIPANTS
3.1a Will the study involve data from males and females? MALES FEMALES 3.1b If NO, explain why only one gender is being selected.
3.2a Will the participants be compensated in any way? YES NO 3.2b If YES, provide details. This information must be included in the Information/Consent documentation.
SECTION 4 DATA COLLECTION
4.1 Are any other data to be collected? e.g. test results, surveys, YES questionnaires, hospital chart information etc. NO
If YES complete the balance of this section - If NO go to Section 5
4.2 What is the Patient chart or clinical record source of that Other departmental records data? Directly from research participant or other informant Departmental or clinic (clinical) database Other (specify)
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4.3 List all data collection instruments and forms to be used in this research. e.g. surveys, questionnaires, interview outlines etc. Submit a copy of all forms which must show a date and version number.
SECTION 5 RISKS AND BENEFITS OF THE RESEARCH
5.1 RISKS, HARMS & DISCOMFORTS: Discuss the risks of the proposed study.
BENEFITS: Discuss any possible direct benefits to the research participants as a result 5.2 of their participation in the study
SECTION 6 PRIVACY & CONFIDENTIALITY ISSUES HSN requires that all persons accessing patient information complete a Confidentiality Agreement/Data Sharing Agreement. Contact the Health Information Services for more information.
Indicate if any of the following d 6.1a e d n e personal identifiers will be i t a c t
collected for research e e l l R
purposes during the course of o the research. (Excluding the C consent form which will contain the participant’s No Personal Identifiers name.) If any are to be collected, Full or Partial Name or Initials indicate which will be retained (upon study Address, Postal, etc. completion) with the research data set once data collection is complete? Full or Partial DOB or Death
Indicate “Retained” if there will Personal No.’s: e.g. OHIP Health Card, SIN be a Master list kept after data collection is complete that Hospital Chart or Record # links participant identifiers to de-identified data. Other Personal Identifiers(specify) 6.1b IF ANY OF THE ABOVE IDENTIFIERS WILL BE COLLECTED give the level of detail to be collected. E.g. full name or initials only; full date of birth or year only; full postal address or 3 digit postal code; etc.
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6.1c IF ANY OF THE ABOVE IDENTIFIERS WILL BE COLLECTED/RETAINED provide a comprehensive rationale explaining why it is necessary to collect/retain this information. (Including the retention of master lists that link participant identifiers with de-identified data.) Acceptable reasons will generally be limited to the following purpose and investigators will need to defend their reasons for collecting and/or retaining identifiers and how the identifiers will be used to achieve the stated purpose. Contact or linkage for follow up or ongoing data collection Provide data for clinical monitoring of the participant Enable data to be withdrawn from data set if participant withdraws consent Return individual results to participant Conduct a data linkage with a high degree of accuracy Do not just copy one of the above reasons into the box below. Investigators must, in their own words, explain fully and defend their reasons for collecting and/or retaining identifiers and explain how the identifiers will be used to achieve the stated purpose.
7.1 In addition to the HSN, identify all agencies or individuals other than the local research team who, for monitoring or auditing purposes, may require access to identifiable or confidential data collected for this research or database/registry, now or in the future. Include the following sentence into all informed consent materials where the participant’s identity is known and access to the records or follow up by HSN is possible. Authorization to Use and Disclose Information for Research subjects Health Authority Agencies such as Health Canada and other regulatory authorities may be granted direct access to your medical records together with representatives of the Health Sciences North Research Ethics Board. By signing this consent, you also permit the principal investigator to use, and disclose health information about yourself for the purposes of this study.”
7.2 Describe the procedures to be used for preserving the confidentiality of data both during the data collection and in the release of the findings. e.g. all identifiers removed once data collected, etc.
7.3a Will anyone other than employees, clinical staff or students of HSN YES where the patients’ original records are located, approach participants or have direct access to a research participant or their records for NO purposes of collecting data or conducting this research? 7.3b If YES indicate who these people are, what their role is, why they need access and what safeguards have been instituted to ensure they adhere to acceptable security practices and maintain confidentiality. 7.4 Indicate which of (check all that apply) the following Data will be encrypted security Data will be password protected measures will Data will be stored on a hospital or other institutional network be/has been drive that has firewalls in place
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undertaken to Records will be stored in a locked cabinet in a secure location protect the data Access to records and data limited to authorized persons and records All identifiers to be removed once data collected/verified Master list linking data with identifiers stored separately from data.
7.5 Indicate how long the data will be retained and if not being kept indefinitely; describe the method of disposal or destruction.
7.6a Are participant data being taken off-site? YES NO 7.6b Will data (i.e. patient data) be taken off site for analyses? YES NO
If YES to either 7.6a or 7.6b complete the balance of this section. If NO go to Section 8. 7.8 Will personal identifiers be included with the data taken off-site? YES Note: Data that leaves the site should not include the patient’s name or other identifiers unless there is a compelling reason. Data that includes identifiable NO personal health information MUST be encrypted before being sent or taken off site or utilized via secure remote access. Master lists must be stored separately from the data.
7.9 Indicate which of the following (check all that apply) security measures will be/has been undertaken to protect the Data will be encrypted data and records Data will be password protected Other (specify)
SECTION 8 PARTICIPANT RECRUITMENT & CONSENT PROCESS 8.1a Will potential participants, be contacted directly to collect data from YES them or recruit them to the study? NO 8.1b If YES, identify who will be contacting the potential participants. If you answer “yes” to this section, ensure that you submit a letter of information with your study.
8.2 What type of No consent to be obtained - Researcher requests waiver consent will be or from REB was obtained Explicit written consent documentation from participants? Explicit verbal consent e.g. telephone surveys Explicit consent - other e.g. completion of questionnaire, survey evidence of consent Passive consent e.g. notices posted with option to opt out Other (please describe)
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8.3 If a waiver to obtain prospective consent is being requested you must explain why. As per the Ontario Personal Health Information Protection Act PHIPA requests to waive consent are generally limited to the following reasons. Investigators must indicate which are relevant and explain why. 8.3a Inappropriateness of consent requirement: There may be potential harms to individual from direct contact e.g. Psychological, social or other harm or distress could be caused by contacting individuals or families. 8.3b Inappropriateness of consent requirement: Contact with individuals not permitted under a previous agreement, law or policy. 8.3c Impracticability of seeking consent due to size and nature of population being studied. 8.3d Impracticability of seeking consent due to proportion of prospective participants likely to have relocated or died since original data or specimen collection. 8.3e Impracticability of seeking consent due to lack of existing or continuing relationship between participants and data holder.
IF YOU ARE ASKING FOR A WAIVER TO OBTAIN PROSPECTIVE CONSENT AND/OR HAVE PRIOR CONSENT YOU HAVE NOW COMPLETED THE FORM.
IF YOU WILL BE OBTAINING CONSENT OR NOTIFYING POTENTIAL PARTICIPANTS PLEASE COMPLETE THE REST OF THE FORM.
8.4 Will posters, advertisements, public notices or telephone solicitation YES be used to recruit or notify participants? NO If YES attach copies of all posters, handouts, notices or advertisements etc. In the case of audio announcements or telephone recruitment provide a written copy of the script
8.5a Will minors or persons not able to consent for themselves be included YES in the study? NO 8.5b If YES, describe the consent process and indicate who will be asked to consent on their behalf.
8.6 Describe opportunities (if any) available to participants to consent to Not Applicable future, as yet unknown, research on their data. In the case of de-identified data this is not an option, but researchers need to think carefully about the logistics and likelihood of being able to contact participants in the future if they promise contact for future consent.
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8.7 Describe what opportunities (if any) will be available to participants to Not Applicable withdraw their data in the future. Please note that it may be necessary to deny participants the right to withdraw data to protect the integrity of research already using the data. If this is the case, this limitation on their ability to withdraw must be made clear in the Letter of Information. In the case of de-identified data withdrawal is not an option.
8.8 If YES, Attach a copy of all documentation that will be (or has been) used to inform and obtain consent from the potential participants about the research.
These are the contact persons for participants who have questions regarding their rights and the conduct of the research. The correct person must be inserted into this sentence and this phrase included in the Letter of Information. “If you have any questions about your rights as a research participant or the conduct of the study you may contact…” If participants are recruited from Your Rights as a Research Subject within HSN the following must be If you have any questions regarding your rights as a included research participant, you may contact the Health Sciences North Research Ethics Board at 705-523-7100, ext. 2409 or by email: [email protected]. The Research Ethics Board is a group of people who oversee the ethical conduct of research studies. These people are not part of the study team. Everything that you discuss will be kept confidential.
Statement of Principal Investigator (PI) 1. I attest that the information in this application is complete and accurate to the best of my knowledge 2. I assume full responsibility for the scientific and ethical conduct of this study. 3. I agree to conduct this study in compliance with the: Tri-Council Policy Statement ICH Good Clinical Practices: Consolidated Guidelines Division 5, Canadian Food and Drug Regulations The provisions of the Ontario Personal Health Information Protection Act (PHIPA) and its applicable regulations The applicable laws and regulations of Ontario 4. I certify that all sub-investigators, researchers and other personnel (Research Team) involved in this study at this institution are appropriately qualified and experienced, or will undergo appropriate training to fulfill their role in this study. 5. I certify that the Research Team will adhere to the protocol and consent form as given clearance by the REB and in accordance with any conditions placed on the REB decision.
Privacy and Security Acknowledgement:
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● On behalf of all members of my research team, I recognize the importance of maintaining the confidentiality of personal health information (PHI) and the privacy of individuals with respect to that information.
● I will ensure that the PHI is used only as necessary to fulfill the specific research objectives and related research questions described in the application approved by the REB. This includes all conditions and restrictions imposed by the REB or HSN, governing the use, security, disclosure, return or disposal of the research participants’ PHI and
● I agree to take any further steps required by the REB or HSN to ensure that the confidentiality and security of the PHI is maintained in accordance with PHIPA, its accompanying regulations and Tri-Council Policy Statement.
______Signature of the Principal Investigator Date
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ADMINISTRATIVE REVIEW PROCESS: HOSPITAL UTILIZATION IMPACT INTENT: The administrative research review process is to determine the impact of a proposed study on the hospital. Such impact includes utilization of hospital resources, staff requirements, financial impact and associated liability.
Principal Investigators (PI) are to submit protocols for all hospital-based research or research utilizing hospital resources to the Administrative Program Director whose program will be impacted most by the study. Regional Cancer Program studies, which utilize some resources for outpatient cancer research, are vetted through the Clinical Research Multi-disciplinary Committee and the Vice–President of Clinical Services HSN/Regional Vice-President. The lead program is identified according to the burden of activities in the protocol and their major impact, [e.g. asthma drug in ED ~ Medical Program; chart review of asthmatics ~ Information Services/Decision Support; pulmonary function studies on Asthmatics ~ Critical Care (Respiratory)]. The attached Program checklist will assist PI’s in directing their protocols. Hospital-based studies or research utilizing hospital resources include all studies that involve hospital inpatients or outpatients, that find subjects through chart review, during hospital visits, or that use hospital labs, pharmacy, diagnostic imaging, admission of subjects. The Principal Investigator must obtain approval from Administrative Program Director (APD) or delegate prior to submitting the proposed protocol to the Research Ethics Board (REB). Before any study begins at HSN, both the Administrative review and the Research Ethics Board review must be completed and given clearance. PROCESS: 1. The PI must complete the attached “Financial Submission Data Sheet for administrative review” and submit it with a copy of the research proposal and protocol to the secretary of the lead program. 2. The PI will contact the APD to identify the major issues, if any, which may include a review of the budget and contract in accordance with Tri-Council Policy Statement, Article 7.3. 3. The APD will solicit input from APDs of other affected areas. Managers of these areas will conduct a secondary review and prepare a brief summary of potential issues and impacts for the APD. This review includes the impact in Diagnostic and Pharmacy areas, and specific utilization, staffing and liability issues. As per attached - “Worksheet for Administrative Director”. 4. At the discretion of the APD, the lead Program Council may review the proposed study, impact summary and researcher response and make recommendations regarding study feasibility within the program at this time. The PI may be invited to meet with the Program Council or Director regarding the issues or may be provided with a summary of issues and impacts and invited to respond. 5. The APD will forward recommendations, if any, to the appropriate individuals/departments and review the issues with the “Senior Manager responsible for research”. A method of billing the principal investigator for use of HSN resources will be set in place. 6. Before any research that involves HSN utilization is started, the Senior Manager responsible for research or the Vice President of the Regional Cancer Program for RCP studies, will indicate approval by signing off on the Administrative Review Portion. 7. This Administrative review of Financial Issues is distinct and separate from the REB review.
TO be completed by Principal Investigator and verified by Administrative Program Director
Financial Submission Data Sheet for Administrative Review
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Name of Research Protocol:
Lead Clinical Program for Administrative Review: The “recovery of utilization costs for institutional and other resources should be considered essential and should be in addition to any overhead charge stipulated by the institution.” Tri-Council Policy Statement: in Article 7.3
1. Will this study utilize hospital resources? Yes No 2. How many patients, research subjects, do you plan to screen? to enroll?
Complete the following Financial Impact Analysis Form (For not applicable services, indicate N/A)
SERVICE Estimated Cost by PI Cost Validation No. of tests per patient For Admin use only Administrative Review $
Laboratory No. tests @
Nursing Patient Units
Diagnostic Imaging No. tests @
Cardio Diagnostic No. tests @
Biomedical Dept.
Information Services/ Decision Support & Information Management Human Resources
Radiation/Chemotherapy
Pharmacy/RCP Pharmacy
Other Other
2. Describe other issues requiring consideration by the hospital administrators.
______Signature, Principal Investigator Applicant Date
______Signature, Lead Administrative Program Director Date
______Signature, Senior Manager Responsible for Research or Date Vice President (VP) Clinical Programs or
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Associate Vice President (VP) Clinical Programs or Vice President of Regional Cancer Program
WORKSHEET FOR LEAD PROGRAM DIRECTOR (Guide for Program Review)
HOSPITAL PROGRAMS/SERVICES AFFECTED BY THIS PROPOSED RESEARCH: Please check all affected areas:
SURGICAL PROGRAM OR Day Surgery Orthopaedics PACU Pre-admission Clinic Options Clinic Inpatient Surgery Infection Control GI Unit Gynaecology
EMERGENCY & MEDICAL PROGRAM Inpatient Medical Critical Transitional Care Emergency Department Trauma Hospitalist Service Stroke Program Base Hospital Neurology
CRITICAL CARE PROGRAM Surgical Intensive Care Critical Care Area Neurosurgical Perfusion Respiratory Therapy Cardiopulmonary Cardiology Cardiac/Pulmonary Rehab FAMILY / CHILD PROGRAM LDRP Intensive Care Nursery Paediatrics Children’s Treatment Infant Development Sexual Assault/Domestic Violence CONTINUING CARE PROGRAM Intensive Rehab Outpatient Rehab Complex Continuing Care Prosthetics & Orthotics Chronic Pain Service ABI Program
MENTAL HEALTH PROGRAM Crisis Intervention Acute Inpatient Psychiatry Eating Disorders Psycho geriatrics Interact Psychology
CLINICAL DIAGNOSTICS & AMBULATORY CARE Diagnostic Imaging Laboratory Pharmacy Ambulatory Care Nephrology HAVEN/HIV Diabetes Ed Genetics Neurodiagnostics
REGIONAL CANCER PROGRAM Systemic Treatment Supportive Care Radiation Inpatient Oncology Palliative Care
DECISION SUPPORT & INFORMATION SERVICES Health Information Clinical Informatics
HOSPITAL COMMITEES
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Pharmacy and Therapeutics (P&T Committee)
(NOTE: All research studies using medication must be sent to the P&T Committee or Pharmacy for RCP studies. The following information is required: purpose of the research, inclusion & exclusion criteria, and all medication information. The information package is to be sent to the Administrative Secretary, Pharmacy, Laurentian Site, 3rd floor. (Ext. 3265). The P&T Committee meets the first week of the month and will review research proposals that are received at the office on the 20th of the month preceding the meeting.
COMMENTS:
Protocol reviewed by: ______Date ______
Protocol reviewed by: ______Date ______
Protocol reviewed by: ______Date ______
Protocol reviewed by: ______Date ______
Administrative Program Director(s), as required, with Approval or No Approval
Signature: ______Date:______ Approved Not Approved
Print Name: ______
Signature: ______Date:______ Approved Not Approved
Print Name: ______
Lead Administrative Program Director: ______Date: ______
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