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Frequently Asked Questions

GRA

When should I use the GRA
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. Guidance on specific topics is available on the Guidelines section of our website. 4. The deadlines for submissions are the second and the last Tuesday of every month (4.00 pm). The REB meets on the first Wednesday and the third Tuesday of every month. Researchers can expect to receive the results of the review within 10 days of the REB meeting. 5. If you are an Undergrad or Master’s student at McMaster University doing minimal risk health science research, please note that there is no deadline for submission. The SRC is a subcommittee of the HIREB and in some cases an application may be referred to the HIREB for additional review. The approval process generally takes 4-5 weeks. 6. Good Clinical Practice (GCP) and Tri-Council Policy (TCPS) Training Requirements : All local principal investigators (LPIs) involved in clinical trials, as defined by the Tri-Council Policy Statement on the Ethical Conduct for Research Involving Humans (TCPS), are required to provide proof of GCP training when submitting an application to the Hamilton Integrated Research Ethics Board. Refer to Section 2-Question 1. For all other (non-clinical trial) research, 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 GCP training by appending their certificate to the REB application. 7. If you have any questions about REB forms, requirements or processes, please contact: Research Ethics Officer: sancan@hhsc.ca or 905-521-2100, ext 44574

Human Tissue Application

When to use the Human Tissue/Blood/Body Fluid Form
Application for the Use of Human Tissue/Blood/Body Fluid for Research Purposes In accordance with Tri-Council Policy, research studies requiring collection or access to human tissue must be reviewed and approved by the Human Tissue Committee (HTC), a sub-committee of HIREB. 1. An application for the study of human tissue for research purposes can arise for several reasons: a) as a retrospective study of tissue previously collected, i.e. archived or banked tissue b) as part of an ongoing clinical trial to gather relevant trial-specific information or as part of a prospective study that requires collection of the use of excess tissue./blood/body fluid from patients and directly related to the objectives of the research project. c) as a prospective study of tissue collected for a specific research study. d) as a collection of tissue/blood/body fluid for research purposes, internally or externally in case of limited sampling. 2. Prior to a submission of the application to HTC, the application form and research plan must first be submitted to site group members of the HTC: a representative of clinical site group/program leader and a site group pathologist. These members will evaluate the scientific value, availability of tissue, and utilization priority of the tissue for the submitted application. Signatures of these site group members are required to acknowledge that appropriate tissue is available at source for the proposed project and that there is demonstrable scientific merit for the proposed project. 3. There is no submission deadline.

Retrospective Review of Medical Charts/Health Data

When to use the Application for Retrospectve Review of Medical Charts & Health Data
Retrospective Review of Medical Charts & Health Data Instructions: You can use this form if the research does not involve contacting patients, or is of quality assurance nature. Privacy Tutorial: All Investigators (including students) conducting retrospective review of health records are required to provide evidence of training for privacy protection of human subjects prior to submission of this Application. This requirement for training may be met by completing the brief web-based program located on the HiREB website at: http://www.hireb.ca/resources/links/. Upon successful completion of the tutorial, print a certificate for your own record and enter the certificate number in the appropriate place on the Application. Quality Assurance and Research Studies – submit the Application form, together with supporting documentation. Applications are not subject or submission deadlines. Applications are reviewed by the Research Ethics Board and the Privacy Office. When in doubt, refer to the HiREB Website Guidelines for examples of Quality Assurance activities, or contact the HiREB Office.

Prospective Database Application

When to Use the Prospective Database Application
Prospective Research Database or an Existing Database Application: Guidelines have been established for creating databases prospectively for general research purposes in order to comply with the provincial privacy legislation (Personal Health Information Protection Act - PHIPA), and the Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans (TCPS). In September 2005, CIHR published a guidance document “Best Practices for Protecting Privacy in Health Research” http://www.cihr-irsc.gc.ca/e/29072.html . It was also utilized in the creation of this REB document. Particular attention must be paid to following privacy rules, the security of the database and limiting access to the database. For further information, please refer to PHIPA legislation, section 44 at: http://www.e-laws.gov.on.ca/DBLaws/Statutes/English/04p03_e.htm KEY POINTS: - Creation of a database for general research purposes requires the researcher to define the scope and purpose of the database in a way that will be meaningful for the REB and any prospective research participants, even if the boundaries are at a relatively general level. - Even though all the research studies that may use data from this database cannot be anticipated or explained in detail at the time the database is being created, the researcher must try to describe the types of studies that could be undertaken - PHIPA states that as a researcher, you must comply with the approved research plan; implement the safeguards for protecting the information outlined in the plan; use personal health information only for the purposes described in the research plan; do not publish personal health information in a way that could reasonably allow others to identify the individual whose information was used in the research; only disclose the information when required by law; do not contact individuals whose information is used in the research unless they have given consent to the disclosing health information custodian to be contacted by you; comply with the terms and conditions of the written agreement that you enter into with the disclosing health information custodians; provide written notice of any breach of the written agreement or any other duties to the disclosing health information custodians. - NOTE: PHIPA transition rules: If you have been using or disclosing personal health information for research purposes without consent within the three years before November 1, 2004 and your research will not continue past November 1, 2007, no action is required. However, if research will continue past November 1, 2007, you must take steps to comply with PHIPA which includes requesting REB approval for your database. ACTION: An application for REB approval must be submitted if a researcher proposes to use existing databases, including clinical databases, for research purposes. Privacy Tutorial All Investigators (including students) are required to provide evidence of training for privacy protection of human subjects prior to submission of this Application. This requirement for training may be met by completing the brief web-based program located on the HiREB Website under Links. Upon successful completion of the tutorial, print a certificate for your own record and enter the certificate number in the appropriate place on the Application. Application Review and Notification 1. Submit the Application form, together with supporting documentation, there is no submission deadline for these applications. 2. Creation of the database can begin after REB approval is received by the researcher. 3. Future studies which will utilize the database also require REB approval using the Application for Retrospective Review. 4. Access to the database is limited to the researcher and his/her delegates as outlined in the proposal. Other access must be approved by the REB.

Amendment Form

How to Complete an Amendment Form
Amendment Request Form: ALL changes to research protocols or information/consent documents, advertisements, study instruments, etc. must have HiREB review and approval prior to implementation, except where necessary to eliminate immediate hazards to study participants. Amendments must be submitted in such a way that: • The old wording is clearly identified (for example, bolded strikethrough text). • The new wording is clearly identified (for example, italicized grey-shaded text). • It is clear why each amendment has been made.. • It is clear whether each amendment increases risk or discomfort for the participant in any way. Please submit: • A cover letter (synopsis) from the Investigator is mandatory. • For changes to existing documents: o One copy of any amended document containing the proposed changes (e.g. protocol, information sheet/consent form, drug or device brochure, advertisement, study instrument, questionnaire, etc.). Ensure that all revised documents have a new version and date. o A detailed explanation/justification for each change. o If the information/consent forms or recruitment advertisements have been changed, provide one “clean” copy of amended document(s). • For new documents: o One copy of any new document (e.g. protocol, information sheet/consent form, drug or device brochure, advertisement, study instrument, questionnaire, etc.). o An explanation / rationale for the newly added document(s) must be provided.

LSAE's & NLSAE's Forms

How to Complete LSAE & NLSAE Forms
INSTRUCTIONS FOR REPORTING OF LOCAL and NON-LOCAL ADVERSE EVENTS DEFINITIONS A. Investigational Product: Any drug, biologic, radiopharmaceutical, vaccine, natural health product, medical device or placebo being given to a research participant B. Adverse Event (AE): Any untoward medical occurrence in a research participant, administered investigational product, including an occurrence which does not have a causal relationship with the product. An AE can be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not related to the investigational product C. Serious Adverse Event (SAE): Is any adverse occurrence or response to a drug/intervention that: • Results in death • Is life-threatening • Requires inpatient hospitalization or prolongation of existing hospitalization • Results in persistent or significant disability/incapacity • Results in a congenital anomaly/birth defect • Based upon appropriate medical judgment, is an important medical event that may jeopardize the health of the research participant or may require medical intervention to prevent one of the outcomes listed above D. Unanticipated Problem: any incident, experience, or outcome (including an adverse event) that meets ALL of the following criteria: • *Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the HiREB-approved research protocol, informed consent document, and/or the Investigator Brochure; and (b) the characteristics of the research participant population being studied; AND • +Related or possibly related to participation in the research, (possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the [intervention(s)] or procedures involved in the research); AND • Suggests that the research places research participants or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized. Note: *Unexpected: an event is “unexpected” when its specificity and severity are not accurately reflected in the HiREB-approved research protocol, the current HiREB-approved informed consent document, the Investigator Brochure, and/or other relevant sources of information; or when the event is not associated with the expected natural progression of any underlying disease, disorder, predisposing risk factor, or condition of the participant(s) experiencing the adverse event. +Related to the research procedures: an event is “related to the research procedures” if in the opinion of the Researcher or sponsor, the event was more likely than not to be caused by the research procedures. REPORTING LOCAL ADVERSE EVENTS • Any local serious adverse event that in the opinion of Local Principal Investigator (LPI) is both unexpected and related or possibly related to, the study intervention or research procedures, must be reported to the HiREB. Please see definitions under “Unanticipated Problem” above. In the case of sponsored multi-site clinical trials, the LPI is unlikely to know if the SAE may pose a threat to other research participants at other sites; thus a local SAE must be reported if it satisfies the first 2 criteria of being unexpected and related/possibly related to, the study intervention. • Use the Local Serious Adverse Event Report Form • Report within 7 business days of becoming aware of the event • All reports submitted to the HiREB must have all research participant identifiers removed (i.e., participant research ID number only) • Once a local adverse event is acknowledged by the HiREB, subsequent important follow-up reports related to the adverse event should be submitted when available, as update(s) • The reporting of SAEs may not be deferred to the Annual Progress Report • Local SAEs must be reported by the LPI to the study sponsor and/or appropriate federal government agencies (eg. Health Canada) • If the local site is part of a multi-centre study, the LPI must also append the most recent Data Safety Monitoring Board (DSMB) or a Sponsor-generated safety Report summarizing SAEs to date and any implications for the risk/benefit ratio, as described below NOTE: The following local adverse events need NOT be reported to the HiREB: • SAE that is expected and considered related to the investigational product or research procedures • SAE that is expected and considered not related to the investigational product or research procedures • SAE that is unexpected and is considered not related to the investigational product or research procedures • Non-serious AE which is expected • Non-serious AE which is unexpected REPORTING OF LOCAL SERIOUS ADVERSE EVENT TO HiREB LOCAL SAE ACTION Unexpected Expected Not Related Related X X Report to HiREB X X No Report to HiREB X X No Report to HiREB X X No Report to HiREB REPORTING NON-LOCAL SERIOUS ADVERSE EVENTS • Upon receipt of a non-local adverse event, a periodic safety update, or safety summary report, the Local Principal Investigator must determine if it meets the HiREB reporting criteria: A Non-local Adverse Event is reportable to the HiREB, if in the opinion of the Local Principal Investigator, it meets the definition of an unanticipated problem AND requires a change to the research and/or informed consent form and/or requires immediate notification to participants for safety reasons. Please see definitions under “Unanticipated Problem” above. • Use the Non-Local Serious Adverse Event Report Form • The report submitted to the HiREB must include all of the following information: a. The description of the unanticipated event(s) b. All previous safety reports concerning similar adverse events c. An analysis of the significance of the current unanticipated event(s) in light of the previous reports d. The proposed research changes, informed consent form changes or other corrective actions to be taken by the sponsor in response to the event(s) • The non-local individual SAE reports, periodic safety updates, or safety summary reports that meet the reporting criteria must be submitted to the HiREB within 15 business days of the Local Principal Investigator becoming aware of the event/report(s) • Reports not meeting these requirements will be returned to the Local Principal Investigator DSMB and SPONSOR-GENERATED SAFETY REPORTS • All DSMB Reports must be forwarded to the HiREB within 15 business days of the Local Principal Investigator becoming aware of them • The DSMB report must be accompanied by a letter from the Local Principal Investigator indicating his/her acceptance of the findings and recommendations of the DSMB

Protocol Deviations Forms

How to Complete a Protocol Deviation Form
Protocol Deviations, Violations and Waivers Form: REB RESPONSE: The REB will not give retroactive approval of violations REPORTING FORMAT: Protocol violations must be reported on the appropriate form as noted below. DEFINITIONS: Protocol Violation General term This is a term broadly used in clinical research to describe any study event whereby the current REB-approved research protocol was not followed, i.e. a change in a research activity. There is general acceptance in the biopharmaceutical industry for two categories of protocol violation, i.e. a protocol deviation and a protocol exception. Protocol Deviation: General Term Discovered after occurrence. Post event report to REB. N.B. The only acceptable protocol deviation is when urgent action is required to eliminate an immediate hazard to a subject. An unanticipated or unintentional divergence or departure from the expected conduct of an approved study that is not consistent with the current research protocol, consent document or study addenda. Protocol Deviations must be reported to the REB within 7 days of their discovery by using the HiREB Protocol Deviation Report attached. A copy of the sponsor protocol violation, deviation or waiver form should be appended to the form. Other supporting documentation should be retained by the Investigator and be made available upon request. Protocol Deviation: Inclusion / Exclusion Waivers Post event notification acceptable for minimal risk waivers only. These are single occurrence deviations in inclusion/exclusion criteria. In general they are a planned exception that should receive REB approval before being implemented. However the REB recognizes that in some cases time may be of the essence in enrolling participants. Therefore, enrollment waivers, that in the opinion of the local Principal Investigator, are minimal risk i.e. have no potential for negative impact on the health and safety of the research participant may be implemented without prior REB approval. All others should be sent to the REB for prior approval using the Amendment Request Form. Protocol Deviations must be reported to the REB within 7 days of implementation if the deviation affects patient safety or the integrity/outcome of the study. All other deviations must be reported within a timely fashion, e.g., no greater than 2 months from the time of occurrence. Protocol Deviation Report. A copy of the sponsor protocol violation, deviation or waiver form should be appended to the HiREB Protocol Deviation Report form attached. Other supporting documentation should be retained by the Investigator and be made available upon request. Do not use the attached Protocol Deviation Report for requests for approval of planned or future exceptions or revisions (i.e. a protocol change that is more than a single occurrence deviation). A divergence or departure from expected conduct of an approved study that is not consistent with the current research protocol, consent document or addenda, that had been anticipated by the investigator, and for which REB grants acceptance must be submitted on the Amendment Request form.

Annual Renewal Forms

When to Use an Annual Renewal Form
Annual Renewal Form: An Annual renewal form is required every year on the study anniversary date. Use this form only if data are being collected or participants are still being followed. If all data collection and participant follow-up has ended and the study is either completed or cancelled, submit a Study Completion Report.

Study Completion Form

When to Use a Study Completion Form
Study Completion Form: Use this form only if all data have been collected and all contact with participants has concluded. The study may not be closed out until both are completed.