POLICY AND PROCEDURE DATE NUMBER Page RVH RESEARCH ETHICS BOARD 20/08/07 Version 7 1 of 38 POLICY & PROCEDURES INDEX 1. Policy…………………………………………………. 3 Introduction……………………………………. 3 Scope and Organization……………………… 4 Research Requiring Review…………………. 4 2. Definitions…………………………………………….. 4 3. Procedures – Review Process……………………… 8 a. Full REB Review………………………………. 8 b. Expedited Review……………………………... 9 c. Retrospective Chart Reviews………………… 10 d. Review Procedures for Ongoing Research… 11 e. Review of Multi-Centered Trials……………… 11 f. Amendments…………………………………… 12 g. Changes to Consent Forms/documents……. 12 4. Reporting Requirements – ADR’s…………………… 12 5. Researcher's Responsibilities………………………. 13 6. Research Guidelines………………………………… 14 a. Guidelines for Risks and Benefits…………… 14 b. Guidelines for Free and Informed Consent… 15 7. Guidelines for Privacy and Confidentiality………… 19 8. Legislation and Guidelines – REB Review……….. 21 9. Schedule “A” – Privacy Tool Checklist……………. 22 10. Schedule “B” - RVH Confidentiality 23 Agreement……………………………………………. 11. Schedule “C” - REB Composition Comparison 28 Chart……………... 12. Schedule “D” – Fee Schedule & Guidelines for Study 29 Budget POLICY AND PROCEDURE DATE NUMBER Page RVH RESEARCH ETHICS BOARD 20/08/07 Version 7 2 of 38 13. Schedule “E” - Article 2.1 TCPS 30 14. Schedule “F” – Sections 44 & 45 PHIPA 34 POLICY AND PROCEDURE DATE NUMBER Page RVH RESEARCH ETHICS BOARD 20/08/07 Version 7 3 of 38 The Royal Victoria Hospital Research Ethics Board POLICY AND PROCEDURES ISSUED BY: DATE ISSUED: August 20, 2007 The Royal Victoria Hospital Research Ethics Board (RVH REB) 1. POLICY Introduction Researchers enjoy important freedoms and privileges, including the freedom of inquiry and the right to disseminate the results thereof, freedom to challenge conventional thought, freedom from institutional censorship, and the privilege of conducting research on human subjects with public monies, trust and support. With this freedom comes responsibility, including the responsibility to ensure that research involving human subjects meets high scientific and ethical standards. The researcher’s commitment to the advancement of knowledge also implies duties of honest and thoughtful inquiry, rigorous analysis, and accountability for the use of professional standards. Peer review of research proposals, the freedoms described above, the findings and their interpretation contribute to accountability both to colleagues and to society 1. The RVH REB will: ensure the maintenance of high ethical and scientific standards in all aspects of research involving human subjects; review and advise on the ethical nature of all protocols involving human subjects at RVH; provide education, guidance and leadership in the application of ethical principles to the conduct of research to investigators, staff and students; comply with the requirements of the Tri-Council Policy Statement on the Ethical Conduct of Research Involving Humans and the Health Canada Good Clinical Practice: Consolidated Guideline. If there is a conflict between the two, the RVH REB will comply with the most demanding guidelines. 1 TCPS Section 1E “Academic Freedoms and Responsibilities”. POLICY AND PROCEDURE DATE NUMBER Page RVH RESEARCH ETHICS BOARD 20/08/07 Version 7 4 of 38 Scope and Organization The RVH REB will ensure adequate evaluation of both scientific merit and scholarly standards of research proposals presented by researchers with respect to studies that involve human subjects at RVH. The purpose of the RVH REB is to review all research involving the use of human subjects at RVH. The RVH REB has the mandate to approve, reject, propose modifications to, or terminate any proposed or ongoing research involving human subjects which is conducted within, or by members of the institution2. Research Requiring Ethics Review by The Royal Victoria Hospital REB All research involving human subjects at RVH or conducted by members of the professional staff of RVH, requires review and approval by the RVH REB in accordance with the Tri-Council Policy Statement (TCPS) before the research can begin 3. Research involving human remains, cadavers, tissues, biological fluids, embryos or fetuses shall also be reviewed by the RVH REB. Research about a living individual involved in the public arena, or about an artist, based exclusively on publicly available information, documents, records, works, performances, archival materials or third-party interviews, is not required to undergo ethics review. Such research requires ethics review only if the subject is approached directly for interviews or for access to private papers, and then only to ensure that such approaches are conducted according to professional protocols and to Article 2.3 of the TCPS. Quality assurance studies, performance reviews or testing within normal educational requirements should also not normally be subject to REB review4. 2. DEFINITIONS Approval (by Research Ethics Board) The affirmative decision of the Research Ethics Board that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the REB, the institution, Good Clinical Practice (GCP), and the applicable regulatory requirements. 2 Article 1.2 TCPS www.pre.ethics.gc.ca/english/policystatement/section1.cfm#1A 3 Article 1.1 TCPS www.pre.ethics.gc.ca/english/policystatement/section1.cfm#1A 4 Article 1.1 TCPS POLICY AND PROCEDURE DATE NUMBER Page RVH RESEARCH ETHICS BOARD 20/08/07 Version 7 5 of 38 Adverse Drug Reaction (ADR) In the pre-approval clinical experience with a new medicinal product or its new usages - particularly as therapeutic dose(s) may not be established - all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. The phrase “responses to a medicinal product” means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e., the relationship cannot be ruled out. Regarding marketed medicinal products: A response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for modification of physiological function (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting) 5. Clinical Trial/Study Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are synonymous. Documentation All records, in any form (including, but not limited to, written, electronic, magnetic, and optical records, and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken. Expedited Review Review by an individual (usually the REB Chair), or subgroup of the REB, as appointed by the Chair, with a turn-around time of no more than 30 days. Full-Board Review Review by a quorum of REB members, as outlined in the REB’s Terms of Reference and as prescribed by PHIPA, TCPS, GCP and 45 CFR 46 requirements, in a face-to-face meeting. Turn-around time is 30 – 90 days. 5 Section 1.1 GCP Guidelines: www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide- ld/ich/efficac/e6_e.html#1.0 POLICY AND PROCEDURE DATE NUMBER Page RVH RESEARCH ETHICS BOARD 20/08/07 Version 7 6 of 38 Good Clinical Practice (GCP) A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. Informed Consent A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form. Institution (medical) Any public or private entity or agency or medical or dental facility where clinical trials are conducted. Investigator A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator. See also Sub-investigator. Investigator's Brochure A compilation of the clinical and non-clinical data on the investigational product(s) which is relevant to the study of the investigational product(s) in human subjects. Legally Acceptable Representative An individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject's participation in the clinical trial. Minimal risk Minimal risk is defined in terms of the probability and magnitude of harms to the potential subjects by participating in the research, compared to their everyday life6 Multi-Centre Trial A clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more than one investigator. 6 C1 Tri-Council Policy Statement (TCPS) POLICY AND PROCEDURE DATE NUMBER Page RVH RESEARCH ETHICS BOARD 20/08/07 Version 7 7 of 38 Protocol A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. Throughout the ICH GCP Guidance the term protocol refers to protocol and protocol amendments. Protocol Amendment A written description of a change(s) to or formal clarification of a protocol. Randomization The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias. REB Research Ethics Board – An independent body constituted of medical, scientific, and non- scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and amendments and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects. Composition is based on legislation, regulations and guidelines (see Schedule “C” attached). Serious Adverse Event (SAE) Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (Including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product (see also the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting)7. Sponsor An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial. 7 Section 1.2 GCP Guidelines www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide- ld/ich/efficac/e6_e.html#1.0 POLICY AND PROCEDURE DATE NUMBER Page RVH RESEARCH ETHICS BOARD 20/08/07 Version 7 8 of 38 Sponsor-Investigator An individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. The term does not include any person other than an individual (e.g., it does not include a corporation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator. Unexpected Adverse Drug Reaction An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator's Brochure for an unapproved investigational product or package insert/summary of product characteristics for an approved product) (see the ICH Guidance for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting). 3. PROCEDURES Review Process There are two types of REB review available at RVH: (a) Full board review; and (b) Expedited review. The level of review that a study will undergo is determined by a risk assessment performed by the REB Chair. Studies deemed to pose a minimal risk of harm to research subjects (in accordance with the TCPS definition of the same), will be eligible for expedited review. Studies involving greater than ‘minimal risk’ will be directed to full-board review. All applications, regardless of the review process, must include impact signatures from both the Clinical and Administrative Directors of the Department. This signature cannot be provided by the Principal Investigator or any of the Co- investigators. Incomplete or illegible submissions may be returned to the Investigator without review. This includes submissions that are not accompanied by the Study Budget/Cost Analysis, and when appropriate, the accompanying fee for review8 In the absence of the REB Chair, an REB board member who is appointed by the Chair will assume the responsibilities of the Chair. Full REB Review With respect to full-board REB review, clinical trial protocols must be submitted 30 days in advance of the REB meeting, for which the Researcher wishes it to be 8 See Schedule “D” POLICY AND PROCEDURE DATE NUMBER Page RVH RESEARCH ETHICS BOARD 20/08/07 Version 7 9 of 38 reviewed. In the event four or more protocols have been submitted for that month, it may be necessary to postpone review until the following meeting. Protocols are added to the agenda on a first-come, first-serve basis. Please note: a) Evaluation of scholarly merit involves a global assessment of the degree to which the research might further the understanding of the phenomenon being studied. The primary test for scholarly merit is the application of scientific and scholarly merit standards, regardless of personal biases or preferences. b) REB approval will be granted where a quorum exists and a majority of the REB has voted in favour of approval. c) Where the Chair or the REB members are of the opinion that a consensus of the REB reveals ethical problems such that ethical approval cannot be granted, the Chair will communicate the problems in writing to the applicant. If the concerns are significant enough, the Chair or the REB members may request that the protocol be resubmitted to the full board, or to a subcommittee of the REB, to ensure that their concerns have been fully addressed. The Chair or 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. d) Where the Chair is of the opinion that a consensus exists against granting ethical approval and attempts to address the ethical problems are unsuccessful, the Chair may disallow research on ethical grounds. e) Citing justification, researchers have the right to request, and upon receipt of the request, the REB has an obligation to provide reconsideration of a negative decision. f) Appeal process is in compliance with The Tri-Council Policy Statement D5 www.pre.ethics.gc.ca/english/policystatement/section1.cfm#1D5 Expedited Review The Chair of the REB will review submissions to assess whether they qualify for the expedited review process. The following types of submissions may qualify for expedited review: a) Have been previously approved but require minor revisions; b) Involve a replication of a previously approved protocol; POLICY AND PROCEDURE DATE NUMBER Page RVH RESEARCH ETHICS BOARD 20/08/07 Version 7 10 of 38 c) Do not create risks greater than the minimum risk threshold and/or; d) Fall into the categories of research which qualifies for expedited review described by the Office for Human Research Protections, U.S. Department of Health and Human Services under section 46.110 9.” http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm#46.110 e) If the proposal is a re-submission for review because of minor revisions to the protocol, involves a replication of a previously approved protocol, and/or has been approved by another REB, the Chair may approve the application based on his or her review. f) If a proposal is new or involves significant revisions, and does not create risks greater than the minimum risk threshold, the Chair may approve the application based on his or her review, or it may be sent to another REB member, or to a subcommittee of the REB. g) The reviewers provide an assessment of the level of risk and any other ethical issues arising from the reviews. h) Where appropriate, the Chair may appoint experts on an ad hoc basis, to review a proposal. i) If the Chair believes more than minimal risk is involved, then the proposal is to be reviewed by a full-board of the REB in a face-to-face meeting. Retrospective Chart Reviews10 Retrospective chart review studies are a means of studying past experiences or circumstances of particular groups of patients. In such studies where researchers are seeking to dispense with the necessity of obtaining informed consent, the following legislation and guidelines apply: 1. PHIPA 2004 Sections 44 and 45 www.e- laws.gov.on.ca/DBLaws/Statutes/English/04p03_e.htm#BK58 ; (see Schedule “F”) 2. Article 2.1 of the Tri-Council Policy Statement (TCPS) www.pre.ethics.gc.ca/english/policystatement/section2.cfm (see Schedule “E) It is the obligation of the researcher to clearly demonstrate and set out in writing to the satisfaction of the RVH REB that the provisions of the above-noted guidelines/legislation have been strictly adhered to. PHIPA 2004 also contains requirements for safe-guarding the privacy and confidentiality of Personal Health Information contained in said chart reviews.11 All retrospective chart review studies which fail to meet these standards will not be approved. 9 45 CFR 46.110 10 (Also see p.8 – Expedited Review) 11 See Schedule “A” attached POLICY AND PROCEDURE DATE NUMBER Page RVH RESEARCH ETHICS BOARD 20/08/07 Version 7 11 of 38 If the study is approved, both the Researcher and Health Records are notified in writing. The Researcher must enter into a [PHIPA-prescribed] Confidentiality Agreement with RVH12, before the retrospective chart review may begin. Review Procedures for Ongoing Research In the event that research remains on-going one year subsequent to the study’s initial approval date, an Application for Annual Re-Approval should be provided to the RVH REB. The investigator should ensure the entire form is completed, including the total number of patients recruited to the study over the past year. The investigator should ensure that the year-to-date figures for patients recruited are accurate as well, before submitting the form for review. Incomplete or inconsistent forms will be returned to the investigator. A formal review of the free and informed consent process is required upon renewal, therefore an original of the most recently approved consent form(s) and/or information sheet(s) should also be submitted. If changes are required to the approved consent form(s) and/or information sheet(s), an original revised form(s), as well as a highlighted copy of the revised form(s) should be submitted to facilitate an expeditious review of the changes. This documentation should be provided to the RVH REB approximately two months prior to the expiry date. This will allow the Chair and/or the RVH REB sufficient time to contact the investigator(s) if there are any questions or concerns about the progress of the study. Failure to comply with this requirement for a timely submission of Annual Re-approval may result in suspension of the study at this site. For annual renewal of approved projects in which there has been little or no change in the ongoing research, the approval can be expedited. If the research protocol involves no more than minimal risk, the approval period is usually extended for an additional twelve-month period. For research that may have significant risks, the RVH REB may request reports on the progress of the research at shorter, predetermined intervals. These reports should include an assessment of how closely the researcher and the research team have complied with the ethical safeguards initially proposed by the RVH REB. Review of Multi-Centered Trials (MCTs) The RVH REB is responsible for the ethical acceptability of research undertaken within its institution. However, in multi-centered research, when several REBs consider the same protocol from the perspectives of their respective institutions, they may reach different conclusions on one or more aspects of the proposed research. In order to facilitate coordination of ethics review, the researcher may wish to distinguish between core elements of the research which cannot be altered without 12 See Schedule “B” attached POLICY AND PROCEDURE DATE NUMBER Page RVH RESEARCH ETHICS BOARD 20/08/07 Version 7 12 of 38 invalidating the pooling of data from the participating institutions, and those elements that can be altered to comply with local requirements without invalidating the research project. It may be necessary for the RVH REB to communicate with other external REBs reviewing the same project. In order to facilitate this communication, the investigator may be asked to provide a list of other REBs that will be reviewing the project. Serious and unexpected adverse drug reactions (ADR’s) reported from MCTs will be assessed to comply with regulatory standards of GCP13 and Health Canada. If the study has a data safety monitoring board (DSMB), adverse drug reaction reporting will be set out according to procedures set by the DSMB. Correspondence between the DSMB and investigator should be copied to the REB. Amendments Any and all changes to previously approved documents must be submitted to the REB for review. These include, but are not limited to, the ethics application, company protocol, questionnaires, and consents. A Summary of Changes should be completed and the revised documents provided (if applicable). Investigators should not implement any changes to research proposals previously approved by the RVH REB until they have received written approval from the RVH REB. Changes to Consent Forms and/or Information Documents Any change to an approved consent form and/or information document must be submitted for review and approval by the RVH REB. An original of the amended document and a highlighted copy of the revised form should be submitted to facilitate an expeditious review of the changes. The RVH REB may request changes to the consent form(s) and/or information documents on the basis of information received such as serious adverse event reports, amendments and reports regarding efficacy. The investigator may only use the revised forms once they have received an approval letter from the RVH REB. Reporting Requirements Serious Adverse Drug Reactions Only adverse drug reactions that are both serious and unexpected, should be reported to the REB14. Please note that a change in risk due to an increase in frequency or severity, can also be considered to be ‘unexpected’. 13 GCP 3.3.8 www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ich/efficac/e6_e.html#3.0 14 Ibid 13 POLICY AND PROCEDURE DATE NUMBER Page RVH RESEARCH ETHICS BOARD 20/08/07 Version 7 13 of 38 The REB requires the Investigator to promptly report to the REB: All adverse drug reactions (ADRs) that are both serious and unexpected. Changes increasing the risk to subjects and/or affecting significantly the conduct of the trial (see GCP 4.10.2). New information that may affect adversely the safety of the subjects or the conduct of the trial. Serious and unexpected adverse events should be reported to the RVH REB within seven days of the event, or notification of the event by the sponsor to the investigator at this institution. The investigator should also comply with the applicable regulatory requirement(s) related to the reporting of serious and unexpected adverse drug reactions to the REB15. 5. RESEARCHER’S RESPONSIBILITIES a) It is the responsibility of the researcher(s) to obtain ethical approval for any active project, funded or not, involving human subjects and to submit that project with complete documentation to the RVH REB. In particular, researchers must be aware that ethical review may in the ordinary course take four to six weeks to complete. Cases involving significant ethical problems may take substantially longer. It is the researchers’ responsibility to ensure that there is adequate lead-time available for ethical review in relation to other deadlines. b) It is the responsibility of the researcher to provide the RVH REB with complete documentation in adequate time. c) If research is ongoing, it is the responsibility of the investigator to ensure that approval of the study does not lapse. An Application for Annual Re-approval should be provided to the RVH REB. d) The investigator should be aware of, and should comply with, GCP and the applicable regulatory requirements. e) The investigator should submit written summaries of the trial status to the REB annually, or more frequently, if requested by the IRB/IEC16. f) The investigator should promptly provide written reports to the sponsor, the REB (see 3.3.8) and, where applicable, the institution on any changes significantly affecting the conduct of the trial, and/or increasing the risk to subjects17. g) If the research is complete, it is the responsibility of the investigator to ensure that a Notice of Closure is provided to the RVH REB. h) The investigator(s) should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial, should meet all the qualifications specified by the applicable regulatory requirement(s), and should 15 Section 4.11 GCP 16 Section 4.10.1 GCP 17 Sectio 4.10.2 GCP POLICY AND PROCEDURE DATE NUMBER Page RVH RESEARCH ETHICS BOARD 20/08/07 Version 7 14 of 38 provide evidence of such qualifications through up-to-date curriculum vitae and/or other relevant documentation requested by REB18. i) Upon completion of the research, the investigator must submit a Notice of Closure form to the RVH REB for review. The investigator should ensure that the entire form is completed, including the total number of participants recruited to the study since the last approval/renewal. The investigator should also ensure that the year-to-date figures for patients recruited are accurate, before submitting the form for review. Incomplete forms will be returned to the investigator. 6. RESEARCH GUIDELINES Guidelines For Risks and Benefits The researcher must document the risks and benefits that are expected within the context of their research. The researcher must demonstrate the proposed methodology is the best one in terms of minimizing possible risk.. Where appropriate in light of the risks involved, the researcher must demonstrate successful prior first-hand experience with the methodology proposed and the absence of detriment to the subjects involved.Risks that go beyond the threshold of minimal risk, including both identifiable and unforeseen risks must be considered. The researcher must be concerned with risks to: a) The subjects involved; b) Clearly identifiable third parties; c) The researcher personally and any staff involved; and d) Broader cultural, ethnic and national interests. The researcher must be concerned with at least the following types of risks: a) Physical harm; b) Psychological harm; c) Injury to reputation or privacy; and d) Breach of any relevant law. Illegal research cannot continue. The Researcher must assess not only the likelihood of a given risk, but also the duration and likely reversibility of its impact should it materialize. ‘Benefits’ include specific advantages to subjects, to third parties, to society or a segment of it, or any general increase in human knowledge. ‘Benefits’ include advantages or increases in knowledge both consciously sought by the researcher and which may arise as byproducts of the research. 18 4.1.1 GCP Guidelines POLICY AND PROCEDURE DATE NUMBER Page RVH RESEARCH ETHICS BOARD 20/08/07 Version 7 15 of 38 It is always the responsibility of the researcher, and of the RVH REB, to ensure that the projected benefits outweigh the possible risks. The more incalculable the risks or the less tangible the benefits, the more cautious the researcher and the RVH REB must be. The RVH REB must ensure that the research design and proposed implementation procedures are consistent with sound research standards and with sound standards of professional conduct and practice, in order to be satisfied that there is no unnecessary exposure to risk. Guidelines for Free and Informed Consent The requirements for free and informed consent are outlined below: a) Research may begin only if (1) prospective subjects, or authorized third parties, have been given the opportunity to give free and informed consent about participation, and (2) their free and informed consent has been given and is maintained throughout their participation in the research. Some exceptions do apply (see (c) below). b) Evidence of free and informed consent by the subject or authorized third party should ordinarily be obtained in writing. Where written consent is culturally unacceptable, or where there are good reasons for not recording consent in writing, the procedures used to seek free and informed consent shall be documented. c) The REB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirement to obtain informed consent, provided that the REB finds and documents that: (i) The research involves no more than minimal risk to the subjects; (ii) The waiver or alteration is unlikely to adversely affect the rights and welfare of the subjects; (iii) The research could not practicably be carried out without the waiver alteration; (iv) Whenever possible and appropriate, the subjects will be provided with additional pertinent information after participation; and (v) The waivered or altered consent does not involve a therapeutic intervention19. In studies including randomization and blinding in clinical trials, neither the research subjects nor those responsible for their care know which treatment the subjects are receiving before the project commences. Such research is not regarded as a waiver 19 Article 2.1 TCPS POLICY AND PROCEDURE DATE NUMBER Page RVH RESEARCH ETHICS BOARD 20/08/07 Version 7 16 of 38 or alteration of the requirements for consent if subjects are informed of the probability of being randomly assigned to one arm of the study or another. Ethical research involving humans requires free and informed consent. For those individuals who lack legal competence, free and informed consent may be granted by an authorized third party. Written evidence of free and informed consent is always preferred, however for some individuals or groups, a verbal agreement may be acceptable. In some types of research, verbal consent may be preferable. In others, written consent is mandatory. Where oral consent is appropriate, the researcher may wish to make a contemporaneous journal entry of the event and circumstances. The investigator may contact the RVH REB to refine the process if necessary. If there is any doubt about an issue involving free and informed consent, researchers should consult with the Chair of the RVH REB. The requirement for free and informed consent should not disqualify research subjects who are not proficient in the language used by the researchers from the opportunity to participate in potential research. Consent may be given provided that one or more items listed in Section 2.1 of the TCPS are used. Free and informed consent must be voluntarily given, without manipulation, undue influence or coercion. Consent must be freely given and may be withdrawn at any time. Undue influence should not take the form of inducement, deprivation or the exercise of control, or authority over prospective subjects. REB review is normally required for research involving naturalistic observation. However, research involving observation of participants in, for example, political rallies, demonstrations or public meetings should not require REB review since it can be expected that the participants are seeking public visibility20. Researchers shall provide, to prospective subjects or authorized third parties, full and frank disclosure of all information relevant to free and informed consent. Throughout the consent process, the researcher must ensure that prospective subjects are given adequate opportunities to discuss and contemplate their participation. Information should be provided at the commencement of free and informed consent whenever possible21. Subject to applicable legal requirements, individuals who are not legally competent shall be asked to become research subjects only when: (a) the research question can only be addressed using individuals within the identified group(s); and 20 Article 2.3 TCPS 21 Article 2.4 TCPS POLICY AND PROCEDURE DATE NUMBER Page RVH RESEARCH ETHICS BOARD 20/08/07 Version 7 17 of 38 (b) free and informed consent will be sought from their authorized representative(s); and (c) the research does not expose them to more than minimal risks without the potential for direct benefits for them22. For research involving incompetent individuals, the REB shall ensure that, as a minimum, the following conditions are met: (a) The research shall show how the free and informed consent will be sought from the authorized third party, and how the subjects’ best interest will be protected. (b) The authorized third party may not be the researcher or any other member of the research team. (c) The continued free and informed consent of an appropriately authorized third party will be required to continue the participation of a legally incompetent subject in research, so long as the subject remains incompetent. (d) When a subject who was entered into a research project through third-party authorization becomes competent during the project, his or her informed consent shall be sought as a condition of continuing participation 23. Where free and informed consent has been obtained from an authorized third party and in those circumstances where the legally incompetent individual understands the nature and consequences of the research, the researcher shall seek to ascertain the wishes of the individual concerning participation. The potential subject’s dissent will preclude his or her participation24. Research involving emergency health situations shall be conducted only if it addresses the emergency needs of individuals involved, and then only in accordance with criteria established in advance of such research by the REB. The REB may allow research that involves health emergencies to be carried out without the free and informed consent of the subject or of his or her authorized third party if ALL of the criteria listed in Article 2.8 of the TCPS apply25. As outlined in the Guideline for GCP (GCP), Section 4.8 titled “Informed Consent of Trial Subjects”, the investigator should also adhere to GCP and to the ethical principles that have their origin in the Declaration of Helsinki. Prior to beginning the trial, the investigator should have written approval from the RVH REB for the protocol, the consent documents and process, and any other written information that will be provided to the participants 26. 22 Article 2.5 TCPS 23 Article 2.6 TCPS 24 Article 2.7 TCPS 25 Article 2.8 TCPS 26 Section 4.8. GCP Guidelines POLICY AND PROCEDURE DATE NUMBER Page RVH RESEARCH ETHICS BOARD 20/08/07 Version 7 18 of 38 The researcher should provide any person who is to give informed consent with the following information as indicated in the Guideline for GCP and the TCPS 27: a) The identity of the researcher. b) That the trial involves research. c) The purpose of the trial. d) The trial treatment(s) and the probability for random assignment to each treatment. e) The trial procedures to be followed, including all invasive procedures. f) The subject’s responsibilities. g) Those aspects of the trial that are experimental. h) The reasonably foreseeable risks or inconveniences to the subject and, when applicable, to an embryo, fetus, or nursing infant. i) The reasonably expected benefits. When there is no intended clinical benefit to the subject, the subject should be made aware of this. j) The alternative procedure(s) or course(s) of treatment that may be available to the subject and their important potential benefits and risks. k) A description of the likely consequences of non-participation if the research is therapeutic. l) An assurance that exemplary care will be taken to safeguard the subject. m) The compensation and/or treatment available to the subject in the event of trial-related injury. n) The anticipated prorated payment, if any, to the subject for participating in the trial. o) The anticipated expenses, if any, to the subject for participating in the trial. p) 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. q) 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. r) 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. s) A description of how the data will be stored and/or when it will be destroyed. 27 Section 4.8.10 GCP Guidelines POLICY AND PROCEDURE DATE NUMBER Page RVH RESEARCH ETHICS BOARD 20/08/07 Version 7 19 of 38 t) 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. u) The person(s) to contact for further information regarding the trial and the rights of trial subjects, as well as a telephone number. v) The person to contact in the event of trial-related injury, as well as a contact number. w) The foreseeable circumstances and/or reasons under which the subject’s participation in the trial may be terminated; x) The expected duration of the subject’s participation in the trial; and y) The approximate number of subjects involved in the trial28. Written consent shall be dated and signed by the participant and by the investigator or their delegate. While there is no prescribed form, specimen forms are available on the RVH REB website www.rvh.on.ca (see Programs & Services then Research Ethics Board) . All consents shall be in writing for projects or proposals involving greater than minimal risk and/or biomedical procedures unless the RVH REB specifically authorizes the use of another format in a particular case, in advance. Where consent is oral, the researcher must make a record of it in an appropriate log or book dated and signed by the researcher. The requirements for consent may be waived if: a) The research involves no more than minimal risk to subjects; b) The waiver is unlikely to adversely affect the rights and welfare of the subjects; c) The research could not be practically carried out without the waiver; d) Wherever possible and appropriate subjects will be provided with additional pertinent information after participation; and e) The waived consent does not involve a therapeutic intervention. 7. GUIDELINES FOR PRIVACY AND CONFIDENTIALITY Right to privacy derives from a “right to security of the person” and “right to be secure against unreasonable search or seizure,” both enshrined in the Canadian Charter of Rights and Freedoms29. At a practical level, this implies that there are limits on the knowledge that investigators may obtain about health information of individuals without the prior consent of these individuals. 28 Section 4.8.10 GCP Guidelines 29 Cited in Kosseim Patricia (ed) A Compendium of Canadian Legislation Respecting the Protection of Personal Information in Health Research POLICY AND PROCEDURE DATE NUMBER Page RVH RESEARCH ETHICS BOARD 20/08/07 Version 7 20 of 38 The RVH REB requires in all studies requiring patient contact that the investigators demonstrate a plan to identify potential patient subjects without breaching their privacy. Investigators must obtain REB approval when obtaining identifiable personal information about human research subjects. Approval for such research must include the following considerations: a) The type of data to be collected; b) The purpose for which the data will be used; c) Limits on the use, disclosure and retention of the data; d) Appropriate safeguards for security and confidentiality30; e) Any modes of observation (e.g., photographs or videos) or access to information (e.g., sound recordings) in the research that allow identification of particular subjects; f) Any anticipated secondary uses of identifiable data from the research; g) Any anticipated linkage of data gathered in the research with other data about subjects, whether those data are contained in public or personal records; and h) Provisions for confidentiality of data resulting from the research31. The investigator has a duty not to share personal information that has been collected on research subjects. Breaches of confidentiality may cause harm to the trust relationship between the investigator and the research subject; to other individuals or groups; and/or to the reputation of the research community. Confidentiality applies to information obtained directly from subjects or from other researchers or organizations that have a legal obligation to maintain personal records confidential 32. Investigators should inform research subjects if their personal information would be provided to the government, government agencies, and personnel from an agency that monitors the research, the research sponsor (e.g., a pharmaceutical company), the REB or a regulatory agency33. It is a requirement of informed consent that any anticipated breach of confidentiality be clearly explained by the researcher to the subject; for example, disclosures required by law (e.g. child abuse; sexually transmitted disease, etc.) 34. It is essential that subsequent uses of data (e.g., research videos for education purposes) be specified in sufficient detail that prospective subjects may give free and informed consent35. 30 See also PHIPA Research Approval Checklist attached as Schedule “A” 31 Article 3.2 TCPS 32 Article 3 TCPS 33 Article 3.2 TCPS 34 Article 3.2 TCPS 35 Ibid POLICY AND PROCEDURE DATE NUMBER Page RVH RESEARCH ETHICS BOARD 20/08/07 Version 7 21 of 38 8. LEGISLATION AND GUIDELINES RELIED UPON FOR REB REVIEW 1. The Tri-Council Policy Statement 2. Health Canada GCP Guidelines 3. 45 CFR 46 (The Common Rule) 4. PHIPA 2004 5. Food & Drug Act, including Schedule 1024 Regulations 6. The Canadian Charter of Rights and Freedoms POLICY AND PROCEDURE DATE NUMBER Page RVH RESEARCH ETHICS BOARD 20/08/07 Version 7 22 of 38 Schedule “A” 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 POLICY AND PROCEDURE DATE NUMBER Page RVH RESEARCH ETHICS BOARD 20/08/07 Version 7 23 of 38 Schedule “B” RVH CONFIDENTIALITY AGREEMENT THIS CONFIDENTIALITY AGREEMENT is made this day of 200 . B E T W E E N: (Hereinafter Referred to as the “Researcher”) - and - ROYAL VICTORIA HOSPITAL (Hereinafter referred to as RVH) WHEREAS (name of researcher) is a clinical researcher wishing to access confidential data contained in the medical records and/or patient charts of the RVH.. AND WHEREAS the RVH considers itself ethically and legally bound to protect the confidentiality of such information within the limits prescribed by Good Clinical Practice, TCP Ethical Guidelines and all applicable legislation including, without limitation, the Personal Information and Protection of Electronic Documents Act 2003 and the Personal Health Information Protection Act, 2004; NOW THEREFORE, for valuable consideration, the receipt and sufficiency of which is hereby acknowledged, THE PARTIES AGREE AS FOLLOWS: POLICY AND PROCEDURE DATE NUMBER Page RVH RESEARCH ETHICS BOARD 20/08/07 Version 7 24 of 38 Recitals True 1. The foregoing recitals are accurate and true. Definitions: 2. (a) “Collect”, in relation to personal health information mean to gather, acquire, receive or obtain such information by any means from any source; (b) “Personal Health Information” as used herein shall include, without limitation, recorded information about an identifiable individual, including, (i) information relating to the race, national or ethnic origin, colour, religion, age, sex, sexual orientation or marital or family status of the individual; (ii) information relating to the physical or mental health of the individual, including information that consists of the health history of the individuals family or of the providing of health care to the individual; (iii) information relating to the education or the medical, psychiatric, psychological, criminal or employment history of the individual or information relating to financial transactions in which the individual has been involved; (iv) any plan of service within the meaning of the Long-Term Care Act, 1994; (v) any information relating to the payments or eligibility for health care in respect of the individual or in relation to the individual’s health number; (vi) genetic information of any nature or kind; (vii) information relating to the donation of any body part or bodily substance of the individual or information derived from the testing or examination of any such body part or bodily substance; (viii) any identifying number, symbol or other particular assigned to the individual, POLICY AND PROCEDURE DATE NUMBER Page RVH RESEARCH ETHICS BOARD 20/08/07 Version 7 25 of 38 (ix) the address, telephone number, fingerprints or blood type of the individual, (x) the personal opinions or views of the individual except where they relate to another individual; (xi) correspondence sent to an institution by the individual that is implicitly or explicitly of a private or confidential nature, and replies to that correspondence that would reveal the contents of the original correspondence; (xii) the views or opinions of another individual about the individual; and, (xiii) the individual's name where it appears with other personal information relating to the individual or where the disclosure of the name would reveal other personal information about the individual. (c) “Research” means a systematic investigation designed to develop or establish principles, facts or generalizable knowledge, or any combination of them, and includes the development, testing and evaluation of research. Representations and Warranties 3. The Researcher represents and warrants as follows: a) That his/her/its review of any Personal Health Information is being done strictly within the confines of bona fide scholarly or statistical medical research and that he/she/it will not collect or attempt to collect any Personal Health Information for any other purpose ; b) The research is being conducted for purposes that cannot be achieved without collecting the Personal Health Information being sought; and, c) It is impractical or impossible to obtain the consent of the individuals to whom the Personal Health Information relates. POLICY AND PROCEDURE DATE NUMBER Page RVH RESEARCH ETHICS BOARD 20/08/07 Version 7 26 of 38 4. RVH does not warrant the quality, accuracy or completeness of any Personal Health Information, which is collected by the Researcher “as is” without warranty or condition of any kind. RVH shall not be responsible for any liability whatsoever or howsoever caused, resulting from adopting or relying upon any Personal Health Information collected by the Researcher. Conditions and Restrictions: 5. Any Personal Health Information collected by the Researcher pursuant to this agreement will only be used for the purposes of bona fide scholarly or statistical research and only in respect of the express purposes stated by the Researcher in its application to the RVH Research Ethics Board for approval of the Study at RVH. 6. Any Personal Health Information collected by the Researcher pursuant to the terms of this Agreement, will be kept secure by the Researcher and the Researcher shall ensure that it will not be made available or accessible to unauthorized persons at any time. 7. The Researcher will, at all times, take all reasonable steps and precautions and shall ensure that adequate safeguards are in place as may be necessary to protect the confidentiality of the information collected by the Researcher from RVH and will not, under any circumstance, permit the release of Personal Health Information in any form that may result in the identification of the individual to whom the information relates. 8. The Researcher shall make no attempt to use the Personal Health Information to identify or contact a person or institution; 9. The Researcher shall not disclose Personal Health Information to any third party individual, corporation or other entity without the express, written consent of the RVH Research Ethics Board. POLICY AND PROCEDURE DATE NUMBER Page RVH RESEARCH ETHICS BOARD 20/08/07 Version 7 27 of 38 10. Prior to any publication of research findings, the Researcher must aggregate any Personal Health Information obtained in order to avoid residual disclosure of the identity of individuals or institutions. Indemnification 11. The Researcher shall indemnify and save harmless the RVH, its directors and officers, medical staff members, servants, employees and agents from and against any and all liability of any nature or kind whatsoever, arising from or in any way related to, the Researchers access to, mining of, or use of any Personal Health Information collected at or from RVH. 12. This Agreement is made under and shall be construed in accordance with the laws in force in the Province in Ontario. 13. The Researcher shall notify the RVH Research Ethics Board immediately in writing if the Researcher becomes aware of any breach of this agreement. 14. Failure of the Researcher to comply with the terms and conditions of this Agreement is cause for immediate termination of the Researchers access to any Personal Health Information in the custody, care or possession of RVH, a report to any applicable Ethics Review Body(ies), and where applicable, a complaint to the Information and Privacy Commissioner or equivalent data protection authority. SIGNED, SEALED and DELIVERED RVH In the Presence of: Chair - Research Ethics Board RESEARCHER Per: Authorized Signing Officer POLICY AND PROCEDURE DATE NUMBER Page RVH RESEARCH ETHICS BOARD 20/08/07 Version 7 28 of 38 SCHEDULE “C” REB Composition Comparison Chart TCPS 5 members of both sexes 2 broad research expertise 1 knowledgeable in ethics Biomedical research – 1 knowledgeable in law 1 community member Membership should be broad enough to reflect the composition of the community the REB serves www.pre.ethics.gc.ca/english/policystatement/sectio n1.cfm#1B2 GCP PHIPA 5 Members 5 Members (1 with no affiliation) Reasonable no. of members with 1 knowledgeable in research ethics collective qualifications/experience to 2 with expertise in methods or areas review types of research seen by the of research institution 1 Professional with expertise in 1 non-scientific privacy and PHI issues 1 independent www.e- laws.gov.on.ca/DBLaws/Regs/English/040329_e. www.hc-sc.gc.ca/dhp-mps/prodpharma/applic- htm#BK16 demande/guide-ld/ich/efficac/e6_e.html#3.0 45 CFR 46 Food & Drug Regs 5 Members of varying expertise 5 Members (majority Canadian sufficient to complete adequate Citizens or Residents) review of the research commonly Both male and female conducted by the institution 2 with scientific expertise Diversity of members possessing 1 knowledgeable in ethics professional competence 1 knowledgeable in biomedical suitable to an IRB research REB may not be drawn entirely 1 community member from 1 profession 1 non-scientific discipline 1 non-affiliated member (no family connections, either) www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb- 1 scientific member dgpsa/pdf/compli-conform/1024_e.pdf 1 non-scientific member www.hhs.gov/ohrp/humansubjects/guidance/45 cfr46.htm POLICY AND PROCEDURE DATE NUMBER Page RVH RESEARCH ETHICS BOARD 20/08/07 Version 7 29 of 38 SCHEDULE “D” FEE SCHEDULE SERVICE FEE Application Fee-Industry Sponsored $1,500.00 Studies Application Fee-Non-Industry $500.00 Sponsored Studies Annual Re-Approval- Industry $500.00 Sponsored Studies Annual Re-Approval- Non-Industry $100.00 Sponsored Studies In hospital trials 20% of budget to be paid to hospital to cover overhead expenses Protocol amendments requiring full $100.00 protocol review Non-Industry studies (that do not have Special Consideration to Waive Fee financial support), e.g. studies for Payment – at the REB’s Discretion Masters, Ph.D. thesis etc. exceptional circumstances may be taken into consideration as to whether fee payment will be required. GUIDELINES for STUDY BUDGETS/COST ANALYSIS36 Required to determine if: o Sufficient budget to ensure that study can be conducted through to completion o Risk of coercion from a monetary perspective o Risk of conflict of interest from a monetary perspective Must be submitted with original proposal Failure to comply may result in delays or halts in the Approval Process 36 See Article 7.3 TCPS POLICY AND PROCEDURE DATE NUMBER Page RVH RESEARCH ETHICS BOARD 20/08/07 Version 7 30 of 38 SCHEDULE “E” TCPS - Requirement for Free and Informed Consent Article 2.1 a. Research governed by this Policy (see Article 1.1) may begin only if (1) prospective subjects, or authorized third parties, have been given the opportunity to give free and informed consent about participation, and (2) their free and informed consent has been given and is maintained throughout their participation in the research. Articles 2.1(c), 2.3 and 2.8 provide exceptions to Article 2.1(a). b. Evidence of free and informed consent by the subject or authorized third party should ordinarily be obtained in writing. Where written consent is culturally unacceptable, or where there are good reasons for not recording consent in writing, the procedures used to seek free and informed consent shall be documented. c. The REB may approve a consent procedure1 that does not include, or that alters, some or all of the elements of informed consent set forth above, or waive the requirement to obtain informed consent, provided that the REB finds and documents that: i. The research involves no more than minimal risk to the subjects; ii. The waiver or alteration is unlikely to adversely affect the rights and welfare of the subjects; iii. The research could not practicably be carried out without the waiver or alteration; iv. Whenever possible and appropriate, the subjects will be provided with additional pertinent information after participation; and v. The waived or altered consent does not involve a therapeutic intervention. d. In studies including randomization and blinding in clinical trials, neither the research subjects nor those responsible for their care know which treatment the subjects are receiving before the project commences. Such research is not regarded as a waiver or alteration of the requirements for consent if subjects are informed of the probability of being randomly assigned to one arm of the study or another. POLICY AND PROCEDURE DATE NUMBER Page RVH RESEARCH ETHICS BOARD 20/08/07 Version 7 31 of 38 Free and informed consent lies at the heart of ethical research involving human subjects. It encompasses a process that begins with the initial contact and carries through to the end of the involvement of research subjects in the project. As used in this Policy, the process of free and informed consent refers to the dialogue, information sharing and general process through which prospective subjects choose to participate in research involving themselves. Article 2.1(a) states the requirement in both ethics and law: to protect and promote human dignity. Ethical research involving humans requires free and informed consent. As elaborated more fully below, free and informed consent is exercised by an authorized third party for those who lack legal competence. Article 2.1(b) states the preference for written evidence of free and informed consent. The article acknowledges that written consent is not always appropriate. For most people in our society, a signed statement is the normal evidence of consent. However, for some groups or individuals, a verbal agreement, perhaps with a handshake, is evidence of trust, and a request for a signature may imply distrust. Nonetheless, in most cases a written statement of the information conveyed in the consent process, signed or not, should be left with the subject. In some types of research, oral consent may be preferable. In others, written consent is mandatory. Where oral consent is appropriate, the researcher may wish to make a contemporaneous journal entry of the event and circumstances. These and like elements may sometimes need to be refined in concert with the REB, which plays an essential educational and consultative role in the process of seeking free and informed consent. When in doubt about an issue involving free and informed consent, researchers should consult their REB. The requirement for free and informed consent should not disqualify research subjects who are not proficient in the language used by the researchers from the opportunity to participate in potential research. Such individuals may give consent, provided that one or more of the following are observed to the extent deemed necessary by the REB, in the context of a proportionate approach to the harms envisaged in the research and the consent processes that are to be used: An intermediary not involved in the research study, who is competent in the language used by the researchers as well as that chosen by the research subject, is involved in the consent process. The intermediary has translated the consent document or approved an existing translation of the information relevant to the prospective subject. The intermediary has assisted the research subject in the discussion of the research study. The research subject has acknowledged, in his or her own language, that he or she understands the research study, the nature and extent of his or her POLICY AND PROCEDURE DATE NUMBER Page RVH RESEARCH ETHICS BOARD 20/08/07 Version 7 32 of 38 participation, including the risks involved, and freely gives consent (see exception in Article 2.1(c)). Consent is not required from organizations such as corporations or governments for research about their institutions. However, individuals who are approached to participate in a research project about their organization have the right to give free and informed consent. In particular, they should be fully informed about the views of the organization's authorities, if these are known, and of the possible consequences of participation. In this context, researchers should pay special attention to confidentiality. Private corporations and organizations have the right as institutions to refuse to cooperate with researchers or to deny them access to their private records if they so wish, and may have rules governing the conduct of their employees. However, such organizations need not be approached for consent, and REBs should not require such an approach. Nor should institutions be given the right to veto research projects. Under Article 2.1(c), the REB should exercise judgment on whether the needs for research justify limited and/or temporary exception to the general requirements for full disclosure of information relevant for a research subject's meaningful exercise of free and informed consent. In such cases, subjects may be given only partial information or may be temporarily led to believe that the research has some other purpose because full disclosure would be likely to colour the responses of the subjects and thus invalidate the research. For example, social science research that critically probes the inner workings of publicly accountable institutions might never be conducted without limited recourse to partial disclosure. Also, some research in psychology seeks to learn about human responses to situations that have been created experimentally. Such research can only be carried out if the subjects do not know in advance the true purpose of the research. In some research, therefore, subjects may be told in advance about the task that they will be asked to perform, yet given additional information, perhaps as part of the consent process or as part of the manipulated experimental conditions, that provides subjects with a different perspective on some aspect of the task or experiment and/or its purpose. Another scenario, in questionnaire research, embeds questions that are central to the researcher's hypothesis within distracter questions, decreasing the likelihood that subjects will adapt their responses to their perceptions of the true objective of the research. For such techniques to fall within the exception to the general requirement of full disclosure for free and informed consent, the research must meet the requirements of Article 2.1(c). The debriefing referred to in Article 2.1(c)(iv) should be proportionate to the sensitivity of the issue. Often debriefing can be quite simple and straightforward. In sensitive cases, researchers should provide, in addition to candid disclosure, a full explanation of why subjects were temporarily led to believe that the research or some aspect of it had a different purpose, or received less than full disclosure. The researchers should give details about the importance of the research, the necessity of having to resort to partial disclosure, and their concern about the welfare of the subject. They should seek to remove any misconceptions that may have arisen, and to reestablish any trust that POLICY AND PROCEDURE DATE NUMBER Page RVH RESEARCH ETHICS BOARD 20/08/07 Version 7 33 of 38 might have been lost, assuring the research subject during debriefing that these research procedures were neither arbitrary nor capricious, but necessary for scientifically valid findings. Debriefing is an important mechanism in maintaining the subject's trust in the research community. Immediate, full debriefing of all persons who have contributed data may not be feasible in all cases. In studies with data collection over a longer term, debriefing may have to be deferred until the end of the project. In some cases, for example in research involving children, it may be more appropriate to debrief the parents, guardians or authorized third parties rather than the subjects themselves. In other cases, it may be more appropriate to debrief the entire family or community. It may sometimes be appropriate to modify the debriefing to be sensitive to the subject's needs and feelings. In studies in which a waiver of informed consent has been allowed, it may still be practicable for subjects to exercise their consent at the conclusion of the study, following debriefing. In cases where a subject expresses concerns about a study, the researcher may give the subject the option of removing his or her data from the project. This approach should be used only when the elimination of the subject's data will not compromise the validity of the research design, and hence diminish the ethical value of participation by other subjects. When subjects express significant concern about being temporarily misled or about the use of partial disclosure in the research, the researcher should report those concerns to the REB. POLICY AND PROCEDURE DATE NUMBER Page RVH RESEARCH ETHICS BOARD 20/08/07 Version 7 34 of 38 SCHEDULE “F” PHIPA - Disclosure for research 44. (1) A health information custodian may disclose personal health information about an individual to a researcher if the researcher, (a) submits to the custodian, (i) an application in writing, (ii) a research plan that meets the requirements of subsection (2), and (iii) a copy of the decision of a research ethics board that approves the research plan; and (b) enters into the agreement required by subsection (5). 2004, c. 3, Sched. A, s. 44 (1). Research plan (2) A research plan must be in writing and must set out, (a) the affiliation of each person involved in the research; (b) the nature and objectives of the research and the public or scientific benefit of the research that the researcher anticipates; and (c) all other prescribed matters related to the research. 2004, c. 3, Sched. A, s. 44 (2). Consideration by board (3) When deciding whether to approve a research plan that a researcher submits to it, a research ethics board shall consider the matters that it considers relevant, including, (a) whether the objectives of the research can reasonably be accomplished without using the personal health information that is to be disclosed; (b) whether, at the time the research is conducted, adequate safeguards will be in place to protect the privacy of the individuals whose personal health information is being disclosed and to preserve the confidentiality of the information; (c) the public interest in conducting the research and the public interest in protecting the privacy of the individuals whose personal health information is being disclosed; and (d) whether obtaining the consent of the individuals whose personal health information is being disclosed would be impractical. 2004, c. 3, Sched. A, s. 44 (3). POLICY AND PROCEDURE DATE NUMBER Page RVH RESEARCH ETHICS BOARD 20/08/07 Version 7 35 of 38 Decision of board (4) After reviewing a research plan that a researcher has submitted to it, the research ethics board shall provide to the researcher a decision in writing, with reasons, setting out whether the board approves the plan, and whether the approval is subject to any conditions, which must be specified in the decision. 2004, c. 3, Sched. A, s. 44 (4). Agreement respecting disclosure (5) Before a health information custodian discloses personal health information to a researcher under subsection (1), the researcher shall enter into an agreement with the custodian in which the researcher agrees to comply with the conditions and restrictions, if any, that the custodian imposes relating to the use, security, disclosure, return or disposal of the information. 2004, c. 3, Sched. A, s. 44 (5). Compliance by researcher (6) A researcher who receives personal health information about an individual from a health information custodian under subsection (1) shall, (a) comply with the conditions, if any, specified by the research ethics board in respect of the research plan; (b) use the information only for the purposes set out in the research plan as approved by the research ethics board; (c) not publish the information in a form that could reasonably enable a person to ascertain the identity of the individual; (d) despite subsection 49 (1), not disclose the information except as required by law and subject to the exceptions and additional requirements, if any, that are prescribed; (e) not make contact or attempt to make contact with the individual, directly or indirectly, unless the custodian first obtains the individual’s consent to being contacted; (f) notify the custodian immediately in writing if the researcher becomes aware of any breach of this subsection or the agreement described in subsection (5); and (g) comply with the agreement described in subsection (5). 2004, c. 3, Sched. A, s. 44 (6). Mixed disclosures (7) If a researcher submits a research plan under subsection (1) that proposes that a health information custodian that is an institution within the meaning of the Freedom of Information and Protection of Privacy Act or the Municipal Freedom of Information and Protection of Privacy Act or that is acting as part of such an institution disclose to the researcher personal health information, together with personal information within the meaning of those two Acts that is not personal health information, those two Acts do not apply to the disclosure and this section applies to the disclosure. 2004, c. 3, Sched. A, s. 44 (7). POLICY AND PROCEDURE DATE NUMBER Page RVH RESEARCH ETHICS BOARD 20/08/07 Version 7 36 of 38 Transition (8) Despite subsection (7), nothing in this section prevents a health information custodian that is an institution within the meaning of the Freedom of Information and Protection of Privacy Act or the Municipal Freedom of Information and Protection of Privacy Act or that is acting as part of such an institution from disclosing to a researcher personal health information, that is personal information within the meaning of those two Acts, if, before November 1, 2004, the researcher entered into an agreement with the custodian under subclause 21 (1) (e) (iii) of the Freedom of Information and Protection of Privacy Act or subclause 14 (1) (e) (iii) of the Municipal Freedom of Information and Protection of Privacy Act and the disclosure is within the scope of the agreement. 2007, c. 10, Sched. H, s. 16. Disclosure under other Acts (9) Despite any other Act that permits a health information custodian to disclose personal health information to a researcher for the purpose of conducting research, this section applies to the disclosure as if it were a disclosure for research under this section unless the regulations made under this Act provide otherwise. 2004, c. 3, Sched. A, s. 44 (9). Research approved outside Ontario (10) Subject to subsection (11), a health information custodian may disclose personal health information to a researcher or may use the information to conduct research if, (a) the research involves the use of personal health information originating wholly or in part outside Ontario; (b) the research has received the prescribed approval from a body outside Ontario that has the function of approving research; and (c) the prescribed requirements are met. 2004, c. 3, Sched. A, s. 44 (10). Same (11) Subsections (1) to (4) and clauses (6) (a) and (b) do not apply to a disclosure or use made under subsection (10) and references in the rest of this section to subsection (1) shall be read as references to this subsection with respect to that disclosure or use. 2004, c. 3, Sched. A, s. 44 (11). Transition (12) Despite anything in this section, a health information custodian that lawfully disclosed personal health information to a researcher for the purpose of conducting research in the three-year period before the day this section comes into force may continue to disclose personal health information to the researcher for the purposes of that research for a period of three years after the day this section comes into force. 2004, c. 3, Sched. A, s. 44 (12). Same, use (13) Despite anything in this section, a health information custodian that lawfully used personal health information for the purpose of conducting research in the three- year period before the day this section comes into force may continue to use personal POLICY AND PROCEDURE DATE NUMBER Page RVH RESEARCH ETHICS BOARD 20/08/07 Version 7 37 of 38 health information for the purposes of that research for a period of three years after the day this section comes into force. 2004, c. 3, Sched. A, s. 44 (13). Repeal (14) Subsections (12) and (13) are repealed on the third anniversary of the day they came into force. 2004, c. 3, Sched. A, s. 44 (14). Note: Subsections (12) and (13) came into force on November 1, 2004. See: 2004, c. 3, Sched. A, s. 99 (2). Disclosure for planning and management of health system 45. (1) A health information custodian may disclose to a prescribed entity personal health information for the purpose of analysis or compiling statistical information with respect to the management of, evaluation or monitoring of, the allocation of resources to or planning for all or part of the health system, including the delivery of services, if the entity meets the requirements under subsection (3). 2004, c. 3, Sched. A, s. 45 (1). Exception (2) Subsection (1) does not apply to, (a) notes of personal health information about an individual that are recorded by a health information custodian and that document the contents of conversations during a private counselling session or a group, joint or family counselling session; or (b) prescribed information in circumstances that are prescribed. 2004, c. 3, Sched. A, s. 45 (2). Approval (3) A health information custodian may disclose personal health information to a prescribed entity under subsection (1) if, (a) the entity has in place practices and procedures to protect the privacy of the individuals whose personal health information it receives and to maintain the confidentiality of the information; and (b) the Commissioner has approved the practices and procedures, if the custodian makes the disclosure on or after the first anniversary of the day this section comes into force. 2004, c. 3, Sched. A, s. 45 (3). Review by Commissioner (4) The Commissioner shall review the practices and procedures of each prescribed entity every three years from the date of its approval and advise the health information custodian whether the entity continues to meet the requirements of subsection (3). 2004, c. 3, Sched. A, s. 45 (4). POLICY AND PROCEDURE DATE NUMBER Page RVH RESEARCH ETHICS BOARD 20/08/07 Version 7 38 of 38 Authorization to collect (5) An entity that is not a health information custodian is authorized to collect the personal health information that a health information custodian may disclose to the entity under subsection (1). 2004, c. 3, Sched. A, s. 45 (5). Use and disclosure (6) Subject to the exceptions and additional requirements, if any, that are prescribed and despite subsection 49 (1), an entity that receives personal health information under subsection (1) shall not use the information except for the purposes for which it received the information and shall not disclose the information except as required by law. 2004, c. 3, Sched. A, s. 45 (6).
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