A02.10.05 Ethical Conduct for Research Involving Humans

Policy Statement

Purpose

Related Policies

Definitions

Procedures and Guidelines

Policy Statement

All research that involves human subjects requires review and approval by the Research Ethics Board (REB) in accordance with this Policy Statement, before the research is started, except as stipulated in section A.1.4. The College expects all researchers to adhere to this policy and its related procedures and guidelines.

NOTE:

Purpose

Douglas College ("the College") requires and supports the highest ethical standards in conducting research involving human subjects to ensure their rights are respected and protected. Researchers at or associated with the College are required to follow research ethics protocols to ensure their research protects human subjects.

Primary institutional responsibility for research involving human subjects at the College is vested in the Douglas College REB and with the individual researchers. This policy applies to all College employees, students and other research personnel associated with the College.

Related Policies

A02.10.06 Academic Freedom

A02.10.03 Commercialization of Intellectual Property

A02.01.01 Conflict of Interest

A08.01.01 College Use of Copyrighted Works

A02.10.04 Integrity in Research and Scholarship

A16.01.04 Records Management and Retention Policy

A02.10.02 Research and Scholarly Activity

Definitions

Procedures and Guidelines

Section 1: Ethics Review

1. Research Requiring Ethical Review
   1. (Article 1.1.a) All research that involves human subjects requires review and approval by the REB in accordance with this Policy Statement and the Tri Council Policy Statement Ethical Conduct for Research Involving Humans, before the research is started, except as stipulated in section A.3. below.
   2. (Article 1.1.b) Research involving human remains, cadavers, tissues, biological fluids, embryos or fetuses.
      
      
   3. Exceptions
      1. (Article 1.1.c) 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 only requires ethics review 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 Tri Council Policy Statement.
      2. Research that is making use of data obtained from pre-existing or archival data bases that are in the public domain with no identifying information being used.
      3. Performance review of College employees.
      4. Assessments of students carried out within normal educational requirements as approved by Education Council, such as approved curriculum guidelines or admissions standards.
      5. Standardized testing conducted by College employees in the normal course of their work where they are qualified to administer such tests.
      6. Data collected by the College that relate directly to, and are necessary for, administering, evaluating or seeking to improve an operating program, service or activity of the College.
      7. Any research not affiliated with or supported by the College, conducted by College employees on their own time, outside their College role, not using College students or resources.
      8. Research involving non-human animal subjects. Researchers must ensure the application of ethical principles and comply with Canadian Council on Animal Care policies and guidelines.
         
         
2. Research Ethics Board
   

   The mandate of the REB is to ensure that ethical principles are applied to all research involving human subjects. It has a role to educate researchers and to review and monitor research proposals and projects. It serves as a consultative body on research ethics and to assist in educating employees about research ethics. It has the responsibility for independent multidisciplinary review of research proposals to determine if they meet ethical requirements and to approve them to be initiated or continue.
   
   Douglas College Research Ethics Board Request for Approval Form

   1. Authority of the Research Ethics Board
      1. (Article 1.2)The College mandates the REB to approve, reject, propose modifications to or terminate any proposed or ongoing research involving a human subject that is conducted within or by members of, the College, using the considerations set forth in this Policy, as a minimum standard.
      2. The REB is an independent standing committee with terms of reference approved by Senior Management. The REB's decision to approve or deny proposals for research or standardized testing are made independently and may not be set aside without formal appeal.
         
         
   2. Membership of the Research Ethics Board
      1. (Article 1.3) The REB shall consist of at least five members, including both men and women, of whom:
         1. at least two are faculty who possess broad expertise in the methods or in the areas of research that are covered by the REB;
         2. at least one member is knowledgeable in ethics;
         3. for biomedical research, at least one member is knowledgeable in the relevant law;
         4. at least one member has no affiliation with the College, recruited from the community served by the institution; and
         5. At least one College administrator (non-voting) who will provide staff support for the REB.
      2. All members will be appointed by Senior Management.
      3. The REB may itself appoint up to two additional voting members of two year terms, with expertise to balance the composition of the REB.
      4. The REB may from time to time also call on specialists to advise on particular proposals that require additional expertise for appropriate review.
      5. Appointment to the REB is for a two year term, with terms of members overlapping. The appointment is renewable to a maximum of three terms.
      6. The REB will elect a Chairperson each year from among its membership. The position is renewable.
      7. Prior to serving, all members of the REB will attend a workshop or orientation session, to ensure that they have an understanding of the principles and practices of ethical review. The workshop requirement may be substituted by the on-line tutorial accessed at http://www.pre.ethics.gc.ca/english/tutorial or a similar tutorial approved by the REB.
         
         
3. Scholarly Review as Part of Ethics Review (required for Full Reviews)
   (Article 1.5)
   1. The REB shall satisfy itself that the design of a research project that poses more than minimal risk is capable of addressing the questions being asked in the research.
   2. The extent of the review for scholarly standards that is required for biomedical research that does not involve more than minimal risk will vary according to the research being carried out.
   3. Research in the humanities and the social sciences which poses, at most, minimal risks shall not normally be required by the REB to be peer reviewed.
   4. Certain types of research, particularly in the social sciences and the humanities, may legitimately have a negative effect on public figures in politics, business, labor, the arts or other walks of life, or on organizations. Such research should not be blocked through the use of harms-benefit analysis or because of the potentially negative nature of the findings. The safeguard for those in the public arena is through public debate and discourse and, in extremis, through action in the courts for libel.
   5. Scholarly and ethical reviews undertaken vary between disciplines. The following mechanisms are among those that should be considered by the REB. The REB may
      1. Conclude that the proposed research has already passed appropriate peer review, for example by a funding agency;
      2. Establish an ad hoc independent external peer review;
      3. Establish a permanent peer review committee reporting directly to the REB;
      4. Assume complete responsibility for the scholarly merit, which would require that it have the necessary scholarly expertise in the discipline to carry out peer review of the research in question.
         
         
   6. In evaluating the merit and the scholarly standards of a research proposal, the REB should be concerned with a global assessment of the degree to which the research might further the understanding of a phenomenon, and not be driven by factors such as personal biases or preferences. REBs should not reject research proposals because they are controversial, challenge mainstream thought, or offend powerful or vocal interest groups. The primary tests to be used by REBs should be ethical probity and high scientific and scholarly standards
      
      
4. Review Procedure
   
   
   1. Proportionate Approach to Ethics Assessment
      (Article 1.6) The REB uses a proportionate approach based on the general principle that the more invasive or harmful the proposed and on-going research, the greater should be the care in its review.
      
      Potential harms are usually understood in relation to risks, which are defined in terms of the magnitude of a harm and the probability of its occurrence. Both potential harms and benefits may span the spectrum from minimal through significant to substantial. A proportionate approach to ethics review thus starts with an assessment, primarily from the viewpoint of the potential subjects, of the character, magnitude and probability of potential harms inherent in the research. The concept of minimum risk provides a foundation for proportionate review. The standard of minimal risk is commonly defined as follows: If potential subjects can reasonably be expected to regard the probability and magnitude of possible harms implied by participation in the research to be no greater than those encountered by the subject in those aspects of his or hers everyday life that relate to the research, then the research can be regarded as within the range of minimal risk. Above the threshold of minimal risk, the research warrants a higher degree of scrutiny and greater provision for the protection of the interests of prospective subjects. There is a similar threshold regarding undue or excessive offers of benefit. As an offer of payment in relation to research participation exceeds the normal range of benefits open to the research subject, it is increasingly likely to amount to an undue incentive for participation.
      
   • 1. Proposals are reviewed and may be approved through one of the means listed below. Regardless of the review strategy, the REB remains responsible for the ethics of all research involving human subjects that is carried out at the College.
        1. Full Review
           Where a proposal poses more than minimal risk (as defined by the Tri-Council Guidelines in Article 1.C.1), the REB will assess the harms and benefits of the proposed research project, may determine if the research design is capable of answering the research questions, and will ensure that the research procedures and materials conform to established ethical standards.
        2. Expedited Review (Results of these reviews will be reported back to the full REB in a timely manner)
           Where a proposal poses only minimal risk or have been approved elsewhere by a Tri-Council policy-compliant REB, the Chair (or designate) of the REB will review the proposal and its conformity to established research ethics standards and practices. Researchers may request an expedited review when submitting their proposal.
        3. Local (Course) Review (Research Conducted by Students as Part of Course Requirements) (Results of these reviews will be reported back to the full REB in a timely manner)
           Research which is conducted by students under the supervision of an instructor as part of an approved course outline does not need approval from the Research Ethics Board. Instead, the appropriate Faculty Education Committee will review the ethics of the generic research activities as part of its curricular review processes. The research activity must be listed in the course Curriculum Guidelines and must refer to the requirements laid out in this Policy. Faculty supervising students will ensure compliance with this Policy. Copies of appropriate generic consent forms and research ethics guidelines approved by the REB should be provided by the instructor to the students. In situations where student research activities will depart from using these forms, the faculty member should refer the matter to the REB for approval.   Where students are carrying out research that is part of a faculty member's own research program, this proposal must be reviewed by the REB as in the Full Review procedure (D1.a.i) or the Expedited Review procedure (D.1.a.ii) outlined earlier.
        4. Review Procedure for On-going Research
           1. (Article 1.13.a) Ongoing research shall be subject to continuing ethics review. The rigour of the review will be in accordance with a proportionate approach to ethics assessment.
           2. (Article 1.13.b) As part of each research proposal submitted for REB review, the researcher shall propose to the REB the continuing review process deemed appropriate for that project.
           3. (Article 1.13.c) Normally, continuing review should consist of at least the submission of a succinct annual status report to the REB. The REB shall be promptly notified when the project concludes.
           4. Beyond scrutinizing reports, the REB will not normally carry out the continuing ethics review, except in specific cases where the REB believes that it is best suited to intervene. For research posing significant risks, the REB should receive reports on the progress of the research project at intervals to be predetermined. These reports should include an assessment of how closely the researcher and the research team have complied with the ethical safeguards initially proposed.
           5. In accordance with the principle of proportionate review, research that exposes subjects to minimal risk or less requires only a minimal review process. The continuing review of research exceeding the threshold of minimal risk, in addition to annual review might include:
              1. formal review of the free and informed consent process;
              2. establishment of a safety monitoring committee;
              3. periodic review by a third party of the documents generated by the study;
              4. review of reports of adverse events;
              5. review of patients' charts; and
              6. a random audit of the process of free and informed consent.
                 
                 
     2. To undergo REB review, researchers will submit to the REB:
        1. The research proposal, in sufficient detail to permit the REB to make an assessment of its ethical acceptability;
        2. Experimental protocol (where appropriate);
        3. Informed consent statement and forms (as necessary). Normally, subjects must be given a copy of the informed consent form which they have signed;
        4. Copies of questionnaires and research instruments (where appropriate);
        5. Statement of formal acknowledgement and/or approval of any agencies or companies whose co-operation is needed to conduct the research or whose support is being or is provided in connection with the research (where applicable);
        6. Copies of any ethical guidelines, other than those approved by the REB, used in preparing the proposal;
        7. Such other material or information as the REB may request.
           
           
   2. Meetings and Attendance
      1. (Articles 1.7, 1.9) The REB will meet regularly and as needed to review requests and carry out REB business. It is necessary for members to attend and participate in face to face meetings.
      2. A quorum for committee purposes for a full review is at least 4 members. Where possible, the REB will reach decisions by consensus; otherwise a simple majority will prevail. The Chair will not vote, except in the event of a tie.
      3. The Administrator of Reference will arrange the meetings, distribute relevant documents and organize the recording and distribution of minutes. He/she will also ensure that all minutes, and relevant records are maintained securely.
         
         
   3. Record Keeping
      1. (Article 1.8) Minutes of all REB meetings shall be prepared and maintained by the REB. The minutes shall clearly document members in attendance, the REB's decisions and any dissents, and the reasons for them. In order to assist internal and external audits or research monitoring and to facilitate reconsideration or appeals, the minutes are accessible to authorized representatives of the College, researchers and funding agencies.
      2. The REB will prepare and maintain adequate documentation of REB activities, including the following:
         1. Copies of all research proposals reviewed, certificates of approval, scientific evaluations, if any, that accompany the proposals, approved sample consent documents, progress reports by researchers and reports of injuries to subjects;
         2. Records of continuing review activities;
         3. Copies of all correspondence between the REB and the researchers;
         4. A list of REB members; and
         5. Written procedures for the REB.
      3. The required records will be retained for three years, and records relating to research that is conducted will be retained for at least three years after completion of the research.
         
         
   4. Decision Making
      1. (Article 1.9) The REB review shall be based upon fully detailed research proposals or, where applicable, progress reports. The REB will function impartially, provide a fair hearing to those involved and provide reasoned and appropriately documented opinions and decisions. The REB will accommodate reasonable requests from researchers to participate in discussions about their proposals, but not be present when the REB is making its decision. When the REB is considering a negative decision, it shall provide the researcher with all the reasons for doing so and give the researcher an opportunity to reply before making a final decision.
      2. Final decisions in the full review that are based on consensus or majority quorum (i.e. at least 4 members present) will be adopted only if the members attending the meeting possess the range and background outlined in section B2 of this policy.
      3. The REB will notify the researchers in writing of its decision to:
         1. Approve the proposed research activity as submitted; or
         2. Require minor modifications of the proposed research activity. The resubmitted proposal will be reviewed by the Chair and the Vice Chair of the REB; or
         3. Require significant modifications or additional information or major revisions. The resubmitted proposal will be reviewed by the REB; or
         4. Disapprove the proposed research activity.
      4. The REB will submit an annual report to Senior Management listing the number of proposals reviewed, approved and denied.
   5. Reconsideration
      1. (Article 1.10) Researchers have the right to request, and the REB has the obligation to provide, reconsideration of decisions affecting a research project.
      2. The REB will be guided by principles of natural and procedural justice in their decision-making. Such principles include providing a reasonable opportunity to be heard, an explanation of the reasons for opinions or decisions, and the opportunity for rebuttal, fair and impartial judgment, and reasoned and written grounds for the decisions.
         
         
   6. Appeals

      Researchers have the right to appeal a decision taken by the REB by submitting in writing their reasons to the Chair. Such appeals will then be submitted to the Research Ethics Board of the University of the Fraser Valley with which Douglas College has a formal agreement to perform this function. The decision of that Research Ethics Board shall be final. Please see Appendix 1 - Research Ethics Board Appeals for details of this agreement.

   7. Conflicts of Interest
      1. (Article 1.12) If the REB is reviewing research in which a member of the REB has a personal interest in the research under review (e.g., as a researcher or as an entrepreneur), conflict of interest principles require that the member not be present when the REB is discussing or making its decision. The REB member may disclose and explain the conflict of interest and offer evidence to the REB provided the conflict is fully explained to the REB, and the proposer of the research has the right to hear the evidence and to offer a rebuttal.
      2. Disclosure of the conflict of interest will comply with the Douglas College Conflict of Interest Policy.
         
         
   8. Review of Multi-Centered Research
      Principles of institutional accountability require that each local REB to be responsible for the ethical acceptability of research undertaken within its institution. However, in multi-centered research, when several REBs consider the same proposal from the perspectives of their perspective institutions, they may reach different conclusions on one or more aspects of the proposed research. To facilitate coordination of ethics review, when submitting a proposal for multi-centered research, the researcher may want to distinguish between core elements of the research " which cannot be altered without invalidating the pool of data from the participating institutions " and those elements that can be altered to comply with local requirements without invalidating the research project.
      For research posing more than minimal risk, REBs may also wish to coordinate the review of multi-centered projects, and to communicate any concerns that they may have with the others REBs reviewing the same project. The needed communication would be facilitated if the researcher provides information on the institutions REBs that will consider the project.
      
      
   9. Review of Research in Other Jurisdictions or Countries
      1. (Article 1.14) Research to be performed by members of the College (employees, researchers, students) outside the jurisdiction of the College shall undergo prospective ethics review both (a) by the College REB; and (b) by the REB, where such exists, with the legal responsibility and equivalent ethical and procedural safeguards in the country or jurisdiction where the research is to be done.
      2. The College is responsible for the ethical conduct of research undertaken by its faculty, staff or students regardless of the location where the research is conducted.

Section 2: Free and Informed Consent

1. Requirement for Free and Informed Consent
   
   
   1. (Article 2.1 a) Research governed by this Policy 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.
      
      
   2. (Article 2.1.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.
      
      
   3. (Article 2.1.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:
      1. The research involves no more than minimal risk to the subjects;
      2. The waiver or alteration is unlikely to adversely affect the rights and welfare of the subjects;
      3. The research could not practicably be carried out without the waiver alteration;
      4. Whenever possible and appropriate, the subjects will be provided with additional pertinent information after participation; and
      5. The waivered or altered consent does not involve a therapeutic intervention.
         
         
   4. (Article 2.1.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 of alteration of the requirements for consent if the subjects are informed of the probability of being randomly assigned to one arm of the study or the other.
      
      
2. Voluntariness
   
   (Article 2.2) Free and informed consent must be voluntarily given, without manipulation, undue influence or coercion.
   
   
3. Naturalistic Observation
   
   (Article 2.3) REB review is normally required for research involving naturalistic observation. However, research involving observation of participants in, for example, political rallies, demonstration or public meetings, should not require REB review, since it can be expected the participants are seeking public visibility.
   
   
4. Informing Potential Subjects
   
   
   1. General Conditions
      (Article 2.4) 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 free and informed consent process, the researcher must ensure that prospective subjects are given adequate opportunities to discuss and contemplate their participation. Subject to the exception in Article 2.1(c), at the commencement of the free and informed consent process, researchers or their qualified designated representatives shall provide prospective subjects with the following:
      1. Information that the individual is being invited to participate in a research project;
      2. A comprehensible statement of the research purpose, the identity of the researcher, the expected duration and nature of participation, and a description of research procedures;
      3. A comprehensible description of reasonably foreseeable harms and benefits that may arise from research participation, as well as the likely consequences of non action, particularly in research related to treatment, or where invasive methodologies are involved, or where there is a potential for physical or psychological harm;
      4. An assurance that prospective subjects are free not to participate, have the right to withdraw at any time without prejudice to pre-existing entitlements, and will be given continuing and meaningful opportunities for deciding whether or not to continue to participate; and
      5. The possibility of commercialization of research findings, and the presence of any apparent or actual or potential conflict of interest on the part of researchers, their institutions or sponsors.
         
         
5. Competence
   1. (Article 2.5) Subject to applicable legal requirements, individuals who are not legally competent shall only be asked to become research subjects when:
      1. The research question can only be addressed using individuals within the identified group(s); and
      2. Free and informed consent will be sought from their authorized representative(s); and
      3. The research does not expose them to more than the minimal risk without the potential for direct benefits for them.
         
         
   2. (Article 2.6) For research involving incompetent individuals, the REB shall ensure that, as a minimum, the following conditions are met:
      1. The researcher shall show how the free and informed consent will be sought from the authorized third party, and how the subjects' best interests will be protected;
      2. The authorized third party may not be the researcher or any other member of the research team;
      3. 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; and
      4. 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..
         
         
   3. (Article 2.7) 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 participation.
      
      
   4. The age of majority in British Columbia is 19 years of age and parental consent is required for subjects younger than 19. Consistent with section 3 above an opportunity must be given to the individual to refuse to participate or to withdraw at any time. A copy of what is written or said to the individual must be included for review by the REB. The REB considers minors attending post secondary education, who are 17 to 18 years of age to be emancipated adults for the purposes of minimal risk research. Parent or guardian consent will only be required if the research study is deemed non-minimal risk or represents an invasion of the family's right to privacy. In either case, justification must be provided in the application for the ethics review. The REB may make an exception to these requirements on a case-by-case basis, but the investigator must provide adequate justification in the application for ethics review (e.g. child no longer lives with parent, there is no invasion of privacy or sensitive issue involved, etc.).
      
      
6. Research in Emergency Health Situations
   
   
   1. (Article 2.8) Subject to all applicable legislative and regulatory requirements, 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 following apply:
      1. A serious threat to the prospective subject requires immediate intervention; and
      2. Either no standard efficacious care exists or the research offers a real possibility of a direct benefit to the subject in comparison with standard care; and
      3. Either the risk of harm is not greater than that involved in standard efficacious care, or it is clearly justified by the direct benefits to the subject; and
      4. The prospective subject is unconscious or lacks capacity to understand risks, methods and purposes of the research; and
      5. Third-party authorization cannot be secured in sufficient time, despite diligent and documented efforts to do so; and
      6. No relevant prior directive by the subject is known to exist.
         
         
   2. When a previously incapacitated subject regains capacity, or when an authorized third party is found, free and informed consent shall be sought promptly for continuation in the project and for subsequent examinations or tests related to the study.

Section 3 Privacy and Confidentiality

1. Accessing Private Information: Personal Interviews
   
   (Article 3.1) Subject to the exceptions in Article 1.1(c), researchers who intend to interview a human subject to secure identifiable personal information shall secure REB approval for the interview procedure used and shall ensure the free and informed consent of the interviewee as required in Article 2.4. As indicated in Article 1.1, REB approval is not required for access to publicly available information or materials, including archival documents and records of public interviews or performances.
   
   
2. Accessing Private Information: Surveys, Questionnaires and Collection of Data
   
   
   1. (Article 3.2) Subject to Article 3.1 above, researchers shall secure REB approval for obtaining identifiable personal information about subjects. Approval for such research shall include such considerations as:
      1. The type of data to be collected;
      2. The purpose for the which the data will be used;
      3. Limits on the use, disclosure and retention of the data;
      4. Appropriate safeguards for security and confidentiality;
      5. 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;
      6. Any anticipated secondary uses of identifiable data from the research;
      7. 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
      8. Provisions for confidentiality of data resulting from the research.
         
         
3. Secondary Use of Data
   
   
   1. (Article 3.3) If identifying information is involved, REB approval shall be sought for secondary uses of data. Researchers may gain access to identifying information if they have demonstrated to the satisfaction of the REB that:
      1. Identifying information is essential to the research; and
      2. They will take appropriate measures to protect the privacy of the individuals, to ensure the confidentiality of the data, and to minimize harms to subjects;
      3. Individuals to whom the data refer have not objected to secondary use.
         
         
   2. (Article 3.4) The REB may also require that a researcher's access to secondary use of data involving identifying information be dependent on:
      1. The informed consent of those who contributed data or of authorized third parties; or
      2. An appropriate strategy for informing the subjects; or
      3. Consultation with representatives of those who contributed data.
      4. (Article 3.5) Researchers who wish to contact individuals to whom data refer shall seek the authorization of the REB prior to contact.
         
         
4. Data Linkage (Article 3.6) The implications of approved data linkage in which research subjects may be identifiable shall be approved by the REB.

Section 4: Conflicts of Interest for Researchers

Section 5: Inclusion in Research

1. (Article 5.1.a) Where research is designed to survey a number of living research subjects because of their involvement in generic activities (e.g., in many areas of health research or in some social science research such as studies of child poverty or of access to legal clinics) that are not specific to particular identifiable groups, researchers shall not exclude prospective or actual research subjects on the basis of such attributes as culture, religion, race, mental or physical disability, sexual orientation, ethnicity, sex or age, unless there is a valid reason for doing so.
   
   
2. (Article 5.1.b) This article is not intended to preclude research focused on a single living individual (such as in a biography) or on a group of individuals who share a specific characteristic.
   
   
3. (Article 5.1.c) Women shall not automatically be excluded from research solely on the basis of sex or reproductive capacity.
   
   
4. (Article 5.3) Subject to the provisions of Articles 2.6 to 2.8, those who are not competent to consent for themselves shall not be automatically excluded from research that is potentially beneficial to them as individuals or to the group that they represent.

Section 6: Clinical Trials

1. Phases of Pharmaceutical Research
   1. (Article 7.1) Phase 1 non-therapeutic clinical trials shall undergo both stringent review and continuous monitoring by an REB independent of the clinical trials sponsor.
      
      
   2. (Article 7.2) In combined Phase 1/11 clinical trials, researchers and the REB shall carefully examine the integrity of the free and informed consent process. Where appropriate, the REB may require an independent monitoring process.
      
      
   3. (Article 7.3) The REB shall examine the budgets of the clinical trials to assure that ethical duties concerning conflict of interest are respected.
      
   4. (Article 7.4) The use of placebo controls in clinical trials is generally unacceptable when standard therapies or interventions are available for a particular patient population.

Section 7: Human Genetic Research

1. Individuals, Families and Biological Relatives (Article 8.1) The genetics researcher shall seek free and informed consent from the individual and report results to that individual if the individual so desires.
   
   
2. Privacy, Confidentiality, Loss of Benefit and Other Harms
   1. (Article 8.2) The researcher and the REB shall ensure that the results of genetic testing and genetic counseling records are protected from access by third parties, unless free and informed consent is given by the subject. Family information in data bank shall be coded so as to remove the possibility of identification of subjects within the bank itself.
      
      
   2. (Article 8.3) Researchers and genetic counselors involving families or groups in research studies shall reveal potential harms to the REB and outline how such harms will be dealt with as part of the research project.
      
      
3. Genetic Counseling
   (Article 8.4) Genetics researchers and the REB will ensure that the research protocol make provision for access to genetic counseling for the subjects, where appropriate.
   
   
4. Gene Alteration (Article 8.5) Gene alteration (including "gene therapy") that involves human germline cells or embryos is not ethically acceptable. Gene alteration for therapeutic purposes and involving human somatic cells may be considered for approval.
   
   
5. Banking of Genetic Material (Article 8.6) Though the banking of genetic material is expected to yield benefits, it may also pose potential harms to individuals, their families and the groups to which they may belong. Accordingly, researchers who propose research involving the banking of genetic material have a duty to satisfy the REB and prospective research subjects that they have addressed the associated ethical issues, including confidentiality, privacy, storage, use of the data and results, withdrawal by the subject, and future contact of subjects, families and groups.
   
   
6. Commercial use of Genetic Data
   
   (Article 8.7) At the outset of a research project, the researcher shall discuss with the REB and the research subject the possibility and/or probability that the genetic material and the information derived from its use may have potential commercial uses.

Section 8: Research Involving Human Gametes, Embryos or Foetuses

1. Research Involving Human Gametes
   
   
   1. (Article 9.1) Researchers shall obtain free and informed consent from the individual whose gametes are to be used in research.
      
      
   2. (Article 9.2) In research, it is not ethical to use ova or sperm that have been obtained through commercial transactions, including exchange for service.
      
      
   3. (Article 9.3) It is not ethically acceptable to create, or intend to create, hybrid individuals by such means as mixing human and animal gametes, or transferring somatic or germ cell nuclei between cells of humans and other species.
      
      
2. Research involving Human Embryos
   1. (Article 9.4) It is not ethically acceptable to create human embryos specifically for research purposes. However, in those cases where human embryos are created for reproductive purposes, and are subsequently no longer required for such purposes, research involving human embryos may be considered to be ethically acceptable, but only if all of the following apply:
      1. The ova and sperm from which they are formed were obtained in accordance with Articles 9.1. and 9.2.;
      2. The research does not involve the genetic alteration of human gametes or embryos.; Embryos exposed to manipulations not directed specifically to their ongoing normal development will not be transferred for continuing pregnancy; and
      3. Research involving human embryos takes place only during the first 14 days after their formation by combination of the gametes.
         
         
   2. (Article 9.5) It is not ethically acceptable to undertake research that involves ectogenesis, cloning human beings by any means including somatic cell nuclear transfer, formation of animal/human hybrids or the transfer of embryos between humans or other species.

Section 9: Human Tissue

1. Free and Informed Consent
   
   
   1. (Article 10.1) Research proposing the collection and use of human tissues requires REB approval. Amongst other things the researcher must demonstrate the following to the REB:
      
      
      1. That the collection and use of human tissues for research purposes shall be undertaken with the free and informed consent of competent donors
      2. In the case of incompetent donors, free and informed consent shall be by an authorized party; and
      3. In the case of deceased donors, free and informed consent shall be expressed in a prior directive or through the exercise of free and informed consent by an authorized third party.
         
         
   2. (Article 10.2) For the purpose of obtaining free and informed consent, researchers who seek to collect human tissue for research shall, as a minimum, provide potential donors or authorized third parties information about:
      1. a. The purpose of the research;
      2. The type and amount of tissue to be taken, as well as the location where the tissue is to be taken;
      3. The manner in which the tissue will be taken, the safety and invasiveness of the acquisition, and the duration and conditions of preservation;
      4. The potential uses for the tissue including any commercial uses;
      5. The safeguards to protect the individuals¿ privacy and confidentiality;
      6. Identifying information attached to specific tissue, and the potential for traceability; and
      7. How the issue of tissue could affect privacy.
         
         
2. Previously Collected Tissue
   1. Article 10.3.a) When identification is possible, researchers shall seek to obtain free and informed consent form individuals or from their authorized third parties, for the use of their previously collected tissue.  The provisions of 10.2 also apply here.
      
      
   2. (Article 10.3.b) When collected tissue has been provided by persons who are not individually identifiable (anonymous and anonymized tissue) and where there are no potential harms to them, there is no need to seek donors' permission to use their tissue for research purposes, unless applicable law so requires.

Appendix 1 - Research Ethics Board Appeals