Human Ethics at Bannatyne campus

In accordance with University of Manitoba policies, any undertaking in which a university affiliated faculty, staff or student investigates or collects data on human participants for research purposes must be approved by a University of Manitoba Research Ethics Board (REB) prior to implementation. This includes research carried out on university premises or conducted elsewhere.

If you are a Winnipeg Regional Health Authority (WRHA) researcher who is either (i) employed by the WRHA or have a written contract for service with the WRHA; or (ii) have privileges under the WRHA's Medical Staff By-Laws and are conducting your research at facilities owned by or operated by the WRHA or under the direction of the WRHA, you may also submit or in some cases be required by WRHA to submit your research to a University of Manitoba REB.

Uncertain if an ethics approval is required?

The researcher must seek the written opinion of the REB chair by sending a one-page summary of the proposal to the REB office.

The definition of research as per University of Manitoba policy used in determining if an activity needs prior REB approval is as follows:

Human research refers to any project that involves the collection of specimens, data or information from persons, through intervention or otherwise. Included are procedures that have a low degree of invasiveness (for example, survey, interviews, naturalistic observations, exercise or psychometric testing, examination of patient records) as well as more invasive procedures (for example, blood sampling, insertion of a cannula, administration of a substance).

This includes all types of research conducted with human participants.  Specifically, prior ethics review and approval is required when research data are derived from, but not exclusively restricted to:

1. Information collected through intervention or interaction with a living individual(s)
2. Identifiable private information about individuals 
3. Human organs, tissues, body fluids  
4. Written or recorded information derived from individually identifiable human participants.

In addition, ethics review is required for the following categories of research that may be overlooked or raise questions about the necessity for such a review:

• Pilot studies and feasibility studies, even those involving only one human participant, require the same scrutiny as full-scale research projects involving many participants. 

• Projects that involve the secondary use of data on human participants gathered in earlier projects

• Research conducted by administrative and academic units that involves the collection of survey replies or the use of records as correlates of survey replies from human participants, for example, students, staff or faculty members. 

FIPPA Policy 1406 - The Ethics of Research Involving Human Subjects Guidelines: Administrative Research, Interviews and Surveys (PDF)

• Research projects in which the researcher is a consultant, unless the researcher has a strict consulting relationship which:
  • (a) the researcher is hired on his or her own time
  • (b) the researcher holds no rights in the work, and
  • (c) neither the researcher nor the university retains any data. 

If any one of these criteria is not met, prior ethics review and approval is required.

• All graduate and undergraduate independent student research projects conducted in partial fulfillment of degree requirements.

Prior ethics review and approval from an REB will not normally be required for:

• A limited type of research most often found within the humanities, fine arts, and in some historical research which involves:
  (a) a public database where aggregated data that cannot be associated with any individual are obtained; and/or
  (b) information already in the public domain (for example,  autobiographies, biographies or public archives).  Nevertheless, it is the responsibility of the researcher to ascertain that any information used from these sources is presented in an accurate fashion. 
• Archival analysis of records by UM departments normally engaged in the collection, maintenance and analysis of such records. Nevertheless, it is incumbent on such units to ensure that the anonymity of individuals and confidentiality of their records are maintained. 
• Class research projects which involve human participants and which are conducted by students on other members of the class as exercises to learn how to conduct research. 
• Per article 2.5 of TCPS 2, quality assurance and quality improvement studies, program evaluations activities and performance reviews, or testing within normal educational requirements when used exclusively for assessment, management or improvement purposes, do not constitute research and do not require REB review. 
• The researcher should seek the written approval of the REB Chair that ethics approval is not required.

The University of Manitoba is committed to complying with the intent of the TCPS 2 with respect to ethic and ethical conduct for research involving human participants.

The Tri-Council Policy Statement 2:  Ethical Conduct for Research Involving Humans TCPS 2 (2022) describes the policies of the Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council of Canada (NSCERC), and the Social Sciences and Humanities Research Council of Canada (SSHRC). The joint Policy expresses the three Agencies continuing commitment to the people of Canada to promote the ethical conduct of research involving human participants.

If you are planning to conduct research with human participants outside of Canada, the Tri-Council Policy Statement (Article 18.3) requires ethics approval at your institution and by an ethics board, where such exists, in the country where the research will be conducted. To find out more about this requirement, get in touch with REB staff.

Remember to factor in extra time for obtaining ethics approval from international ethics bodies often known as Institutional Review Boards (IRBs) or Research Ethics Committees (RECs).

Fee assessment for review of research proposals

The Bannatyne Campus Research Ethics office will assess a fee of $2500 for protocols that are funded all or in part by the private sector. Protocols that are not funded by private sector organizations and protocols with small external grants usually will not be billed.

Research undertaken within undergraduate, graduate or postgraduate training programs and studies funded by national granting agencies will not be billed.

Protocols funded by the private sector

The $2500 fee is not dependent upon approval; that is, if the study is not approved or initiated and REB review has been undertaken the fee will apply. One of the following modes of payment must be specified in the submission package:

• A UM account number from which the fee of $2500 may be debited by processing an interdepartmental charge; or
• A contact person with a billing address and telephone number to which the fee of $2500 may be invoiced.

If the mode of payment is not specified, the Principal Investigator will be billed directly.

Researchers should reference the appropriate Ethics Review Number in all correspondence regarding billing.

Combined submissions

A single fee of $2500 may be charged when two or more investigators, involved in the same study, combine their submission to the Research Ethics Boards. This single fee is subject to the following conditions:

• One investigator (hereafter referred to as the "contact investigator") should submit the package (containing all the submission requirements) on behalf of all the investigators who are making the combined submission.
• The contact investigator's submission package should include the consent forms for all the investigative sites involved in the combined submission. The consent forms for the various sites involved in the combined submission should be identical in content except for site-specific details such as letterhead, investigators' names and contact numbers.
• The cover letter of the submission should indicate the name of the investigator making the submission and the names of the other investigators on whose behalf they are is making the combined submission.
• Throughout the course of the study, the contact investigator is responsible for submitting all amendments, such as Serious Adverse Event reports, on behalf of themselves and all those involved in the combined submission.

When the same protocol is submitted separately by different investigators, each investigator will be billed $2500.

Please direct questions regarding fee assessment to:

Beatrice Kallu
REB Ethics Office
Room P126 Pathology Building
770 Bannatyne Avenue
Winnipeg, Manitoba R3E 0W3

Phone: 204-789-3883
Email: beatrice.kallu@umanitoba.ca

All advertising material must be reviewed and approved by the Research Ethics Board (REB) prior to implementation. Advertisements may be reviewed through delegated review procedures.

The REB will review the information contained in the advertisement and the mode of its communication, such as posters, TV or radio, internet, social media, to ensure that the procedure for recruiting participants is not coercive and does not state or imply a certainty of a favourable outcome or other benefits beyond what is outlined in the consent document and the protocol.

When advertisements are to be taped for broadcast, the REB may either review the final audio or video tape or alternatively, the REB may review the wording of the advertisement prior to taping to preclude re-taping because of inappropriate content.

Content of the advertisements

No claims should be made, either explicitly or implicitly, that a drug, biologic or device is safe or effective for the purposes under investigation, or that the test article is known to be equivalent or superior to any other drug, biologic or device. Such representation would be misleading to subjects and would involve promotion of investigational drugs or investigational devices.

Advertising for recruitment into investigational drug, biologic or device studies should not use terms such as "new treatment," "new medication" or "new drug" without explaining that the test article is investigational. A phrase such as "receive new treatments" implies that all study subjects will be receiving newly marketed products of proven worth.

Advertisements should not promise "free medical treatment" or "free medication" when the intent is only to say participants will not be charged for taking part in the investigation.

Advertisements may state that the participants will be paid, but should not emphasize the payment or the amount to be paid.

Payment to participants for participation in research studies should not be considered a benefit. It is a method for compensating research volunteers for out of pocket expenses, such as parking or meals, and/or lost wages as a result of time spent in the study. Payment to participants should not constitute "undue inducement" by leading to an increase in voluntariness or a decrease in the understanding with which participants agree to participate.

The payment should accrue as the study progresses and should not be contingent upon the participants completing the entire study. Payment of a small proportion as an incentive for completion of the study is acceptable, providing that such an incentive is not coercive. The REB will ensure that the amount paid is reasonable and not so large as to unduly coerce participants to stay in the study when they would otherwise have withdrawn.

The amount and schedule of all payments should be presented to the Research Ethics Board (REB) with the initial submission. The REB will review both the amount of payment and the proposed method and timing of disbursement to ensure that neither is coercive or presents undue influence.

All information concerning payment, including the amount and schedule of payment should be clearly explained in the in the REB Submission Form and informed consent form.

In controlled studies, payment to participants should be equal, irrespective of the treatment arm and irrespective of whether they are patients or "normal" (healthy) control participants.

Gifts and Incentives

“Incentives" or “compensation,” include anything offered to participants, monetary or otherwise, to encourage participation in research. This is distinct from reimbursing participants for minor incidental expenses they incur by participating in the research, such as transportation costs or parking, which is not problematic from an ethics perspective. It should not be assumed that people must be compensated in order to participate in research studies; however, compensation can improve participation rates.

TCPS2 reminds us “because incentives are used to encourage participation in a research project, they are an important consideration in assessing voluntariness. Where incentives are offered to participants, they should not be so large or attractive as to encourage reckless disregard of risks. “

To ensure voluntariness of consent is not compromised, the researcher must justify to the Research Ethics Board in the initial application or any amendments the particular mode and level of incentive.

The researcher should consider applicable issues such as economic circumstances of those in the pool of prospective participants, the age and decision-making capacity of participants, the customs and practices of the community, and the magnitude and probability of harms that may affect the voluntariness of consent in their project.

TCPS 2 also states “Guardians and authorized third parties should not receive incentives for arranging the involvement in research of the individual they represent. However, they may accept reasonable incentives or compensation on behalf of that individual, as long as these are suitable to the circumstances.”

Items that are directly related to the procedures in the trial may be given to the participants. For example, pens may be given where participants are required to complete diary cards and medical aids, such as breast self-exam cards, may be given if relevant to the study. Only items that cannot be perceived as being "unduly coercive" may be given to participants.

Use of lotteries as an incentive

Some researchers may wish to compensate participants using a draw or lottery—defined as a chance to win a substantial prize—instead of or in addition to giving every participant a smaller prize.

There are federal legal issues pertaining to lotteries that must be taken into account if this method is used. For example, a lottery must not require participants to pay money or other valuable consideration in order to participate. The probability of winning the prize should be given when recruiting participants as part of informed consent. In addition, winning the lottery must be based on skill as well as chance. Thus, many lotteries require the participants to answer a skill-testing question in order to qualify for a chance to win the prize.

As a guide for researchers who choose to use this method, the University of Manitoba will require that prizes with a value of $50 or greater have the participant answer a skill-testing question to qualify to win the prize.

Researchers must outline the odds of winning in both the informed consent form/consent disclosure and REB submission form. The informed consent/consent disclosure, when applicable, as outlined above, must also indicate to participants that a skill testing questions is required when the value of the prize is $50 or greater.

Example of skill testing text problem:

“By participating, you are eligible to win a (insert prize). Under federal law, it is necessary that you answer a skill-testing question correctly in order to qualify for a chance to win the prize. If you wish to be considered for this prize, then please answer the following question. (Write your answer in the blank space provided.) Sample mathematical problem (create your own): (13 + 17) divided by 10 = ____. “

The REB collects and reviews all study budgets to ensure that funds are allocated in an ethical manner. Payment to researchers, for research that is sponsored by the private sector, should not be so high as to seem coercive. For research funded by the private sector, granting agencies or other organizations the consent form should contain the following (or similar) disclosure to the research participants:  The study doctor (and or/ institution) is (are) receiving professional fees and financial support from (name of sponsor/funder) to conduct this study.”

Detailed, itemized financial disclosure in the consent form is not necessary, unless the participant requests it.

Recruitment bonuses paid to investigators

Awarding or accepting recruitment bonuses for the recruitment of a certain number of participants or for the recruitment of participants within a certain period of time is unethical.

Offer and acceptance of finders' fees for the recruitment of research subjects

The offer or acceptance of a finder's fee is prohibited—where finders' fees are defined as money or other personal rewards provided to faculty members, trainees or any other individuals simply to identify potential participants for a study.

Compensation to the referring professional may be acceptable when additional duties such as reviewing the clinical protocol and conducting a general eligibility screening are required. The recruit must have provided informed consent for the general eligibility screening to proceed. Compensation to the referee must be disclosed in the informed consent form.

Compensation must not be contingent upon the participants  acceptance into the protocol, agreement to participate, or completion of the protocol. The REB will consider as nominal compensation that is felt to be reasonable for the time and effort expended by the referring professional.

See Guidelines for research involving stored biological materials.

Researchers affiliated with both the National Research Council (NRC) and the University of Manitoba need to submit their research proposals to and receive approval from the Research Ethics Board (REB) of the NRC and a REB of the University of Manitoba prior to initiating the research.

The REBs at both institutions operate in compliance with the Tri-Council Policy Statement of Canada (August 1998), the Personal Health Information Act of Manitoba and other applicable national and international regulatory guidelines. This policy has been developed by the NRC REB and the two REBs at the Bannatyne campus, University of Manitoba in an effort to streamline the ethics review process. (The REBs at the Bannatyne Campus are the Health REB and the Biomedical REB). This policy will be effective starting July 2000.

The Research Ethics Boards at the Bannatyne Campus will conduct a delegated review of new research proposals, or amendments to approved proposals, that have been approved by the NRC REB where the following circumstances apply:

1. The researchers are affiliated with the University of Manitoba and the research involves human subjects, remains, cadavers, tissues or biological fluids.
2. The subjects are adults who are able to provide consent and no intervention is undertaken, except as described in 3, below.
3. The intervention poses no more than "minimal risk" to the participants, for example, some examinations of patient records, secondary analysis of data, use of biological specimens normally discarded, collection of blood and urine specimens, applications of hot and cold to body surfaces, response to visual or auditory stimulus, MRI studies without contrast, may constitute no more than minimal risk).

The submission for "expedited review" to the UM REB must include single copies of the following documents:

• Protocol
• Consent form (if applicable)
• Bannatyne campus REB Submission form
• Letter of approval from the NRC REB
• Any other applicable study specific documents

The REB at the Bannatyne campus will maintain a file on each study. If there are concerns about the research proposal or subsequent amendments to it, the Chair of the university REB has the authority to request full board review. The university REB should be updated on all amendments to study procedures or documents, including approval from the NRC REB for such amendments. Both REBs need to be notified of any Serious Adverse Events. The researchers must submit annual study status reports to both REBs for annual renewal of approval. For both REBs, this can be done using the NRC's Annual Study Status Report format.

Where the research involves greater than minimal risk to research participants, for example, the administration of drugs, invasive procedures, or based on the opinion of the REB Chair, the investigator must submit to both the NRC REB and UM REB for full board review.

Minutes will be recorded at each REB meeting, and the minutes will be approved (or revised as required) at the subsequent meeting. When individuals or organizations request to review the minutes, they will be given access to the sections that pertain to their protocol(s) only, in order to maintain confidentiality. The minutes will include the following information:

General information:

• Meeting date and time
• Meeting location
• Attendance

Study-specific information:

• Principal Investigator's name
• Study title
• Ethics #
• Item reviewed, for example, new protocol, amendment, annual approval
• Names of committee members who abstained from voting, if applicable, and the reason
• General description of the comments and concerns discussed at the meeting
• Outcome of REB review, for example, Approved as submitted, Approved with modifications, Tabled, Not approved

Learn more about the application of the Personal Health Information Act of Manitoba (PHIA) in a research ethics context.

PHIA and research ethics

Please review all situations in which adverse events should be reported below.

Adverse event reporting

Please review the informed consent guidelines section on this page.

Review guidelines within the University of Manitoba digital library documentation.

UM Libraries login

As per ICH GCP 4.5.2, "The investigator should not implement any deviation from, or changes of the protocol without agreement by the sponsor and prior review and documented approval/favourable opinion from the IRB/IEC of an amendment, except where necessary to eliminate an immediate hazard(s) to trial subjects, or when the change(s) involves only logistical or administrative aspects of the trial (e.g., change in monitor(s), change of telephone number(s)."

A protocol deviation is defined any action or inaction that does not correspond to the approved protocol. A protocol deviation may include accidental or unintentional or intentional changes, including changes made to eliminate an immediate hazard to participants or others. Protocol deviations may be major or minor and serious or not serious. 

All protocol deviations, both minor and major, for all research projects   that had not received prior approval by a Bannatyne campus Research Ethics Board through an amendment, must be reported to the Bannatyne Campus REB office as per  the above guideline. This includes clinical trials, observational studies, retrospective records review, registries, biobanks and others. 

As we develop more detailed requirements for reporting privacy breaches or confidentiality breaches please report such as a protocol deviation on the Major Protocol Deviation Form.

Protocol deviation forms

• Protocol Deviation Reporting Requirements (PDF) 
• Minor Protocol Deviation Form (PDF)
• Major Protocol Deviation Form (PDF)

Please review the information below to learn more about guidelines and instructions to submit your Annual Study Status Report (ASSR).

Annual review procedures

Virtual Platform Guidelines- September 2022

Demographic Questions Guidelines- September 2023

Data Storage Guidelines for Research with Human Participants

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If you wish to use a service not listed below, please contact Information Security and Compliance so that a Threat Risk Assessment can be performed on the service to provide assurance of data security. Please refer to the Data Security Classification Guide and the Data Storage Guidelines for Research with Human Participants as appropriate.

• Research involving the use of previously collected biological samples (samples that were either collected for another research project or samples from pathological examinations) must be submitted to a REB for review and approval.
• When identification is possible, researchers shall seek to obtain free and informed consent from the donors, or from their authorized third parties, for the use of previously collected biological material (TCPS, Article 10.3). If obtaining informed consent is not feasible, permission must be sought from the REB prior to use of the samples.
• If informed consent was previously obtained, that is, at the time of sample collection, a copy of the consent form must be forwarded to the REB with the new submission. For identifiable samples, the REB will review the original consent forms to determine whether the subjects agreed to participate in the type of research proposed. If the consent forms are inadequate, the researcher must either obtain consent from the subjects for the current research or, if appropriate, anonymize the samples.
• When biological material has been provided by persons who are not individually identifiable (anonymous and anonymized biological material), and when there are no potential harms to them, there is no need to seek the donor's permission to use their biological material for research purposes (TCPS, Article 10.3).

The following are definitions for terms commonly used in the context of research involving stored biological materials:

• Anonymized samples: Samples that have been permanently stripped of identifiers. Also known as unlinked samples. This does not include samples that have been stripped of identifiers for the purposes of one or more investigators.
• Anonymous samples: Samples that are anonymous due either to the absence of tags and records or the passage of time, such as biological material recovered from archeological sites. Also known as unidentified samples.
• Biological materials: Human tissue, such as bone, muscle, skin, connective tissue, organ tissue, and hair, blood, body fluids, feces, DNA, etc.
• Banking: Storage of biological material for future research.
• Genetic Research: The study of genetic factors responsible for human traits. This includes research that involves the identification of genes that make up the human genome; the functions of genes; and the characterization of normal and disease conditions in individuals, biological relatives, families and groups. (TCPS, p. 8.1).
• Identifiable sample: Samples that can be linked to a specific individual, for example, by way of an identifying tag, patient number or database. Also known as linked, coded or traceable samples.
• Stored biological materials: Biological materials stored for future research.
• Subject: Used to refer to the donor of the biological sample, to be consistent with the Tri-Council Policy Statement. Also referred to as the participant.
• TCPS: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (August 1998).

The collection, storage, and use of human biological materials for research must be undertaken with the free and informed consent of competent donors. In the case of incompetent donors, free and informed consent must be obtained from an authorized third party. In the case of deceased donors, free and informed consent must have been expressed in a prior directive or free and informed consent must be obtained from an authorized third party. (TCPS, Article 10.1).

Informed consent is required when the biological material to be used in research was acquired incidentally to therapeutic interventions (TCPS, p. 10.3). "Acquired incidentally" refers to material left over from clinical samples or extra samples acquired at the same time as clinical samples. The consent form for research use of human biological samples should be separate from the consent form for clinical procedures.

The general principles for informed consent, as outlined in the consent form templates for the Bannatyne Campus, should be applied in addition to the following issues specific to the collection of biological material:

1. The purpose of the research for which biological samples are being collected (TCPS, Article 10.2).
2. The type and amount of the biological sample to be taken; the manner in which sample will be taken; and the safety and invasiveness of acquisition (TCPS, Article 10.2);
3. The potential uses for the sample, including any commercial uses (TCPS, Article 10.2); Use for genetic research must be specified. Note: Generalized descriptions of the potential uses are only acceptable if the samples are anonymized.
4. Potential benefits and harms from the research (including, where appropriate, benefits and harms to families, groups, or communities).
5. Specify how long the samples will be stored (TCPS, Article 10.2). Note: Storage for an indefinite period of time is only acceptable if the samples are anonymized.
6. Specify where the tissue will be stored; and, if applicable, who will be responsible for distributing the tissue for future research.
7. The consent form may be designed with yes/no check-boxes giving subjects the opportunity to consent to or refuse certain categories of research. Examples include:
   • Future use of identifiable samples for any study relating to the condition for which the sample was originally collected;
   • Future use of anonymized samples for any study relating to the condition for which the sample was originally collected;
   • Future use of anonymized samples for studies that are unrelated to the condition for which the sample was originally collected;
   • Use of samples for one particular study;
   • Future contact permitted to ask for permission to do further studies; etc.
8. Describe the safeguards to protect the individual's privacy and confidentiality.
9. Describe any identifying information attached to specific samples, links to personal information, and potential for traceability (TCPS, Article 10.2).
10. When the consent is obtained in a clinical setting, it should be clear that refusal to consent to the research use of biological materials will in no way affect the quality of the patients' clinical care.
11. The subject should be told whether they will be provided with the results of the tests. In the case of anonymized samples, where appropriate, subjects may be given the overall results of the study. The results should be disclosed when they signify a clinical problem and methods to ameliorate or treat the condition are available. If the results will not be disclosed, reasons for this should be provided.
12. Where the samples are identifiable, the subjects should be able to request that his/her sample be destroyed. The exercise of the right to withdrawal is not possible in the case of anonymized samples and the subject should be informed of this in the consent form.
13. Where appropriate, the researcher should inform the subject at the time of consent that the subject is not entitled to any financial or commercial benefits arising from the research.
14. If the biological samples or data derived from the research are to be sent to other researchers or institutions, the subject should be informed at the time of consent to participation and given the opportunity to decline (e.g. using a yes/no check box). The recipient researcher's/institution's policies governing storage and access to stored samples should be forwarded to the REB along with the request for approval.

Guidelines for the Collection of Blood Samples in Research involving Humans

These guidelines can be reviewed under Miscellaneous Forms, Templates and Guidelines on this website.

• The principal investigator or appropriate delegate should control access to stored biological material. The principal investigator should outline plans for the transfer of responsibilities regarding the samples and research data, in the event of his/her departure from the institution, prolonged absence or death.
• The study protocol must describe the storage procedures in detail: where will the samples be stored; how will they be stored to protect the subjects' privacy and confidentiality; who will have access to identifiable information, for example. 
• When transferring genetic material and information between researchers, only coded or anonymized information should be transmitted.

• Rendering samples anonymous has the advantage of increasing confidentiality, however, it has the disadvantage of making it impossible to offer potential benefits of the research to donors and their families. This is important when research may disclose previously undiagnosed conditions, such as an inherited predisposition to breast cancer (TCPS, p. 10.2).
• In addition to the privacy and confidentiality of the individual donors, the REBs should take into account implications of the research to biological relatives of the donors or related communities. When harms to the individual or associated groups can be anticipated, investigators should, to the extent possible, plan their research so as to minimize such harms and should consult, when appropriate, representatives of the relevant groups regarding the study design.

In addition to the guidelines for research involving stored biological material, the following must be considered for genetic research:

• The researcher must ensure that the results of genetic testing and genetic counseling records are protected from access by third parties (e.g. insurers, employers), unless free and informed consent to do so is given by the subject (TCPS, Article 8.2). For example, for some studies the REB may request that there be no mention of the study in the subject's medical charts.
• Family information in databanks must be coded so as to remove the possibility of identification of subjects within the bank (TCPS, Article 8.2).
• Children may be at particular risk for stigmatization both within and beyond the family because of knowledge gained through genetic studies. Genetic research involving children [regarding specific diseases] should not be done unless an effective intervention is available and the information to be gained outweighs the risk of harm. (e.g. it may be appropriate to offer testing to children in a family for an early onset condition such as polyposis coli, for which the knowledge affects treatment options, but inappropriate to test children for an adult onset condition such as Huntington Disease for which no effective prevention yet exists (TCPS, p. 8.4).
• Where appropriate, researchers and the REB shall ensure that the research protocol makes provision for access to genetic counseling for the subjects (TCPS, Article 8.4).
• Gene alteration (including "gene therapy") that involves human germline cells or human embryos is not ethically acceptable. Gene alteration for therapeutic purposes and involving human somatic cells may be considered for approval (TCPS, Article 8.5).

In following additional requirements for informed consent should be addressed for genetic research:

• Discuss potential harms (to the subject, family, group or community) that may result from the genetic research. For example, receiving information regarding susceptibility to genetic disease or identification of blood relationships may cause distress to the subject. Describe how such harms will be dealt with as part of the research project (e.g., genetic counseling, TCPS article 8.4).
• Plans for disclosure of the results of genetic research (to the subject and to family members) must be addressed in the protocol and in the consent forms.
• With the exception of the cases provided by law, no genetic information should be transmitted to insurers, employers, educational institutions and other public institutions without express consent from the subject.

1. Can the current guidelines (for example with respect to length of storage, or informed consent) be applied to research involving samples that were collected prior to the existence of these guidelines?
   Yes, the currently guidelines may be applied. The REBs will address such studies on a case-by-case basis.
2. Do researchers need to specify length of storage for research that does not involve genetic analysis? If not, what is the justification for specifying length of storage for genetic research (other than the fact that it is asked for in the TCPS)?
   • Regardless of the type of sample, genetic or otherwise, length of storage should be specified if the samples are not anonymized. While there is no 'upper limit' for the length of storage, the length must be justified. In certain circumstances it may be necessary to maintain the link to the subject, for example if the results of the research may be beneficial to the subject.
   • If the samples are anonymized, storage for an indefinite period of time is acceptable.
   • The consent form should specify the length of storage and whether the samples are anonymized.
3. Should 'minimal risk' research involving human biological materials qualify for expedited review? For example, some research involving anonymous or anonymized tissue may qualify for expedited review.
   'Minimal Risk' research may qualify for expedited review. This is to be determined by the chair of the appropriate REB on a case by case basis. 
    
4. Would the REB accept consent forms that refer to future use of the samples in general terms, rather than specifying, at the very least, the category of future research (e.g., "research about cardiovascular disease")?
   Such consent forms are only acceptable when the samples are anonymous. If the samples are not anonymous, the consent forms need to be more specific with respect to the type of research.
5. How should our local researchers address ethical concerns with regard to storage and access when other parties (e.g., the sponsor) are banking the samples?
   The consent form should detail who has access and under what circumstances. The recipient researcher's/institution's policies governing storage and access to stored samples should be forwarded to the REB along with the request for approval.

CTRNet members collaborate with each other to develop nationally accepted Polices and Standard Operating Procedures and educational training for Biobanking.

Clinical researchers must be familiar with the details of the Regulations amending the food and drug regulations (1024 - clinical trials) which were amended to require sponsor submission of a clinical trial application (CTA) for drug trials, a reduced default time for Health Canada review of applications, sponsor compliance with Good Clinical Practices (GCP), and Health Canada inspections/compliance verifications. These regulations apply to clinical trials (Phase I – Phase III) for both new investigational drugs and some marketed drugs.

It is important to note, that the use of marketed drugs outside of the approved indication (such as a new age group, new disease entity or new dose range) now require Health Canada approval for use in a clinical trial, whether investigator or industry initiated.

Following receipt of a CTA by a study sponsor and Health Canada's internal review, either a No Objection Letter (NOL) or a "Not satisfactory notice" is issued by Health Canada.

Any protocol amendments following the initial approval of the trial must also be submitted to Health Canada for approval. The Biomedical Research Ethics Board (BREB) withholds the certificate of final ethical approval pending receipt of a copy of the study's 'No objection letter' for new study submissions and subsequent applicable protocol amendments.

Clinical trials involving medical devices require a similar but separate process under the Medical Device Regulations; however REB approval is required by Health Canada prior to the Bureau releasing the Investigational Testing Authorization (ITA) letter. Following receipt of the ITA by the sponsor/Investigator, the BREB requests that the site forward a copy of this letter to the office.

A similar Health Canada review and approval process exists for clinical trials involving natural health products. Under the Natural Health Product Regulations, which came into effect on January 1, 2004, natural health products (NHPs) are defined as:

    Vitamins and minerals
    Herbal remedies
    Homeopathic medicines
    Traditional medicines such as traditional Chinese medicines
    Probiotics, and
    Other products like amino acids and essential fatty acids.

Submissions satisfying the NHP Directorate's requirements will be issued a "Notice of Authorization" to commence the trial. The Biomedical Research Ethics Board (BREB) withholds the certificate of final ethical approval pending receipt of a copy of the study's Notice of Authorization for new study submissions and subsequent applicable protocol amendments.

For further information, please refer to their website.

If there is any uncertainty as to whether a trial involving drugs, food, medical devices and/or natural health products requires Health Canada approval the researcher is encouraged to contact Health Canada.

Health Canada’s site on Types of research with cannabis provides information about regulatory requirements involved with conducting research and development with cannabis. Clinical Trials with cannabis are interventional studies regulated under the Food and Drug Regulations.

The University of Manitoba Health Research Ethics Board (HREB) and Biomedical Research Ethics Board (BREB) will not sign the Health Canada REB Attestation Form. The University of Manitoba HREB/BREB currently uses an Ethics Approval certificate that contains the required attestation as per Health Canada regulations and this should be used by the sponsor in lieu of the Health Canada REB Attestation Form. We refer you to Section 14(b) of the Guidance for Clinical Trial Sponsors: Clinical Trial Application dated 2003/06/25 which states, "Research Ethics Board(s) may wish to use the Research Ethics Board Attestation(s) or develop similar documentation that meets the requirement of Part C, Division 5 of the Food and Drug Regulations".

Some clinical trial records must be retained for a period of 15 years post study closure.

Guidance relating to the retention of records and the conditions under which they are to be made available for monitoring, auditing and inspection related to clinical trials can be found at the following Health Canada website.

• Guidance Document: Drugs for Clinical Trials Involving Human Subjects

Any investigator-initiated projects submitted under a Health Canada (HC) Clinical Trial Application (CTA) involving work done at The University of Manitoba (UM), by UM employees and/or are funded in part or in full by grants/contracts that are held at UM must be sent to Office of Research Service (ORS) prior to submission to HC. Furthermore, any investigator-initiated study submitted under a HC CTA that are funded in part or in full must list UM as the sponsor on the HC application.

When UM is the sponsor, ORS will review and arrange for signing by an authorized university signing official. This review is to ensure the University can fulfill its obligations as the sponsor as outlined in the Regulations. If you have any questions regarding this requirement, please contact UM ORS Contracts Office directly (researchcontracts@umanitoba.ca).

Health Canada's Clinical Trials Database is providing to the public a listing of specific information relating to phase I, II and III clinical trials in patients.

The database is managed by Health Canada and provides a source of information about Canadian clinical trials involving human pharmaceutical and biological drugs. Patients can access the database to determine if a clinical trial has met the regulatory requirements.

The database may also assist Canadians in finding clinical trials that might be relevant to their medical condition.

The Clinical Trials Database is not a registry, and therefore, it does not contain comprehensive information about each clinical trial.

To maximize use of the database and available information, users are advised to link to external resources, including publicly available registries, to obtain further information such as trial objectives and patient eligibility.

• Health Canada's Clinical Trials Database

• Institution/Investigator Initiated Clinical Trials - Health Canada submission requirements
• Guidance for clinical trial sponsors/clinical trial applications
• Preparation of an Application for Investigational Testing - Medical Devices
• Preparation of an Application for Investigational Testing - in vitro Diagnostics Devices
• Clinical Trials for Natural Health Products – Guidance Document
• Record Retention 
• Health Canada's Clinical Trials Database
• Drug Product Database

As per section 5.1.1 of ICH E6, the sponsor is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and all applicable regulatory requirements.

The N2 Quality Committee Guidance for Developing Monitoring Plans can be found at the Forms and templates page on our website. 

Institution/Investigator-Sponsored Clinical Trials

In the situation where a clinical trial is sponsored by an institution/ investigator, and the trial is conducted by a group of physicians at different sites, it is the institution/investigator identified on the CTA as the sponsor, who is required to monitor the trial at all investigative sites.

This institution/investigator assumes the responsibilities of both the sponsor and the qualified investigator. This would include ensuring that all of the sponsor's obligations under Part C, Division 5 of the Regulations are met at each site, and that each site follows GCP.

The monitor should submit a written report to the sponsor after each trial-site visit or trial-related communication. Reports of on-site and/or centralized monitoring should be provided to the sponsor (including appropriate management and staff responsible for trial and site oversight) in a timely manner for review and follow up. Results of monitoring activities should be documented in sufficient detail to allow verification of compliance with the monitoring plan. Reporting of centralized monitoring activities should be regular and may be independent from site visits (ICH E6, 5.18.6).

In addition to monitoring, a sponsor may perform audits of trials. An audit is independent of, and separate from, routine monitoring or quality control functions, and is performed to evaluate a trials conduct and compliance with the protocol, SOPs, ICH E6 and applicable regulatory requirements (ICH E6, 5.19.1).

"The process of free and informed consent refers to the dialogue, information sharing and general process through which prospective subjects decide to participate in research involving themselves" (Tri-Council Policy Statement, p. 2.1). These guidelines have been developed to use with Policy 1406 and the Tri-Council Policy Statement (TCPS) to describe specific procedures required by the Bannatyne Campus Research Ethics Boards (REB's) when researchers are obtaining free and informed consent from prospective participants.

University of Manitoba Policy 1406: The Ethics of Research Involving Human Subjects. May 25, 2000.

TRI-COUNCIL POLICY STATEMENT: Ethical Conduct for Research Involving Humans. August 1998.

International Conference on Harmonisation (ICH): Guidelines for Good Clinical Practice. 1998.

WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI : Ethical Principals Involving Human Subjects, 2002.

3.1 Process

• Informed consent must be obtained from the participant or if the participant is not able to give consent, from the participant's legally acceptable representative (LAR) (e.g. parent, guardian or designated other) prior to involvement in any research related activity. Written evidence of informed consent should be obtained and must be in the case of biomedical clinical trials. If an alternative to written evidence is proposed the researcher must justify to the REB why written evidence will not be obtained.
• When the attending clinician has knowledge of the research, such knowledge should be shared with the patient in an objective way. The clinician should ascertain whether or not the patient is agreeable to be spoken to by research personnel and may identify only those patients who are interested. Under no circumstances should the clinician actively recruit the patient for a research project.
• Someone trained and knowledgeable in all aspects of the study and informed consent procedures must observe the informed consent process and be available to answer questions.
• The informed consent process begins when a member of the research team has the first contact with the participant or the LAR and continues through the course of the study. The initial contact should involve a face-to-face interview where the investigator/delegate gives information in simple, non-technical language that suits the individual's level of understanding and provides adequate opportunities for the participant to ask questions and contemplate participation. After the verbal exchange, the participant should be presented with a consent document and given sufficient time to read the form before agreeing to participate.
• Prior to obtaining consent, whether it is written or verbal, the researcher/delegate must ensure the prospective participants or the LAR adequately understands the purpose of the research study, the nature and extent of his or her participation, and the risks involved. If the risk is high or the issues are complex it may be necessary to administer a series of oral or written questions to confirm comprehension.
• To obtain written evidence of consent, have the participant or LAR initial each page of the consent form and sign the final page where indicated. The person obtaining consent must sign the form as well. In special circumstances a witness or translator are required to sign the consent form if involved in the informed consent process. Each signatory is to date his or her own signature.

3.2 Special Considerations

1.  Illiteracy or Visual Impairment 
An impartial witness should be present during the entire face-to-face interview when the participant or the LAR is unable to read the consent document i.e. illiterate or visually impaired. An impartial witness is a person, who is independent of the research team, who cannot be unfairly influenced by people involved in the trial, who attends the informed consent process if the participant or LAR cannot read the consent form and who reads the consent form and any other written material supplied to the participant.

2.  Non English Speaking Participants 
The Principal Investigator is responsible for ensuring that non-English speaking participants are provided with a consent form/document in the most appropriate language or an appropriate translator is present during the informed consent process.

3.  Exception to Written Evidence of Consent 
The REB recognizes that written evidence of consent may not always be appropriate if the identification of the participant places them at risk (e.g. research examining illegal drug use). Under circumstances such as these, the REB can allow oral consent with a waiver of the requirement for documentation. This requires an oral consent process that uses a REB approved written script, which contains the basic elements of informed consent. The script must be read to the participant in the presence of a witness. The participant will either verbally agree or not agree to participate in the study. Researchers are not required to secure documentation of these informed consent activities if the participant does not want documentation linking them to the research. The investigator should create a unique identifier for the participant and indicate verbal consent of this individual was obtained.

4.  Telephone Consent

• In some minimal risk studies (e.g. questionnaires, surveys) it may be appropriate to obtain informed consent by a witnessed telephone call or initial telephone consent followed by a mail returned consent form.
• Telephone consent that is witnessed by an individual independent of the research team may be acceptable for research in emergency health issues. This consent procedure may be used only when the LAR has not arrived with the potential study participant and is not expected at the hospital within the limited time frame that the research must commence. Where feasible, the LAR should be faxed a copy of the consent and given time to read the consent form or the consent form must be read/explained to them over the phone. The time, relationship and telephone number of the individual who provides consent must be recorded. At the next available opportunity however, a signed consent form should be obtained. The REB office must be notified within 5 days if telephone consent has been obtained as described above.

5.  Surveys 
When research involves the collection of anonymous data via a survey the researcher is not required to obtain written evidence but must provide participants with appropriate information on the study. The researcher may develop a document that follows the University of Manitoba Bannatyne Campus consent template with the signature section deleted or provide a explanatory letter in lieu of a the consent template, outlining the salient issues (e.g. purpose of the study, amount of time to complete the survey, confidentiality provisions, etc). The cover letter or consent must also indicate that consent is inferred from completing and returning the survey.

6.  Records to Be Kept 

• The participant or the LAR is to be provided with a signed copy of the consent (photocopy is acceptable) following the consent process. The signed original must be retained by the Investigator according to the particular institutional policy in either the medical chart or research file. Research genetic consent forms should not be placed in the medical chart of the participant. The consent form must not be forwarded to the study sponsor as it contains identifying information.
• If verbal consent was obtained from the participant, a copy of the informed consent should be left with the participant. This copy should include a note on the signature page that verbal consent was obtained on a specified date.
• Each research unit should develop a policy describing the step-by-step process for obtaining consent and present this to the REB for review. A note must be made in the medical chart or participant's research record describing the procedures/process used to seek free and informed consent. If an REB approved consent policy was followed, a note indicating the policy was followed would be sufficient.

7.  Participant Withdrawal 
If a participant withdraws consent, retain the original consent form in the medical chart or Investigators research file and make a note in the medical chart or Investigator's research file that the participant withdrew from the study. Participants must never be required to sign a document indicating his/her desire to withdraw or specifically required to notify the Investigator in writing of their intent to withdraw. The participant's verbal acknowledgement of withdrawal must be honored.

In principle, acutely ill or incompetent participants, who are incapable of giving free and informed consent, should not be participants in research. It is recognized however, that important studies would be impossible without using participants who are incapable of giving consent, particularly studies which are designed to benefit those very participants. Special procedures are required to ensure respect for free and informed consent and autonomy of these individuals is considered.

4.1 Children

• The consent of the parent or guardian is required for all ages up to 18. The REB may determine that a research protocol is designed for a condition or participant population for which parental or guardian permission is not a reasonable requirement to protect the participant and may waive such requirement (see section for waiver of parental consent).
• Up to 6 years of age, in addition to parental/guardian consent, the child should be provided with appropriate information on the study procedures directly affecting them.
• From the age of 7, the child's willingness to participate in research must be assessed after he /she has been involved in a process that describes the purpose and procedures of the study using terms and concepts that are developmentally and cognitively appropriate. Prior to the discussion, the Investigator/delegate should consult with the parent/guardian to determine whether they want to present the information or if the Investigator/delegate is to present the information. At some point prior to enrolling the child in the research, the investigator/delegate must either observe the parent /guardian discussion or assess the child's understanding and when appropriate provide additional information to ensure the child is adequately informed.
• An age appropriate assent form (see assent form requirements in section 7.0 and assent template) must be developed which can be incorporated into the assent process for children 7-13 years of age. After consultation with the parent/guardian for permission to present the form and an assessment of the child's cognitive skills, the child should be encouraged to read the form or have it read to him/her. If the parent/guardian does not want their child to read the form, the form can be used as a reference during the consent process.
• From approximately the age of 14, children who are able to read should be encouraged to read the informed consent form or an age appropriate assent form after the discussion.
• The child should sign an assent or consent form if they agree to participate. If the child does not want to sign the form but displays their willingness to participate, the process of the discussion must be documented. 
• The child's objection to participating in research should be binding unless the intervention holds out a prospect of direct benefit that is important to the health or well being of that child and is available only in the context of research. It would be desirable in these types of studies if the Investigator/delegate first consult the parent/guardian as to what information will be presented and whether the child's objection to the research would be supported by the parent/guardian. Any objection must be closely evaluated prior to entering the child into the research and the details of the issues documented precisely. The REB must be notified in writing within one working day of the justification to the inclusion of a child who has objected. The REB recommends that the decision of cognitively mature children over the age 13 is respected and not solely decided by the parent /guardian.
• No financial or other inducement should be offered to parents, guardians or children to persuade them to enter their child into a research project: any reasonable expenses incurred, however, should be reimbursed (e.g. transportation costs).
• The Investigator/delegate must document the assent process and are encouraged to develop a policy for the unit, which describes the step-by step processes used to obtain assent/consent. This policy must be submitted to the REB for initial review and approval.

4.2 Incompetent Adults

• Consent of all cases involving research on incompetent adults, excluding some emergency research, must be obtained from the legally acceptable representative, prior to the research project being initiated.
• As with children the incompetent adult must be involved in a similar consent/assent process to the extent reasonably possible and presented with information in concepts/terms they can understand. Their willingness to participate must be assessed and respected when reasonably possible.

"Free and informed consent must be voluntarily given, without manipulation, undue influence or coercion" (TCPS, Article 2.2.) The TCPS clearly instructs research ethics boards to pay particular attention to the "elements of trust and dependency, for example with the doctor/patient or professor/student relationships, as these can constitute undue influence on the patient to participate in research projects" (page 2.4).

For these reasons, the University of Manitoba Bannatyne Campus Research Ethics Boards have concluded:

a) When the Principal Investigator is also the treating physician or clinician (nurse, social worker, etc.) the informed consent process must be supervised and conducted by an individual, who is not involved in providing medical care to the participant. Similarly, a teacher or supervisor must not obtain consent from their students or employees. The Principal Investigator remains responsible for ensuring the delegate conducting the free and informed consent process is trained and knowledgeable in all aspects of the trial.

b) In special circumstances, (e.g., emergency situations when there may insufficient time to contact the designated delegate), the REB's may consider an alternative to the recommended process of consent when it can be ascertained by the Principal Investigator that there is no individual other than the treating clinician/teacher/supervisor who is adequately trained in all aspects of the trial to conduct the informed consent process. The Investigator must make this request to the Board in his/her initial submission justifying the reasons and describing a process to the Board that ensures the prospective participants clearly understands the research role of their clinician/teacher/supervisor and that refusal to participate would not damage the therapeutic relationship or result in the withholding of health/educational services or affect performance appraisals. When the research is not time-sensitive, an alternative approach may involve the treating clinician/teacher/supervisor initially explaining the procedures and risks of the study, followed by the delegate obtaining the actual consent of the individual. The suggested approach is an attempt to avoid the potential for undue coercion or misconception of the intended research component when the treating clinician/teacher/supervisor obtains consent.

6.1 Minimal Risk Studies

In some cases, the Research Ethics Board will consider waiving the requirement to obtain informed consent for protocols that are clearly below minimal risk when it can be demonstrated that the requirement to obtain consent would constitute an unreasonable barrier to the conduct of the research. Researchers asking for a waiver of consent must justify to the committee:

a) Why such a waiver is necessary for the conduct of the research.
b) That the research presents no risks to the participants.
c) That the participants will not be identifiable from the data collected.
d) That the requirement to obtain consent would constitute an unreasonable barrier.
e) The research does not involve a therapeutic intervention.

6.2 Emergency Health Situations

TCPS, Article 2.8 states, "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:

a) A serious threat to the prospective subject requires immediate intervention; and
b) Either no standard efficacious care exists or the research offers a real possibility of direct benefit to the subject in comparison with standard care; and
c) 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
d) *The prospective subject is unconscious or lacks capacity to understand risks, method and purpose of the research; and
e) Third party authorization cannot be secured in sufficient time, despite diligent and documented effort to do so; and
f) No relevant prior directive by the subject is know to exist.

* The REB may determine that lack of opportunity due to time factors as a condition for research to be carried out without free and informed consent.

• The Investigator must provide justification for this waiver in the initial application to the board.
• At the time of enrolment, the Investigator should also consult a patient representative/advocate, if available, to assess the circumstances . When consent of the participant or the LAR is not obtained, the investigator and a physician not involved in the investigations must justify in writing the above conditions and summarize the efforts made to contact the legally authorized representative within 5 working days . This report will initially be reviewed by the Chair of the Board and presented to committee members at the next full board meeting.

6.3 Waiving of Parental Consent

This waiver will usually only be considered for older adolescents, such as high school students and for protocols clearly below minimal risk. In very limited circumstances, the committee will consider a waiver of parental/guardian consent for above minimal risk studies when participation in the research may be beneficial to the participant and third party knowledge of the subject matter may place the adolescent at risk or intimidation (e.g., studies involving investigations of adolescent beliefs and behaviors regarding sexuality or use of recreational drugs; research addressing domestic violence or child abuse). For studies of this nature, the researcher must be certain that the adolescent understands the nature and consequences of the research. The researcher should still encourage the adolescent to discuss the research with the parent/guardian or a child advocate (i.e.. teacher, guidance counselor, or a person who knows the child well) and ensure adequate resources for counseling are available.

Researchers asking for a waiver of parental consent must justify to the committee:

a) Why such a waiver is necessary for the conduct of the research.
b) That the research presents no risks to the participants or that adequate resources are in place to address the potential risks.
c) That adequate steps have been taken to inform the parents of the research when appropriate
d) That each participant has the capacity to consent, meaning he/she is cognitively mature enough to understand the consent procedure and the potential risks involved.

Download the Participant Information and Consent Form (PDF).

When preparing assent forms for children it is especially important to convey information that is sensitive to their perspective on the procedures, risks, discomforts, and inconveniences using terms that are developmentally and cognitively appropriate. The form should be as brief as reasonably possible and no longer than two pages plus one page for the signatures required. The assent form should include all the required elements and sections of the University of Manitoba Bannatyne Campus assent template or justification provided to the REB why the elements have not been included.

CORE is an on-line tutorial that provides contemporary review of issues related to the conduct of safe and ethical conduct of research with humans. Completion of CORE ensures a standard level of research training is achieved before REB approval is given to a researcher working with humans. While it is recognized that many researchers will have already completed the older version of the on-line Tri-Council Policy Statement (TCPS), the National Institutes of Health (NIH) tutorial, or other tutorials specific to Research with Humans, completion of CORE remains a condition of Research Ethics Board (REB) review and approval.

All Principal Investigators (PI’s) must complete CORE prior to be granting final REB approval. All research personnel in direct contact while conducting research with humans or data collected on humans are also required to complete CORE. The REB may indicate this has a condition of approval.

It is estimated that it will take one between three and five hours to complete.  A certificate is made available for those who complete all modules. Researchers, study personnel and students are asked to print and retain a copy of the certificate for verification of completion for audit purposes. The PI's copy will be required to accompany the submission of a project for REB review. Also, some courses may require completion of the CORE tutorial.

The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) is the joint research ethics policy statement of the federal research agencies –Canadian Institutes of Health Research (CIHR), Natural Sciences and Engineering Research Council of Canada (NSERC) and Social Sciences and Humanities Research Council of Canada (SSHRC). TCPS 2 is the first comprehensive revision of this Policy since its adoption in 1998. This document highlights some of the key elements of TCPS 2 in relation to the 1st edition.

• Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans

Health Canada has adopted the International Conference on Harmonization Tri-Partite Guideline: Good Clinical Practice: Consolidated Guideline (GCP) as its own policy. GCP is designed as an ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects and that generate data that are intended to be submitted to regulatory authorities for the purposes of licensing new interventions in health care. GCP should be fully understood by researchers who are carrying out research that they intend to submit to regulatory authorities.

• Good Clinical Practice (GCP): Consolidated Guideline

This document, produced by the Canadian Institutes of Health Research (CIHR) covers best practice guidelines to protecting participant privacy and confidentiality in health research.

• CIHR Best Practices for Protecting Privacy in Health Research (September 2005)

This bank of frequent asked questions is a reference point for human pluripotent stem cell research provisions and is updated by the Canadian Institutes of Health Research as necessary to include new relevant information.

• Human Pluripotent Stem Cell Research: Frequently Asked Questions

These guidelines have been prepared by the Ethics Office of the Canadian Institutes of Health Research (CIHR), in conjunction with its Institute of Aboriginal Peoples' Health, to assist researchers and institutions in carrying out ethical and culturally competent research involving Aboriginal people. The intent is to promote health through research that is in keeping with Aboriginal values and traditions.

• CIHR Guidelines for Health Research Involving Aboriginal People (Draft May 2007)

• Assembly of Manitoba Chiefs Research Policies

Negotiating Research Relationships with Inuit Communities - A Guide to Researchers (PDF)

This guide offers some ideas for how to begin, or improve the process of negotiating research relationships between researchers from a variety of disciplines and Inuit communities in northern Canada.

"Any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects of health outcomes."

Health-related interventions include any intervention used to modify a biomedical or health-related outcome (for example, drugs, surgical procedures, devices, behavioral treatments, dietary interventions, and process-of-care changes). Health outcomes include any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events.

WRHA Researcher (To qualify as a Winnipeg Regional Health Authority (WRHA)  Researcher you must be a researcher who is (i) employed by the WRHA or have a written contract for services with the WRHA; or (ii) have privileges under the WRHA’s Medical Staff By–Law. If you are requesting review as a WRHA Researcher, your study must be carried out at facilities owned by or operated by the WRHA or under the direction of the WRHA.)

• Please summarize your credentials/experience relevant to this project in the signed and dated Bannatyne Campus CV template (maximum 2 page document) provided on the website.
• Do not submit your full CV unless requested by the Board following their review of the application.
• Photocopies of previously signed Bannatyne Campus CV templates for the current calendar year will be accepted.

• The University of Manitoba requiresthat the all Principal Investigators complete the TCPS2 online tutorial (CORE) as a condition of final approval to conduct the study.
• All study team members who are associated with the research project and who will have contact with research participants are encouragedto complete the TCPS2 online tutorial (CORE) before the initiation of the project. This includes (but is not limited to) undergraduate and graduate students, medical residents, research assistants, research coordinators, etc.
• Important Requirement for US Federally Funded projects:  The CORE online course is required for all study team members if the project receives any US Federal funds either directly or indirectly (e.g. NIH, Veterans Affairs, CDC, etc.)

The University of Manitoba requires that all study team members or agents who handle or are exposed to personal information or personal health information during the conduct of the study complete the University of Manitoba PHIA and FIPPA On-line Training modules and sign a pledge of confidentiality that acknowledges that they are bound by written policy and procedures.

The PI must ensure that he/she has a record of all team members who have completed this training in the regulatory binder.

The institutions where the research is conducted may also require additional privacy training and pledge signing.

For individuals who have not completed the University of Manitoba PHIA/FIPPA Training Orientation and pledge signing, the Principal Investigators’ contact information will be provided to the University Access & Privacy Coordinator’s Office for the purpose of ensuring that they do. 

The Research Ethics Board prefers to call the organization or person providing financial support for a study the funder, while the organization/person responsible for the conduct of a clinical investigation is referred to as the sponsor.

Definition of a funder
The organization or person providing financial support for a study.

Definition of a sponsor
A sponsor is an individual, company, institution or organization that takes responsibility for the initiation (e.g., writes the research protocol), management and regulatory compliance for a clinical trial. There can be only one sponsor per trial.

When is it an investigator-sponsored clinical trial? If the investigator initiates and manages a clinical trial, the investigator is acting as the sponsor, then it is an Investigator-Sponsored Clinical Trial.
If, in addition to the above, the investigator is also conducting the trial and supervising the administration, dispensing, and/or use of the investigational product; then the investigator is acting as a sponsor-investigator. The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator. Investigators who also act as sponsors can expect a higher level of preparation and responsibilities.

What to do if the research will be financed by an external organization/company or departmental funds
The term “funder” is not synonymous with sponsor. If the funder does not initiate, manage or have regulatory responsibility for the research, they are not acting as the sponsor.

If the investigator has initiated the research and plans to manage the research but receives funding from an external source (e.g., company, granting agency, institutional department), the investigator is still considered to be the sponsor. It is important to have an agreement in place between institution, the investigator and funder to ensure all parties are protected. Funding applications and all research agreements must be reviewed and approved by institution under which the research will be conducted.

Refers to the funder, sponsor, grantor, or agency (i.e. government, industry, and non-profit organization) that is providing the funds needed to undertake the project. Sometimes the “Sponsor” may not be providing funds but is identified as the individual/institution responsible for the conduct of the study (e.g. PI for Investigator initiated studies).

The office of the Vice President and Research International will assess a fee of $2,500.00 for protocols that are funded by the private sector. Protocols that are not funded by a private sector organization and protocols with small external grants will not be billed. The fee is NOT dependent upon approval and is applied whether the study is reviewed by the full board or in a delegated fashion. The review fee will also apply if the submission is withdrawn after it has been reviewed. (Please review the guideline titled “Fee Assessment Review of Research Proposal” on our website to determine if your protocol will be charged an Ethics Review Fee.)

An application must be filed with Health Canada for human clinical trial trials involving drugs, devices, natural health products or homeopathic medicine in Phase I though III of development and comparative bioavailability trials.  This includes trials involving marketed drugs, devices, natural health products or homeopathic medicine, where the proposed trial is outside of the parameter of the approved Drug Identification Number (DIN), Notice of Compliance (NOC), Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM), e.g. one or more of the following is different:

a) indication(s) and clinical use;
b) target patient population(s)
c) route of administration; and/or
d) dosage regime(s)

The REB requests that you consult with Health Canada if you are using a marketed product in this study to determine if a formal application to Health Canada is required.  This e-mail communication should be attached to the application if it is determined HC approval is not required.

A clinical trial that is initiated and conducted by an institution or an individual investigator. For such trials, the institution or investigator is considered to be the sponsor of the trial and must fulfill all the regulatory obligations of the sponsor as outlined in the regulations.

Responsibility of regulatory requirements

Investigator-sponsored clinical trials represent an important component of the research conducted in Manitoba. When investigator-sponsored trials involve a drug or natural health product, compliance with certain regulations and guidelines is mandatory. The sponsor is responsible for ensuring compliance with all applicable regulations and guidelines.

Sponsor project responsibilities:

• Obtaining Health Canada authorization to conduct the trial (phase 1-3 trials).
• Submitting safety reports to Health Canada.
• Designing the protocol, case report forms and other study documentation.
• Providing mechanisms for quality assurance and control systems with written standard operating procedures.
• Ensuring labeling requirements are met for investigational products.
• Maintaining records to establish trial has been conducted in accordance with the regulations, the protocol and ICH-GCP (Good Clinical Practices).
• Developing a monitoring plan and associated standard operating procedures to ensure participants are protected; protocol and regulatory compliance is assured; and the data is accurate, complete and verifiable. Monitor responsibilities, procedures and reporting must be detailed and documented in a monitoring plan.
• Establishing a data safety plan and monitoring board (as required).
• Securing facilities, services and equipment.

It is essential to be aware of all of the responsibilities of a sponsor; otherwise, in the event of a regulatory inspection or an internal quality audit, the investigator could be cited for non-compliance, leading to suspension or termination of their research.

It is imperative that investigators make themselves aware of all the requirements they must meet early in the planning process.

Applications to the Research Ethics Board (REB) and Health Canada directorate can be concurrent. However, your certificate of REB ethical approval will not be released until the regulatory approval (NOL, ITA or NOA) certificate/letter, approval date and control number are received by the REB.  A copy of the approval should be attached to this application or forwarded upon receipt.

Biological Materials are meant to include human tissue (e.g. bone, muscle, skin, connective tissue, and organ tissue), hair, blood, body fluids, feces, DNA, RNA, etc.) Informed consent is required even when the biological material to be used in research was acquired incidentally to therapeutic interventions. "Acquired incidentally” refers to material left over from clinical samples or extra samples acquired at the same time as clinical samples.

A separate Informed Consent Form or addendum must be presented to participants of clinical drug trials when specimens are being used for genetic analysis or stored for future research purposes.

Refer to our guidelines for research involving stored biological materials above for more information.

The REB may approve research that involves an alteration to the requirements for consent set out in Articles 3.1 to 3.5 if the REB is satisfied, and documents, that all of the following apply:

a. the research involves no more than minimal risk to the participants;
b. the alteration to consent requirements is unlikely to adversely affect the welfare of participants;
c. it is impossible or impracticable to carry out the research and to address the research question properly, given the research design, if the prior consent of participants is required;
d. in the case of a proposed alteration, the precise nature and extent of any proposed alteration is defined; and
e. the plan to provide a debriefing (if any) which may also offer participants the possibility of refusing consent and/or withdrawing data and/or human biological materials, shall be in accordance with Article 3.7B.

Debriefing in the context of Alterations to Consent Requirements (Article 3.7B)

1. Debriefing must be a part of all research involving an alteration to consent requirements (see Article 3.7A) whenever it is possible, practicable and appropriate.
2. Participants in such research must have the opportunity to refuse consent and request the withdrawal of their data and/or human biological materials whenever possible, practicable and appropriate (see Article 3.1).

Article 3.8 Subject to all applicable legal and regulatory requirements, research involving medical emergencies shall be conducted only if it addresses the emergency needs of the 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 medical emergencies to be carried out without the consent of participants, or of their authorized third party, if all of the following apply:

a. a serious threat to the prospective participant requires immediate intervention;
b. either no standard efficacious care exists or the research offers a realistic possibility of direct benefit to the participant in comparison with standard care;
c. either the risk is not greater than that involved in standard efficacious care, or it is clearly justified by the prospect for direct benefits to the participant;
d. the prospective participant is unconscious or lacks capacity to understand the risks, methods and purposes of the research project;
e. third party authorization cannot be secured in sufficient time, despite diligent and documented efforts to do so; and
f. no relevant prior directive by the participant is known to exist.

When a previously incapacitated participant regains decision-making capacity, or when an authorized third party is found, consent shall be sought promptly for continuation in the project, and for subsequent examinations or tests related to the research project.

TCPS 2, Article 3.3 states that “Consent encompasses a process that begins with the initial contact (e.g. recruitment) and carries through to the end of participants’ involvement in the project.  Throughout the process, research has an ongoing duty to provide participant and REBs with all information relevant to the participants’ ongoing consent to participate in the research”.

Investigators should plan to collect personal data at the lowest level of identifiably necessary to achieve the study objectives.  Even a dataset without direct identifiers may present a risk of indirectly identifying data subjects if the database contains extensive information about the individuals concerned and/or the condition under study is particularly rare. 

Study documentation must be kept in a secure locked location/filing cabinet. Computer files should be password protected and encrypted. Data should not be stored or downloaded onto an unsecure computer or unsecure flash drive. When potentially identifying information is entered into a computer or electronic device the database must be PHIA compliant.

The Bannatyne Campus Research Ethics Board and University of Manitoba Research Quality management may review records for Quality Assurance purposes.

Researchers are encouraged to make their data available for further analysis or verification by their peers. When sharing participant data with peers, researchers must be mindful of their responsibility to safeguard participant privacy (see Articles 3.2, 5.1 and 5.5A) and may have to code or anonymize the data to do so.

DATAVERSE is a University of Manitoba data repository managed through the University of Manitoba libraries which may be able to store research data for these purposes.

Researchers shall provide the REB with an acceptable plan for monitoring safety, efficacy/effectiveness (where feasible) and validity. This plan shall describe:

• how participant safety will be monitored and what actions will be taken in the event of a threat to participant safety;
• how intervention efficacy will be monitored (where feasible) and what actions will be taken if efficacy is found to be greater than expected;
• the criteria by which participants may be removed from a study for safety reasons;
• the study-wide stopping rules (if any) by which studies may be stopped or amended due to evidence of inferior safety, superior efficacy or futility; and
• the reporting procedure that will be followed to ensure any information relevant to participant welfare or consent is reported clearly and in a timely fashion to the REB.

A data and safety monitoring plan may (but need not) include the establishment of an independent DSMB (Article 11.7).

The researcher is responsible for providing the REB with an acceptable plan for monitoring the safety of participants, including a plan for the tabulating, analysis and reporting of safety data, and the sharing of other new information in a form that permits REBs to interpret and respond appropriately.

The following factors should be considered to determine whether a study, with or without stopping rules, should have an independent DSMB:

• the magnitude of foreseeable research-attributable harms to participants;
• whether the circumstances of the participants make them vulnerable in the context of research;
• the feasibility of interim data analysis;
• the complexity of the study and conflicts of interest.

In general, researchers should ensure that participating individuals, groups and communities are informed of how to access the results of the research. Results of the research should be made available to them in a culturally appropriate and meaningful format, such as reports in plain language in addition to technical reports.

The REB needs to be satisfied that participants are informed of conflict of interest matters in the consent process.  The REB does not require that the investigator identify holdings in managed mutual funds to be declared in the conflict of interest statement.