University of Manitoba - Faculty of Medicine - Research Ethics

Research Ethics Guidelines

The following guidelines were developed by the Bannatyne Campus Research Ethics Boards to be used with the University of Manitoba's Policy 1406 governing research involving human subjects.

A. Fee Assessment for Review of Research Proposals Which Protocols Will be Charged an Assessment Fee?

The office of the Dean of Medicine will assess a fee of $2500.00 for protocols that are funded by the private sector. Protocols that are not funded by private sector organizations and protocols with small external grants 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 $2500.00 fee is NOT dependent upon approval. The billing procedure and the proceeds will be operated at an arm's length from the Research Ethics Board, through the office of the Dean of Medicine. One of the following modes of payment must be specified in the submission package:

A University Account Number from which the fee of $2500.00 may be debited by processing an interdepartmental charge; or
A contact person with a billing address to which the fee of $2500.00 may be invoiced.

If the mode of payment is not specified, the Principal Investigator will be billed directly. Details regarding the mode of payment should be forwarded to:

Denise Cannon
Research Office
Room P126 Pathology Building
770 Bannatyne Avenue
Winnipeg, Manitoba
R3E 0W3

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

Combined Submissions

A single fee of $2500.00 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, contact numbers etc.
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 she/he is making the combined submission.
Throughout the course of the study, the contact investigator is responsible for submitting all amendments, Serious Adverse Event reports etc. on behalf of herself/himself and all those involved in the combined submission.

When the same protocol is submitted separately by different investigators, each investigator will be billed $2500.00.

Any questions regarding fee assessment should be directed to:

Denise Cannon
Research Ethics Board
Phone: (204) 789-3883
Denise.Cannon@med.umanitoba.ca

Return to the top of the page

B. Advertising for Study Subjects

All advertising material must be reviewed and approved by the REB prior to implementation. Advertisements may be reviewed through expedited review procedures. The REB will review the information contained in the advertisement and the mode of its communication to ensure that the procedure for recruiting subjects is not coercive and does not state or imply a certainty of 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/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 and/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 subjects will not be charged for taking part in the investigation.

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

Return to the top of the page

C. Payment to Research Subjects

Payment to subjects 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, 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 subjects agree to participate.

The payment should accrue as the study progresses and should not be contingent upon the subject 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 subjects to stay in the study when they would otherwise have withdrawn.

The amount and schedule of all payments should be presented to the 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 informed consent form.

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

Gifts and Incentives

When considering material for distribution to the participants, item 4.8.3 of the ICH Harmonized Tripartite Guideline on Good Clinical Practice should be considered:

"Neither the investigator, nor the trial staff, should coerce or unduly influence a subject to participate or to continue to participate in a trial".

Items that are directly related to the procedures in the trial may be given to the participants. For example, pens may be given where patients 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 can not be perceived as being "unduly coercive" may be given to participants.

Return to the top of the page

D. Payment to Investigators

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, the consent form should contain the following (or similar) disclosure to the research subjects: "There may be financial gain to the Principal Investigator and/or his department or institution from your participation in this study." Detailed, itemized financial disclosure 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 subjects or for the recruitment of subjects 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 subjects 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 patient's 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.

Return to the top of the page

E. Guideline to Research Involving Stored Biological Materials

This guideline has been developed by the Bannatyne Campus Research Ethics Boards to address ethical issues pertaining to the collection, storage and use of human biological materials for research purposes. It is intended to aid researchers and Research Ethics Boards (REBs) in the application of principles outlined in sections 8 and 10 of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (August 1998).

Definitions 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 (e.g. biological material recovered from archeological sites). Also known as 'unidentified' samples.
Biological Materials: Human tissue (e.g. bone, muscle, skin, connective tissue, organ tissue), 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 (e.g. 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: The term 'subject' is 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).

Collection of Biological Material for Research

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.

Informed Consent for collection of biological material for research

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:

The purpose of the research for which biological samples are being collected (TCPS, Article 10.2).
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);
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.
Potential benefits and harms from the research (including, where appropriate, benefits and harms to families, groups, or communities).
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.
Specify where the tissue will be stored; and, if applicable, who will be responsible for distributing the tissue for future research.
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.
Describe the safeguards to protect the individual's privacy and confidentiality.
Describe any identifying information attached to specific samples, links to personal information, and potential for traceability (TCPS, Article 10.2).
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.
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.
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.
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.
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.

Previously Collected Biological Materials

Research involving the use of previously collected biological samples (i.e. 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 (i.e. at 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).

Storage of Biological Materials for Research

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 (i.e. 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 etc.).
When transferring genetic material and information between researchers, only coded or anonymized information should be transmitted.

Ethical Issues for the REB to consider

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.

Genetic Research

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).

ICF for Genetic Research

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.

Related issues that have been raised frequently at REB meetings:

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.
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.
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.
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.
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.

Return to the top of the page

F. Review Procedures for Researchers Affiliated with the National Research Council (NRC) and the University of Manitoba

Researchers affiliated with both the 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 REB's 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 an "expedited review" of new research proposals (or amendments to approved proposals) that have been approved by the NRC REB where the following circumstances apply:

The researchers are affiliated with the University of Manitoba and the research involves human subjects, remains, cadavers, tissues, or biological fluids.
The subjects are adults who are able to provide consent and no intervention is undertaken (except as described in 3, below).
The intervention poses no more than 'minimal risk' to the participants (e.g. 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 University 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, and
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 subjects (e.g. administration of drugs, invasive procedures, or based on the opinion of the REB Chair) the investigator must submit to both the NRC REB and University of Manitoba REB for full board review.

Return to the top of the page

G. REB Meeting Minutes

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 (e.g. new protocol, amendment, annual approval)
Names of committee members who abstained from voting (if applicable) and the reason.
General description of the comments/concerns discussed at the meeting.
Outcome of REB review (e.g. Approved as submitted, Approved with modifications, Tabled, Not approved)

Return to the top of the page

H. Application of PHIA in a Research Ethics Context

The application of the Personal Health Information Act of Manitoba (PHIA) in a Research Ethics Context

This document, pertaining to the application of PHIA to research involving personal health information (PHI) was developed to provide guidance to:

1. Researchers to follow when they are requesting Research Ethics Board (REB) approval for research involving PHI.

2. REBs to follow when they are considering approval of research proposals involving PHI.

Authority of REB to Conduct PHIA Review

Under Section 24(2)(b) of PHIA, approval must be given by an "institutional research review committee" if the personal health information is maintained by a trustee other than the government or government agency. The institutional research review committee must be a committee established by the facility or a university to ensure that adequate safeguards are in place to protect the PHI. Under the PHIA, the "trustee" is a health professional, health care facility, public body, or health services agency that collects and maintains personal health information.

The university REB will be responsible for granting approval for health research in accordance with Section 24(2)(b) of PHIA. This approval will be limited to approval of the protocol research plan. The trustee is responsible for disclosing the PHI for research after approval has been granted by the REB.

The REB will address the following issues in their review process:

1. Recruitment

The REB must be provided with explicit information as to how patients are going to be recruited and approached (e.g. through review of medical charts, direct contact with patients, etc.) to ensure that the importance of the research outweighs the intrusion into privacy. The REB must be assured that safeguards are in place to protect the confidentiality of PHI. The approval to access PHI (i.e. logs, etc.) and to approach individuals about a research study will be incorporated into the REB review process.

The REB submission form has been revised to ensure that appropriate questions are asked as to how the researcher intends to recruit subjects for each specific project and, if appropriate, the REB can approve the proposed method or recommend an alternate method. For example:

In some situations, access to PHI should not be granted until consent is obtained from the individual.

In some situations, posting posters in appropriate areas may be required.

In some situations access to patients names and addresses (for contact purposes only) can be obtained from a departmental database, if the investigator is also involved with providing health care to that group of individuals in that organization (e.g. Nephrologists providing care to dialysis patients at St. Boniface Hospital).

If the investigator is not involved with providing care to that group of individuals (patients), then the physicians who are involved with providing health care should advise their patients (where appropriate) of the research project and either ask the patient to contact the researcher or obtain the patient's permission to forward their name and address to the researcher.

The examples above are analogous to "use" and "disclosure" of personal health information as provided for in PHIA. The researcher who is also involved with providing health care would "use" the personal health information for contact purposes; the physician who is involved with providing health care, but not involved with the research would "disclose" the personal health information to the researcher (which requires the patient's consent).

In situations like Dialysis and Lung Function Clinics, it is recommended that a consent form be developed. The patient obtaining care from those clinics could consent to their names and addresses being used by the group of physicians and nurses who are both providing health care and conducting research, for the purpose of contacting the patient to discuss possible participation in research studies.

In some exceptional situations, it may be potentially beneficial for individuals to be approached as quickly as possible to discuss the research study. In these situations it may be appropriate to allow access to the patient's PHI prior to discussions between the individual and researchers. Example:

Stroke Study. There is no good treatment for embolic stroke at present. A new IV drug is being tested to prevent brain damage from stroke. The new drug may offer a chance to the patient that would otherwise not be provided. Drug must be started within 6 hours of onset of stroke symptoms. Symptom onset occurs at home, patient must physically get to hospital, be triaged and diagnosed. Already much time has elapsed. Researcher is aware of patient, but cannot begin screening process until permission is given via clinical staff for study staff to approach patient. This process may involve the family and patient asking many questions about the study and may interfere both with their time together and with clinical staff assessing the patient for direct care. Under these stressful circumstances the patient/family may simply decline and not be provided with an opportunity to potentially receive better treatment. This situation could be avoided if the study staff gained access to the chart to see if the patient is even a candidate for the study.

The REB must address recruitment issues for each study separately. REB approval must be study specific.

2. Security

In their submission to the REB, researchers must:

Specify safeguards to protect PHI

Specify procedures to destroy PHI

Specify long term storage of PHI (only information which identifies an individual needs to be secured (locked))

Where appropriate, specify why the PHIN (personal health identification number) is being collected. (PHIN should not be used unless it is absolutely necessary)

If PHIN is being used, specify how the PHIN is going to be linked.

3. Consent Forms

Consent forms must specify who will be accessing and/or copying records containing PHI and which records (e.g. Medical Records, if so at which site; Research Study Records; Physician's office records, etc.)

Disclosure of personal health information may be made without the consent of the individual only if the committee has determined that:

the research is of sufficient importance to outweigh the intrusion of privacy that would result from the disclosure of PHI,
the research purpose cannot reasonably be accomplished unless identifying PHI is provided in a form that identifies or may identify individuals,
it is unreasonable or impractical for the person proposing the research to obtain consent from the individuals the PHI is about, and
the research project contains:
1. reasonable safeguards to protect the confidentiality and security of the personal health information, and
2. procedures to destroy the information or remove all identifying information at the earliest opportunity consistent with the purpose of the project.

4. Section 24(5): Clarification

Section 24(5) of PHIA deals with disclosure of names and addresses.

If a research project will require direct contact with individuals, a trustee shall not disclose personal health information about those individuals under this section without first obtaining their consent. However, the trustee need not obtain their consent if the information consists of only the individuals' names and addresses.

With respect to the last sentence above, the research study must have been considered and approved under this section by a REB before names and addresses can be released.

Researchers (who are not involved in health care) asking Manitoba Health for random sample of persons (names and addresses) require approval by the Health Information Privacy Committee (HIPC) before Manitoba Health provides names and addresses.

5. Section 24(4): Research Agreement

The researcher must agree to the following:

Not to publish PHI in any form that could reasonably identify the individuals concerned.
To use the PHI solely for the purposes of the approved research project. If researchers will be approaching individuals participating in a study about future studies, the consent to participate in the original study should include consent to same.

Return to the top of the page

I. Reporting and Monitoring Adverse Events

J. Informed Consent Guidelines

K. Procedures for Reviewing Research Requiring Administration of Radioactive Substances to Healthy Human Volunteers

L. Procedures for Reporting Protocol Deviations

Return to the top of the page

The Canadian Tumour Repository Network(CTRNet)

is a translational cancer research resource, linking cancer researchers with provincial tumour banks.