Guide to completing a human research ethics application (Form 101)

A. General information

A1. Title of project

A2., A3., A4. Names of faculty investigator/supervisor, collaborators, and student investigator

A5. Level of project

A6. Funding status

A7. Multi-site research study

A8. Ethics review by other institutions' Research Ethics Boards

A9. Department committee clearance for undergraduate and graduate thesis research

A10. Expected project commencement date and expected project completion date

A11.  Conflict of interest

B. Summary of the proposed research

B1a. Purpose and/or rationale for proposed project

B1b. Lay summary

C. Details of the study

C1. Methodology and procedures

C2.Participants involved in the study

C3. Recruitment process and study location

D. Benefits of the research

E. Risks of the research

E1. Identification of known and anticipated risks

E2. Procedures and safeguards for protection of participants

F. Information and consent process

F1. Information consent process and information letter and consent form

F2. Exceptions to requirement for written consent

F3. Individuals who may not be able to give their own consent

G. Anonymity and confidentiality

H. Partial disclosure and deception

Researcher's agreement

Other information

Application process

Ethics review process

Ethics review decision

Researcher's obligations

Obtaining clearance of modifications to approved projects

Annual renewal and study closure

Reporting adverse events and protocol deviations

Pre-review consultation

A. General information

The following information is provided to assist researchers in the completion of a research ethics application which is Form 101.

A1. Title of project

The title of the project should describe as briefly as possible the area/focus of the project for which ethics clearance is sought. Further, if possible, the title should be identical to that on a corresponding grant application. If the title given on the grant application cannot be the title for the ethics application then the grant application title should appear in section A6. If the title on the Form 101 is different from that on the Information Consent Letter (ICL), as in the case of deception studies, then the title on the ICL should appear in parenthesis after the Form 101 title.

A2., A3., A4. Faculty investigator/supervisor, student investigator

Principal and co-investigators

Faculty members involved in a research project may either be named as the Principal Investigator (PI) or Co-Investigators (CI). The principal investigator assumes primary responsibility for the execution of the study at all locations and may either be a Waterloo faculty member or a faculty member at another institution.  Refer to Policy 76 - Faculty Appointments and the Guideline defining research conducted under the auspices of the University of Waterloo. 

In the case of multi-jurisdictional research, a Waterloo research ethics committee may be only one of a series of institutions which are obligated to review the protocol. Unless covered by a specific institution to institution agreement, all multi-jurisdictional research requires ethical clearance from a Waterloo research ethics committee (REC) in addition to the other institutional research ethics boards for all other organizations involved with the research project. PIs should first obtain ethics clearance from their home institution before seeking approval from other participating organizations.

The PI is the individual who assumes responsibility for the conduct of the research. A post-doctoral fellow can be listed as co-investigator with a faculty member listed as PI and who must also sign the Form 101. A student in a course project, conducting an Honour's project/thesis, or Master's or PhD thesis is not a principal or co-investigator. The student must be listed as a student investigator.

Research involving human participants conducted by Waterloo adjunct faculty is not under the jurisdiction of a Waterloo research ethics committee or Office of Research Ethics, unless a Waterloo faculty member with regular faculty appointment or a research faculty appointment is the principal investigator.  

Research conducted by members of Waterloo administration are listed as the investigators.

Faculty supervisor

In cases where the project under review is conducted by a student for a fourth year course project or for undergraduate or graduate thesis purposes, the faculty member who supervises this project must be listed. In the case of a course project, the reference may be shown as faculty instructor, faculty supervisor, or course instructor.

For a student project or thesis where a faculty supervisor is an adjunct faculty member there must be also a faculty supervisor who is a Waterloo faculty member with a regular faculty appointment or a research faculty appointment. See Policy 76 - Faculty Appointment and research under the auspices of Waterloo.

Project supervisor (Form 101A)

The faculty member who supervises the project must be listed as the project supervisor for studies conducted by a student for an undergraduate or graduate course.

Student investigator

Students who are responsible for the data collection are listed as the student investigator. This includes projects which are conducted for thesis or course work purposes as well as projects where the student is a co-investigator with a faculty member. This also includes PhD and Master's candidates although they are principally responsible for data collection. When a course project involves more than one student, all student names must be listed on the application with a contact number such as a local extension or home telephone number and e-mail address. There should be one student who will liaise with the Office of Research Ethics on behalf of the group.

A5. Level of project

Choose the category which describes the level of the research. If the project falls into more than one category each category should be noted. Projects which involve persons in more than one category choose "other" and type in the type of project. For example, collaborative research between faculty and graduate student.

A6. Funding status

The provision of information about external as well as internal funding already in place, or being sought, is important since it assists in maintaining accurate records within the Office of Research for notification to Research Grants and Research Finance for access to funds and continuing access to the research funds.

Include the title of the grant or sponsored proposal or protocol in the text box labelled "Name of other grant or contract, and provide the title of the grant/sponsor proposal". Give the granting agency or sponsor first, followed by the title. Separate the name and the title by a comma and add the word "title".

A7. Multi-site research study

Some research studies involve collaborative partnerships among researchers and may include participation of several populations. A project is multi-site if it is conducted by:

  • a team of researchers affiliated with different institutions,
  • researchers affiliated with different institutions independently conducting several research projects where the data are combined at some point to form one overall research project,
  • a Principal Investigator affiliated with one institution collecting data or recruiting research participants at different institutions, or
  • a Principal Investigator who has multiple institutional affiliations (e.g., two universities, a university, and a hospital) who is collecting data at more than one of the institutions.

A8. Ethics review by other institutions' iesearch ethics boards

With an increased focus on collaborative, multi-site research it is common for several institutions to be involved as settings for specific parts of a single project. Projects involving human participants may undergo ethics review by Research Ethics Boards at some or all of the participating institutions. Researchers are requested to provide details on the outcome of other institutions' ethics reviews of their project, with date, to indicate if an ethics review decision from another Research Ethics Board is pending or if the researchers plan to submit to any other Research Ethics Board(s).

A9. Department committee clearance for undergraduate and graduate thesis research

Certain departments require that student undergraduate and graduate thesis or proposals be reviewed and approved by the student's thesis committee prior to submission of a corresponding research ethics application for ethics review. Researchers are requested to indicate whether or not any prior review, whether it be informal or formal, at the departmental level has occurred or is intended to occur and the outcome of this review. Departments that do not have requirements for approval of thesis proposals this should be indicated by checking "No, not a departmental requirement".

A10. Expected project commencement date/expected project completion date

The start date refers to the beginning of a formal recruitment process. In the case where recruitment does not involve a formal process, the commencement date should reflect the date associated with commencement of the information-consent process. Completion of a study can be defined as the point at which data collection and analysis have been completed to answer the original research questions. 

Researchers should be aware that the ethics review process normally requires 2 to e weeks from receipt of the application in the Office of Research Ethics if the application is reviewed by a delegated reviewer. Applications that are determined to require full or sub-committee review will require a longer ethics review interval. This should be factored into the anticipated start date for the project. Research must not begin prior to notification of ethics clearance. An anticipated start date and completion date are requested on the application form.

A11. Conflict of interest

A conflict of interest may arise when activities or situations place an individual or institution in a real, potential, or perceived conflict between research duties or responsibilities and personal, institutional or other interests.

See definition of “conflict of interested” of Memorandum of Understanding (MOU) on the Roles and Responsibilities in the Management of Federal Grants and Awards.

A conflict of interest could compromise:

  • the independence or objectivity of the research, or
  • the trust relationships of the researcher(s) with research participants, the study sponsor(s), the University of Waterloo, or collaborating/partnering institutions.

Faculty and student researchers hold trust relationships, either directly or indirectly, with participants, research sponsors, institutions, and society. These trust relationships can be put at risk by conflicts of interest.

Decision-making and relationships of participants with research team members may be affected when there are dual or multiple roles of researchers. A dual role occurs when the researcher or a team member is acting as both a researcher and say a course instructor, employer, physician, counsellor, supervisor, or caregiver. The dual role may create conflicts and also, undue influences, power imbalances, or coercion.

Real, potential or perceived financial conflicts of interest could affect research design or threaten the ethical integrity of the research. Researchers are to disclose, through Appendix B, financial and in-kind payment to the researchers and family members by the sponsors, any commercial interests, and relationships such as consulting, and any other relevant information that may affect the project. For example donations to the University of Waterloo by the research sponsor.

In the TCPS2, it states that researchers shall disclose in research proposals they submit to the REB any real, potential or perceived individual conflicts of interest, as well as any institutional conflicts of interest of which they are aware that may have an impact on their research. Upon discussion with the researcher, the REB shall determine the appropriate steps to manage the conflict of interest.

If there is a need for a researcher with a conflict of interest in a research project to be involved in some aspect of the project, the extent of the involvement will be reviewed and explicitly endorsed by the REB. Participants should also be informed during the information-consent process of the conflict and the extent of the researcher’s involvement.

B. Summary of proposed research

B1a. Purpose and/or rationale for proposed project

Researchers must include a detailed description of the purpose and rationale for conducting the project. Recognizing that some projects may involve quantitative or qualitative data collection approaches, and others may use a combination of techniques, this section requests details on the hypotheses or research questions to be considered. In support of their application, faculty researchers should include a copy of their grant proposal and student investigators are encouraged to attach a copy of their thesis proposal where available.

If the project is a clinical trial or a study to test a medical device, the researchers should indicate this in the purpose statement. In addition to the purpose, the researchers are to provide the hypothesis, justification for the study, and objectives.  

A clinical trial is a research study conducted in humans to answer specific health questions. Any reference to clinical trial that appears in the Form 101 application and accompanying appendices need to refer to a clinical trial involving a drug, natural health product, or medical device. Human experimentation and development of medical devices are not always established by phased development as with drugs, so are often referred to as medical device testing. 

Purpose: The purpose section should describe the main reason  the study is being conducted and should include the direct implications or applications of the study. The reason for conducting the study could be to determine safety, effectiveness, dosage level, etc.

Hypothesis: The hypothesis section should outline the aim of the research which is the precise research questions being evaluated in the study.

Justification for the study: The justification section must include background evidence that explains the need for the study. This section should explain what is unique about the study and what new research questions can be answered to support the ethical opinion that the proposed research has value.

Objectives: The objectives section must outlined the specific outcomes or endpoints of the research.

B1b. Lay summary

Researchers are required to provide a summary of approximately 100 words that describes the project in lay language. There should be no jargon. Use simple terms so someone with no academic knowledge of the area can understand the project. This should include the purpose, the anticipated benefits, and procedures to be used.

C. Details of the study

C1. Methodology/procedures

C1a. Researchers are asked to indicate in the list of procedures options all of the procedures to be used in their study.

C1b. This section requests complete details on all procedures including qualitative or quantitative techniques in which participants will be asked to participate. These must be detailed sequentially, as they will occur for the participant, and described in terms which can be understood by reviewers without specialized knowledge of the research area.

Researchers who use procedures which have already received prior ethics clearance must restate and describe these procedures in the current application. Where applicable, this section should also present the research design and describe it. For example, a cross-over design or a repeated measures design.

Any Standard Operation Procedures that are relevant should be referenced in this section.

Interview and survey procedures

In studies where the procedures to be used are surveys or  interviews a copy of all materials must be appended to the application form at the time it is submitted for ethics review. For example, interview script or questionnaire. For surveys and questionnaires, the researcher should indicate whether or not they have been standardized (i.e., an empirically developed assessment or test tool with established reliability and validity as determined by repeated evaluation of the method and results). For a web-survey, researchers need to indicate if the survey will be mounted on a Waterloo server or if it will be developed and conducted through a service such as Survey Monkey or Qualtrics.

For telephone or door-to-door surveys a detailed script is to be provided with the application, including the questions or responses that will be given depending who answer’s the door or phone. If research assistants or other staff will be hired or recruited to conduct the survey, then the training materials or manuals are to be included with the application.

Physiological measurement procedures

In studies where data are collected using physiological measurement procedures, researchers must be aware of the following additional guidelines:

  • Blood or other body fluids and tissue samples: When the nature of the project requires researchers to draw blood samples, or to take samples of other body fluids or tissue samples, they must describe the procedures in sequence indicating the volume or amount to be sampled and frequency of sampling. They must also indicate their awareness of, and willingness to follow, universal precautions for handling blood and body fluids. Participants must be advised of researchers' adherence to these universal precautions in the information letter.
  • Training of personnel. When invasive procedures are used, the name of the person conducting these procedures must be listed, as well as details on the person's training and qualifications to conduct the procedures.
  • Sharing of equipment or repeated use of equipment. In studies where equipment will be used on or by more than one participant, or where there will be repeated use of the equipment on or by the same participant on different occasions, the mechanism for adequately sanitizing or sterilizing the equipment between participants or between sessions must be described in the application. Participants must be advised of this procedure in the information letter. 
  • Use of drugs. When marketed drugs, prescription or otherwise, are to be administered, information on drug dosage, frequency, and route of administration must be listed in this section of the application or through Appendix A. A copy of related information from the Compendium of Pharmaceutical Specialities must be included. The name of the person who will conduct the procedures, and that person's training and qualifications to do so, must be outlined.
  • Exercise testing. In studies involving exercise testing such as cycling or physiological procedures such as heart rate, a description of all tests or procedures must be included or appended to the application. In addition, the researcher must include a copy of a current health status form to be used to confirm potential participants are in good health, as well as to ensure potential participants do not have any of the specified exclusion criteria. Arrangements for provision of medical supervision during testing sessions must be described as well as details on availability of emergency equipment such as a defibrillator.

C2. Participants involved in the study

C2.a. Researchers are asked to indicate list all of the participants who are either Waterloo and non-Waterloo participants to be involved in their study.

C2b. The persons who will be participants in the study must be described with respect to group affiliation, gender, age range, and any other characteristics. If the study focuses on a particular population which has defined characteristics that are relevant to the study, or will impact recruitment procedures or study procedures, then those characteristics are to be described in this section. For example, participants with a particular condition may tend to be of a particular age, gender, and have specific health issues.

To the extent possible, researchers are encouraged to include both genders in the sample. When this is not possible, a rationale is required. Special procedures and ethical consideration are required when the study involves children or other vulnerable participants.

C2c. Researchers are to provide the number of participants to be recruited for successful completion of the study with an explanation for the sample size.

For a clinical trial, medical device testing, or study with procedures posing greater than minimal risk:

  1. indicate how the sample of participants will be obtained or if a convenience sample, describe the sample,
  2. indicate the anticipated number of study participants recruited locally such as at Waterloo,
  3. indicate the anticipated number of study participates to be recruited at all other sites for multi-site research,
  4. for all study types including pilot studies, justify the sample size on scientific grounds,
  5. if a formal sample size calculation has not been done, justify why it is not required or not possible giving a rationale for the number of participants specified,
  6. if the main hypothesis test will be a two-sample comparison of means and a power calculation has been done, provide the:
    • primary outcome measure,
    • anticipated mean value of outcome measure in control group,
    • anticipated variance of outcome measure within group,
    • Alpha Error (Type 1 error test) indicating also whether test is one or two-sided,
    • difference in means to be detected,
    • statistical power with specified sample sizes in control and treatment groups

C3. Recruitment process and study location

C3a. Researchers are asked to indicate in the list of recruitment source options all of the recruitment sources to be used in their study.

C3b. Details are requested on the procedures to be used in recruitment as well as who will do recruitment. If the information letter will be sent by e-mail or mail to recruit participants then provide this information. If the student investigator will be recruiting participants then explain how they will contact potential participants, including how contact information was obtained for potential participants. 

For both on-campus and off-campus recruiting, a copy of a recruitment notice or poster or e-mail must be appended to the application. In the case of surveys conducted by mail, a covering letter to the questionnaire must be used and appended to the application. The covering letter should be typed and on the letterhead of the researcher's department.

In the case of telephone and door-to-door surveys, researchers must ensure that prospective participants receive advance notification about the study enabling them to verify the study's authenticity if they so choose. This will ensure people will not feel pressured to make a decision about whether or not to participate. A copy of the advance notification as well as any telephone preamble must be submitted for review.

A copy of the telephone recruitment script must be provided for ethics review for studies involving use of telephone recruitment of persons. These may or may not be individual who have indicated to the researcher a willingness to be contacted about the study.

For studies involving the recruitment and participation of students or teachers from local school systems, refer to the guidelines for research within Waterloo Region Schools for specific information. The requirements for conducting research in either the Waterloo Region District School Board or the Waterloo Catholic District School Board are outlined in this section.

Researchers are reminded that certain participant groups may experience real or perceived pressure to volunteer in their study due to the relationship between the person responsible for their recruitment and themselves. This is a particular challenge when the person involved in recruitment is in a position of authority. In such situations prospective participants will not necessarily feel free to volunteer or to decline, and also may not feel free to withdraw their consent at any time. Wherever possible, arrangements should be made to ensure that persons involved in recruitment are at arms' length from the prospective participants. For example,

  • in employment settings, supervisors or managers should not assist researchers in recruitment by inviting persons who report to them to take part in the study;
  • professors should not recruit students who are in their own classes to be participants in their own studies;
  • physicians who also are researchers should not recruit their patients into their study.

Researchers must be sensitive to the potential for prospective participants to feel pressure to volunteer, and where this exists, take appropriate steps to minimize this.

Refer to the Tri-Council Policy Statement (TCPS) on special research considerations with vulnerable populations such as children and adolescents, developmentally handicapped persons, prisoners, and cognitively-impaired persons etc.

C3c. Researchers are to indicate whether or not their study is to take place on or off-campus as well as the specific location. Field research outside of Canada normally requires ethics review by an institutional review board or committee within that jurisdiction.

C4. Remuneration of participants

Researchers must describe all details of any financial, or other remuneration, of participants for their travel, parking, or participation time in the study, such as an hourly rate. Expectations for remuneration should be communicated to the participants before the person's involvement begins.

Where possible, remuneration must be available on a prorated basis. This arrangement is intended to ensure that a person does not continue in a study past the point when they would prefer to withdraw because this is the only way they can be remunerated.

The total amount of remuneration should not be so high as to unduly influence or induce a person to volunteer, or to continue in a study past the point at which they otherwise would discontinue participation.

Other types of remuneration are acceptable such as gift cards, theatre tickets, or t-shirts with decals related to the study.

C5. Feedback to participants

It is recommended that researchers, whenever possible, provide participants with a letter of appreciation as well as an executive summary of the results from the study. This ensures that the experience of participating in a study is an educational one and that participants' contributions to the success of the study are acknowledged.

However, there may be situations where it is not possible or feasible to provide feedback to individual participants such as an anonymous questionnaires or in pilot studies. In these situations, researchers are asked to consider other communication routes for feedback such as a web-site for study results, an article in a company newsletter, or a poster at an agency.

Feedback arrangements may also vary according to the source of participants, for example:

Participants from local school systems: Researchers who conduct projects within Waterloo Region Schools are required to provide feedback based on aggregated results of their studies to the principals as well as to the Senior Manager, ORE to provide to the school board. Researchers must ensure that they fulfil this commitment.

Participants from local agencies and non-university community: For research conducted within community agencies, it is recommended that researchers send agency personnel who have volunteered as research participants, a letter of appreciation, and an executive summary or a copy of the final report of the study in which they have participated. Researchers who offer to do so must ensure that they fulfil this commitment.

D. Potential benefits of the study

D1. and D2. Potential benefits from the study

All studies must have benefits in order to justify being conducted. Thus, the researcher is required to provide a description of known or potential benefits to society from the completion of the proposed project. In most cases there will not be benefits to the participants.

Remuneration is not considered a benefit to the participant and should not be listed as such.

The experience of taking part in university research or being involved in an interview is also not a benefit to the participant. 

E. Potential risks for the study

E1. Identification of known and anticipated risks

Researchers must include in the application form a complete and clear description of all known risks as well as reasonably anticipated risks which might be expected to occur. Researchers are reminded that risks may be physiological, psychological, emotional, economic or social in nature. 

The TCPS defines “minimal risk” research as "research in which the probability and magnitude of possible harms implied by participation in the research is no greater than those encountered by participants in those aspects of their everyday life that relate to the research".

Although a researcher may view risks associated with their study as minimal, a reviewer or the Research Ethics Committee may have a different opinion.

E2. Procedures/safeguards for protection of participants

Researchers must indicate the steps to be taken to ensure that risks are minimized to the extent reasonably possible. In the case of procedures involving greater than minimal risk such as psychological or physiological research, researchers must outline their appropriate credentials to deal with any negative impact on the participants which may be attributed to participation in the study. Researchers who do not have this expertise must have arrangements in place for provision of referral services or intervention for dealing with any negative impact on participants.

For student projects involving potential psychological risk, the faculty supervisor must ensure the student researcher will be adequately supervised throughout the conduct of the project and that procedures are in place to ensure an appropriate and timely response for participants.

F. Information and consent process

F1. Information consent process and information letter and consent form

Researchers must explain in the application form the process to be used to adequately inform prospective participants in regard to details about the study as well as the procedure to be used to obtain consent.

A copy of the document to be used in this process must be appended to the application for ethics review.

Normally, participants who agree to participate in a study other than one involving use of a questionnaire or telephone survey, must be provided with an opportunity to give their consent in writing. See exceptions to this in the next section, section F2.

Two copies of the information-consent letter must be signed. The researcher retains one and the other is provided to the participant for their records.

A number of important details or elements must appear in the information letter to ensure that the participants have been adequately informed. An acceptable information letter normally would include:

  • name of faculty investigator and student investigators, where applicable,
  • departmental affiliation with local telephone extension and e-mail address for each investigator,
  • a statement indicating that the project is research and the purpose for conducting the study and this should include several sentences outlining the rationale for the study,
  • a description in lay language of all procedures:
    • studies involving questionnaires or interviews, the information letter should provide examples of the types of questions to be asked or themes to be explored,
    • studies involving physiological procedures, additional separate sheets explaining each procedure may be appended, and
    • when the information letter is longer than one page and the study involves physiological measurement procedures, the participant and investigator must initial each page.
  • a description of all known or anticipated benefits to society and to the participant from the conduct of the project however if none are expected, this should be stated,
  • a description of all known or reasonably anticipated risks to participants from participating in the study,
  • details of time commitment required for participation in the study or if the study involves more than one session, the time for each session should be indicated,
  • details about any plan to re-contact participants for follow-up sessions or subsequent participation in related projects,
  • procedures to ensure confidentiality of data and anonymity of participants,
  • details concerning remuneration for participants whether it be financial or otherwise,
  • information on duration of retention of data and arrangements for ensuring security of the data,
  • details on participants' right to withdraw consent to participate at any time without fear of reprisal,
  • details on what a person needs to do or say to communicate a decision to withdraw from the study,
  • for studies involving questionnaires or interviews, a statement should be included which advises that participants may decline answering any questions they prefer not to answer,
  • statement that encourages participants to contact the researchers in the event they have any question pertaining to their involvement in the study and a telephone number and e-mail address for the researchers is provided, and
  • statement that the project has been reviewed by and received ethics clearance through a University of Waterloo Research Ethics Committee including details on how to contact the Director of the Office of Research Ethics with any concerns or questions about their participation.

Re-contacting participants

Researchers who wish to re-contact participants about involvement in a follow up associated with the current study or separate future studies must indicate this possibility in the application form. This plan for re-contact also must be described in the initial letter to the participants and consent obtained for this re-contact. Participants also must be advised that agreement for subsequent contact does not oblige them to participate in future studies, and that they can decide this at the time of contact.

F2. Exceptions to requirement for written consent

Many circumstances exist where written informed consent cannot reasonably be collected. For example, in studies relying on use of anonymous questionnaires, a comprehensive cover letter to the questionnaire is a requirement, and is used to inform prospective participants. This cover letter must include the same detailed information as the information letter and differs only in that there is no section for participants' signatures.

Consent to participate is implied by completion and return of the survey.  For a telephone interview verbal consent is reasonable. The researchers must include a verbal consent script in the application. See the sample information letters with consent forms.

F3. Participation by those who cannot give their own consent

When minors are involved as participants, written permission of parents or a legal guardian is usually required. For studies not conducted within a school board, with no known or anticipated risks, parental permission is generally not sought for youth aged 16 years or older.

Some school boards prefer active information with passive parental permission for youth in high school. Often, school boards will provide this information concerning parental permission on their website in the policy section.

Adolescents who no longer live with their parents can give their own consent to participate in research. Similarly, university students who have not yet attained age of majority are considered to be adults and can consent for themselves.

Adults who are cognitively impaired or developmentally challenged may be legally unable to give their own consent. In these cases consent from a legal guardian is required. However, the research should be explained to persons who are not competent to consent for themselves and they should be given the opportunity to provide their own assent or consent for themselves.

G. Anonymity of participants and confidentiality of data

Any information provided by an individual participant as a result of their participation in a study will be considered confidential and will not be released unless the participant gives consent or unless release is required by law. It is the responsibility of the researcher to ensure that once collected, data with personal identifiers are securely stored in a locked area, and are accessible only to authorized personnel such as members of the research team. Further information concerning personal identifiers is given below.

Names associated with raw data must be replaced at the first opportunity by a letter or numerical coding system. All reports from the research should use a coded system of references and no identifying information, which could directly or inadvertently breach confidentiality.

Participants must be aware of the arrangements in place to ensure confidentiality of data, the duration the data will be retained, and the purposes for which the data will be used. When no longer required, data must be destroyed in a manner which protects the participants' identities such as shredding of records, erasing of recordings, or deleting of computer files.

Human research data sets and confidentiality

A human research data set, hereafter referred to as a data set, is a compilation of data elements collected from or about human participants in research. See guidelines on data and information security.

Personal identifiers within a data set can include both direct and indirect identifiers. 

Direct identifiers point directly to a particular individual such as their  name, address, Social Insurance Number, student identification number, or hospital patient number. 

Indirect identifiers can also point to an individual by focusing attention on unique cases or in combination with other information in the data set. For example, educational institute from which respondent graduated and year of graduation, exact occupation held, combining any of gender, race, job and location.

A de-identified data set refers to original data that subsequently has been stripped of all elements or variables, including but not limited to personal identifiers, that might enable a reasonably informed and determined person to deduce the identity of the participant.

For research that requires that data elements or variables later be linked to an individual's identity, the original data set should be partitioned into two data sets such as a de-identified data set and an identity-only data set. The latter should contain any and all personal identity information absolutely necessary for future conduct of the research.

The following are direct identifiers that are to be removed from information/data to be de-identified.  

  • Names.
  • Geographic subdivisions smaller than a province or territory, including street address, city, region, municipality, postal code except for the initial three digits of a postal code,
  • Elements of dates, except year, related to an individual,
  • Telephone numbers,
  • Fax numbers,
  • Email addresses,
  • Social Insurance numbers,
  • Health Card numbers,
  • Medical Record or Health Plan numbers,
  • Account numbers,
  • Certificate or license numbers,
  • Vehicle identifiers and serial numbers, including license plate numbers,
  • Device identifiers and serial numbers,
  • Biometric identifiers, including fingerprints and voiceprints,
  • Web universal resource locators or URLs,
  • Internet protocol, or IP, address numbers,
  • Full-face photographic images, or
  • Any other unique identifying number, characteristic, or code.

This list is revised from information in the U.S. Health Insurance Portability and Accountability Act, HIPAA, and has been adopted in Canada.

Anonymized information is irrevocably stripped of identifiers, and a code is not kept to allow future re-linkage.

Anonymous information never had identifiers associated with it such as responses from an anonymous survey.

The following are additional requirements that must be outlined if personal health information is being collected or as secondary data analysis (PHIPA):

  • A description of the research proposed to be conducted and the duration of the research.
  • A description of the personal health information required and the potential sources.
  • A description of how the personal health information will be used in the research, and if it will be linked to other information, a description of the other information as well as how the linkage will be done.
  • An explanation as to why the research cannot reasonably be accomplished without the personal health information and, if it is to be linked to other information, an explanation as to why this linkage is required.
  • An explanation as to why consent to the disclosure of the personal health information is not being sought from the individuals to whom the information relates.
  • A description of the reasonably foreseeable harms and benefits that may arise from the use of the personal health information and how the researchers intend to address those harms.
  • A description of all persons who will have access to the information, why their access is necessary, their roles in relation to the research, and their related qualifications.
  • The safeguards that the researcher will impose to protect the confidentiality and security of the personal health information, including an estimate of how long information will be retained in an identifiable form and why.
  • Information as to how and when the personal health information will be disposed of or returned to the health information custodian.
  • The funding source of the research.
  • Whether the researcher has applied for the approval of another research ethics board and, if so the response to or status of the application.
  • Whether the researcher’s interest in the disclosure of the personal health information or the performance of the research would likely result in an actual or perceived conflict of interest with other duties of the researcher.

H. Deception and partial disclosure research

Prospective participants must receive complete detail about the purpose of the study before being asked to agree to participate. However, legitimate methodological  reasons exist for either misrepresenting or withholding details related to the study purpose and thus, conflicts with the requirement for provision of informed consent. See guidelines on deception and using partial disclosure in research

Whenever deception or partial disclosure is to be used the researcher must outline in the application form the nature of the deception, a rationale for its use as well as why the study cannot be done using an alternate design. It is generally accepted that providing the participant with full information about the study purpose and hypotheses would impact participants' behaviour during the study or their responses in ways that render the data unusable.

Because deception can negatively impact a participant’s feelings of trust in the specific study, or about research in general, participants must undergo a debriefing process at the end of their involvement. This process is an opportunity for the researcher to provide an explanation both verbally and as a written feedback letter of why deception was needed in the particular study, what the deception was, and provides an opportunity to answer any questions in regard to the use of deception. Following the debriefing process, participants are asked for their written consent to use the data obtained in the course of their participation in the study.

Deception is not applicable in course projects.

Researcher's agreement

By signing the agreement, all of the faculty, students, and staff investigators must indicate they have read the Tri-Council Policy Statement (TCPS) and agree to conduct their project in accord with information specified in this document.

In the case of student research, the faculty or project supervisor's signature indicates the student's project is deemed to be valid and worthwhile and that they will provide the necessary supervision of the student throughout the conduct of the study.

Completion of the TCPS tutorial is also mandatory.

Other information

Application process

All researchers who plan to conduct research with humans must apply to the ORE for ethics clearance of their projects. The faculty investigator assumes responsibility for ensuring that a complete and signed copy of the application, with attachments, is submitted to the Office of Research Ethics. As well, the online application is electronically submitted.

Ethics review process

The ethics review process is intended to protect the safety, welfare, and rights of the research participants. To this end, each research proposal is carefully and closely scrutinized by a Research Ethics Committee or delegated reviewer, depending on the risk level associated with the study.

This process ensures:

  • the procedures are ethically, legally, and medically acceptable,
  • the amount and type of information communicated to the participants by the researchers is appropriate and adequate, and
  • consent obtained from the participants can be considered fully informed.

In addition, the application is screened to ensure that all foreseeable risks and benefits to the participants are clearly communicated to prospective participants by the researcher. Further, risks inherent in the project must be adequately identified and weighed against the potential benefits of the research. In the review process, the application is examined to ensure that it complies with Waterloo Statement on Human Research as well as the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans and other professional and ethical standards.

The ethics review process requires 2 to 3 weeks from the date the application form is received in the Office of Research Ethics. This duration may vary depending on:

  • the number of applications under review at one time,
  • if the application is incomplete when received, or
  • if full Committee review is required. 

At certain points during the fall and winter terms, the review-clearance interval may be longer due to the large number of applications received at these times. Faculty supervisors should bring this to the attention of students under their supervision.

Ethics review decision

The faculty investigator is provided with written notification of the ethics review decision. A research project does not receive full ethics clearance until all revisions and comments are satisfactorily addressed.

Revisions and responses in response to ethics review feedback should be submitted to the Office of Research through ohrac@uwaterloo.ca or mail within a 10 day period. The revised materials are reviewed and when considered acceptable, the principal investigator or faculty investigator is notified of full ethics clearance.

Researchers whose project does not meet the guidelines, and thus the ethics review decision is deferred on ethical grounds, will receive written notification of this from the Research Ethics Committee who then work with the researchers to resolve ethical concerns or issues.

Researcher obligations

Clearance of modifications to approved projects

As a condition of ethics clearance, researchers must conduct their projects according to the details they have provided in the application form, Form 101, and for which ethics clearance has been granted.

However, it is recognized that situations occur where modifications must be made to an approved project such as the design, sample, or procedures. It is the responsibility of the faculty investigator to notify the Office of Research Ethics of any modifications to the approved protocol and to seek prior ethics clearance of these modifications. A request form for clearance of modifications must be used for this purpose.

If the proposed modifications are substantial, researchers are encouraged to contact the Office of Research Ethics to determine if the proposed modifications can be included under the original project or if they are sufficiently substantive to require submission of a new application.

Annual report or study closure form

As a condition of ethics clearance, the Research Ethics Committees require researchers to complete an annual report, using Form 105, outlining the status and progress of the project. This is consistent with the Committee's responsibilities around monitoring ongoing protocols that have received ethics clearance. In addition to requesting details about numbers of participants enrolled in the project, the form collects details on procedural changes from those originally approved as well as details on the occurrence of any adverse or negative events. Failure to provide an annual progress report can result in suspension of ethics clearance.

Reporting adverse events

Researchers have an obligation to immediately report within 24 hours to the Director of the Office of Research Ethics on behalf of the Research Ethics Committees, any occurrence of an adverse events associated with a project that has ethics clearance.

The Director, in consultation with other Committee members, will offer recommendations and advice to the researcher on a course of action and will monitor the subsequent progress of the study as appropriate.

In a case where the Committee deems the risk to future participants to be substantial, a project may be suspended temporarily or indefinitely. This decision would be reached in consultation with the researchers. In addition, researchers must provide an annual summary, using Form 106, of an adverse event to the Office of Research Ethics.

Pre-review consultation

Pre-application consultation is available to student and faculty researchers about matters pertaining to the application, review and clearance processes. For further details on this and other educational workshops and activities offered through the Office of Research Ethics.

ethics process
pre submission and training
q and a
application process
review committess
renewals
modifications
report problems
close a study
need help?