FAQ

Step 1: Send an outline of your concerns along with supporting documents to hreb@mtroyal.ca.

Step 2: The HREB Chair will review your concerns and provide an initial response within 2 weeks.

Step 3: If the researcher is not satisfied with the Chair's decision, the appeal will be sent to the full HREB for review. The researcher will be invited to present her/his/their case to the HREB within 30 days.

Step 4: The researcher will be notified in writing of the HREB's decision.

Step 5: If the researcher disagrees with the HREB's decision, s/he/they can file a written request to the Associate Vice-President, Research, who shall convey it to the Chair of the Appeal Board (at the University of Calgary).

Step 6: The researcher will receive a notification on the University of Calgary Ethics Appeal Board decision. Decisions of the Research Ethics Appeal Board are final and binding in all respects.

For instance, one recruitment process was approved a month ago and now I'm having the exact same process rejected on a new application. I'm confused.

HREB is comprised of several faculty reviewers. Given the process can be subjective, feedback may vary to some degree. Nonetheless, all HREB reviewers are guided by the human research ethics in the TCPS2.

After you receive your ethics clearance letter (via email), which will be signed by the HREB Chair or designate.

You are not required to use the consent template posted on the HREB website, however it is strongly recommended. At a minimum your consent form must include the information outlined by TCPS2, such as evidence of free and informed consent, participation requirements, and risks and benefits of being a participant.

The TCPS2 mandates the submission of annual status reports for multi-year research projects outlining a summary of the studies activities including any unanticipated events. The progress report indicates that you are planning to continue with the study beyond the anniversary of your study's clearance period. Progress reports must be submitted by, or before, the anniversary date of your study clearance.

You can close your ethics application by submitting your Completion Report to HREB. This may only occur after your last contact with participants for data collection or data analysis. Completion reports must be submitted by the anniversary data of your study clearance or as soon as the study is completed (for projects lasting less than one year).

All research activities must cease or desist after the study's expiry date. Additionally, funding cannot be accessed for expired studies until a Progress or Completion Report has been submitted, and ethical clearance has been granted.

Yes. Researchers are required to submit modification requests to HREB before making any changes to previously approved protocols. The requested modifications must not be implemented before HREB approval has been granted.

(For example, a loss of some of my data, an accidental breach in confidentiality/anonymity, or a participant complaint, etc.)

Unanticipated events must be reported to the Research Compliance Office (hreb@mtroyal.ca) immediately.

The Continuing Ethics Review (CERs) process refers to any review of ongoing research conducted by HREB after initial approval and throughout the lifespan of the project. This is to ensure that all stages of a research project are ethically sound and in accordance with the TCPS2 (Article 6.14) requirements.

For example, student assignments or student interviews with stakeholders?

No. HREB does not grant retroactive approvals. Ethics clearance must be obtained before the initiation of any contact with human participants for research purposes. This includes but is not limited to participant recruitment and data collection.

Yes. Any research that involves contact with human participants requires ethics approval before data collection can begin.

HREB is guided by the TCPS2 definition of research as "an undertaking intended to extend knowledge through disciplined inquiry and/systematic inquiry. The term "disciplined inquiry" refers to an inquiry that is conducted with the expectation that the method, results, and conclusions will be able to withstand the scrutiny of the relevant research community." As such, HREB does not review research that is not intended for dissemination. If a researcher decides to begin research without HREB approval and finds interesting results, s/he cannot disseminate the findings because ethical clearance was not obtained and HREB does not grant retroactive approvals.

The Mount Royal University HREB has identified three dimensions as important to differentiating quality assurance studies and program review from research studies:

1. The goal of the study.
2. The consumer of the study's findings.
3. The focus of the research question.

Refer to the document Guidelines for differentiating between Quality Assurance (or Program Review) and Research for details.

According to the TCPS2, secondary use refers to the use in research of information originally collected for a purpose other than the current research purpose.

Researchers shall seek HREB review, but are not required to seek participant consent, for research that relies exclusively on the secondary use of non-identifiable information. In the case of secondary use of identifiable information, researchers must obtain consent from participants unless the researcher satisfies all the requirements in TCPS2 Article 5.5A.

Student Human Research Ethics (SHREC) applications are required for courses where the assignment(s) includes the development of research skills where the use of human participants is required. These projects must be limited to minimal risk studies.

The applications are reviewed by the Student Human Research Committee (SHREC). Principal Investigators take on the role of overseeing all projects within their courses (and if they are applying for multiple sections - they are responsible for all projects' ethical considerations). Ethical approval for undergraduate class projects is valid for up to one (1) year if there are no changes to the course assignment(s). If instructors wish to repeat the assignment the following year, a "declaration of continuance" form can be used to reapply. If a revised or different assignment is used, a new CBSRE application must be submitted.

What steps should I take if my study needs to be approved by the University of Calgary's Conjoint Health Research Ethics Board (CHREB)?

1. Biomedical and health studies falling within the Health Information Act should be submitted to the Conjoint Health Research Ethics board (CHREB) through the University of Calgary's IRISS System.
   
   2. After approval, MRU Researchers must complete the CHREB application in the MRU ROMEO system. MRU researchers are also required to submit their approval letters, approved application forms and all supporting documents (e.g. recruitment advertisements, consent forms, questionnaires, interview guides, debriefing forms etc) in ROMEO.
   
   All Modifications, renewals, progress and completion reports approved by CHREB must be submitted to MRU HREB throughout the life span of the project.

I am a co-investigator with colleague from other universities. Do I require MRU ethics approval if the study has been approved at another university?

Yes. MRU researchers working as part of research teams for studies that have been approved at other universities must complete an External Ethics application form. This form can be found on ROMEO.

I am a researcher not affiliated with MRU. Do I need HREB ethics approval to conduct my research at MRU?

Yes. External researchers not affiliated with MRU who have been granted ethics clearance from other postsecondary institutions and are planning to recruit MRU participants must register on the MRU ROMEO system and complete the External Ethics application form.

Researchers affiliated to non-Canadian universities are required to complete the Full HREB application form after registering on the ROMEO system.

The ROMEO registration portal for external applications can be accessed by clicking here.

I have grant funding, but my initial stages do not require ethics clearance, so what should I do?

Please complete a Release of Funds form and submit it to hreb@mtroyal.ca

This form can be found on the ethics and compliance website.

Yes. Participants need to know how their data will be used, how they can ask questions, and how they can withdraw from the study. Often people put this information on the first screen of the online survey with a statement indicating that continuing with the survey indicates consent.

I am a researcher conducting research with individuals based on their membership in unique and distinct communities. What factors should I take into consideration?

Answer:

Researchers working with distinct communities that include non-Indigenous people should consider participants' social, health, economic and cultural contexts when assessing risks (See TCPS2, Chapter 2, Article 2.11 for additional information).

Does self-study or autoethnography research require HREB review?

Answer:

Yes, research involving human participants requires ethics review and approval before the research commences. This includes autoethnographic research, even if the researcher is the only human participant. Self-study done for the purpose of research as defined in TCPS 2, and involving human participants also falls within the scope of TCPS 2 and requires REB review (Application of Article 2.1).

MRU Policy indicates that you should keep it for a minimum of 5 years after collection. If you want to keep it longer, you should indicate that on the ethics application and explain your rationale for the extended retention period.

Anonymized data may be kept indefinitely.

What should I do if I want to make changes to my study because:

a) I cannot get enough participants
b) New co-researchers are joining my team
c) I received new funding for the project, etc.

Please complete an ethics Modification Form via ROMEO.

What should I do if I am required to disclose my research through law (e.g. when served with a search warrant for your research data)?

If you are subpoenaed for your research data, please contact MRU Legal Services immediately at ext. 5602. MRU Legal Services will advise you on how to proceed.

While awaiting a legal decision on the request to access your data, the requested data/documents should be placed in a sealed envelope and you should indicate on the envelope that you are asserting privilege over the contents. This is particularly important where the research data was collected with a promise of confidentiality being made to the study participants.

Research data includes all materials connected to the study (e.g., surveys, questionnaires, research notes, audio and video recordings, transcripts, master lists, photographs, private records, consent forms etc).

Identifiable data refers to information that may reasonably be expected to identify an individual, alone or in combination with other available information. There are two types of identifiable information:

• Directly identifying information (Personal Identifiers) – the information identifies a specific individual through direct identifiers (e.g., full name, employee ID, student ID, Personal Health Number etc). The collection of identifiable information can be minimized by using initials instead of name, age instead of full date of birth.
• Indirectly identifying information (Personally Identifiable Data) – the information can reasonably be expected to identify an individual through a combination of indirect or unique identifiers (e.g., birth date, gender, place of residence etc).

You can create a master list by replacing or coding identifiers (e.g., name, full date of birth) with a unique study ID number. These identifiers should be kept separate from the study data and linked to study data by study number only.

Anonymous data refers to information that never had identifiers associated with it (e.g., anonymous surveys) and risk of identification of individuals is low or very low.

Anonymized data refers to information that has been stripped of direct identifiers, a code is not kept to allow future re-linkage, and risk of re-identification of individuals from remaining indirect identifiers is low or very low.

You can store your data in a locked filling cabinet or room only accessible to research team members, encrypting computer files, using firewalls, password protected devices (e.g. computers, tablets, mobile phones etc).

MRU requires that all materials connected to the study data be maintained for a minimum of 5 years.