H漫画

Research Ethics Board (REB) approval is required when conducting research with living people, with information provided by living people or with human biological materials (from living or deceased individuals).

For the purposes of research involving humans, research is defined as an undertaking intended to extend knowledge through a disciplined inquiry and/or systematic investigation. Human participants are defined as individuals whose data, or responses to interventions, stimuli or questions by the researcher, are relevant to answering the research questions (). 

Research involving humans includes conducting research, including data analysis, with information provided by human participants, regardless of whether or not that information was collected by you (for instance, it could be provided by a data custodian or shared by a research team member). 

Research involving humans that involves multiple jurisdictions may require the oversight of multiple research ethics boards. Multi-jurisdictional research is described in . See FAQ #2 for review of multi-jurisdictional research at H漫画.  

Research exempt from research ethics board review is described in .  Activities not requiring REB review are described in .  

For more detailed information, H漫画 University researchers should contact Research Ethics at ethics@dal.ca or phone 902.494.3423. Researchers at other institutions should contact their respective Research Ethics advisors.

Maybe. Pursuant to the Tri-Council Policy Statement Ethical Conduct for Research Involving Humans (), H漫画 is accountable for research conducted under its auspices no matter where the research is taking place. At H漫画, the review process for multi-jurisdictional research will depend on the situation.

A.  Research approved by the NSHA, IWK or HHN REBs - H漫画 University has formal agreements with the Nova Scotia Health Authority, Horizon Health Network (NB) and the IWK Health Centre. If a research study has been approved by one of their research ethics boards, H漫画 researchers do not additionally require REB approval at H漫画, regardless of their role on the project.

Process 鈥� No additional application is required. H漫画 is notified of research projects involving H漫画 researchers approved by these boards directly. If your project receives funding administered by H漫画 University, you may need to submit your affiliated REB approval to post-award staff in the Office of Research Services to open your research account.

B.  Research approved by another TCPS-bound institution (H漫画 researcher is not the PI or co-PI)  鈥� If the research has already received research ethics board approval from another TCPS-bound institution and a H漫画 researcher is NOT the Principal Investigator, the nominated Principal Investigator or a Co-Principal Investigator for the study, the research may be eligible for board of record review. See the  [Word] for the full list of eligibility criteria. Importantly, the full scope of the research involving humans with which H漫画 will be affiliated must be described and approved by the board of record.

Process 鈥� Apply for . The Research Ethics Board will issue an acknowledgment letter recognizing the REB from the other TCPS-bound institution as the board of record for the research project.

C.  Research approved by a another TCPS-bound institution where a H漫画 researcher is the PI or co-PI 鈥� If a H漫画 researcher is the PI, nPI or co-PI on the project, or is the researcher with primary administrative or financial responsibility for the project, or the researcher responsible for leadership of the project, it must undergo H漫画 REB review and approval.

Process 鈥� Apply for H漫画 REB approval.

All documents for multi-jurisdictional review must be submitted to ethics@dal.ca  in a single electronic file (MS Word or PDF format) in accordance with the .

D.  Research approved by a non TCPS-bound institution - If the research has already received research ethics board approval from another institution that is not bound by the TCPS (e.g. a non-Canadian institution), the research will require H漫画 REB review and approval regardless of the role of the H漫画 researcher.

Process 鈥� Apply for H漫画 REB approval.

All documents for multi-jurisdictional review must be submitted to ethics@dal.ca  in a single electronic file (MS Word or PDF format) in accordance with the .

It normally takes about 4 weeks to receive a response from the Research Ethics Board (REB). In most cases, your first response to a new research ethics application will be a review letter in which the REB requests further information or makes recommendations for changes.

When you respond to this initial review letter, it can take another 4 weeks to provide another REB review of your submission.  You should plan at least 8 weeks from submission to approval, and this estimate is highly variable depending on the nature of the project, the quality of the initial ethics submission and the timeliness of communication between the researcher and the REB.

After you receive REB approval, you may find that you would like to make changes to your project. If this is the case, you will need to submit an  [DOC] to the board. Again, you should plan for about 4 weeks to have your amendment request assessed and the review to be communicated with you.

If your research extends 12 months or more beyond the initial REB approval date, you will need to submit an  [DOC 69 kB] for continuing review. This should be submitted at least 21 days prior to the current approval鈥檚 expiry date (which will be found on your approval letter).

Please note that there are no research ethics reviews in August.

Some parts of the review process will be beyond your control. There are an increasing number of submissions and each must be reviewed by the research ethics staff, board chair and by volunteer board members who give it careful ethical review and prepare written feedback for you. This takes time.

The best way you can contribute to a speedier review process is to submit a carefully prepared application that highlights the ethical considerations relevant to your study. You should read the application and submission instructions carefully and provide the requested information.

It is also highly recommended that you complete the online . 

Research requires REB review, but program evaluation, quality assurance and quality improvement activity is exempt from REB review (as per ). The  offers more interpretation of this question on its website (Scope 鈥� Questions 2 and 7).

It is often difficult to determine what activities qualify for an exemption from research ethics review. The H漫画 Research Ethics boards have developed  [PDF 740 kB]. The guidelines intended to guide researchers and evaluators (including students) as they determine whether their proposed activity constitutes research, program evaluation (PE), or quality improvement (QI), and therefore whether it requires research ethics review or is exempt.

Please note that intent to publish does not in itself determine whether the activity is research (therefore requiring REB review). 

No. There is a whole chapter devoted to the consent process in the . You must ensure that consent is documented (TCPS 3.12), but that documentation does not need to be a written consent form, although this format is common and appropriate in many instances.

Researchers should consider the most appropriate means of ensuring potential participants receive all the information necessary to make an informed decision about whether or not to participate in research (TCPS 3.2 details the required elements of informed consent) as well as the most appropriate way to document a participant鈥檚 consent, and describe this fully in the research ethics submission.

Sample consent forms are available in the  section.

Yes. REB review is not required for research that relies exclusively on secondary use of anonymous information (). Anonymous information is information that never had identifiers associated with it (). Although you may be receiving the information in an 鈥渁nonymous鈥� format, the fact that the data was once identifiable means that the research doesn鈥檛 qualify for an exemption from REB review according to the TCPS.

H漫画 University does not have a policy on the duration of retention of research information. The  offers more interpretation of this question on its website (Question 5). It is common to keep data for five years, but there is normally no requirement to do so. 

From a research ethics perspective, the most important consideration is protecting the privacy and confidentiality of research participants who have entrusted you with their information.  Sometimes, participants have no expectation of privacy, other times, there are very high expectations.  However long you propose to keep research-related information (consent forms, participant codes, video/audio tapes, survey answers, interview transcripts, datasets, biological materials, etc.), you should carefully consider how long you actually need to keep identifiable information.  Generally, more identifiable the information, the safer it is not to keep it in an identifiable form. However, there is also no requirement to destroy data after a set period of time. The TCPS states that 鈥渞esearchers shall provide details to the REB regarding their proposed measures for safeguarding information, for the full life cycle of information: its collection, use, dissemination, retention and/or disposal鈥� (). You may choose to retain research data longer term; if so, please describe the rationale, if and how the data will be anonymized or destroyed, and how appropriate security safeguards will be in place for the full life cycle of information ().

After. You must have your supervisory committee approval first. Your committee may offer recommendations that will require changes to your research project. This is the project you should present to the Research Ethics Board for ethical review.

The REB recommends the use of  or  for web-based survey research. Opinio is a Dal hosted and supported tool researchers can use to collect survey information online. The survey data from Opino are stored on H漫画 servers and therefore helps researchers adhere to various pieces of privacy legislation, and the H漫画 Policy for the Protection of Personal Information from Access Outside Canada.

REDcap is a secure web application for building and managing online surveys and databases. Like Opinio, the data are stored on H漫画 servers and similarly upholds the same privacy legislation and H漫画 Policies mentioned above. Some researchers will find REDCap to be better suited to more complex research designs. 

If researchers would like to use a different survey tool, they must be mindful of the requirements to protect personally identifiable information (PII) of participants (or information, when combined with other information that could become personally identifiable). Not all surveys collect PII, but those that do must demonstrate to the REB that:

• Any PII is stored on Canadian servers. This is required to comply with the Personal Information International Disclosure Protection Act, and the H漫画 Policy for the Protection of Personal Information from Access Outside Canada.
• If the PII is not to be stored on Canadian servers, then the risks to participants of having their data stored outside of Canada (and potentially subject to access by foreign governments), must be clearly presented in the consent documents.  

Yes. Before making a submission to a H漫画 University research ethics board, you must first secure the appropriate Faculty or department-level permissions. Documentation of this permission (or approval) must be appended to your H漫画 University research ethics submission.

To conduct research involving medical students, please follow the   of the Undergraduate Medical Education Curriculum Committee.

To conduct research involving all residents, please follow the  of the Postgraduate Medical Education Committee.

To conduct research involving residents of a particular program only, please secure the approval of the relevant Residency Program Committee.

Yes, this change will require an amendment request. In your amended submission, the sections that may require updating include:

• 2.4.1 Informed Consent - Describe any changes to the consent process, such as documenting verbal consent instead of a written signature.
• 2.5.1  Methods and Analysis -  Describe how the interviews/focus groups will be conducted remotely. Include details such as which service/software will be used, what form of recording will occur (audio only or audio and visual), what type of recording device will be used (external or software integrated).
• 2.6.1 Privacy and Confidentiality 鈥� Explain how the recordings will be captured and stored (encryption of audio and video data is required) as well as the plans for retention and/or destruction of the recording. If videoconferencing will be used, address measures that will be taken to ensure privacy/confidentiality. Note that Microsoft Teams is H漫画鈥檚 . If you choose to use Zoom, refer to the provided by H漫画 ITS.
• Recruitment and Consent Materials - You may also need to update your recruitment materials if they reference in-person interviews and the consent form(s) (e.g. 鈥渨hat you鈥檒l be expected to do鈥�).

Sometimes as a researcher you may want to record a research session with participants, such as interviews or focus groups. Recording interviews means that personally identifiable information is being collected about a person鈥攁s their face and/or voice is personally identifying鈥攁nd this enhanced risk to participants should be carefully weighed against convenience for you the researcher. If recording a research session is integral to the success of the research,  for this purpose.

If you do not need to record the video for the research and audio will serve the purposes for the research, it is recommended to only record the audio. Always collect as little personally identifying information as needed for the research purposes and images of a face with a voice are more personally identifying than just a voice.

When collecting personally identifying information about a participant, researchers need to be in compliance with H漫画鈥檚 Protection of Personal Information Policy, and the . This means that the personally identifiable information must not be accessible outside of Canada or participants need to give informed consent for their information to be accessible outside of Canada. 鈥淚nformed鈥� consent means they are informed about the security and privacy risks. It is the researcher鈥檚 responsibility to understand those risks and communicate them clearly to the participant. Recordings taken using Microsoft Teams are securely routed and stored in Canada.

If you choose to use another videoconferencing tool to record research sessions (such as Zoom, Skype for Business, Collaborate Ultra, etc.), you will need to learn if any of the participant data is accessible from outside of Canada at any time (e.g., if audio and video content is routed outside of Canada during recording, or when stored afterwards). If personally identifiable information is accessible outside of Canada (either with video or audio), Section 2.6.5 of the Prospective REB application form should be checked 鈥淵es鈥�, and an explanation should be provided about how compliance with the H漫画 policy is being achieved (usually this means that participants are informed about this via the consent form). Ensure that consent information is clear about potential security and privacy risks of any technology used. If you have questions about the security and privacy risks of other tools, consult with Dal ITS at support@dal.ca.

Another option to recording using the videoconferencing tool is to record on a separate device like a hand-held recorder or smartphone app (use one that does not sync to the cloud). This way the recorded information is more secure as it is not connected to the internet.

Remember, the more sensitive the research, the more diligent you must be in ensuring rigorous privacy protection for your participants.

Note: The information provided here is correct as of November 2023. We will endeavour to keep this FAQ current. However, technology and H漫画鈥檚 recommended best practices may change without notice to the Research Ethics office.