National Research Centre
Medical Research Ethics Committee
MEDICAL RESEARCH ETHICS COMMITTEE
Apply for Exemption of Ethical Review
Guidelines for exemption of ethical review.
The purpose of this Standard Operating Procedure (SOP) is to describe which clinical research projects can be exempted from ethics review and do not require the approval of the Medical Research Ethics Committee (MREC). The Exemption Form AX 01/SOP 05-C/V5 is designed to standardize the process of exemption.
This SOP applies to the all protocols submitted for exemption from review by the MREC. The specific points in the Exemption Form should guide the Chairperson of MREC to determine whether the protocol qualifies for exemption from review. The decision should be taken by the Chairperson in consultation with the Vice Chairperson and should be informed to the Members in the forthcoming MREC meeting.
- Responsibility
It is the responsibility of the MREC Chairperson or whom he/ she will delegate to consider the decision in the Exemption Form with reasons. The MREC Secretariat is responsible for recording and filing the decision including the reasons for that decision. The Chairperson/ Vice Chairperson must sign and date letter conveying the decision AX 01/SOP 05-C/V5 .
- Detailed instructions
5.1 Receive the submitted documents
- The Secretariat will receive the Exemption from review Application Form AX 01/SOP 05-C/V5,
Protocol and other documents submitted by the investigators.
5.2 Determining the protocols eligible for exemption from review
The proposal submitted for initial review or where investigator have requested for the exemption from review stating the reason in the ‘Review Exemption Application Form’ to the MREC will be evaluated for the exemption from review.
Proposals which involve less than minimal risk fall under this category.
Minimal risk would be defined as one which may be anticipated as harm or discomfort not greater than that encountered in routine daily life activities of the general population or during the performance of routine physical or psychological examinations or tests. However, in some cases like surgery, chemotherapy or radiation therapy, great risk would be inherent in the treatment itself, but this may be within the range of minimal risk for the research participant undergoing these interventions since it would be undertaken as part of current everyday life.
The MREC Member will determine whether a protocol qualifies for exemption from review based on the following criteria. Final decision will be made by the Chairperson.
The research proposals which do not involve live human participants or data derived from them are exempt from ethics review. For example,
- Audits of educational practices
- Experimental Research on non-human non-animal cells
- Research on microbes cultured in the laboratory
- Research on immortalized cell lines
- Analysis of data freely available in public domain
In some circumstances research which appears to meet low risk criteria may need to be reviewed by the MREC. This might be because of requirements of:
- The publisher of the research
- An organization which is providing funding resources, existing data, access to participants etc.
5.3 Recording the decision on Exemption Form in consultation with the Chairperson
- If the protocol and related documents satisfy the criteria as listed in 5.2, the assigned Member in consultation with the Chairperson will review the brief summary of the project and the Exemption Form. The Member will record the decision
5.4 Communicate the decision to the Investigator & MREC members in forthcoming meeting
- The reviewing member will communicate the decision to the Principal Investigator within 5 working days after the decision regarding the exemption is taken.
- The reviewing member will inform the MREC members about the decision at the next full board meeting and minute it in the meeting notes.
- The reviewing member / Chairperson may keep the application for review and decision regarding exemption at the next full board meeting.
- Any changes to the protocol must be brought to the notice of the MREC prior to implementation by the investigator. Any correspondence with the MREC office regarding this action should mention the allocated study number indicated at the top of this letter. The MREC will determine if requested protocol changes alter the risks: benefits analysis of the study, thereby requiring a change in review or exemption category. In such cases investigator will have to resubmit the study protocol and related documents for change review process.
Exemption from review: A research study is said to be exempt from review when it does not require the Medical Ethics Committee approval for its conduct
[1]WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects
https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/ (6 th September 2022)
Annexure 1 AX 01/SOP 05-C/V5 Application for Review Exemption Form
Annexure 2 AX 02/SOP 05-C/V5 Approval of Exempt Review Document
Please check that your application / summary has discussed:
- Procedures for voluntary, informed consent
- Privacy & confidentiality
- Risk to participants
- Needs of dependent persons
- Conflict of interest
- Permission for access to participants from other institutions or bodies
- Inducements
N.B.: No research can be counted as low risk if it involves:
- Invasive physical procedures or potential for physical harm
- Procedures which might cause mental/emotional stress or distress, moral or cultural offence
- Personal or sensitive issues
- Vulnerable groups
- Cross cultural research
- Investigation of illegal behavior(s)
- Invasion of privacy
- Collection of information that might be disadvantageous to the participant
- Use of information already collected that is not in the public arena which might be disadvantageous to the participant
- Use of information already collected which was collected under agreement of confidentiality
- Participants who are unable to give informed consent
- Conflict of interest e.g., the researcher is also the lecturer, teacher, treatment-provider, colleague or employer of the research participants, or there is any other power relationship between the researcher and the research participants.
- Audio or visual recording without consent
- Withholding benefits from “control” groups
- Risks to the researcher
This list is not definitive but is intended to sensitize the researcher to the types of issues to be considered. Low risk research would involve the same risk as might be encountered in normal daily life.
Consent Form
Form template, waiver of consent, apply for waiver of informed consent, guidelines for waiver of informed consent.
Under the Policy for the Protection of Human Participants, MREC may approve an informed consent process that:
- Waives the requirement to obtain informed consent, or
- Alters some or all of the elements of informed consent, or
- Waives the requirement to document informed consent (i.e., to obtain a signature)
Waiver or Alteration of Informed Consent
For research that is no more than minimal risk the MREC may approve a request to waive of some or all of the required elements of informed consent under specific circumstances. Waivers of informed consent are primarily requested for researches involving the secondary analysis of existing data or in researches involving deception. However, in all circumstances the intent of this waiver criterion is to require debriefing for participants in deception research
- To waive in total or to alter informed consent elements, the MREC must determine that:
- The research involves no more than minimal risk to subjects;
- The research could not be carried out practicably without the waiver or alteration;
- The waiver or alteration will not adversely affect the rights and welfare of the subjects; and ,
- Whenever appropriate, the participants or legally authorized representatives will be provided with additional pertinent information after participation.
- Note: If the research involves identifiable private information or identifiable biospecimens , this research could not be carried out practicably without using the information/specimen in an identifiable form.
- It is not appropriate to request a waiver of documentation of informed consent for human subject projects that collect biospecimens.
Waiver of Documentation of Informed Consent
For some researches, the MREC will approve a request to waive the documentation of informed consent. This means that the study team must provide the participant with the required consent information, but the study team is not required to obtain the participant’s signature on the informed consent document. Each participant (or legally authorized representative) will be asked whether the participant wants documentation linking the participant with the research, and the his/ her wishes will govern;
In all cases, even if MREC approves a waiver of documentation of consent, MREC will review a written description of the information provided to participants and should be offered a copy of the consent information for their records even when a signed document is not required for the study.
A waiver of documentation is permissible when:
- The signature on the informed consent document would be the only record linking the participant to the research and the principal risk of harm to the participant would be a breach of confidentiality. For example, for research on sensitive topics, such as domestic violence or illegal activities; OR
- The research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside the research context. OR
- Alternative mechanism for documenting that informed consent was obtained.
For example:
- Surveys/interviews conducted via telephone or online and involves minimal risk.
- Retrospective chart reviews
- Studies of existing pathology specimens
- Ethnographic research
- Passive (opt-out) consent.
- Public Demonstration Researches: MREC may waive or alter the requirements for informed consent in research involving public benefit and service programs if MREC finds and documents that:
- The research or demonstration project is to be conducted by or subject to the approval of state or local government officials; and
- The research is designed to study, evaluate or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs; and
- The research could not practicably be carried out without the waiver or alteration.
- Screening, Recruiting, and Determining Eligibility Researches: MREC may approve a research proposal in which a researcher will obtain information or biospecimens for the purpose of screening, recruiting, or determining the eligibility of prospective participants without the informed consent of the prospective participant or the participant’s legally authorized representative, if either of the following conditions are met:
- The researcher will obtain information through oral communication with the prospective participant or legally authorized representative, or
- The researcher will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.
- Waiver of Requirement for Parental Permission: For research involving children as participants, MREC may waive the requirement to obtain parental permission if it finds and documents that:
- An appropriate mechanism for protecting the children who will participate as participants in the research is substituted.
- The research involves no more than minimal risk to the participants;
- The waiver or alteration does not adversely affect the rights and welfare of the participants;
- The research cannot practicably be carried out without the waiver or alteration e.g., domestic violence or children abuse;
- When appropriate, the participants will be provided with additional pertinent information after participation.
For emergency research , MREC may approve a waiver of consent or documentation in emergency research protocols in which participants are unable to give informed consent at the time of enrollment due to their medical condition. However, these studies require additional steps to ensure that potential participants in the communities where the study takes place have adequate opportunity to learn about the study at any time:
- “Community Consultation” prior to MREC submission of the full study protocol
- “Public Disclosure” (such as advertisements)
- Before study initiation, MREC will assess and evaluate the plans for the investigation and its risks and expected benefits
- After study completion, of study results and the demographics of the study population.
“Emergency Use of an Investigational Agent” prior to MREC Review and Approval: MREC may waive or alter the requirements for informed consent under the following requirements
- MREC receives a request to use an investigational agent without informed consent, MREC will assess whether or not the regulatory criteria apply.
- Where MREC is informed after the use of an investigational agent without informed consent, MREC will assess whether or not regulatory criteria were followed according to Appendix A
Exception from informed consent requirements for emergency research
- MREC may approve the waiving of informed consent in emergency research if it finds anddocuments each of the following requirements and are met with the concurrence of a licensed physician who is a member of or consultant to MREC and who is not otherwise participating in the clinical investigation:
- The human subjects are in a life-threatening situation, available treatments are unproven or unsatisfactory, and the collection of valid scientific evidence, which may include evidence obtained through randomized placebo-controlled investigations, is necessary to determine the safety and effectiveness of particular interventions.
- Obtaining informed consent is not feasible because:
- The subjects will not be able to give their informed consent as a result of their medical condition;
- The intervention under investigation must be administered before consent from the subjects’ legally authorized representatives is feasible; and
- There is no reasonable way to identify prospectively the individuals likely to become eligible for participation in the clinical investigation.
- Participation in the research holds out the prospect of direct benefit to the subjects because:
- Subjects are facing a life-threatening situation that necessitates intervention;
- Appropriate animal and other preclinical studies have been conducted, and the information derived from those studies and related evidence support the potential for the intervention to provide a direct benefit to the individual subjects; and
- Risks associated with the investigation are reasonable in relation to what is known about the medical condition of the potential class of participants, the risks and benefits of standard therapy, if any, and what is known about the risks and benefits of the proposed intervention or activity.
- The clinical investigation could not practicably be carried out without the waiver.
- The proposed investigational plan defines the length of the potential therapeutic window based on scientific evidence, and the investigator has committed to attempting to contact a legally authorized representative for each participant within that window of time and, if feasible, to asking the legally authorized representative contacted for consent within that window rather than proceeding without consent. The investigator will summarize efforts made to contact legally authorized representatives and make this information available to MREC at the time of continuing review.
- MREC has reviewed and approved informed consent procedures and an informed consent document. These procedures and the informed consent document are to be used with participants or their legally authorized representatives in situations where use of such procedures and documents is feasible. MREC should have reviewed and approved the procedures and information to be used when providing an opportunity for a family member to object to a subject’s participation in the clinical investigation consistent with paragraph (A) (7) (v) of this appendix.
- Additional protections of the rights and welfare of the subjects will be provided, including, at least:
- Consultation (including, where appropriate, consultation carried out by MREC) with representatives of the communities in which the clinical investigation will be conducted and from which the subjects will be drawn;
- Public disclosure to the communities in which the clinical investigation will be conducted and from which the subjects will be drawn, prior to initiation of the clinical investigation, of plans for the investigation and its risks and expected benefits;
- Public disclosure of sufficient information following completion of the clinical investigation to apprise the community and researchers of the study, including the demographic characteristics of the research population, and its results;
- Establishment of an independent data monitoring committee to exercise oversight of the clinical investigation; and
- If obtaining informed consent is not feasible and a legally authorized representative is not reasonably available, the investigator has committed, if feasible, to attempting to contact within the therapeutic window the subject’s family member who is not a legally authorized representative, and asking whether he or she objects to the subject’s participation in the clinical investigation. The investigator will summarize efforts made to contact family members and make this information available to MREC at the time of continuing review.
- MREC is responsible for ensuring that procedures are in place to inform, at the earliest feasible opportunity, each participant, or if the participant remains incapacitated, a legally authorized representative of the subject, or if such a representative is not reasonably available, a family member, of the participant’s inclusion in the clinical investigation, the details of the investigation and other information contained in the informed consent document.
MREC shall also ensure that there is a procedure to inform the participant, or if the subject remains incapacitated, a legally authorized representative of the subject, or if such a representative is not reasonably available, a family member, that he or she may discontinue the participant’s participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
If a legally authorized representative or family member is told about the clinical investigation and the participant’s condition improves, the participant should also to be informed as soon as feasible.
If a participant is entered into a clinical investigation with waived consent and the participant dies before a legally authorized representative or family member can be contacted, information about the clinical investigation is to be provided to the participant’s legally authorized representative or family member, if feasible.
- MREC determinations required by paragraph (a) of this section and the documentation required byparagraph (e) of this section are to be retained by MREC for at least 3 years after completion of the clinical investigation, and the records shall be accessible for inspection and copying by Supreme Council of Research Ethics.
- Protocols involving an exception to the informed consent requirement under this section must be performed under a separate investigational new drug application (IND) or investigational device exemption (IDE) that clearly identifies such protocols as protocols that may include participants who are unable to consent. The submission of those protocols in a separate IND/IDE is required even if an IND for the same drug product or an IDE for the same device already exists.
- If MREC determines that it cannot approve a clinical investigation because the investigation does notmeet the criteria in the exception provided under paragraph (a) of this section or because of other relevant ethical concerns, MREC will document its findings and provide these findings promptly in writing to the clinical investigator and to the sponsor of the clinical investigation. The sponsor of the clinical investigation must promptly disclose this information to the relevant authority and to the sponsor’s clinical investigators who are participating or are asked to participate in this or a substantially equivalent clinical investigation of the sponsor, and to other research ethics committees that have been, or are, asked to review this or a substantially equivalent investigation by that sponsor.
DEFINITIONS
- Clinical investigation: The terms research, clinical research, biomedical research, clinical study,study, clinical trial, trial, and clinical investigation are deemed to be synonymous for purposes of this) The term means: For drugs (including biological drugs): Any experiment in which a drug/biologic is administered or dispensed to, or used involving, one or more human participants.
- For devices: Any investigation or research involving one or more participants to determine the safety oreffectiveness of a device.
- Clinical Investigator: An individual who actually conducts a clinical investigation (i.e., under whose immediate direction the test article is administered or dispensed to a subject). In the event an investigation is conducted by a team of individuals, the investigator is the responsible leader of that team.
- Community: A community means a group or groups of people who live and work in a particular regionand who may be linked by common interests; an interacting population of different kinds of individualsconstituting a society or association; or, simply an aggregation of mutually related individuals in a given A community may also include persons who share common experiences or conditions.
- Community consultation: Community consultation means providing the opportunity for discussions with, and soliciting opinions from, the community or communities in which the study will take place and from which the study subjects will be drawn.
- Data Monitoring Committee (DMC): A clinical trial DMC is a group of individuals with pertinent expertise that reviews on a regular basis accumulating data from one or more ongoing clinical trials.The DMC advises the sponsor regarding the continuing safety of current trial participants and those yetto be recruited to the trial, as well as the continuing validity and scientific merit of the trial.
- Emergency Research: A planned clinical investigation that requires prior written authorization toproceed and involves participant(s) who are in a life-threatening situation for which available treatments orin vitro diagnostic tests are unproven or unsatisfactory.
- Family member. Any one of the following legally competent persons: spouse, parents, children, brothers, sisters, and spouses of brothers and sisters, and any individualrelated by blood or affinity whose close association with the subject is the equivalent of a family
- Legally competent: may vary but generally includes an age of majority and an assessment of mental capacity.
- Medical Research Ethics Committee (MREC): The board committee formally designated by National Research Centre to review, to approve the initiation of, and to conduct periodic review of, biomedical researchinvolving human participants. The primary purpose of such a review is to ensure the protection of the rightsand welfare of the human subjects.
- Legally authorized representative (LAR): An individual or judicial or other body authorized under applicable law to give informed consent on behalf of a prospective subject to the participant’s participation in the procedure(s) involved in the research.
- Life-threatening: Diseases or conditions where the likelihood of death is high unless the course of thedisease or condition is interrupted.
- Public disclosure: dissemination of information about the emergency research sufficient to allow a reasonable assumption that the communities areaware of the plans for the investigation, its risks and expected benefits, and the fact that the study will beconducted without obtaining informed consent for most or even all subjects. Public disclosure alsoincludes dissemination of information after the investigation is completed so that the communities andscientific researchers are aware of the study’s results.
- Sponsor: A person who takes responsibility for and initiates a clinical investigation. A sponsor may be an individual, a company, a governmental agency, an academic institution,a private organization, etc.
- Therapeutic window:
The therapeutic window is the time period, based on available scientific evidence, during which administration of the test article might reasonably produce a demonstrable clinical effect.
For investigations of in vitro diagnostic devices that meet the criteria for emergency research, the therapeutic window is the time period, based on available scientific evidence, during which diagnosis must occur to allow administration of appropriate therapy.
Request for Waiver of Informed Consent
Request for Waiver of some Items of Informed Consent
Request for Waiver of Documentation of Informed Consent
Section 1: About the Waiver of Informed Consent
Use this form if none of the required elements of consent are given. A waiver of informed consent completely waives the requirement to obtain informed consent. The MREC may approve a consent procedure which does not include some or all of the required elements of informed consent provided all of the following are true:
- The research involves no more than minimal risk
- The waiver of informed consent will not adversely affect the rights and welfare of the subjects
- It is not practicable to conduct the research without the waiver or alteration
Whenever appropriate, participants will be provided with additional pertinent information after their participation.
PLEASE NOTE: MREC will take into consideration the risks and potential harms involved in the research before granting a waiver of informed consent. Additionally, there are restrictions for when MREC may waive the requirements for child assent and parental permission.
Section 2: Who Needs to Complete this Form
If you choose “waiver of informed consent / waiver of informed consent documentation or waiver of some items of informed consent box in the CONSENT FORM DOCUMENT, you will need to complete this form as part of your application.
Apply for Appeal
The president and vice president of NRC for research and international affairs will oversee the research practices and will assure that these practices will conform to the principles of research ethics. Part of this assurance includes the establishment of an appropriated constituted Medical Research Ethics Committee (MREC) which shall have the responsibility to review and monitor research involving human or animal subjects.
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Research at HMPPS
Conducting Research in Prisons, Probation or HMPPS Headquarters
Anybody seeking to undertake research (specifically the application of research methods) involving staff and/or offenders in prison establishments, across the Probation Service or within His Majesty’s Prison and Probation Services (HMPPS) Headquarters are required to formally apply for approval to the HMPPS National Research Committee (NRC).
The NRC exists to ensure:
- The research applicant, Ministry of Justice (MoJ) and HMPPS attain best value from the research conducted.
- The resource implications and impact of the research activity on operational delivery are considered.
- The robustness and relevance of the research is adequately assessed.
- Matters of data protection, security and research ethics are dealt with in a consistent manner.
MoJ Areas of Research Interest
The MoJ Areas of Research Interest (ARI) sets out the department’s medium-term research priorities, in line with our strategic objectives for the justice system. It highlights where new research is needed and can have the most impact for policy and practice. Researchers should consider the ARI in their application and explain how their research can help address these strategic evidence needs. Applications will be assessed against this as one of the review criteria.
How to submit an application
Making an application.
All NRC applications must be made using the online application form – HMPPS NRC Online Application Form
A Word version of the online form can be found here: NRC Online Application Form ( MS Word Document , 54.6 KB ) . This document should be used for drafting purposes; only applications submitted using the online form will be processed and reviewed.
For projects also requiring approval from health and social care bodies, applications should be made through the Integrated Research Application System (IRAS) . It is the responsibility of the applicant to check if Health Research Authority (HRA) approval is also required. The HRA has a decision tool to help you decide - Is my study research? (hra-decisiontools.org.uk)
Applications for secondary data analysis should be submitted via the usual NRC process.
Supporting documentation must be uploaded via the online application form.
Guidance on applications
Guidance on the NRC process, including information that should be included in the application form and tips for completing your application is available here: NRC Application Guidance ( PDF , 605 KB , 31 pages ) .
Review and approval process
Applications must be submitted by 5pm on the last working day of the month to be considered in the following month of reviews.
The NRC reviews a maximum of 14 multi-site applications per month. This cap operates on a first-come-first- served basis with any surplus applications carried over into the following month.
For more information on the review and approvals process, please refer to the NRC application guidance document.
Student applications
Undergraduate Students: Due to the potential volume of applications, the NRC is unable to accept research proposals from undergraduate students. This applies even when HMPPS or MoJ business support is provided.
Postgraduate (Masters) Students: We are unable to accept Masters applications without written evidence of HMPPS/MoJ business support. Business support should be from Prison Group Director (PGD) for custody, Regional Probation Director (RPD) for community or Deputy Director level for HQ requests. A letter/email of support must be uploaded with the NRC application. We are unable to process applications without this confirmation.
Postgraduate (Doctoral) Students: The Committee does accept student applications at doctoral level. Business support is beneficial but not required.
Amendments to previously approved research
NRC approval should be sought for amendments to already approved applications. This can include, but not limited to, changes to the prisons or probation regions included in your research, the methodology or the research team.
NRC Amendment Guidance – NRC Amendment Guidance ( PDF , 251 KB , 3 pages )
NRC Amendment Form – NRC Amendment Form ( MS Word Document , 33.9 KB )
Completed forms should be submitted to the NRC mailbox: [email protected]
NRC decisions
We will notify you of the NRC decision by updating the status of your application in the online application portal. A decision letter will also be emailed to the lead researcher. We may ask that the research is also submitted to an appropriate local research ethics committee (for example, University, NHS or research body).
Successful applicants
If your application is successful, you will be required to prepare a research summary (maximum of five pages) at the end of your project which:
- summarises the research aims and approach
- highlights the key findings
- sets out the implications for HMPPS and MoJ decision-makers
Provision of the research summary is essential to ensure that MoJ and HMPPS are notified of your research findings and the value of your research is maximised.
Unsuccessful applicants
If your application is unsuccessful, we will provide reasons in the decision letter. You are allowed one resubmission. The reasons for the previous rejection should be fully addressed.
Related Links
General NRC related queries: [email protected]
Accessing HMCTS data - Get access to HMCTS data
Research involving the judiciary - Judicial participation in research projects - Courts and Tribunals Judiciary
Statistics at MoJ - Statistics at MOJ - Ministry of Justice - GOV.UK (www.gov.uk)
Accessing the Justice Data Lab - Accessing the Justice Data Lab service - GOV.UK (www.gov.uk)
Research through Data First - MOJ: Data First, application form for secure access to data - GOV.UK (www.gov.uk)
MoJ Areas of Research Interest (ARI) - Ministry of Justice: areas of research interest 2020 - GOV.UK (www.gov.uk)
MoJ Publications - Research and statistics - GOV.UK (www.gov.uk)
Research with MoJ’s agencies and Arms-Length Bodies - Research within MOJ’s agencies and arm’s length bodies - GOV.UK (www.gov.uk)
Data protection guidance can be found on the Information Commissioner’s Office website - http://ico.org.uk
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Research Ethics Board: Overview of the Health Canada and Public Health Agency of Canada REB
- About the REB
- Apply for ethics review
- Continuing ethics review forms
- Policies, guidelines and resources
- Consent process
Research involving humans can greatly benefit human society, but it must be done in a way that protects and respects the research participants. The Health Canada and Public Health Agency of Canada (PHAC) Research Ethics Board (REB) was created to provide this oversight. It reviews all research from Health Canada and PHAC that involves humans (including living individuals, human biological materials and information from or about humans) to ensure that it meets the highest ethical standards, and that the greatest protection is provided to research participants. Specifically, the Health Canada-PHAC REB reviews all research involving humans that is:
- Carried out by Health Canada or PHAC (intramural);
- Performed by Health Canada or PHAC in collaboration with external researchers;
- Carried out on Health Canada or PHAC premises; or
- Conducted under contract to Health Canada or PHAC.
The REB may also review research that is funded by Health Canada or PHAC through grants and contributions to external researchers who do not have access to another research ethics board.
The Health Canada-PHAC REB does not review research that is not carried out by, funded by, or otherwise undertaken in association with Health Canada or PHAC. Research projects not associated with Health Canada or PHAC should be referred to the REB at the lead investigator's institution and/or the REB at the institution(s) where the research is being conducted.
In addition, the Health Canada-PHAC REB does not oversee or regulate other REBs in Canada. Like other Canadian REBs, the Health Canada-PHAC REB is guided by the principles of the second edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2). TCPS 2 is the official human research ethics policy of the three federal research funding agencies (the Canadian Institutes of Health Research, the Natural Sciences and Engineering Council of Canada, and the Social Sciences and Humanities Research Council of Canada). The Agencies have mandated the Secretariat on Responsible Conduct of Research (SRCR) and the Panel on Research Ethics (PRE) with the evolution, education and interpretation of the policy. Questions about the interpretation of TCPS 2 should be directed to the SRCR at [email protected] .
Human clinical trials are also subject to Health Canada regulatory requirements. For further information regarding these regulatory requirements, researchers may contact the relevant Health Canada clinical trials office as appropriate.
On this page
Applying for ethics review, maintaining ethics approval, closing a study, annual reports of reb activities.
Researchers must obtain ethics approval in writing from the Health Canada-PHAC REB before the research begins. Research approved by another Canadian REB must also be reviewed by the Health Canada-PHAC REB if it involves researchers from Health Canada or PHAC or if it meets any of the other criteria described above.
Full details on the application process can be found in the Apply for ethics review section of the website. Key elements of the application process include:
- Pre-submission consultation with the Health Canada-PHAC Privacy Management Division for a privacy risk assessment
- PHAC departmental approval (for PHAC researchers only)
- Independent scientific peer reviews of the research protocol
- The application form and all required supporting documents (as described in the application form instructions )
The application deadline for initial REB ethics review is 3 weeks before each monthly REB meeting. If an application is deemed to represent minimal risk to participants, it may be sent at the discretion of the REB chair to delegated review (consisting of the Chair or Deputy Chair and one other REB member) rather than full REB review. Note that the application requirements and review process are the same, regardless of the level of risk. However, because delegated review meetings are held more frequently, minimal risk applications are accepted at any time and may be reviewed more quickly.
Applicants are encouraged to contact the REB Secretariat before submitting their proposal to determine the level of risk associated with the study. The REB Secretariat can also provide advice on whether a study meets the definition of research involving humans and therefore requires REB review.
All research approved by the Health Canada-PHAC REB is subject to continuing ethics review by the REB throughout the life of the project. To maintain a valid ethics certificate, applicants are required to submit annual progress reports to the REB, seek approval for amendments to the research protocol, and report any unanticipated issues or events.
Submissions for continuing ethics review are accepted at any time and are normally reviewed within one to two weeks at a delegated review meeting. Information and forms for continuing ethics review are available on the Research Ethics Board: Continuing ethics review forms web page.
Researchers must notify the REB upon completion or termination of their project by submitting a Completion/termination report form (PDF format, 8 pages). Submissions are accepted at any time and are normally reviewed within one to two weeks.
The REB Secretariat produces an annual report for the Deputy Minister of Health and the President of PHAC, summarizing the activities of the Board and the Secretariat during the fiscal year. The reports include details on the number and profile of submissions, outcome of REB reviews, and approval times.
- 2019-20 Annual Report
- 2020-21 Annual Report
- 2021-22 Annual Report
- 2022-23 Annual Report
Health Canada-PHAC Research Ethics Board Secretariat 70 Colombine Driveway, Room 941C, PL: 0909C Brooke Claxton Building, Tunney's Pasture Ottawa, ON K1A 0K9
Telephone: 613-941-5199 Facsimile: 613-941-9093 Email: [email protected]
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The NRC Research Ethics Board meets regularly (see meeting schedule below). Protocols can be submitted at any time and may be processed outside of the meeting schedule if they are eligible for Chair or Sub-committee review. Protocols that are eligible for sub-committee review, but are submitted on or near the meeting submission deadline, will ...
The NRC Research Ethics Board (NRC-REB) helps NRC and its researchers maintain high standards in ethics in research involving human participants. These procedures support the work of the NRC-REB within the framework of the National Research Council (NRC) Policy for Research Involving Human Subjects (RIHS) (2014).
The NRC Research Ethics Board (NRC- REB) helps NRC and its researchers maintain high standards in ethics in research involving human participants. These procedures support the work of the NRC-REB within the framework of the National Research Council (NRC) Policy for Research Involving Human Subjects (RIHS) (2014).
Learn more about the NRC's commitment to high ethical standards in research involving humans and get details about the policies and standards of the NRC Research Ethics Board, which reviews all NRC research involving human participants for approval.
Medical Research Ethics Committee (MREC): The board committee formally designated by National Research Centre to review, to approve the initiation of, and to conduct periodic review of, biomedical researchinvolving human participants. The primary purpose of such a review is to ensure the protection of the rightsand welfare of the human subjects.
Undergraduate Students: Due to the potential volume of applications, the NRC is unable to accept research proposals from undergraduate students. This applies even when HMPPS or MoJ business ...
Consistent with the NRC Policy on Research Involving Human Participants (the NRC Policy), the NRC affirms that excellence in ethics and respect for human dignity are essential to excellence in research. NRC is therefore committed to supporting research involving human participants only when it has approval of the NRC Research Ethics Board (NRC ...
The NRC Research Ethics Board (NRC-REB) helps NRC and its researchers maintain high standards in ethics in research involving human participants.
2All of the manual annotation studies were approved by the NRC Research Ethics Board (NRC-REB). Protocol numbers can be found on corresponding project pages. REB review seeks to ensure that research projects involving humans as participants meet Canadian standards of ethics.
Information and forms for continuing ethics review are available on the Research Ethics Board: Continuing ethics review forms web page. Closing a study. Researchers must notify the REB upon completion or termination of their project by submitting a Completion/termination report form (PDF format, 8 pages). Submissions are accepted at any time ...