About the programme


The Caribbean Public Health Agency (CARPHA) is the principal regional institution charged with providing strategic direction in analyzing, defining and responding to the public health priorities of Member States. Research is one of its core functions and it has a responsibility to facilitate the establishment of systems that ensure that all studies conducted in its Member States comply with the highest ethical standards. These systems will include facilities for the independent review of the ethical acceptability of research involving humans to ensure that participants’ rights, dignity, safety and well-being are protected. CARPHA’s roles include building capacity in its Member States to establish and manage research ethics committees as well as hosting an independent Committee.

CARPHA’s Research Ethics Committee (REC) will provide ethical oversight for research involving human participants conducted under its auspices, that is, research conducted by staff or funded by CARPHA. Upon request, the services of the REC will also be extended to CARPHA Member States (CMS).

purpose of the committee

The Committee will provide independent review of the ethical acceptability of research on behalf of CARPHA, that is, approve, reject, propose modification or terminate any ongoing or proposed research involving human participants to be conducted under CARPHA’S auspices or and within its jurisdiction.

objectives of the committee

  • The Committee shall conduct independent review of the ethical acceptability of research involving human participants to be conducted or supported/ funded by CARPHA.
  • The Committee shall ensure all the ethical requirements for research involving human participants are met by all researchers and shall safeguard the dignity, rights, safety, and well-being of all research participants and communities paying special attention to investigations that may involve vulnerable participants.
  • The Committee shall monitor research projects after approval through appropriate, well documented procedures such as periodic and final reports as well as site visits.
  • The Committee shall ensure that researchers comply with all regulatory requirements, guidelines and laws.
  • The Committee shall provide technical assistance/advice on matters related to research ethics to Chief Medical Officers, Research Ethics Committees and other officials from CMS. This may include the conduct of reviews of research proposals for ethical acceptability, on request.
  • The Committee shall provide ethical oversight for multi-country studies.

APPLICATION PROCESS FOR ETHICAL REVIEW BY CARPHA’s RESEARCH ETHICS COMMITTEE

In keeping with the regional mandate of the Caribbean Public Health Agency, CARPHA’s Research Ethics Committee will provide ethical review and oversight for research involving human participants, and upon request, will provide these services to those CARPHA Member States that do not have research ethics committees, or who have research proposals that involve multi-country studies, or where proposals may exceed their own levels of expertise.

Proposed research within member countries must be submitted to a local research ethics committee or to the country’s Ministry of Health for a priori ethical review of the proposal. The Ministry may seek the review from its own research ethics committee, if one exists, or from the CARPHA Research Ethics Committee, as it deems fit. Such submissions should meet the requirements as stated below in the sections ‘The Ethical Requirements for Research with Human Participants’, ‘Submission Procedures’, and ‘Documents Required for Review.’ Submissions should be sent to the Chair of the REC: carpha.rec.chair@gmail.com

Ethical Basis for the Decision-Making Process of the REC

Decision-making on research submitted for review will be based on:

  • International Guidance Documents
  • Human Rights Instruments
  • National Laws and Policies
  • These documents will be accessed through websites/webpages where pertinent and available.CARPHA’s REC has adopted as its basis for decision making the Ethical Requirements for Research with Human Participants as well as the Fundamentals Considerations necessary in Research with Human Participants recommended by the Bioethics Society of the English Speaking Caribbean

The Ethical Requirements for research with human participants

For a research programme involving human participants to be considered “ethical”, it must meet all the following seven (7) requirements for research with human participants:
l. Value. The research project must be scientifically or socially valuable (e. g. improved health-related infrastructure, capacity-building). It could also lead to an increase in the body of knowledge available to policy makers, program managers, health practitioners, or the general public.
2. Scientific validity. The research must be conducted in a rigorous and valid scientific manner.
3. Fair selection of research participants.
The participants in the research should be chosen only because of their relation to the subject being researched, and not because they are easily accessible.
4. A favourable risk benefit ratio. A person’s participation in research should be accompanied by a favourable balance of potential benefits and potential harm.
5. Respect for persons. This requires that a person’s choice be respected, and that persons incapable of making their own choices be protected. It also includes respect for a person’s right to withdraw from the research process, and confidentiality of personal information.
6. Informed consent. All the requirements for “informed consent” should be met.
7. Independent review of the research.
All research should be subjected to review by a group of persons independent of the researchers, before the start of any research.
An eighth (8th) requirement exists when the research involves international collaboration:
8. Collaborative partnership. Overseas and local collaborators share the responsibility for determining the health problem and value of the research to the local community, for respecting the community’s values and traditions, and ensuring that the enrolled participants and the community receive fair benefits from the conduct of the research.

Fundamental considerations necessary in research with human participants

A. The scientific design of the research.
A clear scientific objective should be stated, the methodology should be valid and practically feasible, sufficient sample size (for adequate statistical power and representativeness) should exist to achieve the objective, a plausible plan for data analysis should exist, and the research process should be implementable.
B. The care of participants.
The welfare of participants should be carefully monitored throughout the period of their involvement in the research, and they should be provided appropriate treatment for any untoward event or severe adverse reactions resulting from the research.
C. The ethical and scientific standards and practices of the communities within which the proposed research will take place.
Researchers should be fully aware of the foregoing.
D. The contribution that the research can make to health.
While respecting the role of serendipity in research discoveries, the proposed research should be responsive to the health needs of the community within which it will occur, and should reflect the priorities of that community. Further, the principle of justice requires that any product developed as a result of the research in a particular community, should be made reasonably available to the inhabitants of that community. In international research and/or research for financial gain, host communities should also ensure that they realize improvements in health-related infrastructure, proportional financial investments in the community’s health, and/or capacity-building benefits from the research endeavour.
E. Avoidance of unethical conduct.
Researchers should avoid all forms of unethical conduct in the proposing, performing, and reporting of the research.
F. Reporting of conflicts of interest.
All potential conflicts of interest (e. g. personal, financial, and career) should be reported on the submission of the research protocol.
G. Vulnerable populations.
Special safeguards are necessary where research is proposed to involve vulnerable persons, including: children, prisoners, pregnant women, the foetus, persons living with HIV/AIDS, the mentally impaired, substance abusers, the elderly and terminally ill patients.
H. On-going monitoring of research.
For proposed research involving more-than-minimal risk independent and on-going monitoring of the research project should be done by the research ethics committee. The principal investigator/researcher also has the obligation to provide monitoring information to the committee, particularly of any adverse events on a predetermined basis.

Decision-Making Procedures


Decisions taken by the REC should emerge from thorough and inclusive discussion and deliberation with fair exchange of opinion and ideas.

  • The Chairperson will clearly outline the rules of engagement for discussions and deliberations.
  • A respectful and inclusive tone should be used at all times.
  • At the start and each meeting, committee members shall declare conflicts of interest and give permission to be recorded.
  • The Chairperson would be responsible for the decision-making process. Decision would be taken by either vote or consensus.
  • Researchers and funding agencies should not be present during the decision making process.
  • A member should withdraw from the meeting during which a decision is to be taken where a conflict of interest arises.
  • Decisions should be made only in meetings where a quorum is present.
  • External expertise should be sought when members lack knowledge on a particular research area. Expert consultants should not participate in decision-making.
  • Conditional decisions may be made in circumstances where the applicant can be given clear suggestions for revisions and the procedure specified for having the application reviewed again subsequently.
  • Research protocols involving no more than minimal risk can be given expedited/ delegated review i.e. reviewed by one or more members and not the full committee. The final decision shall rest with the Chair.

  • A. Submission Procedures:

    DOCUMENTS
    1. Checklist - For Documents required for Protocol Submission

    2. The Application Form

    i. Submission requirements shall be easily accessed through the above link

    Application Process :

    a) Applications should be submitted on the prescribed application form electronically (scanned and emailed when signatures are required) to the Chairperson of CARPHA's Research Ethics Committee. Chair: carpha.rec.chair@gmail.com
    b) All relevant core documents (see Section B below for a list of the documents for review) should be submitted along with the application form for review.
    c) The application form and all core documents should be submitted in English.
    d) Applicants shall submit research proposals for REC review prior to the start of recruitment of participants, formal data collection, access to data or human specimen collection.
    e) Applicants must seek REC approval for conducting pilot studies.
    f) The committee will meet to review applications monthly; the deadline for submission for review shall be the 15th of each month.
    g) Applicants will be sent an email acknowledging receipt of the application package.
    h) Applicants will be notified by the administrative officer when incomplete packages have been submitted.
    i) Applicants will be informed of the Committee’s decision within two weeks of the meeting where the decision was made.
    j) Supplementary information or changes to the core documents should be submitted to the REC within two weeks of the date when the request for review was made. Applicants requiring additional time must formally write to the Chairperson outlining justifications for the required extension.
    k) Applicants seeking to make changes to an approved research protocol must submit proposed changes to the REC for approval.

    B. Documents required for review:


    i. Signed and dated application form.
    ii. The protocol for the proposed research project (clearly identified and dated) together with supporting documents and appendices as outlined in the Guidelines for the Content of Research Protocols recommended by Bioethics Society of the English Speaking Caribbean
    Available from:
    iii. When the research involves an experimental product (such as a pharmaceutical or medical device under investigation), an adequate summary of all safety, pharmacological, pharmaceutical, and toxicological data available on the study product, together with a summary of clinical experience with the study product to date (e.g. recent investigator’s brochure, published data, a summary of the product’s characteristics) must be submitted.
    iv. Any regulatory clearance.
    v. Statements of conflicts of interest.
    vi. Plans for publication and knowledge sharing.
    vii. Current curricula vitae of the principal investigators.
    viii. A description of arrangements for insurance coverage for research participants, if applicable.
    ix. Disclosure of all previous decisions (including those leading to a negative decision or modified proposal) by other RECs or regulatory authorities for the proposed study, whether in the same location or elsewhere, and indication of the reasons for previous negative decisions and modification(s) to the proposal made on that account.
    x. Any other information relevant to the study e.g. consent forms, data capture instruments, advertisement, participant information sheets, adverse event sheets etc.

    C. Review procedures:
    i. Applications and protocols shall be disseminated to REC members two weeks before meeting date when the review is to take place.
    ii. The Chairperson will determine the level of review that should be given to research protocols. The level of REC review shall be determined by the level of foreseeable risks to participants.

    Two level of research ethics review apply:

    a) Full Ethical Review – Ethics review by the full REC. This shall be the default requirement for research involving human participants.
    b) Expedited/Delegated Review - The Chairperson will determine when a research protocol involves no more than minimal risk and can be given expedited/ delegated review i.e. reviewed by one or two members and not the full committee.
    iii. After deliberations and discussions, a decision will be taken either by vote or by consensus - to be determined by the Chairperson.
    iv. The Chairperson will routinely notify all members of any expedited reviews that have been conducted between meetings.

    SECTION V: COMMUNICATING A DECISION


    A. The administrative officer shall be responsible for contacting the Primary Investigator/Study Coordinator to communicate in writing the decision taken by the REC. This shall include reasons and appropriately documented opinions and decisions.
    B. Applicants shall be informed of the REC’s decision within two weeks of the meeting when the decision was taken.
    C. When a decision is taken to revise and submit, the reviewers’ comments will be included in the feedback.

GLOSSARY

  • Ethics

  • Moral principles that govern a person’s behaviour or the conducting of an activity (Oxford Dictionary). Ethics is concerned with moral principles, values and standards of conduct (World Health Organization)

  • Bioethics:
  • A field of ethical enquiry that examines ethical issues and dilemmas arising from health, health care, and research involving humans (World Health Organization).

    Health Research

    The development of knowledge with the aim of understanding health challenges and mounting an improved response to them (World Health Organization).

  • Research Ethics Committee
  • Group of individuals who undertake the ethical review of research protocols involving humans, applying agreed ethical principles; also known as ethical review board [ERB], ethical review committee [ERC], human research ethics committee; [HREC], institutional review board [IRB] (World Health Organization).

REFERENCES


Bioethics Society of the Eastern Caribbean (BSEC): Templates for Establishing Research Ethics Committees in the Caribbean [Internet] [cited July 2013]. Available from:

Brown S. Standard Operating Procedures. South Metropolitan Health Service [Internet]: 2010 [cited July 2013] Available from:

College of Health Sciences. Standard Operating Procedures for Institutional Research & Ethics Committee. Eldoret, Kenya, [cited July 2013] Available from:

Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada. Tri Council Policy Statement (TCPS2): Ethical Conduct of Research Involving Humans, December 2010

Pan American Health Organization (PAHO). Ethics Review Committee Standard Operating Procedures for submitting Research Proposals. [Internet]. Washington, USA: 2009 [cited September 2013] Available from:


World Health Organization (WHO). Standards and Operational Guidelines for Ethics Review of Health-Related Research with Human Participants. [Internet]. Geneva, Switzerland: 2012 [cited September 2013] Available from:

The World Medical Association (WMA) Declaration of Helsinki – Ethical Principles for Medical Research involving Human Subjects – Oct. 2013
Available from:

The Belmont Report – 1979
Available from:

The Council of International Organization of Medical Sciences (CIOMS) – 2002 Available from: