Mary Johnston Hospital

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Mary Johnston Hospital 

Healing Together

Ethics Review Committee

Our dedication lies in upholding ethical standards in institutional research as we strive to heal together.

Ethics Review Committee (ERC) is the body that will implement the institutional policy of overseeing the ethical soundness of the institutional research produced by researchers and MJH residents. All institutional research proposals must undergo ethics review and shall gain certification clearance from the MJH ERC.

Research ethics involves the application of moral principles to research activities. It ensures that research is conducted responsibly and with integrity, respecting the rights and well-being of participants, researchers, and society.

Core Principles:

  • Integrity: Honesty and transparency in all aspects of research.
  • Respect for Persons: Protecting the autonomy and dignity of research participants.
  • Beneficence: Maximizing benefits and minimizing harm to participants and society.
  • Justice: Ensuring fair distribution of research benefits and burdens.

Key Issues in Research Ethics:

  • Informed Consent:
    Ensuring participants understand the purpose, risks, and benefits of the research.
    – Obtaining voluntary agreement from participants to take part in the study.
  • Privacy and Confidentiality:
    – Protecting participants’ personal information from unauthorized access or disclosure.

    – Maintaining anonymity when possible.

Updates

FAQs

Research ethics involves the application of moral principles to research activities. It ensures that research is conducted responsibly and with integrity, respecting the rights and well-being of participants, researchers, and society.

Definition:

  • Research ethics provides guidelines for responsible and moral conduct in research.
  • It encompasses principles and standards that guide researchers in their interactions with participants, data, and the broader community.

Core Principles:

  • Integrity: Honesty and transparency in all aspects of research.
  • Respect for Persons: Protecting the autonomy and dignity of research participants.
  • Beneficence: Maximizing benefits and minimizing harm to participants and society.
  • Justice: Ensuring fair distribution of research benefits and burdens.

Key Issues in Research Ethics:

  • Informed Consent:
    Ensuring participants understand the purpose, risks, and benefits of the research.
    – Obtaining voluntary agreement from participants to take part in the study.
  • Privacy and Confidentiality:
    – Protecting participants’ personal information from unauthorized access or disclosure.

    – Maintaining anonymity when possible.

Data Integrity:

  • Ensuring accuracy and reliability of data collection, analysis, and reporting.
  • Avoiding fabrication, falsification, and plagiarism.

Conflict of Interest:

  • Disclosing any financial, personal, or professional interests that could bias the research.
  • Managing conflicts to ensure objectivity.

Global Perspective:

  • Research ethics standards can vary across countries and cultures, reflecting different values and norms.
  • International guidelines, such as the Declaration of Helsinki, provide a framework for ethical conduct in research involving human subjects.

Local Perspective (Philippines, Metro Manila):

  • In the Philippines, research ethics is governed by national laws, regulations, and institutional review boards (IRBs).
  • The Philippine Health Research Ethics Board (PHREB) sets standards for health research ethics review.
  • Local IRBs review research proposals to ensure compliance with ethical standards and protection of participants’ rights.

Examples of Ethical Violations:

  • Tuskegee Syphilis Study: Withholding treatment from African American men with syphilis without their informed consent.
  • Milgram Experiment: Subjects were deceived into thinking they were administering electric shocks to other participants.

Importance of Research Ethics:

  • Promotes trust between researchers and the public.
  • Ensures the safety and well-being of research participants.
  • Enhances the credibility and validity of research findings.
  • Upholds the integrity of the research profession.

Related Concepts:

  • Institutional Review Board (IRB): A committee that reviews research proposals to ensure ethical standards are met.
  • Code of Conduct: A set of guidelines outlining ethical principles and responsibilities for researchers.
  • Informed Consent Form: A document that provides participants with information about the research and obtains their consent to participate.

Values:

  • Honesty: Being truthful and transparent in all aspects of research.
  • Objectivity: Minimizing bias and striving for impartiality.
  • Openness Sharing data, methods, and results with the scientific community.
  • Accountability:Taking responsibility for one’s actions and decisions in research.

Research ethics review is a process designed to evaluate research proposals involving human participants or animals to ensure they adhere to ethical standards and guidelines. It protects research participants, researchers, and the organization by ensuring research is conducted ethically and appropriately.

Detailed overview:

Purpose:

– To ensure research studies are conducted ethically and responsibly.
– To protect the rights, safety, and well-being of research participants.
– To enhance the credibility and validity of research findings.

Key Aspects Evaluated:

Social and Academic Significance: Assessing the importance and relevance of the proposed research.
Risk Minimization: Ensuring that potential physical or mental harm to participants is minimized.
Informed Consent: Verifying that participants are fully informed about the research content, risks, and benefits, and that their consent is voluntary.
Data Management: Confirming that research data and personal information are appropriately managed and protected.
Conflict of Interest: Identifying and addressing any potential conflicts of interest that may affect the fairness of the research.

Steps in the Review Process:

1. Application: Researchers submit a detailed research proposal to the Ethics Review Committee
2. Administrative Screening: The ERC reviews the submission for completeness and identifies any missing information.
3. Risk Assessment: The chair assesses the risk level of the research and assigns it to a full board meeting or delegated review.
4. Review: Board reviewers conduct an ethical review and provide feedback.
5. Revisions: Researchers respond to the ERC review and submit a revised proposal, if necessary.
6. Approval: Once the ERC is satisfied, ethical approval is granted, typically for up to 12 months.

Type of Review:

  • Full Committee Review: Required for proposals that present more than minimal risk to human subjects.
  • Expedited Review: Used when research procedures present no more than minimal risk to participants.
  • Exemption from Review: Granted when there is no possibility of harm arising from the research or when the information is publicly available.
  • Continuing Review: Periodic reviews to monitor the progress of the study and renew approval.

Outcomes of the Review:

  • Approved as Submitted: The proposal is approved without modifications.
  • Approved Conditionally: Approval is contingent upon satisfactory amendments or clarifications.
  • Not Approved: The proposal requires additional information or rewriting and must be resubmitted.
  • Rejected: The proposal is ethically unacceptable and cannot be approved

Ongoing Responsibilities:

  • Researchers must report any changes to the research project to the ERC for approval.
  • Continuing review and approval are required, with annual and final reports submitted to the ERC.
  • Adverse events or incidents must be reported to the ERC in writing.

Having your research reviewed is essential for several reasons, primarily to ensure ethical conduct, protect participants, and maintain research integrity.

Ethical Conduct:

    • Protection of Participants: Research ethics review ensures the safety, rights, and well-being of human participants.
    • Adherence to Standards: It guarantees that your research adheres to established ethical principles and guidelines.

Credibility and Validity:

      • Enhanced Trust: Ethical review enhances the credibility of your research findings, promoting trust among the public and scientific community.
      • Scientific Rigor: It helps maintain the integrity and validity of your research methods and data.

Legal and Institutional Requirements:

  • Compliance: Many institutions and funding agencies require ethical review as a condition for conducting research.
  • Legal Protection: Ethical approval can provide legal protection for researchers and institutions in case of disputes or complaints.

Risk Management:

  • Identification of Risks: Review boards can identify potential risks to participants that researchers may have overlooked.
  • Minimization of Harm: It helps in developing strategies to minimize potential harm or discomfort to participants.

Community Trust and Acceptance:

    • Public Confidence: Ethical review fosters public confidence in research by demonstrating a commitment to responsible conduct.
    • Community Support: It can increase community support for research by ensuring that it is conducted in a fair and respectful manner.

Professional Responsibility:

  • Accountability: Researchers are held accountable for their actions and decisions through the review process.
  • Ethical Awareness: It promotes ethical awareness and encourages researchers to reflect on the ethical implications of their work.

Funding and Publication:

  • Grant Approval: Many funding agencies require ethical approval before awarding grants for research projects.
  • Journal Acceptance: Most reputable journals require evidence of ethical review before considering research for publication.

Global Perspective:

  • International Standards: Ethical review ensures compliance with international standards for research involving human subjects.
  • Cross-Cultural Sensitivity: It promotes culturally sensitive research practices, particularly in diverse populations.

Local Perspective (Philippines, Metro Manila):

  • Philippine Health Research Ethics Board (PHREB): In the Philippines, research ethics is governed by national laws, regulations, and institutional review boards (IRBs).
  • Local IRBs: Local IRBs review research proposals to ensure compliance with ethical standards and protection of participants’ rights.

Examples of Consequences for Not Having Research Reviewed:

  • Rejection of Publication: High-impact journals may reject research that has not undergone ethical review.
  • Loss of Funding: Funding agencies may withdraw financial support for research conducted without proper ethical approval.
  • Legal Ramifications: Researchers may face legal action if their research violates ethical standards or harms participants.

Values Reinforced by Ethical Review:

    • Justice: Ensuring fair distribution of research benefits and burdens.
      • Respect: Treating participants with respect and dignity.
      • Integrity: Conducting research with honesty and transparency.
      • Beneficence: Maximizing benefits and minimizing harm to participants and society.

There are four types of reviews

(1) Exempted from Review,
(2) Expedited Review, 
(3) Full Board Review, and 
(4) Continuing Review.

The table below presents the different types of reviews and describes the proposals that would qualify for each type.

Type of Review Description

Exempted

Proposals are usually exempted from review when they:

(1) do not pose more than minimal risk to study participants,

(2) are categorized under institutional quality assurance, evaluation
of public service programs, public health surveillance, educational
evaluation activities, and consumer acceptability tests, and 

 

Informed consent is a process that provides individuals the opportunity to willingly participate in research. It is not just a form appended to a research proposal. It’s a fully articulated process that details how informed consent will be obtained, when informed consent will be obtained, and who will be facilitating the process. In general, the following requirements are recommended when obtaining informed consent:

1. Consent must be obtained by the investigator or a designated individual.
2. Consent must be obtained before any research-related procedures are performed on the participant.
3. Consent must be given voluntarily. The participant or their legal representative must not be forced to participate or, if they wish to withdraw, to continue to participate.
4. Consent is documented by having the participant or their legal representative sign the informed consent form (with date). The signature indicates that informed consent documents have been adequately discussed and the participant or their legal representative is freely giving their informed consent.

It’s important to note that the informed consent process is not a singular event. Researchers must ensure that participants are adequately informed and continue to provide their consent throughout their participation. Therefore, informed consent is an ongoing process. In some cases, research ethics committees may recommend including an expiry date for informed consent and will require researchers to renew consent with their participants.

Informed consent forms (ICF) are often used to facilitate the informed consent process.

Research ethics committees assess the ICF together with the informed consent procedures described in the methodology/procedures section of the research protocol.

For ICFs, at the minimum, research ethics committees check for the following components:

● Research Statement
● Description of participants’ involvement
● Statement of risks
● Statement of benefits
● Description of confidentiality procedures
● Information regarding compensation
● Statement of voluntary participation and right to withdrawal
● Information regarding contact persons

Apart from these components, committees also check the language used in the ICF. Information should be presented in non-technical language and in a manner that is easily understood by their prospective participants.

Having an ICF with all of these components is not enough. Researchers need to ensure voluntary consent of participants by describing the informed consent process in their protocol.

Contact us

Mary Johnston Hospital
Ethics Review Committee

(02) 5318 - 6600 loc 415

mjhospitalerc@gmail.com

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