Ethics Unlocked: Navigating the Maze of Research Clearance

Research plays a crucial part in advancing human knowledge and resolving intricate challenges. Nevertheless, it is imperative to acknowledge that research necessitates the utmost commitment to integrity and strict adherence to ethical norms. Research ethics is a discipline that prescribes the ethical principles and regulations that researchers are obligated to adhere to in order to safeguard the welfare of participants, uphold the integrity of scientific inquiry, and protect the rights of all parties involved.

A. Research Ethics

The establishment of research ethics serves as the foundation for ethical scientific investigations. By upholding moral values, researchers protect human participants, animal subjects, and the wider environment. The practice of conducting research ethically is to establish the reliability, credibility, and replicability of the findings. This, in turn, plays a significant role in advancing knowledge and promoting societal improvement. Below are the key principles to be considered in research ethics.

1. Informed Consent

   1. Obtaining informed consent is paramount in research involving human subjects.

   2. Researchers must provide clear and comprehensive information about the study's purpose, procedures, potential risks, and benefits to participants.

   3. Voluntary and informed consent allows individuals to make autonomous decisions about research participation.

2. Beneficence and Non-Maleficence

   1. Researchers must prioritise the well-being of their participants.

   2. This means maximising potential benefits and minimising risks.

   3. Avoiding harm is just as crucial as promoting good.

3. Privacy and Confidentiality

   1. Protecting the privacy of participants is vital.

   2. Researchers must ensure that the data collected is kept confidential and used only for the study.

   3. Anonymity should be maintained whenever possible to safeguard participants' identities.

4. Integrity in Data Collection and Reporting

   1. Researchers must maintain the highest level of honesty and accuracy when collecting, analysing, and reporting data.

   2. Falsification, fabrication, or selective reporting of results are unethical and undermine the scientific process.

5. Respect for Participants' Autonomy

   1. Researchers must acknowledge and respect the autonomy of their participants.

   2. They should treat them with dignity, honour their choices, and accommodate any special needs or considerations.

6. Minimising Conflict of Interest

   1. Researchers should disclose any potential conflicts of interest that might compromise the integrity of the research or its findings.

   2. Transparency is essential in maintaining trust with the scientific community and the public.

B. Research Ethics Omission

Research ethics plays a crucial role in providing researchers with a moral framework to navigate the intricate terrain of scientific investigation. By establishing a collective commitment to prioritise participants' well-being, uphold their autonomy, and preserve a culture of honesty across all research undertakings, we may actively contribute to cultivating an ethical, dependable, and influential research community that facilitates progress and nurtures confidence in the scientific enterprise.

Adherence to ethical norms is not merely a duty but a moral obligation that plays a crucial role in safeguarding the integrity and credibility of research findings. Failure to adhere to research ethics can seriously affect researchers and study participants. There are several potential consequences of omitting research ethics.

1. Potential Harm to Participants

   1. In the absence of adequate ethical considerations, participants may be exposed to physical or psychological harm, infringements on their privacy, or instances of exploitation.

   2. It is incumbent on researchers to prioritise the welfare and security of their subjects.

2. Invalid Research Findings

   1. Ethical misconduct can potentially undermine the integrity and validity of research findings.

   2. Unethical practices can introduce bias, compromise data reliability, and produce skewed outcomes.

3. Loss of Trust and Credibility

   1. Instances of ethical transgressions can undermine the standing of researchers and their affiliated institutions.

   2. The consequences may include a decline in public trust, diminished credibility within the academic community, and potential disapproval from funding agencies.

4. Legal and Regulatory Implications

   1. In certain instances, failing to adhere to research ethics can have legal ramifications.

   2. Breaches of ethical guidelines can lead to legal consequences, including litigation, monetary penalties, or other legal measures, against both the researchers involved and the institutions they are affiliated with.

5. Research Rejection and Retraction

   1. In scholarly publishing, journals and academic publishers customarily require substantiating documentation attesting to the ethical approval obtained for research publications.

   2. Failure to obtain ethics approval or to fraudulently assert ethics approval can result in the rejection of research for publication and the retraction of previously published work.

6. Academic and Professional Sanctions

   1. Researchers who are found to have engaged in ethical misconduct may be subject to disciplinary measures by their academic institutions or professional associations.

   2. Potential consequences for violating research protocols may include disciplinary actions such as withdrawal of research privileges, temporary suspension, or termination of employment.

7. Institutional Repercussions

   1. Institutions might be held liable for the research activities carried out by their members.

   2. The absence of enforcement or oversight of ethical standards can result in reputational harm and the erosion of credibility.

8. Barred from Future Research

   1. Researchers who have been found guilty of ethical violations may face consequences, such as being barred from conducting future research.

   2. It involves human participants or limits their research activities in other ways.

9. Impact on Research Funding

   1. The allocation of research funding is significantly influenced by funding agencies' requirements to obtain evidence of ethical approval before disbursing awards.

   2. Failure to adhere to research ethics guidelines may lead to the rejection of funding applications or the termination of ongoing grants.

10. Stifling Scientific Progress

    1. Unethical research methodologies can hinder the replication of findings and foster scepticism within the scientific community.

    2. This phenomenon poses a significant obstacle to the advancement of scientific knowledge and the fostering of collaborative efforts.

C. Research Ethics Committee (REC)

Research Ethics Committees (REC) or Institutional Review Boards (IRB) are paramount in upholding ethical principles in research. This entity evaluates research proposals to determine their adherence to ethical norms and regulatory requirements. Before granting research clearance, the evaluators assess the study's potential risks and benefits, review the consent process, and ensure the protection of participants' rights.

Based on the Guidelines of the Research Ethics Committee (REC) and Researchers (Revision 2022 Ver. 2) published by the Research Management Centre (RMC), Universiti Teknologi MARA (UiTM), Shah Alam, Malaysia, REC was created to evaluate, grant approval, or declining ethical applications for any research that involves human subjects, whether conducted within UiTM or by researchers or students affiliated with UiTM. Both researchers and institutions play a significant role in the field of research. The primary duties of the REC encompass:

1. Reviewing applications for ethics approval for research involving human participants;

2. Determining the classification of risk into:

   1. Minimal Risk

      1. The predicted chance and amount of injury or discomfort in the research do not exceed those typically encountered daily or during routine physical or psychological evaluations.

   2. More than Minimal Risk

      1. Research activities that include risks beyond the minimum threshold for human involvement.

   3. Exempted Category

      1. Justifications for exemption from ethics review include but are not limited to the following:

         1. Research does not involve human participants, human tissues and biological samples;

         2. Research does not collect sensitive and identifiable secondary data of an individual;

         3. Research involves content analysis, textual analysis, or meta-analysis;

            1. non-identifiable data lawfully collected

            2. public or private records

            3. published or unpublished reports

            4. documents available in libraries, repositories, archives, and websites

            5. case study, doctrinal study, or policy study

            6. conceptual paper, which synthesises knowledge from the previous study on a particular topic and presents it in a new context with the aim of filling knowledge gaps

            7. market surveys, opinion polls or online votes, and consumer acceptability tests

            8. studies based on video recordings obtained from public domains

            9. filming of documentaries or documentation of cultural or traditional practices that have obtained prior approval from the relevant parties or authorities

            10. activities for quality assurance purposes related to the evaluation of public service programs, public health surveillance, and educational evaluation

3. Approving or rejecting the ethics research application;

4. Imposing restrictions and conditions on research, if necessary;

5. Reviewing submitted progress reports; and

6. Suspending or revoking approval of research.

a. REC Meeting

REC is committed to adhering to rigorous ethical principles to safeguard the dignity, rights, and well-being of research study participants. Each college, faculty, branch, and research excellence entity has its own Research Committee responsible for ensuring the university's research agenda is achieved. Part of the Research Committee's duties is to provide scientific review and verify applications for ethics approval before submission to the REC. REC meetings are conducted as follows:

1. The meetings are scheduled at least once a month.

2. Meeting dates are announced at the beginning of the year.

3. The agenda and documents to be discussed at the REC meeting are circulated electronically to REC members/reviewers at least one week before each scheduled meeting.

4. The Secretary takes minutes in all REC meetings.

5. The minimum required quorum is five members.

6. At least one member whose primary interest is in a non-scientific area.

7. At least one member who is independent of the institutional/trial site.

8. Applications in the More than Minimal Risk category require the researchers or students to present their work orally in the presence of the research supervisor.

9. Members of REC will review applications in the Minimal Risk category without any oral presentation.

b. Research Ethics Approval

1. The reviewers will consider the following matters for approval:

   1. scientific design and conduct of the study

   2. recruitment of research participants

   3. care and protection of research participants

   4. protection of research participants’ confidentiality

   5. informed consent process

   6. community considerations

   7. public policy considerations

2. A decision should be communicated in writing or by email to the applicant, preferably within two weeks from the decision's date.

3. Four categories of decisions are made on ethics approval applications:

   1. Approved

   2. Conditional Approval

   3. Re-present

   4. Rejected

4. Applicants whose applications are subject to conditional approval must submit the duly amended documents within 90 days of the REC's letter informing them of the condition.

   1. If the amended documents are not submitted within the prescribed period, a fresh application must be made unless the Chairman instructs otherwise.

   2. The amended documents will be tabled at the meeting for discussion by REC members before a decision is made.

5. Applicants aggrieved by the REC's decision have the right to appeal for reconsideration.

   1. Appeals must be submitted in writing within two weeks of decision notification and include all supporting documents.

   2. The REC will deliberate on the appeal at the next scheduled meeting.

   3. The REC reserves the right to invite the applicant to appear before the Committee during the appeal.

   4. The appeal will be settled promptly, and the REC's decision is final.

D. Research Ethics Clearance Solutions

The process of seeking research ethics clearance, also referred to as obtaining ethical approval or IRB approval, is an essential step in conducting research involving human subjects. The precise procedure may vary depending on the institution and the research's characteristics. The fundamental steps involved for a researcher in seeking research ethics clearance can be outlined as follows:

1. Review ethical guidelines.

   1. It is imperative to acquaint oneself with the ethical rules and laws governing research involving human subjects in a specific jurisdiction or geographical area.

   2. This may encompass global guidelines such as the Declaration of Helsinki, as well as national guidelines tailored to the specific context of one's country.

2. Prepare research protocol.

   1. Formulate an elaborate research protocol that delineates the research objectives, research questions, methodology, data collection procedures, participant recruitment, informed consent procedures, safeguarding of privacy, identification of potential harms and benefits, and strategies to uphold the confidentiality and anonymity of the individuals involved.

   2. The protocol should comprehensively integrate ethical considerations across the whole research procedure.

3. Complete ethical review forms.

1. Researchers must complete comprehensive ethical review forms when applying for ethics clearance, in accordance with the protocols established by most institutions.

2. Typically, these forms request details about the study, including the associated risks and rewards and the procedures implemented to protect participants. Please ensure that the provided forms are completed accurately and completely.

4. Design an informed consent form.

1. Develop an informed consent document that explains the research study to prospective participants, including the purpose, objectives, procedures, risks, benefits, confidentiality measures, and participants' right to withdraw at any time without penalty.

2. It is imperative to secure written consent from participants before their inclusion in the study.

5. Submit the application.

1. You must submit the research protocol and all requisite documentation, such as duly completed ethical review forms and informed consent documents, to your academic institution's relevant REC or IRB.

2. It is advisable to adhere to the submission rules set by the relevant institution or organisation, which may include submitting both hard copies and digital versions.

6. Review process.

1. The ethics review board evaluates your application to ascertain how your study aligns with ethical norms.

2. Individuals may need revisions or clarifications, so it is important to be prepared to respond effectively to any feedback they may provide.

7. Getting approval and commencing.

1. Upon obtaining approval for your research, you may proceed to commence your study.

2. It is imperative to consistently adhere to the authorised research protocol throughout the study and promptly notify the REC of any deviations or unanticipated ethical concerns that may arise.

8. Renew and report.

1. It is common for ethical clearance to have a designated duration.

2. If one's study extends beyond the initially permitted duration, applying for a renewal may become necessary.

3. You may need to periodically submit progress reports to the ethics review board throughout your study.

E. Ethics Approval Application Solutions

Source: https://www.recuitm.org/have-you-applied

It is imperative to approach the ethical clearance process with due diligence and prioritise the conscientious design and execution of research, considering the participants' well-being and rights. The absence of appropriate ethical approval might result in significant ramifications, potentially culminating in the dismissal of one's study or the imposition of disciplinary measures.

A researcher at UiTM conducting research involving humans must obtain ethics approval before commencing the research project, as depicted in the following diagram. The Research Ethics Depository (RED) website contains an online system for UiTM research ethics applications. Please read the manual first before using the RED system.

Given the potential ramifications outlined, researchers must adhere to ethical principles and obtain appropriate ethical approval before undertaking research with human subjects. Ethics clearance plays a crucial role in safeguarding research integrity, promoting a respectful approach towards participants, and ensuring adherence to ethical standards. Consequently, it contributes to the production of important and reliable scientific contributions.

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