J.5 — Human and Animal Research Ethics

Document Control Information

Policy Code: J.5
Standard: J. Research and Scholarly Activities
Status: published
Version: 2
Process Owner: Research & Post Graduate Education
Prepared By: Research & Post Graduate Education
Reviewed By: QAIE
BOT Approval: approved
First Issue Date: 23 Sept 2023
Last Review Date: 24 Jun 2024
Relevant To: DMU Stakeholders
Used With: —

Modification History

Version	Date	Update Information	Author/ Reviewer
V 1.0	September 2023	Policy First Implemented	Director, Research & Post Graduate Studies Dept/ Research & Ethics Committee
V1.1	June 2024	Included VC- Research & Post Graduate Education Dept/ Research & Ethics Committee	QA & IE Dept

Purpose and Scope

Purpose:
The University is concerned about protecting the human rights, dignity, health, safety and privacy of research subjects, the welfare of animals and the integrity of the environment.

Scope:
All research conducted by faculty and students of DMU, where the research involves and/or uses,

Human subjects
Human data or human material
Clinical Trials of Investigational Medicinal Products (CTIMPs)
Vulnerable persons, such as children or adults
Any health-related research project that involves humans, their tissue and /or data,
Research that does not involve human participants but has ethical considerations.
Research work on animal subject

The scope could also be extended to any other area of concern in the best interest of the University that the Research Ethics Committee decides.

Abbreviations and Definitions

Human Subject: A living individual about whom a researcher/ investigator (whether faculty or student) conducts research obtains data through intervention, interaction with the individual, or identifiable confidential information.

Intervention: Includes physical procedures by which data are gathered and manipulations of the subject's environment performed for research purposes.

Interaction: Includes communication or interpersonal contact between the researcher and human subject.

Confidential information: Information about behavior that occurs in a context in which an individual can expect that no observation or recording is taking place and information provided for specific purposes by an individual and which the individual can expect will not be made public.

Policy Statement

POlicy Statement:
The Research Ethics Committee (REC)
The committee shall be headed by the Chairperson and members from various fields of subspecialties from the faculty members of the University. The Committee will also have lay people from the society and might consult a legal advisor when needed. Conflict of interest should be avoided while selecting REC members.

Any institution officers/ administrators should not serve as members of Ethical committee. An administrator of the institution or one who owns the institution, should not serve as member of Research and Ethics Committee.
Members from different departments and sectors should be included in the Ethical committee to minimize conflict of interest.

If a member is an investigator or if he/she thinks he has a conflict of interest, he/she should declare conflict of interest and is prohibited from voting on any matter in which there is conflict. This is applicable for ethical issues and grant approving decisions.

Committee Meetings
The Research Ethics Committee meetings will be held at least four times a year, two during each academic semester.
Quorum requirements and attendance

The quorum for meetings of the Committee is sixty per cent of the total number of members, including the following:

The Chair or the Deputy Person.
At least two expert members, with relevant clinical and/or medical expertise.

A member who is unable to attend a meeting may submit comments in writing on any agenda item, ahead of the time of the meeting by at least 48 hours (about 2 days).
Where a quorum is not fulfilled, the Committee must not commence, continue, or conclude any discussion with the purpose of determining the Committee's opinion on an application for ethical review.

Task force
A task force might be formed to consider the following:

Further investigation or clarification of an application.
Consideration of substantial amendments.
Monitoring of ongoing research studies or review of progress reports.
Any other business that requires urgent action as decided by the Committee.
The task force shall consist of no less than two people approved by most of the Committee members in attendance.

Attendance of other members:
The Principal Investigator, or another key investigator, can be invited to attend the meeting at which his/her application is to be reviewed to respond directly to queries from the Committee for further information or clarification of critical points for decision making.

It is not compulsory for the Principal Investigator to attend the meeting planned to discuss his research application; however, it might be an advantage for the researcher to attend or allocate a representative.

Policy Statement — Continued

Procedure for Policy
5.1. Research Involving Human Subject
Conducting research at DMU entails interviewing people involved in the research program: students, experts, physicians, pharmacists, patients, bystanders, etc. To the academic community, such interviews are referred to as "human subjects," as these individuals are human beings and subjects within one's research project. Because the University system must permit all research conducted on its premises or outside, students must fill out required protocols, explanation forms, and draft permission slips.

1. Procedure for getting started with Human Subjects Research

In all cases verbal or written consent should be obtained from the human subject according to the level of research to be conducted.
In dealing with children, written consent should be obtained from the child's parent or guardian.
A statement that the study involves research and an explanation of purpose.
The expected time duration of the subject's participation
Explain the purpose and design of the project. Where will the project be conducted? How will the data be recorded?

2. Risks
Most of the risks will not apply if you are not interviewing pregnant women, children, or disabled individuals. Things to be addressed:

Psychological damage
Invasion of privacy

3. Safeguards
The benefits/ safeguards must outweigh the risks when selecting a research topic.
Things to address:

Minimizing the invasion of privacy
Procedures of destroying data upon the subject's request
Data storage

4. Ethical data collection, storing and ensuring data integrity

All research that directly involves research subjects must ensure receiving informed consent.
All data collection procedures must be transparent.
The data collected should be minimal to answer the stated purposes.
Deidentify personal details of all data collected to protect privacy and anonymity.
All data must be stored in a password-protected drive that is only accessible to the researchers and the data should not be altered or edited.
All the relevant data will be stored for five years after completion of the study and then deleted from all devices.
The data should not be shared with third parties.
Participants who request to withdraw from the study can withdraw their data at any point.
Continuous audit of data collected will take place to ensure privacy and security.

5.2. Research Involving Animal Subjects
The fundamental principle for animal use in research and education is the three R's (Replacement, Reduction, and Refinement)

Research involving Animal Subjects

Whenever possible, alternatives to animal use should be applied for research and education, and if animal use is unavoidable, a minimal number of animals should be used, with a "proper" attitude towards them. A proper attitude means that the animal has an intrinsic value and should be respected.

The Research Ethics Committee should ensure that this "respect" of experimental animals covers the following points:

(The following points are adapted from the guidelines of the Institutional Animal Care and Use Committee IACUC)

Procedures with animals will avoid or minimize discomfort, distress, and pain to the animals, consistent with sound research design.
Procedures that may cause more than momentary or slight pain or distress to the animals will be performed with appropriate sedation, analgesia, or anesthesia, unless the investigator justifies the procedure for scientific reasons in writing.
Animals that would otherwise experience severe or chronic pain or distress that cannot be relieved will be painlessly killed at the end of the procedure or, if appropriate, during the procedure.
The living conditions of animals will be appropriate for their species and contribute to their health and comfort. The animals' housing, feeding, and nonmedical care will be directed by personnel trained and experienced in the proper care, handling, and use of the species being maintained or studied.
Medical care for animals will be available and provided as necessary by qualified personnel.
Personnel conducting procedures on the species being maintained or studied will be appropriately qualified and trained in those procedures.
Methods of euthanasia used will be consistent with the recommendations of the American Veterinary Medical Association (AVMA) Panel on Euthanasia unless a deviation is justified for scientific reasons in writing by the investigator.

The Research and Ethics Committee should review and approve the animal use protocol of each research team. The protocol must cover at least these points:
(The following points are adopted from the guidelines of IACUC)

Identification of the species and approximate number of animals to be used.
Rationale for involving animals, and for the appropriateness of the species and numbers used.
A complete description of the proposed use of the animals.
A description of procedures designed to assure that discomfort and injury to animals will be limited to that which is unavoidable in the conduct of scientifically valuable research, and that analgesic, anesthetic, and tranquilizing drugs will be used where indicated and appropriate to minimize discomfort and pain to animals.
A description of any euthanasia method to be used.

The reasonability and the expectation of the study conducted on animals must justify their use. The research must have a new idea and be of value to be publishable in indexed journal.

Responsibilities for Application

The Research Ethics Committee expects the Principal Investigator to complete the appropriate forms in collaboration with other researchers and submit them to the Committee. He/she should make sure that the research project does not commence until the written agreement of the Committee is obtained.

Attached Documents & References

EA-F-06 Ethical Approval Letter.docx
AS-F-03 Animal Study Approval Form.docx
HS-F-07-Human Study Approval Form.docx
CF-F-05 Consent Form_2.docx