Ethics Committee | Mar Sleeva Medicity Palai

Welcome to the Institutional Human Ethics Committee (IHEC)!

Our mission is to safeguard the dignity, rights, safety, and well-being of all individuals participating in research conducted at our institute. We firmly believe that while the goals of research are important, they must never compromise the health and well-being of those involved.

At IHEC, we are committed to upholding the cardinal principles of research ethics: Autonomy, Beneficence, Non-maleficence, and Justice. We meticulously review all research proposals to ensure compliance with these principles throughout the planning, conduct, and reporting phases of the study.

Registration Details

2023 – IHEC reregistered with Central Drugs Standard Control Organization (CDSCO) – Registration No.: ECR/1810/Inst/KL/2023
2023 – IHEC provisionally registered with National Ethics Committee Registry for Biomedical and Health Research, Department of Health Research – Registration No.: EC/NEW/INST/2023/3757

Scope of Review:

IHEC reviews a wide range of research protocols involving human participants, including:

Case studies
Disease and drug registries
Epidemiological devices
In vitro studies involving human samples and derived primary cell lines
Investigator Initiated research studies
Retrospective studies
Studies involving Devices
Studies involving Pharmaceuticals

List of Members

Sl. No	Name & Qualification	Designation	Affiliation
1	Dr. Sudhayakumar N., MD, DM (Cardiology)	Chairman	Non-affiliated
2	Dr. Nithish P.N. MD, PDCC(CTVS)	Member Secretary	Affiliated
3	Dr. Thomas P.T., MS (General Surgery)	Clinician	Affiliated
4	Adv. Fr. Alvin T Abraham., L.L.B.	Legal Expert	Non-affiliated
5	Dr. Geena George., MD in Microbiology	Medical Scientist	Affiliated
6	Mrs. Roselind George., MA, M Phil	Lay person	Non-affiliated
7	Mrs. Darlin Donald., MSW	Social scientist	Non-affiliated

Review Process:

The review process begins with investigators submitting documents to IHEC at least four weeks prior to the meeting. The committee members carefully assess each study protocol considering:

Scientific design
Potential risks and benefits
Subject selection procedures
Compensation provisions
Privacy protection measures
Community involvement
Data analysis plans
Regulatory compliance
Investigator competence
Study site infrastructure

ETHICS COMMITTEE PROTOCOLS

Sl. No	Title of the Standard Operating Procedures (SOPs)	SOP No.
1	Constitution of Institutional Human Ethics Committee (IHEC), Selection, Roles and Responsibilities of Members of the IHEC	MSMP/SOP-02/V1
2	Selection and Responsibilities of Representatives of Vulnerable Population	MSMP/SOP-05/V1
3	Management of Submission of Research Study Protocol and Study Related Documents	MSMP/SOP-07/V1
4	Initial Full Board Review of Research Study Protocols	MSMP/SOP-08A/V1
5	Dealing with Participants’ Requests and Complaints Coming to Ethics Committee	MSMP/SOP-18/V1
6	Reviewing Proposals Involving Vulnerable Populations	MSMP/SOP-20/V1