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HEALTH RESEARCH ETHICS COMMISSION

ABOUT KEPK-FKIK UIN

In accordance with the Regulation of the Minister of Health of the Republic of Indonesia Number 7 of 2016 concerning the National Health Research and Development Ethics Commission which states that health research and development involving humans as subjects and experimental animals as subjects must be in accordance with the ethical principles of health research and development whose results can be used to support health services in order to realize the highest level of public health. Therefore, it is important for the Health Research Ethics Committee (KEPK) of the Faculty of Medicine and Health Sciences, UIN Maulana Malk Ibrahim Malang to provide services, research reviews, especially for students of the Faculty of Medicine and Health Sciences, UIN Maulana Malk Ibrahim Malang who conduct research using humans, experimental animals and plants as research subjects.

 BACKGROUND

In accordance with the Regulation of the Minister of Health of the Republic of Indonesia Number 7 of 2016 concerning the National Health Research and Development Ethics Commission which states that health research and development involving humans as subjects and experimental animals as subjects must be in accordance with the ethical principles of health research and development, the results of which can be used to support health services in order to realize the highest possible level of public health.

Therefore, it is important for the Health Research Ethics Committee (KEPK) of the Faculty of Medicine and Health Sciences, UIN Maulana Malk Ibrahim Malang to provide services and research reviews, especially for students of the Faculty of Medicine and Health Sciences, UIN Maulana Malk Ibrahim Malang who conduct research using humans, experimental animals and plants as research subjects.

Service Hours

Acceptance of Submission Files Ethical Clearance held every Monday-Friday from 09.00-15.00 WIB

KEPK FKIK Secretariat Room, Ar Rohim Building, Campus 3 UIN Maulana Malik Ibrahim Malang.

Contact person:

Nanang Khulafa'ur Rosyidin, A.Md.Ak, S.Tr.Kes

HP: +62 895-3609-07576 (service according to working days and hours)

 VISION AND MISSION

VISION

The realization of the Health Research Ethics Commission (KEPK) of the Faculty of Medicine and Health Sciences, UIN Maulana Malik Ibrahim Malang which is Rahmatanlil 'alamin, applies Islamic values and is highly competitive, has excellence in Islam, science, leadership, expertise, independence and professionalism.

MISSION

  1. Protecting humans, animals and plants involved in research in the fields of medicine and health sciences.
  2. Establish cooperation with national and international health research ethics commissions.

Improving the quality of institutions through National KEPK accreditation.

READING MATERIAL:

  1. Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants (WHO 2011)
  2. International Ethical Guidelines for Health-related Research Involving Humans (WHO 2016)
  3. 2017 Minister of Health Regulation on Patient Safety

 ETHICAL CLEARANCE PROCESS FLOW

 COMPLETENESS OF THE PROPOSED ETHICAL CLEARANCE

    1. Application letter from prospective researcher
    2. Cover letter from the institution
    3. Research proposal (triplicate) includes:
      1. CHAPTER 1 Introduction (background, problem formulation, objectives and benefits of the research)
      2. CHAPTER 2 CONCEPTUAL FRAMEWORK AND HYPOTHESES (if any)
      3. CHAPTER 3 Research Methods:
        • Research design
        • Place and time of research
        • Type of sample, sampling procedure, sample size, inclusion and exclusion criteria
        • Research variables and operational definitions
        • Research instruments/tools for collecting data/research materials
        • Research procedures: interventions given/carried out (describe in detail the steps taken)/data collection methods (describe in detail)
        • How to record during the study, including side effects and complications if any
        • Data analysis plan
      4. BIBLIOGRAPHY
    4. Research protocol form 
      Research protocol form with human subjects 
      Research protocol form with animal subjects 
      Research protocol form with Biological Subjects stored  
      Research protocol form with microbial subjects 
    5. Checklist of 7 ethical standards for health research
    6. List of research teams and their expertise/specializations 
    7. Researcher's curriculum vitae
    8. Financing information including detailed outlines
    9. Ethical clearance for similar research (if any)
    10. Informed consent form along with a list of explanations (PSP) provided to participants  specifically for research with human subjects
    11. Statement Letter that Research Has Not Been Conducted 

Submission Procedure

  1. Submitting a letter of application for ethical compliance from the proposing institution:
    1. For prospective researchers (students), the application letter must be signed by the Scientific Paper supervisor OR the Head of Department/Study Program
    2. For researchers (lecturers), the application letter must be signed by the Principal Researcher (Chief Researcher)
  2. Fill out the application form and complete the files and forms that have been filled in, then send them via LINK
  3. Submit the application form and complete files in 1 copy and put them in a folder according to the provisions.

Assessment Process (revision)

  1. Proposals that have been submitted to the secretariat will be processed for completeness of the files (2 days)
  2. Proposals that have passed the administration stage will be distributed to 2 reviewers (7 days)
  3. The results of the reviewer will be returned to the secretariat and will be followed up by the chairperson according to the input and suggestions from the reviewer (1-3 days)
  4. The secretariat will send the results of the ethical review to the proposer via the researcher's e-kepk account (improvement or ethical pass 7-10 days)
  5. In certain cases that require a full board hearing, a presentation will be held in the KEPK-FKIK UIN Maulana Malik Ibrahim Malang courtroom (10 days)
  6. For proposers who are declared to have passed the ethics test, certificates can be collected at the KEPK-FKIK UIN Maulana Malik Ibrahim Malang secretariat.

The completeness of document

  1. 1. Application letter from prospective researcher
  2. 2. Cover letter from the institution
  3. 4. Ethics Protocol Form for Health Research with Human Subjects
  4. 4.1 Microbial Test Protocol Form
  5. 4.2-Animal-Test-Protocol-Form
  6. 4.3-BBT-Test-Protocol-Form
  7. 4.4 Microbial Test Protocol Form
  8. 5.Checklist of 7 KEPK UIN Malang Standards
  9. 6-and-7-CURRICULUM-VITAE-FORM
  10. 8-RESEARCH-BUDGET-PLAN-AND-SCHEDULE-FORMS
  11. 9-FORM-PSP-and-INFORMED-CONSENT
  12. 10-Letter-Statement-Not-Researched

Chairman

Dr. Doby Indrawan, MMRS

Secretary

Ria Ramadhani Dwi Atmaja, S.Kep., NS., M.Kep

Member

Dr. Avin Ainur Fitrianingsih, M. Biomed

Nanang Khulafa'ur Rosyidin, A.Md.Ak

Prasetyaning Indrianis, S.Ab

Tasks and Work Programs

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