Table of Contentsmrinstitute.org/Form SOP MRIN EC 2019/Guideline for PI... · 2019-01-22 · Medicine, Universitas Pelita Harapan (FK UPH), Universitas Pelita Harapan or Siloam Hospitals

Mochtar Riady Institute

for Nanotechnology

Ethics Committee (MRIN EC)

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Table of Contents 1 The Importance of Ethics ………………………………………………………………………………… 2 2 Who has to submit an Ethics Application?.................................................................................. 2 3 Procedure for Protocol Submission for Initial Review and Resubmission……………. 3 4 Procedure for Submission for Protocol Amendment………………………………………….. 6 5 Procedure for Continuing Review…………………………………………………………………… 6 6 Serious Adverse Event and Unexpected Adverse Drug Reaction 8 7 Final Report of Study……………………………………………………………………………………… 11 8 Study Termination…………………………………………………………………………………………. 11 9 Type of Review………………………………………………………………………………………………… 12 10 Length of Review……………………………………………………………………………………………… 12 11 References ……………………………………………………………………………………………………… 12 12 Appendices………………………………………………………………………………………………………. 13 12.1 Application Form for Initial Review………………………………………………………… 13 12.2 Summary Sheet of Study Protocol…………………………………………………………… 15 12.3 Protocol Submission for Clinical Trial Research 18 12.4 Protocol Submission Form for Health-Related Research including Survey,

Registry, Surveillance, Epidemiology, Humaniora, Stored Biological Specimen, Non-Clinical……………………………………………………………………………………………………..

23

12.5 Informed Consent Form and Check List …………………………………………………... 34 12.6 Protocol Amendment Submission Form …………………………………………………... 36 12.7 Continuing Review Application Form ……………………………………………………… 39 12.8 Serious Adverse Event Report Form………………………………………………………… 40 12.9 Unexpected Adverse Event Summary Report……………………………………………. 49 12.10 Study Report Form………………………………………………………………………………… 41 12.11 Study Termination Application ……………………………………………………………… 44 12.12 Flow Chart of Application Submission Process………………………………………… 45 12.13 Glossary………………………………………………………………………………………………… 46 12.14 List of Abbreviation………………………………………………………………………………… 48 12.15 Template for Information Subject…………………………………………………………… 49 12.16 Template Informed Consent Form …………………………………………………………. 52


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1. The Importance of Ethics

Research involving animals should be based on a fundamental moral commitment to

the individual concerned. The research should also result in advancing human

welfare, knowledge and understanding. It is a universal requirement mandated by all

research bodies that all institutions should establish an Ethics Committee to monitor

research activities.

2. Who has to submit an Ethics Application?

Anyone employed in Mochtar Riady Institute for Nanotechnology (MRIN), Faculty of

Medicine, Universitas Pelita Harapan (FK UPH), Universitas Pelita Harapan or Siloam

Hospitals who intends to undertake a research or teaching project involving any form

of human studies has an ethical responsibility toward the subjects of that project. This

includes research carried out on MRIN premises or conducted elsewhere.

The MRIN Ethics Committee is the body that reviews and approves such projects to

ensure that the ethical responsibilities are appropriately addressed in the project.

Their review is based on details provided by the completion of an ethics application

for research involving human subjects

The following guideline is prepared to assist Researcher/ Principal Investigator (PI)

to outline the submission requirements for full or expedited review of new protocols

and modification to an approved protocol. As an ethics conduct has to be maintained

throughout a study, this guideline describes procedure for additional report

mechanism after a protocol is approved.


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3. Procedure for Protocol Submission for Initial Review and Resubmission

New research protocol should be submitted for Initial Review by the MRIN EC to

obtain ethics approval. Investigation and/ or collection of data on human subjects lfor

research purposes; requires ethics approval by MRIN EC prior to implementation.

The Procedure for Protocol Submission for Initial Review or Resubmission is as

follows:

1. Complete Application Form for Initial Review (Form AF/01-010/2019/01.3).

2. Complete Summary Sheet of Study Protocol (Form AF/02-010/2019/01.3).

3. Complete Protocol Submission Form AF/03-010/2019/01.3 for Clinical Trial

Research, or Form AF/04-010/2017/01.2 for Health-Related Research including

Survey, Registry, Surveillance, Epidemiology, Humaniora, Stored Biological

Specimen, Non-Clinical,

a. two (2) copies of Form AF/01-010/2019/01.3

b. two (2) copies of Form AF/02-010/2019/013 and

c. two (2) copies of either Form AF/03-010/2019/01.3 or AF/04-

010/2019/01.3 depending on the type of research including the attachment

d. one (1) copy of Cover Letter from referring Institute

e. one(1) copy of original research proposal as approved by Advisor or

Institutional Head.

f. Research Proposal should contain:

Title

Table of Content

Summary of Research

Background

Research Problem

Aim /Objective . consist of General aim and specific aim

Benefit or Outcome of Research


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Hypothesis

Materials and Methods including

a. Theoretical and Conceptual Frame Work

b. Time and Place

c. Study design

d. Sample Number, Sample calculation

e. Inclusion , Exclusion Criteria, With drawal Criteria

f. Definition of Operation

g. Instruments and Process of Data Collection

h. Management and Data Analysis

i. Method of Analysis, etc

Detailed Budget

Timeline

References

Example of Incidence Card for Study Subjects

Example of Informed Consent (In Bahasa Indonesia)

Guidelines for Informed Consent:

Informed Consent should be written in Bahasa Indonesia, and include all of the “elements of consent” listed below. Write in plain language that is easy for a potential participant to understand. Avoid long words or sentences, and write in short, to-the-point sentences. Avoid repetition of sentences, and make the document as short as possible without leaving out important information.

Obtaining participant’s consent is a process. Participation in a study should be truly voluntary, and the participant should understand what he or she is agreeing to do. The investigator must make sure that the participant understands all the important elements of the consent form at the time the consent form is signed, and during the research study. The participant should understand that participation is voluntary and that he or she can withdraw from the study at any time.

Elements of Informed Consent: 1. A statement that the study involves research, with an explanation of the purposes of the research. The expected duration of the participant's participation; A description of the procedures to be followed and identification of any procedures which are experimental.


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2. A description of any reasonably foreseeable risks or discomforts to the participant. 3. A description of any benefits to the participant or to others which may reasonably be expected from the research. 4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant 5. A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained; 6. For research involving more than minimal risk, an explanation as to whether any compensation is available. If injury occurs, an explanation as to whether any medical treatments are available, what they consist of, or where further information may be obtained; 7. An explanation of whom to contact for answers to related questions about the research and research participants' rights; and whom to contact in the event of a research-related injury to the participant; 8. A statement that participation is voluntary. A statement that refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled.

In addition, the Informed Consent may contain the following items when

appropriate :

a) A statement that the particular treatment or procedure may involve risks to the participant (or to the embryo or fetus, if the participant is or may become pregnant), which are currently unforeseeable

b) Anticipated circumstances under which the participant's participation may be terminated by the investigator without regard to the participant's consent

c) Any additional costs to the participant that may result from participation in the research

d) The consequences of a participant's decision to withdraw from the research and procedures for orderly termination of participation by the participant

e) A statement that significant new findings developed during the course of the research, which may relate to the subject's willingness to continue participation, will be provided to the subject

f) The approximate number of subjects involved in the study


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To assist the Principal Investigators (PI) in the design of their informed consent,

a Template is attached in the Appendix (chapter 10)

5. All documents are to be submitted in both formats, hard and soft copy (pdf

file) with the signatures. The soft copy with the signature of the PI must be

emailed to MRIN EC Secretariat ([email protected]).

6. MRIN EC Secretariat will verify the completeness of submitted documents. The

MRIN EC will only consider complete documents for ethical review.

7. If necessary, MRIN EC may invite the Principal Investigator (PI) to give

clarification on issues that can arise during review process.

8. When the review process has been concluded, MRIN EC Secretariat will notify

the PI about MRIN EC’s Decision, if the approval is granted, requires major or

minor modification, or rejected.

9. In case a minor or major revision is required, after revision the PI has to

resubmit all forms again (items a – e) to MRIN EC for a re-review. Changes made

in any of the documents must be typed/ written in bold letters, and indicated in

the cover letter when the documents are resubmitted.

10. Please include table of revision as following for the resubmission

MRIN EC Recommendation Revision from PI Remark/Page No.

11. The decision on the resubmission will be communicated to the PI once MRIN EC

has finished conducting the re-review.

4. Procedure for Submission for Protocol Amendment

During the course of the study, investigators can amend the protocol/project

proposal from time to time. The PI should submit the amendments to the MRIN EC for

either “expedited” or full review by submitting 3 (three) copies of the Protocol

Amendment Submission Form (AF/01-013/2019/01.5), including the letter from the

mailto:[email protected]


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referring institution and 1 copy of the latest protocol/project proposal approved by

MRIN EC.

All documents are to be submitted in both formats, hard and soft copy (pdf file) with

the signatures. The soft copy with the signature of the PI must be emailed to MRIN EC

Secretariat ([email protected]).

Criteria for “expedited” review may include:

administrative revisions, such as correction of typos

addition or deletion of non-procedural items, such as the addition of study personnel names, laboratories, research population , etc

non-significant risk research activity

the research activity with only minor changes from previously approved protocol

Changes in protocol, which increase risk to study participant are subject to full review

by the MRIN EC. Examples are changes in study design, which may include but are not

limited to:

additional treatments or the deletion of treatments

any changes in inclusion/exclusion criteria

change in method of dosage formulation, such as, oral changed to intravenous

significant change in the number of subjects

significant decrease or increase in dosage amount

MRIN EC Secretariat will notify the PI if the protocol amendment is approved or not.

In case the MRIN EC votes to require modifications to any of the documents, or the

protocol amendment, the Secretariat sends a written request about the specific

changes to the PI asking him or her to make the necessary changes and resubmit the

documents to MRIN EC.

5. Procedure for Continuing Review

The purpose of a continuing review is to monitor the progress of the entire study to

ensure continuous protection of the rights and welfare of research participants.



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Depending upon the degree of risk to the participants, the nature of the studies, and

the vulnerability of the study participants and duration of the study, the MRIN EC may

choose to review or monitor the protocols more frequently.

MRIN EC Secretariat will inform the ‘Study team’ in advance regarding the due date

for the continuing review by post, e-mail or by other appropriate means. The PI is

required to fill up and submit 3 copies of the Continuing Review Application Form

(AF/01-014/2019/01.5) and 1 copy of the latest project proposal approved by the

MRIN EC.

The MRIN EC will conduct a review of the study and the Secretariat will inform the PI

after a decision has been reached no later than 7 working days after the review has

taken place.

All documents are to be submitted in both formats, hard and soft copy (pdf file) with

the signatures. The soft copy with the signature of the PI must be emailed to MRIN EC

Secretariat ([email protected]).

Elements for Progress Report including:

1. Have there been any changes to the project since the previous ethics approval

(Renewal or Amendment)?

2. Please provide a brief summary of the progress of the study.

3. Include information surrounding study implementation details (such as the

recruitment of participants) and whether or not the study is progressing as planned.

4. Please document any issues that might pose a challenge to the study meeting its

proposed timelines. Attach supporting documents if necessary.

5. During the course of the project have any ethical concerns or difficulties arisen?

6. Please list any Amendments that have been submitted since the date indicated on

the Letter of Initial Ethics Approval

7. Has your study experienced any unanticipated problems?

8. Have all SAEs been reported since your study was initially approved?

9. If SAEs have occurred but have not been reported, please explain why they have

not been reported, give details of these events, and provide your opinion on whether

these are study-related, whether they affect the ethics of continuing the study, and

whether they necessitate any changes to the informed consent process. Please

provide an overall assessment.



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6. Serious Adverse Event and Unexpected Adverse Drug Reaction

Unanticipated risks are sometimes discovered during the course of studies.

Information that may impact on the risk/benefit ratio should be promptly reported to

and reviewed by the MRIN EC to ensure adequate protection of the welfare of the

study participants.

The unanticipated risks may as well include any event that in the investigator’s

opinion may adversely affect the rights, welfare or safety of subjects in the study.

The investigators or sponsors must report the SAE within 7 working days after the

incident occurred and unexpected events should be included in the continuing review

report submitted to MRIN EC. Investigators should use Forms Serious Adverse Event

Report (AF/01-019/2017/01.2) or Unexpected Adverse Event Summary Report

(AF/02-019/2017/01.2) to inform the MRIN EC about the event.

Categories of incidence for Serious Adverse Event (SAE) and Unexpected Adverse

Drug Reaction (ADR) are listed in Table 1.

Table 1. Criteria for SAE and Unexpected ADR

Serious Adverse Event (SAE)

The adverse event is SERIOUS and should be reported when the patient outcome is:

Death - Report if the patient's death is suspected as being a direct outcome of the adverse event.

Life-Threatening - Report if the patient was at substantial risk of dying at the time of the adverse event or it is suspected that the use or continued use of the product would result in the patient's death.

Examples: Pacemaker failure; gastrointestinal hemorrhage; bone marrow suppression; infusion pump failure which permits uncontrolled free flow resulting in excessive drug dosing.


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Hospitalization (initial or prolonged) - Report if admission to the hospital or prolongation of a hospital stay results because of the adverse event.

Examples: Anaphylaxis; pseudomembranous colitis; or bleeding causing or prolonging hospitalization.

Disability- Report if the adverse event resulted in a significant, persistent, or permanent change, impairment, damage or disruption in the patient's body function/structure, physical activities or quality of life.

Examples: Cerebrovascular accident due to drug-induced hypercoagulability; toxicity; peripheral neuropathy.

Congenital Anomaly - Report if there are suspicions that exposure to a medical product prior to conception or during pregnancy resulted in an adverse outcome in the child.

Examples: Vaginal cancer in female offspring from diethylstilbestrol during pregnancy; malformation in the offspring caused by thalidomide.

Requires Intervention to Prevent Permanent Impairment or Damage – Report if suspect that the use of a medical product may result in a condition which required medical or surgical intervention to preclude permanent impairment or damage to a patient.

Examples: Acetaminophen overdose-induced hepatotoxicity requiring treatment with acetylcysteine to prevent permanent damage; burns from radiation equipment requiring drug therapy; breakage of a screw requiring replacement of hardware to prevent malunion of a fractured long bone.

Unexpected Adverse Drug Reaction (ADR)

Unexpected ADR is an adverse reaction, the nature or severity of which is not consistent with the informed consent / information sheets or the applicable product information (e.g., investigator’s brochure for the unapproved investigational product or package insert / summary of product characteristics for an approved product.


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7. Final Report of Study

Once the study has been completed, the Principal Investigator is required to fill up

and submit 3 copies of the Study Report Form (AF/01-015/2019/01.4), and one set of

the latest project proposal/protocol. All the amendments approved by the MRIN EC

should be stated in the latest project proposal/protocol. Report written in letter

format, or in a format provided by the Sponsor (in case of Clinical Trial) may be used.

Each Board member will review the Final Report, and if appropriate to the

discussions, MRIN EC may call for consensus on whether to request further

information or to take other action with the investigator.

All documents are to be submitted in both formats, hard and soft copy (pdf file)

with the signatures. The soft copy with the signature of the PI must be emailed

to MRIN EC Secretariat ([email protected]).

8. Study Termination

Protocols are usually terminated at the recommendation of the MRIN EC, Data Safety

Monitoring Board (DSMB), Scientific Director, sponsor or other authorized bodies

when subject enrollment and subject follow-up are discontinued before the scheduled

end of the study; or when the safety or benefit of the study participants is doubtful or

at risk. Upon notification from MRIN EC Secretariat the Principal Investigator is then

required to prepare and submit Study Termination Memorandum (AF/01-

018/2019/01.4) to MRIN EC. Once the review has been completed, MRIN Secretariat

will inform the PI of MRIN EC’s decision on the study termination.



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9. Type of review

The protocol submission will be determined as Exempted, Expedited or Full Board by

the Secretary of EC.

10. Length of Review

PI will receive notification from Secretariat within 1-4weeks after the submission of

completed document for expedited and exempted and 7 working days after the full

board meeting.

11. References

1. World Medical Association (WMA) Declaration of Helsinki - Ethical Principles

for Medical Research Involving Human Subjects, 2008

2. World Health Organization (WHO) - Standards and Operational Guidance for

Ethics Review of Health-Related Research with Human Participants, 2011

3. Institutional Animal Care and Use Committee Guidebook, 2002

4. Pedoman Nasional Etik Penelitian Kesehatan, Komisi Nasional Etik

Penelitian Kesehatan, 2011.

5. Standard Operating Procedures Mochtar Riady Institute for Nanotechnology

Ethics Committee (MRIN EC), 2013

6. Policy and Guidance of Office for Human Research Protections (OHRP). US

Department of Health and Human Services. (30 Sep. 1998). Retrieved 7 April

2014 from http://www.hhs.gov/ohrp/policy/consentckls.html.

7. Informed Consent Guidance. Johns Hopkins Medicine Office of Human Subjects

Research - Institutional Review Boards (October 2012). Retrieved 7 April 2014

from http://www.hopkinsmedicine.org/institutional_review_board/

guidelines_policies/guidelines/informed_consent_i.html.


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12. Appendices

12.1. Application Form for Initial Review (AF/01-010/2019/01.3)

APPLICATION FORM for INITIAL REVIEW

Protocol Title:

Protocol number: Total Participants to be included:

STUDY TYPE: (Mark “ “ whichever apply to the study) Survey Social Medical Community based Individual based Screening Observational Epidemiology Intervention study Clinical Trial: Phase I Phase II Phase III Phase IV Genetic Study Retrospective Prospective Others………………………………..

STUDY POPULATION:: Healthy Patient Vulnerable groups

CHARACTERISTICS of PARTICIPANTS PARTICIPATED : Age Range: 0 -17 yrs 18 - 44 yrs 45 - 65 yrs > 66 yrs Pediatric None < 1 yr 1-3 yrs 4 -14 yrs Impaired None Physically Cognitively Mentally

REQUESTED EXCLUSION OF PARTICIPANTS: None Male Female Children Other (specify) ) SPECIAL RESOURCE REQUIREMENTS (check all that apply):

Intensive Care Isolation unit Surgery Pediatric Intensive Care Transfusion CAT scan

Gene therapy Controlled substances (Narcotics/Psychotropics) Prosthetics Gynecological services Others, specify…………….

Organ transplantation, specify………………………… ……………………………. IONIZING RADIATION USE (X-rays, radioisotopes, etc): None Medically indicated only INVESTIGATIONAL NEW DRUG (IND) / DEVICE (IDE): None IND IDE FDA No.:……………… FDA No:……………………

Name:…………………. Name:……………………… Sponsor:………………. Sponsor:…………………...

Holder:………………… Holder:……………………...

PROCEDURE USE: Invasive Non-invasive

MULTI-SITE COLLABORATION: YES NO FINANCIAL DISCLOSURE: YES NO INSTITUTE RESEARCH CONTACT Name:……………………………………………………………………………………

Address: ………………………………………………………………………………… Telephone:…………………………………………

Fax:………………………………………………… E-mail:……………………………………………...


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Conflict of Interest Declaration (Relationship with sponsor)

Are you a regular employee of the sponsor?

Yes

No

Other ties with the sponsor Yes N

o

PARTICIPATING INVESTIGATORS (add extra pages if necessary):

First / Last Name Institution Telephone / Fax No.

E-mail

1.

2.

3.

4.

5. CONTACT PERSON: Name:……………………………………………………………………………………. Institute/ Address:…………………………………………………………………….. ……………………………………………………………………………………………. Telephone:……………………………………………………………………………… Fax:………………………………………………………………………………………. E-mail:…………………………………………………………………………………… SIGNATURE:

__________________ Date: ………………..

Principal Investigators

TYPE OF INITIAL REVIEW:* ASSIGNED REVIEWERS:*

☐ Exempted from Review

☐ Expedited Review

☐ Full Board Review

1.

2.

3.

SIGNATURE: Date:…………………

*to be filled by Chairperson./Vice chairperson/ Secretary MRIN EC


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12.2. Summary Sheet of Study Protocol (AF/02-010/2019/01.3)

SUMMARY SHEET OF STUDY PROTOCOL

Title of the Protocol*

Principal Investigator (Name, Institution)*

Sponsor

Abstract*

Type of Protocol (Screening, Survey, Clinical Trial, etc)*

Aims*

Anticipated Outcome*


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Inclusion and Exclusion Criteria*

Withdrawal or discontinuation Criteria

Mode of Intervention to the Human/ Animal Subjects*

Methodology (Synopsis of Study Design)*

Analysis method*


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Timeline*

Schedule and Duration of Treatment

Efficacy or Evaluation Criteria (Response/ Outcome)

Safety Parameters Criteria (Toxicity)

* indicates required field Principal Investigator Signature _____________________________________ ___________________ Name Date


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12.3. Protocol Submission for Clinical Trial Research (AF/03-010/2019/01.3)

PROTOCOL SUBMISSION FORM FOR CLINICAL TRIAL

To be filled by Principal Investigator (copy of 5)

Please fill out the form completely and return to the Secretariat of MRIN Ethics Committee (MRIN-EC), Jalan Boulevard Jendral Sudirman 1688, Lippo Karawaci, Tangerang 15810, Tel. +62 21 54210123, Fax. +62 21 542 10110, Email : [email protected] Protocol Registration No. (To be filled by the Secretariat of MRIN EC) A. General Information

1 Principal Investigator: (Title, Name, Institution)

2 Title of Research:

3. Type of Research: Non-Cooperation National Collaboration International Collaboration (Attach ethical approval from corresponding country) Involvement of Foreign Researcher (Attach approval from the State Ministry for Science and Technology)

4 Description of the Study in brief: Mark whatever applied to the study.

Randomized Stratified Randomized Open-labeled Double blinded Placebo controlled Treatment controlled Cross-over Parallel Interim Analysis Use of Tissue samples Use of Blood samples Use of genetic materials Multicenter study Screening Descriptive

5 Type of Proposal: New Protocol Continued Protocol


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Modified Protocol Amendment Protocol If continued or modified, please state previous SP3 No.:

6 Institution

7 Funding Resources

8 Total of Research Funding Rp

9 Research Location

10 Research Period Start................................ End...............................

11 Has this protocol been submitted to other Ethics Committee before

Yes; accepted rejected No

B. Clinical Trial 12 Type of Research: (Tick more than one when appropriate)

Explorative/Descriptive Quantitative (Deductive)

Cross-

sectional

Case-

control

Pre-

Post test

Cohort Clinical

Experiment

Quantitative (Inductive)

13 Clinical Trial Phase

Phase I Phase II Phase III Phase IV

14 Purpose of Clinical Trial:

15

Subject Inclusion Procedures: a. Number of Subjects

b. Inclusion Criteria


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c. Exclusion Criteria

d. Withdrawal/Drop Out Criteria

e. Acquisition of Subject’s Informed Consent

e.1 Summarize information disclosure procedure to subject (Materials conveyed; Speaker; Means of information delivery; Self-informing through provided manuscripts/Group Session/Accompanied by family/Close acquaintance/Private session; Compensation; Q&A session, etc.)

e.2 Detail relationship between information giver with observed subject

Physician – Patient Teacher- Student Employer-Employee

No Relationship Others: …………………..(please specify)

16 Information on subtance or medical measure on trial (Has such clinical trial taken place before, are safety data and benefits of previous identical/similar study or studies from other countries available?)

17 Will biological samples be sent abroad? Yes No If Yes, Please include Material Transfer Agreement

18 Clinical Trial Process a. Administration of Intervention (Dose regimen, invasive measures, reference

drugs, placebo) Provide explanatory guidance on procedure: dose and administration, frequency, interval, invasive measures taken, radiation, etc.

b. Selection of Outcome Indicator


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c. Interim Analysis

d. Clinical Trial Termination Procedure

e. Time Estimate for Processing of One Subject

(minute(s)/hour(s)/day(s)/week(s)/month(s)/year(s)) f. Possible occuring subject involving ethical problem (e.g. inconvenience, please

put to record)

19

Adverse Event (AE) a. Documentation (Details of events occurring during treatment)

b. Analysis c. Emergency Rescue System d. Subject Withdrawal from Research at the Cause of AE e. Subject Compensation

21 Data Analysis a. Efficacy

b. Safety

20 Post-Research Responsibility (Capacity building, benefits for local community,

treatment maintenance on subjects, etc.)


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Principal Investigator Signature __________________ __________________ Name Date

C. Document Completeness (Tick box when appropriate) One copy cover letter from referring institution Two copies of original proposal as approved by advisor or institute director (attach

approval from authorized parties). Outline of research proposal should refer to guideline for PI Item 3.3f.

Two copies of application form for initial review

Two copies of medical research ethics submission form for clinical trial

Two copies of research proposal summary supplemented with supporting attachments

Attachment 1. Information for Subject

Attachment 2. Informed Consent Form & Check list

Attachment 3. List of Research Team with Corresponding Expertise and Job Description

Attachment 4. CV of Principal Investigator include GCP Training Certificate

Attachment 5. Memorandum of Understanding between Researcher, Sponsor and Research Institution (For Research Collaboration)

Attachment 6. Ethical Approval from Other Institution (When Available)

Attachment 7. Case Report Form/ Incidence Card

Attachment 8. Forms: Questionnaire, Laboratory/Radiology Examination Request, Laboratory/Radiology Examination Results

Attachment 9. Adverse Event Report Form

Attachment 10. Investigator’s Brochure (When Necessary)

Attachment 11. Investigational Drugs Approval from BPOM (New Drugs/Food Trial)

Attachment 12. Budgeting Details and Funding Resources

Attachment 13. Others (e.g. Workflow)


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12.4. Protocol Submission Form for Health-Related Research including Survey, Registry, Surveillance, Epidemiology, Humaniora, Stored Biological Specimen, Non-Clinical (AF/04-010/2019/01.3)

PROTOCOL SUBMISSION FORM FOR HEALTH RELATED RESEARCH SURVEY, REGISTRY, SURVEILLANCE, EPIDEMIOLOGY, HUMANIORA, STORED

BIOLOGICAL SPECIMEN, NON-CLINICAL To be filled by Principal Investigator (copy of 5)

Please fill out the form completely and return to the Secretariat of MRIN Ethics Committee (MRIN-EC), Jalan Boulevard Jendral Sudirman 1688, Tangerang 15810, Tel. +62 21 54210123, Fax. +62 21 54210110, Email : [email protected] Protocol registration no.:

(To be filled by the Secretariat of MRIN EC) A. General Information

1 Principal Investigator: (Title, Name, Institution)

2 Title of Research:

3 Type of Research Survey Registry Surveillance Epidemiology Humaniora Stored/ Archived Biological Specimen Non-Clinical


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Non-cooperation National collaboration International collaboration (Attach ethical approal from corresponding country) Involvement of foreign researcher (Attach approval from the State Ministry for Science and Technology)

4 Description of the Study in brief: Mark whatever applied to the study.

Randomized Stratified Randomized Open-labeled Double blinded Placebo controlled Treatment controlled Cross-over Parallel Interim Analysis Use of Tissue samples Use of Blood samples Use of genetic materials Multicenter study Screening Descriptive

5 Type of Proposal New Protocol Continued Protocol Modified Protocol Amendment Protocol If continued or modified, please state previous SP3 No.:

6 Institution

7 Funding Resources

8 Total of Research Funding

Rp

9 Research Location

10 Period of Research Start................................


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End...............................

11 Has this protocol been submitted to other Ethics Committee before

Yes; accepted rejected No

B. Health-Related Research 12 Research Description

a. Research Type and

Design

Explorative/Descriptive

Quantitative/Deductive

Cross

Sectional

Case

Control

Cohort

Community

Experiment

Public/population

Experiment

Qualitative/ Etnographical participatory

b. Type of Samples Individual

Population

Institutional

c. Number of Samples

1). Based on problem

Yes No

2). Based on minimum requirement for function:

- participant observation

- indepth interview

Yes

No

3). Based on population number (representative ness of the samples)

Yes

No


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d. Sample Collection 1). Probability :

Simple Random

Progressive Random

Point Prevalence Survey

Cluster

2). Non Probability

Purposive Samples

Quota Samples

Chunk Samples Volunteer Samples

e. Type of Data Primary

Secondary

f. Data Collection Interview

Physical Examination

Laboratory and/or Radiology Examination Document Analysis

g. Time estimate for processing of one subject: ................. (minute(s)/hour(s)/day(s)/week(s)/month(s)/year(s)*) * delete as applicable

13 Will biological samples be sent abroad? Yes No If Yes, Please include Material Transfer Agreement

14 Possible occurring subject involving ethical problem a. Data Confidentiality Yes No

b. Research Risk

b.1. Interference of routine Yes No


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healthcare service activities

b.2. Causing adverse effects on subject

Yes No

b.3. In opposition to common cultural values

Yes No

b.4. Occurrence of economical loss and stigmatization of subject

Yes No

c. Participation Stimulation

c.1. Incrementing on new knowledge

Yes No

c.2. Provision of medical attention

Yes No

d1. Compensation

Yes No

If yes, state form of compensation: Item(s)

Cash

Insurance

d2. Gift ( please state it) ................................................................................ e. Factors affecting compensation (coercion)

e.1. Researcher-Subject Relationship

Yes No

e.2. If yes, state type of relationship:

Physician-Patient

Teacher-Student

Employer-Employee

Others

15 Informed Consent

a. Informed Consent Grouping: Individual

Public

b. Please detail means to invite subjects in participating in research when using individual/public groups. By verbal consent or situations where no informed consent is available, please provide explanatory feedback.

16 If the research involves healthy individuals, please state the method of

examination


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If the research involves affected individuals, please state the method of examination

17 Please name type of intervention (Information session, mass treatment, training, etc.)

18 Please details documentation procedure during research, including adverse effects and subsistent complications.

C. Document Completeness (Tick on box when appropriate) One copy of cover letter from referring institution

One copy of original proposal as approved by advisor or institute

director. (attach approval from authorized parties). Outline of research

proposal should refer to guideline for PI Item 3.3f.

Two copies of application form for initial review

Two copies of medical research ethics submission form for clinical trial

Two copies of research proposal summary supplemented with supporting

attachments

Attachment 1. Information for Subject Attachment 2. Informed Consent Form & checklist Attachment 3. List of Research Team with Corresponding Expertise and

job description Attachment 4. CV of Principal Investigator Attachment 5. Memorandum of Understanding between Researcher,

Sponsor and Research Institution (For Research Cooperation) Attachment 6. Ethical Approval from Other Institution (When Available)

Attachment 7. Case Report Form/ Incidence Card

Attachment 8. Forms: Questionnaire, Laboratory/Radiology Examination Request, Laboratory/Radiology Examination Results

Attachment 9. Adverse Event Report Form

Attachment 10. Investigator’s Brochure (When Necessary)

Attachment 11. Budgeting Details and Funding Resources


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Attachment 12. Others (e.g. Workflow)

Principal Investigator Signature

__________________ __________________ Name Date


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12.5. Informed Consent Form & checklist AF/05-010/2018/01.3 To be attached on the protocol submission form For Health Related Research Survey, Registry, Surveillance, Epidemiology, Humaniora, Stored Biological Specimen, Non-Clinical Or Clinical Trial Indicate if the ICF has the specified element Page and paragraph where element

is found (if it is not related , please state not applicable)

1. Statement that the study involves research

2. Statement describing the purpose of the

study

3. Study-related treatments and probability

for random assignment

4. Study procedures including all invasive

procedures

5. Responsibilities of the participant

6. Expected duration of participation in the

study

7. Approximate number of participants in

the study

8. Study aspects that are experimental

9. Foreseeable risks to participant/embryo/

fetus/nursing infant; including pain,

discomfort, or inconvenience associated

with participation including risks to

spouse or partner; and integrating risks as

detailed in the investigator’s brochure

10. Risks from allowable use of placebo (as

applicable)

11. Reasonably expected benefits; or absence


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of direct benefit to participants, as

applicable

12. Expected benefits to the community or to

society, or contributions to scientific

knowledge

13. Description of post-study access to the

study product or intervention that have

been proven safe and effective

14. Alternative procedures or treatment available to participant

15. Compensation or insurance or treatment entitlements of the participant in case of study-related injury

16. Anticipated payment, if any, to the

participant in the course of the study;

whether money or other forms of material

goods, and if so, the kind and amount

17. Compensation (or no plans of

compensation) for the participant or the

participant’s family or dependents in case

of disability or death resulting from study-

related injuries

18. Anticipated expenses, if any, to the

participant in the course of the study

19. Statement that participation is voluntary,

and that participant may withdraw

anytime without penalty or loss of benefit

to which the participant is entitled

20. Statement that the study monitor(s),

auditor(s), the MRIN EC and regulatory

authorities will be granted direct access to


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participant’s medical records for purposes

ONLY of verification of clinical trial

procedures and data

21. Statement that the records identifying the

participant will be kept confidential and

will not be made publicly available, to the

extent permitted by law; and that the

identity of the participant will remain

confidential in the event the study results

are published; including limitations to the

investigator’s ability to guarantee

confidentiality

22. Description of policy regarding the use of

genetic tests and familial genetic

information, and the precautions in place

to prevent disclosure of results to

immediate family relative or to others

without consent of the participant

23. Possible direct or secondary use of

participant’s medical records and

biological specimens taken in the course

of clinical care or in the course of this

study

24. Plans to destroy collected biological

specimen at the end of the study; if not,

details about storage (duration, type of

storage facility, location, access

information) and possible future use;

affirming participant’s right to refuse

future use, refuse storage, or have the

materials destroyed

25. Plans to develop commercial products

from biological specimens and whether

the participant will receive monetary or

other benefit from such development


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26. Statement that the participant or

participant’s legally acceptable

representative will be informed in a timely

manner if information becomes available

that may be relevant to willingness of the

participant to continue participation

27. Statement describing access of participant

to the result of the study

28. Statement describing extent of

participant’s right to access his/her

records (or lack there of vis à vis pending

request for approval of non or partial

disclosure)

29. Foreseeable circumstances and reasons

under which participation in the study

may be terminated

30. Sponsor, institutional affiliation of the

investigators, and nature and sources of

funds

31. Statement whether the investigator is

serving only as an investigator or as both

investigator and the participant’s

healthcare provider

32. Person(s) to contact in the study team for

further information regarding the study

and whom to contact in the event of study-

related injury

33. Comprehensibility of language used


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12.6. Protocol Amendment Submission Form (AF/01-013/2019/01.5)

Protocol Amendment Submission Form

PROTOCOL NUMBER: SUBMITTED DATE:

PROTOCOL TITLE:

PRINCIPAL INVESTIGATOR:

INSTITUTE:

Telephone:

PARENT PROTOCOL APPROVED PERIOD DATE: NO. OF AMENDMENT:

A. Summary of previous protocol amendment (if any)

Approval amendment nomor.

Original Protocol Short description of the amendment

Approved

date

B. Describe of amendment requested

C. Reason of amendment requested :

SIGNATURES: Date:…………….. Principal Investigator

TYPE OF AMENDMENT REQUESTED: filled by Secretary/Vice person/Chairperson

EXPEDITED

FULL BOARD


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COMMENTS: (filled by Reviewer) : ……………………………………………………………..

……………………………………………………………………………………………………….

………………………………………………………………………………………………….. .

SIGNATURES: Date:……………. Protocol Reviewer

DECISION :

Approved

Minor revision

Major revision

Disapproved

APPROVALS Date: …………... Chairperson/Vice chair person, MRIN EC COMPLETION Date: ………….. Secretary, MRIN EC


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12.7. Continuing Review Application Form (AF/01-014/2019/01.5)

Continuing Review Application Form

PROTOCOL No.: Submission date :

PROTOCOL TITLE:

ETHICAL APPROVAL PERIOD :

INSTITUTE MEDICAL ADVISOR:

ACTION REQUESTED: Renew - New participant accrual to continue

Renew - Enrolled participant follow up only

Terminate - Protocol discontinued HAVE THERE BEEN ANY AMENDMENTS SINCE THE LAST REVIEW?

NO

YES (Describe briefly in attached narrative)

SUMMARY OF PROTOCOL PARTICIPANTS:

Accrual ceiling set by MRIN EC/KEPK MRIN New participants accrued since last review Total participants accrued since protocol began

ACCRUAL EXCLUSIONS

NONE

MALE

FEMALE

OTHER (specify: ) IMPAIRED PARTICIPANTS

None

Physically

Cognitively

Both HAVE THERE BEEN ANY CHANGES IN THE PARTICIPANT POPULATION, RECRUITMENT OR SELECTION CRITERIA SINCE THE LAST REVIEW?

NO

YES (Explain changes in attached narrative) HAVE THERE BEEN ANY CHANGES IN THE INFORMED CONSENT PROCESS OR DOCUMENTATION SINCE THE LAST REVIEW?

NO

YES (Explain changes in attached narrative)

HAS ANY INFORMATION APPEARED IN THE LITERATURE, OR EVOLVED FROM THIS OR SIMILAR RESEARCH THAT MIGHT AFFECT THE MRIN EC/KEPK MRIN’S EVALUATION OF THE RISK/BENEFIT ANALYSIS OF HUMAN SUBJECTS INVOLVED IN THIS PROTOCOL?

NO

YES (Discuss in the attached narrative)

HAVE ANY UNEXPECTED COMPLICATIONS OR SIDE EFFECTS BEEN NOTED SINCE LAST REVIEW?

NO

YES (Discuss in the attached narrative) HAVE ANY PARTICIPANTS WITHDRAWN FROM THIS STUDY SINCE THE LAST MRIN EC/KEPK MRIN APPROVAL?

NO

YES (Discuss in the attached narrative) INVESTIGATIONAL NEW DRUG/DEVICE NONE IND IDE FDA No. ………………………….. Name: …………………………… Sponsor: …………………………

Holder: ……………………………

IONIZING RADIATION USE (X-rays, radioisotopes, etc)

None

Medically indicated only

HAVE ANY PARTICIPATING INVESTIGATORS BEEN ADDED OR DELETED SINCE LAST REVIEW?

NO

YES (Identify all changes in the attached narrative) HAVE ANY NEW COLLABORATING SITES (INSTITUTIONS) BEEN ADDED OR DELETED SINCE THE LAST REVIEW?

NO

YES (Identify all changes and provide an explanation of changes in the attached narrative)


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CHANGE IN MEDICAL ADVISOR / INVESTIGATOR?

NONE

DELETE:…………………………………………….

ADD: …………………………………………………

HAVE ANY INVESTIGATORS DEVELOPED AN EQUITY OR CONSULTATIVE RELATIONSHIP WITH A SOURCE RELATED TO THIS PROTOCOL WHICH MIGHT BE CONSIDERED A CONFLICT OF INTEREST?

NO

YES (Append a statement of disclosure)

Results Include the information below on the progress report (Use extra blank paper, if more space is required.)

1. Have there been any changes to the project since the previous ethics approval (Renewal or Amendment)?

2. Please list any Amendments that have been submitted since the date indicated on the Letter of Initial Ethics Approval

3. Please provide a brief summary of the progress of the study.

4. Include information surrounding study implementation details (such as the recruitment of participants) and whether or not the study is progressing as planned.

5. Please document any issues that might pose a challenge to the study meeting its proposed timelines. Attach supporting documents if necessary.

6. During the course of the project have any ethical concerns or difficulties arisen?

7. Has your study experienced any unanticipated problems?

8. Have all SAEs been reported since your study was initially approved?

9. If SAEs have occurred but have not been reported, please explain why they have not been reported, give details of these events, and provide your opinion on whether these are study-related, whether they affect the ethics of continuing the study, and whether they necessitate any changes to


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the informed consent process. Please provide an overall assessment.

Signature of P.I.:

Date:

MRIN EC/KEPK MRIN

Comment/Decision:

………………………..

……………………………………

Approved

Minor revision

Major revision

Disapproved

SIGNATURES:

Date:………………… Protocol Reviewer

APPROVALS

Date:…………………

Chairperson/Vice chairperson, MRIN EC

COMPLETION

Date:…………………

Secretary, MRIN EC


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12.8. Serious Adverse Event Report Form (AF/01-019/2017/01.2)

Serious Adverse Event Report Form

Principal Investigator:…………………………………….. Application No:

Study Title:………………………………………………………. Protocol No.:

Name of the study medicine/device………………………..…………………

Report Date :………… initial follow-up Onset date:……………

Sponsor:………………………………………………… Date of first use: ………………………..

Subject’s initial/number: Age: Male Female

Subject’s history:

Laboratory findings:

SAE:

Treatment: Outcome: resolved on-going

Seriousness: Death

Life Threatening Hospitalization – initial prolong Disability / Incapacity Congenital Anomaly Other…………………………………

Relation to Drug Device study Not related Possibly Probably Definitely related Unknown

Changes to the protocol recommended?

No Yes , attach proposal

Changes to the informed consent form recommended?

No Yes , attach proposal

Reviewed by:………………………………………………… Comment:…………………………………………………….…………………………………………………………………

Date:……………

Action:…………………………………


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12.9. Unexpected Adverse Event Summary Report (AF/02-019/2017/01.2)

Unexpected Adverse Event Summary Report

Principal Investigator:………………………………………………………………………….

Application No:

Study Title:……………………………………………………………………………………... Protocol No.:

Name of the studied medicine/device………………………..…………………………….. This report covers the period :

Sponsor:………………………………………………………………………………………... From…………………To……………….

# Description of Unexpected Adverse Events

Date of Event (D/M/Y)

Date start and end of Tx (D/M/Y)

F or M

Initial

Age (Y)

Serious Yes No

Related to Study Yes No

Concomitant medication

Intervention


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12.10. Study Report Form (AF/01-015/2019/01.4)

Page 1 of 2

Study Report Form

Protocol No.: Submission date :

Protocol Title : Principal Investigator: Parent Protocol Approval Period Date:

Phone number: E-mail address : Sponsor’s Name

Address:

Phone : E-mail : Study site(s): Total Number of study participants :

No. of Study Arms:

Number of participants who received the test articles: Study materials:

Treatment form:

Study dose(s):


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Duration of the study

Objectives:

Results: (Use extra blank paper, if more space is required.)

Summary of previous protocol amendment (if any)

Approval amendment nomor.

Short description of the amendment

Approved date

Adverse /Unanticipated Events

Did you experience any unanticipated adverse events, complication or incidence

Yes No

If yes, describe the event and how it was handled

Did you receive any complaints about the research ?

Yes No

If yes, describe the complaint and how it was handled

Data Storage

1. Where are your project files being stored ?

2. Have you verified the status of all project files and confirmed they are stored in a safe and secure location ? Data must be kept for at least 3 years after project is completed

Yes No


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If No, Please explain :

Signature of PI :

Date:

Accepted Accepted with remarks . If accepted with remarks, please state the remarks : ………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………….

SIGNATURES:

Date:………………… Protocol Reviewer

ACCEPTED:

Date: ……………….. Chairperson/Vice chairperson, MRIN EC COMPLETION:

Date:…………………

Secretary, MRIN EC


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12.11. Study Termination Memorandum (AF/01-018/2019/01.4)

Study Termination Application

PROTOCOL NUMBER: ASSIGNED No.:

PROTOCOL TITLE:

PRINCIPAL INVESTIGATOR:

PHONE : E-MAIL:

INSTITUTE:

SPONSOR:

MRIN EC APPROVAL DATE:

DATE OF LAST REPORT:

STARTING DATE: TERMINATION DATE:

NO. OF PARTICIPANTS:

NO. ENROLLED:

SUMMARY OF RESULTS

ACCRUAL DATA:

P.I.SIGNATURE: DATE:


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12.12. Flow Chart of Application Submission Process


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12.13. Glossary Initial Review The first time review of that protocol made by two or

three individual reviewers (MRIN EC members or non-members) in advance of the full Committee meeting, and comments of the reviewers will be reported to the full Committee meeting.

Phase I studies Initial introduction of an investigational new drug (IND) into humans, studies designed to determine the metabolism and pharmacological actions of drugs in humans, and studies designed to assess the side effects associated with increasing doses.

Phase II study A Study of drug metabolism, structure-activity relationships, and mechanism of action in humans, as well as studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes.

Phase III study A Study expands controlled and uncontrolled trials performed after preliminary evidence suggesting effectiveness of the drug has been obtained. They are intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

Phase IV study A study that seeks to expand an approved medication’s use into a new population, new indication, or new dose.

Stipulation Specify as terms of or condition for an agreement, contract, etc. state, put forward for a necessary condition.

Expedited review A review process by only two or more designated MRIN EC/KEPK MRIN members who then report the decision to the full Board meeting. An expedited review is a speedy one for minor changes to the approved protocol and for research proposal with minimal risk in nature.

Approved Protocols Protocols that have been approved by the MRIN EC/KEPK MRIN may proceed.

Protocols that have been approved with recommendations by the MRIN EC/KEPK MRIN may not


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proceed until the conditions set by the MRIN EC/KEPK MRIN in the decision have been met. Protocols should be amended and submitted to the MRIN EC/KEPK MRIN within one month for re-review.

Suspension Termination

Stop until further clarification Permanently stop of the study

Adverse Event Any untoward medical occurrence in a patient or clinical investigation participant administered an investigational product and which does not necessarily have a causal relationship with this treatment. The adverse event can therefore be any unfavorable or unintended sign or experience associated with the use of the investigational product, whether or not related to the product.

Adverse Drug Reaction

In the pre-clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not established all noxious or unintended responses to the product related to any dose should be considered adverse drug reactions. The phrase “responses to a medicinal product” means that a causal relationship between the product and the adverse event is at least a reasonable possibility, i.e., the relationship can not be ruled out.

Regarding marketed products, a response to a product which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis or therapy of diseases or for modification of physiological function.

IND Investigational New Drugs means substances with

potential therapeutic actions during the process of scientific studies in human in order to verify their potential effects and safety for human use and to get approval for marketing.


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12.14. List of Abbreviation ADR Adverse Drug Reaction DSMB Data Safety Monitoring Board EC Ethics Committee IND Investigational New Drugs MRIN Mochtar Riady Institute for Nanotechnology PI Principal Investigator SAE Serious Adverse Event


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Informed Consent harus diberikan sebelum peneltian dimulai. 12. 15. Template Information for Subject

“Gunakan susunan kalimat atau kata kata dengan bahasa yang dimengerti oleh orang

awan dan hindari bahasa teknis, medis ataupun asing. Jika subyek hanya mampu

berkomunikasi dalam Bahasa daerah, maka lembar penjelasan disesuikan dengan

kemampuan berbahasa subyek”

1. Latar belakang, tujuan dan manfaat : J

Contoh :

Selamat pagi/siang Bapak/Ibu, saya ………….. (Sebutkan nama dokter), dokter

bidang ….. (sebutkan keahlian dokter dalam bidang apa) di rumah sakit ……,

bermaksud untuk memberikan informasi bahwa saat ini sedang berlangsung penelitian

terhadap ………….... (sebutkan penelitian dalam bahasa sederhana yang bukan

medis atau ilimiah), untuk keperluan pengembangan ilmu pengetahuan, yang nanti

hasilnya akan sangat bermanfaat untuk kepentingan perbaikan …………(sebutkan

manfaat dari penelitian tersebut dimasa yang akan datang.) . Penelitian ini akan

dilakukan di rumah sakit/intitusi (sebutkan nama ). Dengan biaya

dari……………(sebutkan sumber biaya)

2. Lama dan jumlah subyek penelitian

Contoh : Penelian ini akan mengumpulkan data (sample) sebanyak ………. , dimana

penelitian ini akan berlangsung ..…….(bulan/minggu/tahun), dari…. sampai …..

3. Alasan pemilihan subyek

Bapak ibu terpilih ikut serta dalam penelitian karena memenuhi persyaratan sebagai

subyek penelitian.

4. Prosedur Penelitian

Jelaskan prosedur Penelitian :

Jelaskan peserta diminta untuk menanda-tangani lembar persetujuan apabila

bersedia berpartisipasi pada Penelitian.

Jelaskan prosedur penelitian : wawancara,, pemeriksaan fisik dan lain-lain

Jika pengambilan data berupa wawancara, jelaskan siapa , dimana,

bagaimana, berapa lama wawancara dilaksanakan, serta jelaskan data-data

apa yang ingin diperoleh (contoh : Usia, Riwayat Penyakit, Kebiasaan

merokok, dll)

Jika pengambilan data berupa pemeriksaan fisik, seperti pengambilan

darah/pemeriksaan USG,


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a. Jelaskan yang harus dilakukan oleh peserta sebelum pengambilan darah

dan setelah pengambilan darah.

b. Jelaskan siapa yang bertugas mengambil darah tersebut,

c. Jelaskan berapa banyak darah yang akan diambil, (setengah sendok teh

atau…)

d. Jelaskan bagian tubuh yang akan diambil darahnya/diperiksa

e. Jelaskan alat yang akan digunakan

f. Tempat dilakukan pengambilan darah/pemeriksaan tersebut.

g. Jelaskan perlakuan terhadap sisa sampel darah

h. Jika pengambilan data berupa pemberian obat, mohon di jelaskan dosis

dan prosedur pemberian obat.

i. Jika data diperoleh dengan cara menggunakan video/recorder untuk

peserta yang tidak dapat membaca dan menulis, penjelasan oleh peneliti

dan jawaban dari peserta untuk bersedia ikut/menolak penelitian direkam

dengan menggunakan video atau recorder . Jelaskan/perlihatkan bahwa

video/recorder masih belum berisi rekaman apapun (baru).

5. Kewajiban subyek

Subyek penelitian diminta mengikuti prosedur penelitian.

6. Kemungkinan Resiko

Contoh :

Efek samping pengambilan darah (ini hanya sebagai contoh yang akan diambil,

disesuaikan dengan penelitian), mungkin akan menyebabkan………, sedangkan

pemeriksaan ……… tidak ada efek sampingnya.

Jika terjadi efek samping yang tidak diinginkan, jelaskan perlindungan yang

diberikan. Apakah ada asuransi atau perlindungan apa yang ditanggung oleh

Peneliti/Sponsor.

7. Penjelasan kompensasi bagi subjek (ada/tidak ada harus dijelaskan)

Contoh :

Apabila ada penggantian ongkos transport bagi peserta, mohon sebutkan nominal

pengganti yang wajar pada peserta.

8. Hak Mengundurkan diri

Contoh :


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Keikutertaan bapak/ibu adalah bersifat sukarela tanpa paksaan dan dapat

mengundurkan diri kapanpun tanpa kehilangan hak untuk memperoleh pelayanan

kesehatan di rumah sakit

9. Penjelasan perlindungan terhadap kerahasiaan peserta penelitian:

Contoh :

Semua informasi yang Bapak/Ibu berikan akan dirahasiakan dan hanya digunakan

dalam penelitian ini. Data-data akan disimpan di …….. dan dimusnakan…….Bila

data Bapak/Ibu dipublikasikan, kerahasiaannya tetap akan dijaga.

10. Kesediaan ikut serta dalam penelitian

Contoh :

Jika bapak/ibu menyetujui ikut serta dalam penelitian ini, silahkan menandatangani

lembar persetujuan di bawah ini.

11. Nama Jelas, alamat penangung jawab & nomor telepon kontak

Contoh :

Apabila ada yang perlu ditanyakan, kami akan dengan senang hati

menjelaskannya. Bapak/Ibu dapat menghubungi dokter/peneliti di bawah ini :

Nama : …………………………

Alamat : ………………………

No HP : ……………………...

12. Penutup

Contoh : Demikianlah penjelasan ini, semoga dapat berpartisipasi. Terimakasih.


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12. 16. Template Informed Consent Form

SURAT PERSETUJUAN SETELAH PENJELASAN (INFORMED CONSENT)

Yang bertanda-tangan di bawah ini, N a m a : U s i a : Setelah diberikan penjelasan dan memahami, dengan ini saya menyatakan dengan sukarela, tanpa paksaan dari pihak manapun bersedia/tidak bersedia* sebagai peserta pada penelitian …..(SEBTUKAN JUDUL PENELITIAN) ,……(NAMA PENELITI) Saya bersedia diwawancara, diperiksa atau diambil darahnya ……(SEBUTKAN BAGIAN MANA SUBYEK AKAN DIPERIKSA) maupun kegiatan lain yang berhubungan dengan penelitian ini. Saya bersedia data hasil pemeriksaan dianalisis dan dipresentasikan untuk publikasi ilmiah dimana Identitas pribadi saya hanya diketahui oleh Peneliti, Sponsor dan yang berhubungan dengan penelitian ini saja. Sewaktu –waktu saya berhak untuk mundur dari penelitian tanpa kehilangan hak saya sebagai pasien. Demikian Surat Persetujuan ini dibuat dengan sebenar-benarnya, tanpa tekanan dari pihak manapun. Tempat/Tanggal, ………………….. Saksi, (jika diperlukan) Yang menanda-tangani Surat Persetujuan, Hubungan dengan subyek : …………… (……………………………) (………………………………..) NamaJelas & Tanda-Tangan Nama Jelas &Tanda-Tangan Saya telah membaca dengan akurat atau menyaksikan pembacaan akurat dari bentuk persetujuan kepada peserta potensial, dan individu tersebut memiliki kesempatan untuk mengajukan pertanyaan. Saya mengonfirmasikan bahwa individu tersebut telah memberi persetujuan dengan bebas.

Saya

Peneliti,

(………………………………..) Nama Jelas &Tanda-Tangan *coret yang tidak perlu


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A. Informed Consent dengan melibatkan Anak - anak

Penelitian yang melibatkan subyek anak – anak , lembar informasi dan persetujuan harus diberikan kepada orang tua/wali dan anak.

Persetujuan yang ditanda-tangani oleh orang tua atau wali tidak menggantikan persetujuan yang diberikan oleh anak. Persetujuan yang diberikan oleh anak merupakan tambahan atas persetujuan dan kerja sama anak untuk ikut Penelitian .

Isi Lembar informasi pada dasarnya sama seperti di atas akan tetapi perlu penjelasan mengapa melibatkan anak-anak kepada orang tua/wali dan kepada anak itu sendiri.

Bila subjek anak, belum bisa tanda-tangan, persetujuan oleh anak bisa dilakukan dengan cap jempol

Contoh :

Saya telah menanyakan kepada anak Bapak/Ibu dan mereka mengerti prosedur Penelitian tentang ….

Penelitian ini telah kami jelaskan kepada ayah/ibu/wali adik dan mereka setuju adik ikut serta Penelitian ini, dan setelah diberikan penjelasan oleh kami apakah adik bersedia ikut serta penelitian.

B. Informed Consent Subyek rentan

Penelitian yang menggunakan subyek rentan dengan pertanyaan atau penyakit yang bersifat sensitive yang berkaitan dengan harga diri subyek (rendah diri/malu) ,bisa dapat diminta langsung atau dikonfirmasikan melalui perantara yang dapat dipercaya.

Contoh :

I. Secara tidak langsung

Kami akan melakukan penetian yang mencakup topic sensitive (sebutkan Penelitian tersebut) apakah kami dapat menghubungi langsung Bapak/ Ibu atau anak Bapak/Ibu.

Dengan cara apakah kami dapat menghubungi Bapak/Ibu.

Bapak/Ibu atau anak Bapak/Ibu tidak harus menyetujui berkomunikasi dengan kami karena kami mengerti sulit untuk mengambil keputusan ini . Oleh karenanya sebelum kami berkomunikasi dengan Bapak/Ibu atau anak Bapak/Ibu, kami memberikan kesempatan Bapak/Ibu atau anak Bapak/Ibu bertanya sebanyak mungkin lewat mediator kami tentang penelitian ini dan memberi tahu kami keputusan Bapak/Ibu.


for Nanotechnology


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II. Langsung dengan subyek

Bila data didapat dari subyek, jelaskan tempat yang specific dimana pembicaraan informasi yang diperoleh tidak didengar /diketahui oleh orang lain.

Table of Contentsmrinstitute.org/Form SOP MRIN EC 2019/Guideline for PI... · 2019-01-22 · Medicine, Universitas Pelita Harapan (FK UPH), Universitas Pelita Harapan or Siloam Hospitals

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