MochtarRiady Institute for Nanotechnology
Ethics Committee (MRIN EC)
SOP/008/2020/01.5
Effective date :
2 January 2020
Page 1 of 27 Title:
008. Use of Study Assessment
Form
Table of Contents
No. Content Page No.
Table of Contents ................................................................................................................ 1
1. Purpose ........................................................................................................................ 2
2. Scope ........................................................................................................................... 2
3. Responsibility ............................................................................................................. 2
4. Flow chart ................................................................................................................... 2
5. Detailed instructions ................................................................................................... 3
5.1 Summarize the protocol in an Application Assessment Form. ........................... 3
5.1.1 General Protocol Information ......................................................................... 3
5.2. Review the study protocol .................................................................................. 3
5.3. Examine the qualification of investigators and of study sites. ............................ 4
5.4. Review study participation. ................................................................................ 4
5.5. Examine community involvement and impact. .................................................. 4
5.6. The reviewer makes a decision. .......................................................................... 5
5.7 Gather the assessment reports. ............................................................................ 5
5.8. Record the MRIN EC/KEPK MRIN decision. ................................................... 5
6. Glossary ...................................................................................................................... 6
7. Annex .......................................................................................................................... 6
8. References ................................................................................................................... 6
Annex 1 Study Assesment Form for Human Subject ......................................................... 7
Annex 2 Informed Consent Form………………………………………………………...10
Annex 3 Notification of Decision …………………………………………………... ... ..16
Annex 4 Ethical Approval ……………………………………………………………….18
Annex 5 Elements of the Review for Human Subject ...................................................... 19
Annex 6 Checklist for Placebo - Control Studies ……………………………..................22 Annex 7 Document History………………………………………………........................24
MochtarRiady Institute for Nanotechnology
Ethics Committee (MRIN EC)
SOP/008/2020/01.5
Effective date :
2 January 2020
Page 2 of 27 Title:
008. Use of Study Assessment
Form
1. Purpose
This SOP describes how the MRIN EC members use the assessment forms when
reviewing the study protocols initially submitted for approval. The Assessment Form
(AF/01-008/2020/01.5 is designed to standardize the review process and to facilitate
reporting, recommendation and comments given to each individual protocol.
2. Scope
This SOP applies to the review and assessment of all protocols submitted for initial
review and approval from the MRIN EC. The specific questions in the Assessment Form
must be adequately addressed in the protocol itself and/or protocol-related documents
under review.
Relevant points made during discussion and deliberation about a specific protocol should
be recorded on the form.
The decision reached by the committee and the reasons for its decision is recorded on the
Application Assessment Form.
3. Responsibility
It is the responsibility of the reviewers to fill the assessment form along with decision and
comments they might have after reviewing each study protocol. The MRIN EC
Secretariat is responsible for recording and filing the decision, relevant points and
deliberation about a specific protocol, including the reasons for that decision. The
Chairperson and Secretary of the MRINmust sign and date to approve the decision in the
form.
4. Flow chart
No. Activity Responsibility
1 Summarize the protocol in an Assessment Form
EC Secretariat
2 Review the Study Protocol
ECMembers / Reviewers
3 Examine qualification of Investigators and
study sites
ECMembers / Reviewers
MochtarRiady Institute for Nanotechnology
Ethics Committee (MRIN EC)
SOP/008/2020/01.5
Effective date :
2 January 2020
Page 3 of 27 Title:
008. Use of Study Assessment
Form
4 Review study participation
EC Members / Reviewers
5 Examine community involvement and impact
EC Members / Reviewers
6 Make a decision
EC Reviewers
7 Gather Assessment Reports
ECSecretariat
8 Record the MRIN EC/KEPK MRIN’s Decision EC Secretariat
5. Detailed instructions
5.1 Summarize the protocol in an Application Assessment Form.
5.1.1 General Protocol Information
Record general information about the protocol in the form
AF/01-008/2020/01.5 (Annex 1) or AF/02-008/2020/01.5
(Annex 2) such as:
Title of the protocol
Protocol number and date
Principal Investigators, license & contact number
Co-investigators & contact number
Funding agency & contact number
Study types
Duration of the study
Status of the protocol – New / Revised / Amended
Review status – Regular / Expedited / Emergency
Reviewer’s name
Objective and description of the Study
5.2. Review the study protocol
Need for human participants for study
Need theuse of biological agents / materials
Objectives of the study
Review of Literature
Sample Size
Methodology and data management
MochtarRiady Institute for Nanotechnology
Ethics Committee (MRIN EC)
SOP/008/2020/01.5
Effective date :
2 January 2020
Page 4 of 27 Title:
008. Use of Study Assessment
Form
Inclusion/exclusion criteria
Control arm (placebo, if any)
Withdrawal or discontinuation criteria
Refer to Annex 5 for guidance in reviewing protocol
5.3. Examine the qualification of investigators and of study sites.
Consider whether study and training background of
theparticipating investigators relate to the study.
Examine disclosure or declaration of potential conflicts of interest
Can facilities and infrastructure at study sites accommodate the
study?
Non-physician principal investigators (PI) should be advised by a
physician when necessary
5.4. Review study participation.
Voluntary, non-coercive recruitment/participation
Procedures for obtaining informed consent
Contents of the patient information sheet
Contents and language of the informed consent document
Translation of the informed consent document in the local
Language used – plain and easy to understand by general public
Contact persons with address and phone numbers
Privacy and confidentiality
Risks – physical / mental / social
Benefits – to participants and to others
Compensation – Reasonable / unreasonable
Involvement of vulnerable participants
Provisions for medical/psychosocial support
Treatment for study related injuries
Use of biological materials
5.5. Examine community involvement and impact.
Community consultation
Involvement of local researchers and institutions in the protocol
design, analysis and publication of the results
MochtarRiady Institute for Nanotechnology
Ethics Committee (MRIN EC)
SOP/008/2020/01.5
Effective date :
2 January 2020
Page 5 of 27 Title:
008. Use of Study Assessment
Form
Contribution to development of local capacity for research and
treatment
Benefit to local communities
Availability of study results
5.6. The reviewer makes a decision.
Record the decision by marking in the desired block any of the
following:“Approved, minor revision, major revision, or
Disapproved.”
Include comments, suggestion and reason for disapproval.
Check the completeness and correctness of the assessment form.
Sign and date the decision form.
Give or send the complete forms to the EC Secretariat.
5.7. Gather the assessment reports.
Collect the assessment forms and the review result from each
reviewer.
Organize the forms in order.
Summarize the comments, suggestions, and opinions of each study
in the meeting agenda.
Follow SOP/021/2020/01.5 Preparation of meeting agenda and
minutes.
5.8. Record the MRIN EC decision.
Complete the information.(by the Secretariat)
List participating members and their votes.
Summarize the guidance, advice and decision reached by the
MRIN EC members.
Sign and date the document. (by the Chairperson of the MRIN EC
or by the Secretary, where applicable)
Make a copy of the completed decision form.
Keep the original copy in the file labeled “MRIN EC’s decision”.
Keep the copy of the decision form with the study protocol
Return the file and the protocol to the appropriate shelves.
Use Annex 2 to communicate MRIN EC’s Decision to PI
Use Annex 3 as a template for MRIN EC’s Ethical Approval
MochtarRiady Institute for Nanotechnology
Ethics Committee (MRIN EC)
SOP/008/2020/01.5
Effective date :
2January 2020
Page 6of 27 Title:
008. Use of Study Assessment
Form
D:\Ethics Committee\SOP\
6. Glossary
Study Assessment
Form
An official record that documents the protocol review
process.
Document Document may be of any forms, e.g., paper, electronic mail
(e-mail), faxes, audio or video tape, etc.
7. Annex
Annex 1 AF/01-008/2020/01.5 Study Assessment Form for Human Subject
Annex 2 AF/02-008/2020/01.5 ICF Form
Annex 2 AF/02-008/2020/01.5 MRIN EC Notification of Decision
Annex 3 AF/03-008/2020/01.5 Ethical Approval
Annex 4 AF/04-008/2020/01.5 Elements of the Review for Human Subject
Annex 5 AF/05-008/2020/01.5 Checklist Placebo - Controlled Studies
Annex 6 AF/06-008/2020/01.5 Document History
8. References
Operational Guidelines for Ethics Committees that Review Biomedical
Research, World Health Organization, 2000, Geneva.
Surveying and Evaluating Ethical Review Practices, World Health
Organization, 2002, Geneva.
International Conference on Harmonisation (ICH) Harmonised Tripartite :
Guideline for Good Clinical Practice E6(R1), Current Step 4 version dated
10 June 1996, November 2005, November 2016
Undang-undang Kesehatan No. 36 Tahun 2009 pasal 44.
Standards and Operational Guidance for Ethics Review of Health-Related
Research with Human Participants, 2011, World Health Organization,
Pedoman Nasional Etik Penelitian Kesehatan, Komisi Nasional Etik
Penelitian Kesehatan, 2011.
SIDCER Self-Assessment Tool, http://www.fercap-sidcer.org/selftool.php,
accessed January 2013.
Associated SOPs: SOP/021/2020/01.5
International Ethical Guidelines for Health related Research Involving
Humans , CIOMS, 2016, Geneva
Pedoman Cara Uji Klinik Yang Baik Di Indonesia, Edisi III, 2016, Badan
Pengawas Obat dan Makanan, Republik Indonesia
Standard Operating Procedures, Cambridge University
MochtarRiady Institute for Nanotechnology
Ethics Committee (MRIN EC)
SOP/008/2020/01.5
Effective date :
2January 2020
Page 7of 27 Title:
008. Use of Study Assessment
Form
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Annex 1
Form AF/01-008/2020/01.5
Study Assessment Form for Human Subject
Protocol Number : Date (D/M/Y):
Protocol Title :
Principal Investigators: License: No:
Institute: Contact No.
Co – investigator(s): Contact No.
Total No. of Participants: No.of Study site:
Funding Agency: Contact No.
Duration of the Study: Status: New Revised Amended
Reviewer’s name : Contact No.
Type of the Study : Intervention Epidemiology Observation
Document based Individual based Genetic
Social Survey Others, specify……………………….
Review Status: Full Board Expedited Exempted
Please mark and fill comments if any suggestion or recommendation from the
reviewers.
1 Objectives of the Study
Clear Unclear
Comment :
2 Need for Human Participants
Yes No
Comment:
3 Methodology (study design)
Clear Unclear
Comment:
MochtarRiady Institute for Nanotechnology
Ethics Committee (MRIN EC)
SOP/008/2020/01.5
Effective date :
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Page 8of 27 Title:
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Annex 1
Form AF/01-008/2020/01.5
4 Background Information and Data
sufficient insufficient
Comment:
5 Risks and Benefits Assessment
acceptable unacceptable
Comment:
6 Inclusion Criteria
appropriate inappropriate
Comment:
7 Exclusion Criteria
appropriate inappropriate
Comment:
8 Withdrawal Criteria
appropriate inappropriate
Comment:
9 Involvement of Vulnerable
Participants
Yes No
Comment:
10 Voluntary, Non-Coercive
Recruitment of Participants
Yes No
Comment:
11 Sufficient number of participants?
Yes No
Comment:
12 Control Arms (placebo, if any)
Yes No
Comment:
13 Are Qualification and experience
of the Participating Investigators
appropriate?
Yes No
Comment:
MochtarRiady Institute for Nanotechnology
Ethics Committee (MRIN EC)
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Annex 1
Form AF/01-008/2020/01.5
14 Disclosure or Declaration of
Potential Conflicts of Interest
Yes No
Comment:
15 Facilities and infrastructure of
Participating Sites
Appropriate Inappropriate
Comment:
16 Community Consultation
Yes No
Comment:
17 Involvement of Local Researchers
and Institution in the Protocol
Design, Analysis and Publication
of Results
Yes No
Comment:
18 Contribution to Development of
Local Capacity for Research and
Treatment
Yes No
Comment:
19 Benefit to Local Communities
Yes No
Comment:
20 Availability of similar Study /
Results
Yes No
Comment:
21 Are blood/tissue samples sent
abroad?
Yes No
Comment:
MochtarRiady Institute for Nanotechnology
Ethics Committee (MRIN EC)
SOP/008/2020/01.5
Effective date :
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Annex 2
Form AF/02-008/2020/01.5
Study Assessment Form for ICF
Please mark and fill comments if any suggestion or recommendation from the
reviewers
1. Statement that the study involves research
Yes No
Comment
2. Statement describing the purpose of the
research
Yes No
Comment
3. Study-related treatments and probability for
random assignment
Yes No
Comment
4. Study procedures including all invasive
procedures
Clear Unclear
Comment
5. Responsibilities of the participant
Clear Unclear
Comment
6. Expected duration of participation in the
study
Yes No
Comment
7. Approximate number of participants in the
study
Yes No
Comment
8. Study aspects that are experimental
Yes No
Comment
MochtarRiady Institute for Nanotechnology
Ethics Committee (MRIN EC)
SOP/008/2020/01.5
Effective date :
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Annex 2
Form AF/02-008/2020/01.5
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
Yes No
Comment
10. Risks from allowable use of placebo (as
applicable)
Yes No
Comment
11. Reasonably expected benefits; or absence of
direct benefit to participants, as applicable
Yes No
Comment
12. Expected benefits to the community or to
society, or contributions to scientific
knowledge
Yes No
Comment
13. Description of post-study access to the study
product or intervention that have been
proven safe and effective
Clear Unclear
Comment
14. Alternative procedures or treatment available
to participant
Clear Unclear
Comment
15. Compensation or insurance or treatment
entitlements of the participant in case of
study-related injury
Appropriate Inappropriate
Comment
MochtarRiady Institute for Nanotechnology
Ethics Committee (MRIN EC)
SOP/008/2020/01.5
Effective date :
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Annex 2
Form AF/02-008/2020/01.5
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
Appropriate Inappropriate
Comment
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
Appropriate Inappropriate
Comment
18. Anticipated expenses, if any, to the
participant in the course of the study
Appropriate Inappropriate
Comment
19. Statement that participation is voluntary, and
that participant may withdraw anytime
without penalty or loss of benefit to which
the participant is entitled
Yes No
Comment
20. Statement that the study monitor(s),
auditor(s), the MRIN EC and regulatory
authorities will be granted direct access to
participant’s medical records for purposes
ONLY of verification of clinical trial
procedures and data
Comment
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
Yes No
Comment
MochtarRiady Institute for Nanotechnology
Ethics Committee (MRIN EC)
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Annex 2
Form AF/02-008/2020/01.5
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
Yes No
Comment
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
Yes No
Comment
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
Yes No
Comment
25. Plans to develop commercial products from
biological specimens and whether the
participant will receive monetary or other
benefit from such development
Yes No
Comment
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
Yes No
Comment
MochtarRiady Institute for Nanotechnology
Ethics Committee (MRIN EC)
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Annex 2
Form AF/02-008/2020/01.5
27. Statement describing access of participant to
the result of the study
Yes No
Comment
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)
Yes No
Comment
29. Foreseeable circumstances and reasons under
which participation in the study may be
terminated
Yes No
Comment
30. Sponsor, institutional affiliation of the
investigators, and nature and sources of
funds
Yes No
Comment
31. Statement whether the investigator is serving
only as an investigator or as both investigator
and the participant’s healthcare provider
Yes No
Comment
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
Yes No
Comment
MochtarRiady Institute for Nanotechnology
Ethics Committee (MRIN EC)
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Annex 2
Form AF/02-008/2020/01.5
33. Comprehensibility of language used
Clear Unclear
Comment
34. Recommendations :
35 Conclusion:
Approved
Minor revision
Major revision
Disapproved
Tangerang, Date.............................20...
Reviewer
MochtarRiady Institute for Nanotechnology
Ethics Committee (MRIN EC)
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Annex 3
Form AF/03-008/2020/01.5
Page 1 of 2
Mochtar Riady Institute for Nanotechnology
Ethics Commitee (MRIN EC)
Notification of Decision
No. :
Protocol no. :
Protocol Title :
Principal Investigator:
DATE OF MEETING :
SUMMARY OF THE MRIN EC MEETING :
Review of Revised Application
Yes No
Date of Previous review:
DECISION OF THE EC :
a. Approved
b. Minor revision*
c. Major revision*
d. Disapproved
Please be noted that this is a notification only.
*Ethical Approval Letter will be issued after MRIN EC has reviewed your
resubmitted documents.
* The revise protocol should be submitted within 7 days
* If the revise protocol has not been submitted after 90 days, you are required to
submit a new protocol to MRIN EC
dd/mm/year
Chairperson, Secretary, ____________________ __________________
MochtarRiady Institute for Nanotechnology
Ethics Committee (MRIN EC)
SOP/008/2020/01.5
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Annex 3
Form AF/03-008/2020/01.5
Page 2 of 2
RESULT OF MRN EC REVIEW
Principal Investigator’s name
Title of Research
Reviewer’s recommendations
MochtarRiady Institute for Nanotechnology
Ethics Committee (MRIN EC)
SOP/008/2020/01.5
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Annex 4 Form AF/04-008/2020/01.5
ETHICAL APPROVAL No. ……….
The Mochtar Riady Institute for Nanotechnology Ethics Committee (MRIN EC) certifies that the following protocol and related documents have been reviewed to the research entitled : …………………………………………………………………………………………
…………………………………………………………………………………………
Principal Investigator: …………………… Protocol Number : ………………………… Version Number of ICF : ……………….. Submitted on : ……………………….. Last Revision dated on /Version ................ Has confirmed this protocol is approved. This ethical approval is valid from dd/mm/year until dd/mm/year. Should there be any modification (amendment) and / or extension of the study, the Principal Investigator is required to resubmit the protocol for approval. A progress (50% of research) and final summary report must also be submitted to MRIN EC Please be noted that you must notify the MRIN EC in writing regarding any alteration to the research and protocol deviation. You must also notify the MRIN EC immediately in the event of any Serious Adverse Event (SAE) and Suspected Unexpected Serious Adverse Reaction (SUSAR) on participants or of any unforseen events that might affect continued ethical acceptability of the research. Tangerang, …….. Mochtar Riady Institute for Nanotechnology Ethics Committee Chairperson, Secretary, ___________________ _____________________
MochtarRiady Institute for Nanotechnology
Ethics Committee (MRIN EC)
SOP/008/2020/01.5
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Annex 5 Form AF/05-008/2020/01.5
Elements of the Review involving human subject The primary task of an EC lies in the review of research proposals and their
supporting documents, with special attention given to the informed consent process,
documentation, and the suitability and feasibility of the protocol, MRIN EC’s need to
take into account prior scientific reviews, if any, and the requirements of applicable
law and regulations. The following should be considered, as applicable
1. Scientific Design and Conduct of the Study
1.1 The appropriateness of the study design in relation to the objectives of the
study, the statistical methodology (including sample size calculation), and the
potential for reaching sound conclusions with the smallest number of research
participants;
1.2 The justification of predictable risks and inconveniencesweighed against the
anticipated benefits for the researchparticipants and the concerned
communities;
1.3 The justification for the use of control arms;
1.4 Criteria for prematurely withdrawing research participants;
1.5 Criteria for suspending or terminating the research as awhole;
1.6 The adequacy of provisions made for monitoring and auditingthe conduct of
the research, including the constitutionof a data safety monitoring board
(DSMB);
1.7 The adequacy of the site, including the supporting staff,available facilities, and
emergency procedures
1.8 The manner in which the results of the research will bereported and published;
2 Recruitment of Research Participants
2.1 The characteristics of the population from which the researchparticipants will
be drawn (including gender, age,literacy, culture, economic status, and
ethnicity);
2.2 The means by which initial contact and recruitment is tobe conducted;
2.3 The means by which full information is to be conveyed topotential research
participants or their representatives;
2.4 Inclusion criteria for research participants;
2.5 Exclusion criteria for research participants;
3 Care and Protection of Research Participants
3.1 The suitability of the investigator(s)’s qualifications andexperience for the
proposed study;
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3.2 Any plans to withdraw or withhold standard therapies forthe purpose of the
research, and the justification for suchaction;
3.3 The medical care to be provided to research participantsduring and after the
course of the research;
3.4 The adequacy of medical supervision and psycho-socialsupport for the
research participants;
3.5 Steps to be taken if research participants voluntarily withdrawduring the
course of the research;
3.6 The criteria for extended access to, the emergency use of,and/or the
compassionate use of study products;
3.7 The arrangements, if appropriate, for informing the researchparticipant’s
general practitioner (family doctor), includingprocedures for seeking the
participant’s consent to do so;
3.8 A description of any plans to make the study product availableto the research
participants following the research;
3.9 A description of any financial costs to research participants;
3.10 The rewards and compensations for research participants(including money,
services, and/or gifts);
3.11 The provisions for compensation/treatment in the case ofthe
injury/disability/death of a research participant attributableto participation in
the research;
3.12 The insurance and indemnity arrangements;
4 Protection of Research Participant Confidentiality
4.1 A description of the persons who will have access to personaldata of the
research participants, including medicalrecords and biological samples;
4.2 The measures taken to ensure the confidentiality and securityof personal
information concerning research participants;
5 Informed Consent Process
5.1 A full description of the process for obtaining informedconsent, including the
identification of those responsiblefor obtaining consent;
5.2 The adequacy, completeness, and understandability of writtenand oral
information to be given to the research participants,and, when appropriate,
their legally acceptablerepresentative(s);
5.3 Clear justification for the intention to include in the researchindividuals who
cannot consent, and a full accountof the arrangements for obtaining consent or
authorizationfor the participation of such individuals;
5.4 Assurances that research participants will receive informationthat becomes
available during the course of the researchrelevant to their participation
(including their rights,safety, and well-being);
5.5 The provisions made for receiving and responding to queriesand complaints
from research participants or their representativesduring the course of a
research project;
MochtarRiady Institute for Nanotechnology
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6 Community Considerations
6.1 The impact and relevance of the research on the local communityand on
theconcerned communities from whichthe research participants are drawn;
6.2 The steps taken to consult with the concerned communitiesduring the course
of designing the research;
6.3 The influence of the community on the consent of individuals;
6.4 proposed community consultation during the course of theresearch;
6.5 The extent to which the research contributes to capacitybuilding, such as the
enhancement of local healthcare, research,and the ability to respond to public
health needs;
6.6 A description of the availability and affordability of anysuccessful study
product to the concerned communitiesfollowing the research;
6.7 The manner in which the results of the research will bemade available to the
research participants and the concernedcommunities.
MochtarRiady Institute for Nanotechnology
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Annex 6 Form AF/06-008/2020/01.5
Checklist for Placebo – Controlled Studies
1. Benefits of standard treatment (This is a consideration of the background conditions,
and is generally not subject to change through modification of the protocol): 1. Is
there a standard treatment for this condition?
2. Is standard treatment widely accepted?
3. Has efficacy of the treatment been consistently proven?
4. Are all newly diagnosed patients with this condition put in standard treatment (vs. 5.
Does the treatment act on the basic mechanism of the disease (vs. symptoms)?
5. Are most (85%) of the patients with this condition responsive to standard treatment If
1 to 6 are yes, placebo is not recommended; if one or more are no, consider placebo.
6. Are the side effects of the standard treatment severe?
7. Does standard treatment have many uncomfortable side effects?
8. Does standard treatment have contraindications that prevent some subjects from
9. Is there substantial (25%) placebo response in this disease? If 7 to 10 are no, placebo
is not recommended; if one or more are yes, consider placebo.
1. II. Risks of placebo (This is a consideration of the background conditions, and is
generally not subject to change through modification of the protocol):
1. Is the risk of using placebo instead of treatment life threatening? If yes, placebo is 2.
Is the use of placebo instead of treatment likely to lead to permanent damage?
2. Is the risk of using placebo instead of treatment likely to cause irreversible disease 4.
Can the use of placebo instead of treatment lead to an acute emergency?
1. Is the risk of using placebo instead of treatment the persistence of distressing
2. Is the risk of using placebo instead of treatment severe physical discomfort or pain? If
4 to 6 are yes, placebo is not acceptable unless risk management is adequate.
2. 111. Protocol rlsk management (This group involves elements that can be modified
through changes to the research):
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Ethics Committee (MRIN EC)
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1. Is there benefit in the overall management of the subject in the study? If yes, consider
placebo; if no, placebo is not recommended.
2. Will the discontinuation of previous treatment put the subject in danger of acute If no,
consider placebo; if yes, placebo is not recommended.
3. Are subjects at high risk for the use of placebo excluded? If yes, consider placebo; if no,
placebo is not recommended.
4. Is the duration of the study the minimum necessary in relation to the action of the If yes,
consider placebo; if no, placebo is not recommended.
5. Are there clearly defined stopping rules (criteria in assessment tests, values in observed
or other)? alternatives (vs. resistant or refractory)? being treated? not acceptable. yes,
placebo is not acceptable. progression? If yes, placebo is not acceptable. symptoms?
relapse when transferred to placebo? drug? safety laboratory tests, time of evaluation), or
early escape, to withdraw the subject in case helshe does not improve? laboratory tests)
progression of the disease before the subject experiences severe consequences? safety
laboratory tests, time of evaluation), or early escape, to withdraw the subject before the
advent of severe disease progression? If yes, consider placebo; if no, placebo is not
recommended.
6. Is risk monitoring adequate to identify (schedule of assessment tests and safety If yes,
consider placebo; if no, placebo is not recommended.
7. Are there clearly defined stopping rules (criteria in assessment tests, values in If yes,
consider placebo; if no, placebo is not recommended. Ethical Concerns in Placebo-
controlled Trials 255 TABLE 1 Continued
8. If the risk of placebo is an acute emergency, are rescue medication and emergency
treatment available? If applicable and the answer is yes, consider placebo; if applicable
and answer is no, placebo is not recommended. If applicable and the answer is yes,
consider placebo; if applicable and the answer is no, placebo is not recommended.
9. If the risk of placebo is severe physical discomfort or pain, is there rescue If applicable
and the answer is yes, consider placebo; if applicable and the answer is no, placebo is not
recommended. modified through changes to the consent form): If yes, consider placebo;
if no, modify consent form. If yes, consider placebo; if no, modify consent form. If yes,
consider placebo; if no, modify consent form.
10. If the risk of placebo is the persistence of distressing symptoms, is concurrent medication
to control them allowed? medication? IV. Risk disclosure in the consent form (This
group involves elements that can be
a. Are the risks of getting placebo instead of active treatment fully disclosed?
b. Are the risks of the test drug disclosed?
c. Are the advantages of alternative treatments explained?
MochtarRiady Institute for Nanotechnology
Ethics Committee (MRIN EC)
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Effective date :
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Annex 7
Form AF/07-008/2020/01.5
Document History
Author Version Date Description
EC Members 01.0 2 January 2013 Finalversion
Ivet, Lia,
Mona
01.1 11 October 2014 1. Synchronize the topic number and
SOP number
2. Format Document History :
Author, Version, Date and
Description of the main change
3. Purpose : The Assessment Form
((AF/01-008/2014/01.1 (Human
Subject) or AF/02-008/2014/01.1
(Animal Study) &AF/03-
008/2014/01.1)
4. Section 5.5. Review Animal Study
5. Section 5.7. EC Decision :
Approved,Approved with minor
revision,approved wtih major
revision, dissaproved
6. Correction for Annex 1, Annex 2,
Annex 3, Annex 4 and Annex 5;
follow section 5.7
7. Glossary : Animal Research/Study and Animal Welfare
8. Use a separate assessment form for
animal studies : Annex 2 : Study
assessment for Animal study and
Annex 8 : Elements of review for
Animal study
9. Annex 6 : Ethical Approval to include
requirement for PI to submit A. SAE,
SUSAE Report. B. Protocol Deviation
Reports
Lia, Mona 01.2 20 February 2016 1. Form Annex 1: Replace Decision
Approved with Minor revision to
be Minor Revision and Replace
Approved with Major Revision to
be Major Revision.
2. Form Annex 2: Replace Decision
Approved with Minor revision to
be Minor Revision and Replace
MochtarRiady Institute for Nanotechnology
Ethics Committee (MRIN EC)
SOP/008/2020/01.5
Effective date :
2January 2020
Page 25of 27 Title:
008. Use of Study Assessment
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D:\Ethics Committee\SOP\
Approved with Major Revision to
be Major Revision.
3. Form Annex 3: Replace Decision
Approved with Minor revision to
be Minor Revision and Replace
Approved with Major Revision to
be Major Revision.
4. Form Annex 4: Replace Decision
Approved with Minor revision to
be Minor Revision and Replace
Approved with Major Revision to
be Major Revision.
5. Item 5.7 recor the decision in the
desired block any of the following
“Approved, Approved with Minor
revision, Approved with major
revision, or disapproved replace to
Approved, Minor revision , Major
revision and Dissapproved
Magdarina D.
Agtini,
SintakGunaw
an, Lia Siti
Halimah,
Dondin
Sajuthi
01.3 1 April 2017 3. Delete
KomisiEtikPenelitianKesehatan
(KEPK) on the header
4. Item 5.5, to add Glossary of
reviewing animal study and to
change the word of physical with
and hazard
5. Item 5.9 : Delete the sentence of
List participating members and
their votes 6. Revise numbers of Annex from 9
Annex to 8 Annex
Annex 1 item No. 3
(Methodology) : to add “study
design”
Delete Annex 3 (Assesment
Report), Annex 5 became
Annex 3
Delete Annex 4 (MRIN
EC/KEPK MRIN’s decision),
Annex 6 became Annex 4.
Replace the sentence :” The
MochtarRiady Institute for
Nanotechnology Ethics
Committee (MRIN EC), after
conducting review on the
research Protocol entitled” to “
MochtarRiady Institute for Nanotechnology
Ethics Committee (MRIN EC)
SOP/008/2020/01.5
Effective date :
2January 2020
Page 26of 27 Title:
008. Use of Study Assessment
Form
D:\Ethics Committee\SOP\
The MochtarRiady Institute
for Nanotechnology Ethics
Committee (MRIN EC), after
conducting review based on
Helsinki Declaration of the
research Protocol entitled”.
Replace the word “revision”
to “ Last revision/Version”
Add new Annex (Annex 5) for
Ethical Exemption
Annex 7, 8 and 9 became Annex 6, 7 and 8
LSH/MW/IS 01.4 2 January 2019
1. Item 1 : Purpose : Delete the
wording “orAF/02-008/2018/01.4
(Animal Study))”
2. Item 4 Flowchart : Delete review
of Animal Study
3. Item 5.3 Box 4 : Delete the word
of veterinarian
4. Item 5.5. : Delete review of
Animal Study
5. Item 5.6 to 5.9 became item 5.5. to
5.8
6. Annex 2 : Delete Form for
Animal Study
7. Annex 4 : to Include information
regarding Protocol Deviation,
delete receive no.
8. Annex 7 : Delete Annex 7
Element review for Animal Study
9. Annex 8 became Annex 7
10. Annex 3 to Annex 7 became
Annex 2 to 6
11. Annex 3 : Delete receive no.
12. Glossary : Delete glossary for
Animal study, welfare and housing
13. Reference : Delete guideline
regarding animal study
MochtarRiady Institute for Nanotechnology
Ethics Committee (MRIN EC)
SOP/008/2020/01.5
Effective date :
2January 2020
Page 27of 27 Title:
008. Use of Study Assessment
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D:\Ethics Committee\SOP\
IS,MW,LSH,
GE
01.5 2 January 2020 1. Responsibility : replace the
statement of “ the scientific
director (if applicable)” with “
Secretary”
2. Annex 1 : separate assessment
form and study assessment form
for ICF
3. Annex 1 & 2 : replace with “please
mark and fill comments “ Please
mark and fill comments if any
suggestion or recommendation
from the reviewers.”
4. Annex 3 : to add statement of “The
revise protocol should be
submitted within 7 days
* If the revise protocol has not
been submitted after 90 days, you
are required to submit a new
protocol to MRIN EC
5. Annex 4 : delete (ETHICAL
EXEMPTION)
6. Annex 6 : add Element Review of
Placebo
7. References :
Delete link WHO
Delete FERCAP SOP
Add ICH 2016
Add SOP Cambridge university