mochtarriady institute for nanotechnology sop/008/ 20/01.5 …mrinstitute.org/sop/008. use of study...

MochtarRiady Institute for Nanotechnology

Ethics Committee (MRIN EC)

SOP/008/2020/01.5

Effective date :

2 January 2020

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



SOP/008/2020/01.5

Effective date :

2 January 2020

of 27 Title:


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



SOP/008/2020/01.5

Effective date :

2 January 2020

of 27 Title:


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



SOP/008/2020/01.5

Effective date :

2 January 2020

of 27 Title:


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



SOP/008/2020/01.5

Effective date :

2 January 2020

of 27 Title:


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



SOP/008/2020/01.5

Effective date :

2January 2020

of 27 Title:


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

http://www.fercap-sidcer.org/selftool%20.php



SOP/008/2020/01.5

Effective date :

2January 2020

of 27 Title:


Form


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:



SOP/008/2020/01.5

Effective date :

2January 2020

of 27 Title:


Form


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


Comment:

8 Withdrawal Criteria


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:



SOP/008/2020/01.5

Effective date :

2January 2020

of 27 Title:


Form


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:



SOP/008/2020/01.5

Effective date :

2January 2020

of 27 Title:


Form


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



SOP/008/2020/01.5

Effective date :

2January 2020

of 27 Title:


Form


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


Comment



SOP/008/2020/01.5

Effective date :

2January 2020

of 27 Title:


Form


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


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


Comment

18. Anticipated expenses, if any, to the

participant in the course of the study


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



SOP/008/2020/01.5

Effective date :

2January 2020

of 27 Title:


Form


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



SOP/008/2020/01.5

Effective date :

2January 2020

of 27 Title:


Form


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



SOP/008/2020/01.5

Effective date :

2January 2020

of 27 Title:


Form


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



SOP/008/2020/01.5

Effective date :

2January 2020

of 27 Title:


Form


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, ____________________ __________________



SOP/008/2020/01.5

Effective date :

2January 2020

of 27 Title:


Form


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



SOP/008/2020/01.5

Effective date :

2January 2020

of 27 Title:


Form


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, ___________________ _____________________



SOP/008/2020/01.5

Effective date :

2January 2020

of 27 Title:


Form


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;



SOP/008/2020/01.5

Effective date :

2January 2020

of 27 Title:


Form


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;



SOP/008/2020/01.5

Effective date :

2January 2020

of 27 Title:


Form


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.



SOP/008/2020/01.5

Effective date :

2January 2020

of 27 Title:


Form


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):



SOP/008/2020/01.5

Effective date :

2January 2020

of 27 Title:


Form


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?



SOP/008/2020/01.5

Effective date :

2January 2020

of 27 Title:


Form


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





SOP/008/2020/01.5

Effective date :

2January 2020

of 27 Title:


Form



be Major Revision.





be Major Revision.





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 “



SOP/008/2020/01.5

Effective date :

2January 2020

of 27 Title:


Form


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



SOP/008/2020/01.5

Effective date :

2January 2020

of 27 Title:


Form


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

mochtarriady institute for nanotechnology sop/008/ 20/01.5 …mrinstitute.org/sop/008. use of study...

Documents