10- naco ethical guidelines for operational research

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ETHICAL GUIDELINES FOR

OPERATIONAL RESEARCH ON

HIV/AIDS

Version 2008

NATIONAL AIDS CONTROL ORGANISATION

Ministry of Healt ! Fa"ily #elfare$

Go%ern"ent of In&ia



CONTENTS

1. Introduction

1.1 Preamble

1.2 Basic Responsibility of the Ethics Committee

1.3 Composition of NAC Ethics Committee1.! "erms of Reference of #embers

2. Principles for Ethical Issues

2.1 $eneral Principles for Ethical Issues

2.2 %pecific Principles

2.2.1 Informed consent of Participants

2.2.2 Essential Information for prospecti&e research participants

2.2.3 Confidentiality for prospecti&e research participants2.2.! Conflicts of Interest

2.2.' International collaboration(assistance in E&aluation and perational

Research2.2.) %pecial Concerns

3. Researcher*s relations +ith the media and publication practices

!. Ethical Issues in Epidemiolo,ical Research

'. -istinction bet+een research and pro,ram e&aluation

). Community participation

. Ethical Issues in /uestionnaire based research

0. Ethical Issues in ocus $roup -iscussion

. Ethical Issues in Internet Based Research

1. Procedure for Ethical Re&ie+ of Proposals

11. %ubmission of Application

12. -ecision ma4in, process

13. Re&ie+ Process

APPENDI'(

A))en&i* A5 Application orm

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+, INTRODUCTION

+,+ Prea"-le

NAC Ethics Committee for Research is constituted +ith responsibility to ensure that the

ethical implications of any research underta4en are afforded serious consideration prior to

the commencement of a pro6ect and that such research is consistent +ith le,islati&e and

statutory re7uirements.

"he rationale for ethical appro&al is to ensure that the process of research is conducted

8ethically* and responsibly and ensures protection of pri&acy and not e9ploitati&e of

participants. "his mainly in&ol&es establishin, procedures for the informed consent of

those sub6ects in&ol&ed in research: as +ell as appropriate handlin, of the research

findin,s ;e.,. secure stora,e of data< and material. "he hi,hest ethical standards must be

upheld +hen collectin, beha&ioral or biolo,ical data on =I>(AI-%: as due to sti,ma and

human ri,hts issues around =I>(AI-%: the study participants may e9perience

psycholo,ical: social: physical or economic harm.

All the research acti&ities in&ol&in, human participants should be conducted in accordance

+ith the four basic ethical principles: namely autonomy ;respect for person(participant<

beneficence: non?maleficence ;do no harm< and 6ustice. "he ,uidelines laid do+n are directed

at application of these basic principles to research in&ol&in, human participants.

+,. asi0 Res)onsi-ility of te Co""ittee

"he basic responsibilities of NAC Ethics Committee are defined as follo+s5?

1. "o protect the di,nity: ri,hts and +ell bein, of the potential research participants.

2. "o ensure that uni&ersal ethical &alues and international scientific standards are e9pressed

in terms of local community &alues and customs.

3. "o assist in the de&elopment and the education of a research community responsi&e to

local health care re7uirements.

+,1 Co")osition of NACO Eti0s Co""ittee

"he NAC Ethics Committee for Research consists of the e9perts in epidemiolo,ical:

beha&ioral and social disciplines. In addition: a le,al e9pert and a representati&e from the

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community are also included. "he Chairman of the Committee should not be appointed

from the NAC so that independence of the committee can be maintained. "he #ember

%ecretary should be the officer in?char,e for perational Research in NAC +ho should

or,ani@e the functionin, of the Committee. "he number of members in the ethics committee

should be bet+een 0 and 12.

ollo+in, +ill be the composition of the Ethics Committee5?

1. Chairperson Eminent e9pert ha&in, &ast e9perience in health or social sectors

2. ne ? t+o e&aluation and operational research scientist(e9perts from &arious Institutes

3. ne le,al e9pert or retired 6ud,e

!. ne e9pert in bioethics or e7ui&alent

'. ne e9pert in epidemiolo,ical: social or beha&ioral scientist( representati&e of non?

,o&ernmental &oluntary a,ency(philosopher( ethicist( theolo,ian

). ne ? t+o persons from basic medical science area. ne representati&e of P=A net+or4 ;representati&e from the community< +ho ha&e no

affiliation +ith the institution or or,anisation: are not currently in&ol&ed in medical:

scientific: or le,al +or4: and +ho are preferably from the community in +hich the institution

or or,anisation is located.

0. #ember %ecretary E9?officio in?char,e of perational Research at NAC

"he Ethics Committee can ha&e as its members: indi&iduals from other institutions or

communities +ith ade7uate representation of a,e and ,ender ;minimum 2'D members +ill be +omen< to safe,uard the interests and +elfare of all sections of the community(society. If

re7uired: sub6ect e9perts could be in&ited to offer their &ie+s: for instance: pediatrician:

statistician: epidemiolo,ist: demo,rapher: anthropolo,ist: ethno,rapher: etc. It +ould be

preferable to appoint person trained in bioethics or persons ac7uainted +ith ethical ,uidelines

and la+s of the country. ne representati&e of P=A net+or4 ;representati&e from the

community< +ho should be a+are of local: social and cultural norms: as this is the most

important social control mechanism.

+,2 Ter"s of Referen0e of Me"-ers

"he "erms of References should include date of appointment: duration of the term: the policy

for remo&al: replacement: resi,nation procedure: fre7uency of meetin,s: and payment of

processin, fee to the Ethics Committee for re&ie+: honorarium(consultancy to the

members(in&ited e9perts etc. and these should be specified in the standard operatin,

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procedures ;%P< +hich should be made a&ailable to each member. Committee should ha&e

its o+n +ritten %Ps accordin, to +hich committee should function. "he %Ps should be

updated periodically based on the chan,in, re7uirements. "he term of appointment of

members could be e9tended for another term and a defined percenta,e of members could be

chan,ed on re,ular basis. %ubstitute member may be nominated if meetin,s ha&e been

continuously missed by a member due to illness or other unforeseen circumstances. or this

the criteria for number of missed meetin,s may be defined in the %P.

., PRINCIPLES FOR ETHICAL ISSUES(

Any research usin, the human bein,s as participants shall follo+ the principles ,i&en

belo+.

.,+ General Prin0i)les(

"he follo+in, 12 principles are common to all areas of research.

I, Prin0i)les of essentiality +hereby the research entailin, the use of human participants

is considered to be absolutely essential after a due consideration of all alternati&es in the

li,ht of the e9istin, 4no+led,e in the proposed area of research. After the careful

consideration: the committee comes to the conclusion that the said research is necessary

for the ad&ancement of 4no+led,e and for the benefit of +ell bein,.

II, Prin0i)les of %ol3ntariness$ infor"e& 0onsent an& 0o""3nity a4ree"ent +hereby

research participants are fully informed of the research and the impact and ris4 of such

research on the participant and others and +hereby the research participants retain the

ri,ht to abstain from further participation in the research irrespecti&e of any le,al or other

obli,ation.

Fhere any research entails treatin, any community or ,roup of persons as a research

participant: these principles of &oluntariness and informed consent shall apply: mutatis

mutandis: to the community as a +hole and to each indi&idual member +ho is the

participant of the research.Fhere the human participant is incapable of ,i&in, consent: it is considered to be

essential that consent should be ta4en by someone +ho is empo+ered and under a duty to

act on their behalf.

"he principles of informed consent and &oluntariness are fundamental principles to be

obser&ed throu,hout the research and e9periment: includin, its conse7uences and applied

'



use so that research participants are continually 4ept informed of any and all

de&elopments in so far as they affect them and others.

"he nature and form of the consent and the e&identiary re7uirements to pro&e that such

consent +as ta4en: shall depend upon the de,ree and seriousness of the in&asi&eness into

the concerned human participant*s person and pri&acy: health and life ,enerally: and: the

o&erall purpose and the importance of the research.

Ethics committee shall decide +hether the consent to be ta4en in the particular research

or its +ai&er based on the de,ree of ris4 that may be in&ol&ed.

III, Prin0i)les of non5e*)loitation +hereby as a ,eneral rule: research participants are

remunerated(compensated for their in&ol&ement in the research or e9periment

irrespecti&e of the social and economic condition or status: or literacy or educational

le&els. Each research shall include an in?built mechanism for compensation for the

human participants either throu,h insurance co&er or any other appropriate means to

co&er all foreseeable and unforeseeable ris4s by pro&idin, for remedial action and

comprehensi&e aftercare: includin, treatment durin, and after the research or e9periment:

in respect of any effect that the conduct of research or e9perimentation may ha&e on the

human participant and to ensure that immediate recompense and rehabilitati&e measures

are ta4en in respect of all affected: if and +hen necessary.

IV, Prin0i)les of )ri%a0y an& 0onfi&entiality +hereby the identity and records of the

human participants of the research or e9periment are as far as possible 4ept confidentialand that no details about identity of said human participants: +hich +ould result in the

disclosure of their identity: are disclosed +ithout &alid scientific and le,al reasons +hich

may be essential for the purposes of inter&entions: +ithout the specific consent in +ritin,

of the human participant concerned: or someone authori@ed on their behalf and after

ensurin, that the said human participant does not suffer from any form of hardship:

discrimination or sti,matisation as a conse7uence of ha&in, participated in the research

or e9periment.

"he %upreme Court of India has rules on the issue of the ri,ht to confidentiality of

sub6ects +ith =I> infection and the breach of confidentiality in order to protect the health

of third parties. "he opinion of the court is that the ri,ht to pri&acy and confidentiality is

not absolute. "he issues relatin, to confidentiality and partner notification +ithin the

conte9t of =I> infection are comple9. "he ri,ht of the indi&idual to confidentiality can be

)



conflict +ith the ri,ht of the partner to be protected from the ris4 of infection.

Confidentiality is essential to pre&ent discrimination. n the other hand the seriousness

of the threat to the health of unsuspectin, third parties resulted in the debate on informin,

people at ris4: also 4no+n as partner notification. NAC therefore encoura,es

moti&ation of the =I> positi&e persons to disclose their status to the se9?partner.

V, Prin0i)les of )re0a3tion an& ris6 "ini"i7ation +hereby due care and caution is

ta4en at all sta,es of the research and e9periment ;from its inception as a research idea:

its subse7uent research desi,n: the conduct of the research or e9periment and its

applicati&e use< to ensure that the research participant and those affected by it includin,

community are put to the minimum ris4: suffer from no 4no+n irre&ersible ad&erse

effects: and ,enerally: benefit from and by the research or e9periment and that re7uisite

steps are ta4en to ensure that both professional and ethical re&ie+s of the research are

underta4en at appropriate sta,es so that further and specific ,uidelines are laid do+n: and

necessary directions ,i&en: in respect of the conduct of the research or e9periment.

VI, Prin0i)les of )rofessional 0o")eten0e +hereby the research is conducted at all

times by competent and 7ualified persons +ho act +ith total inte,rity and impartiality

and +ho ha&e been made a+are of preferably throu,h trainin,: the ethical considerations

to be borne in mind in respect of such research or e9periment.

VII, Prin0i)les of a00o3nta-ility an& trans)aren0y +hereby the research or

e9periment +ill be conducted in a fair: honest: impartial and transparent manner after fulldisclosure is made by those associated +ith the research or e9periment of each aspect of

their interest in the research: and any conflict of interest that may e9ist

and +hereby: sub6ect to the principles of pri&acy and confidentiality and the ri,hts of the

researcher: full and complete records of the research inclusi&e of data and notes are

retained for such reasonable period as may be prescribed or considered necessary for the

purposes of post?research monitorin,: e&aluation of the research: conductin, further

research ;+hether by the initial researcher or other+ise< and in order to ma4e such

records a&ailable for scrutiny by the appropriate le,al and administrati&e authority: if

necessary.

VIII, Prin0i)les of te "a*i"isation of te )3-li0 interest an& of &istri-3ti%e 83sti0e

+hereby the research and its subse7uent applicati&e use are conducted and used to benefit

all human 4ind and not 6ust those +ho are socially better off but also the least



ad&anta,ed and in particular: the research participants themsel&es and or the community

from +hich they are dra+n.

I', Prin0i)les of instit3tional arran4e"ents +hereby there shall be a duty on all

persons connected +ith the research to ensure that all the procedures re7uired to be

complied +ith and all institutional arran,ements re7uired to be made in respect of the

research and its subse7uent use or application are duly made in a bonafide and

transparent manner and to ta4e all appropriate steps to ensure that research reports:

materials and data connected +ith the research are duly preser&ed and archi&ed.

', Prin0i)les of )3-li0 &o"ain +hereby the research and any further research:

e9perimentation or e&aluation in response to: and ori,inatin, from such research is

brou,ht into the public domain so that its results are ,enerally made 4no+n throu,h

scientific and other publications sub6ect to such ri,hts as are a&ailable to the researcher

and those associated +ith the research under the la+ in force at that time.

'I, Prin0i)les of totality of res)onsi-ility +hereby the professional and moral

responsibility: for the due obser&ance of all the principles: ,uidelines or prescriptions laid

do+n ,enerally or in respect of the research or e9periment in 7uestion: de&ol&es on all

those directly or indirectly connected +ith the research or e9periment includin, the

researchers: those responsible for fundin, or contributin, to the fundin, of the research:

the institution or institutions +here the research is conducted and the &arious persons:

,roups or underta4in,s +ho sponsor: use or deri&e benefit from the research: or prescribeits use so that: inter alia: the effect of the research or e9periment is duly monitored and

constantly sub6ect to re&ie+ and remedial action at all sta,es of the research and

e9periment and its future use.

'II, Prin0i)les of 0o")lian0e +hereby: there is a ,eneral and positi&e duty on all

persons: conductin,: associated or connected +ith any research entailin, the use of a

human participant to ensure that both the letter and the spirit of these ,uidelines: as +ell

as any other norms: directions and ,uidelines +hich ha&e been specifically laid do+n or

prescribed and +hich are applicable for that area of research or e9perimentation: are

scrupulously obser&ed and duly complied +ith.

0



.,. S)e0ifi0 Prin0i)les(

.,.,+, Infor"e& Consent of Parti0i)ants( or all e&aluation and operational research

in&ol&in, human participants: the in&esti,ator must obtain the informed consent of the

prospecti&e participant or in the case of an indi&idual +ho is not capable of ,i&in, informed

consent: the consent of a le,al ,uardian. Informed consent protects the indi&idual*s freedom

of choice and respect for indi&idual*s autonomy and is ,i&en &oluntarily to participate in

research or not.

"he purpose and ,eneral ob6ecti&es of the study has to be e9plained to the participants

4eepin, in mind their le&el of understandin,. Ade7uate information about the research is

,i&en in a simple and easily understandable unambi,uous lan,ua,e in a document 4no+n as

the Informed Consent orm +ith Participant Information %heet. In the conte9t of de&elopin,

countries: obtainin, informed consent has been considered many times as difficult(

impractical ( not meetin, the purpose on &arious ,rounds such as incompetence to

comprehend the meanin, or rele&ance of the consent and culturally bein, dependent on the

decision of the head of the family or &illa,e(community head. =o+e&er: there is no

alternati&e to obtainin, indi&idual*s informed consent.

In this conte9t: the role of in&esti,ator is crucial and s(he should remain &i,ilant and

conscious of her( his obli,ations to+ards the participants( patients: all throu,h the course of

the studies.

"he latter should ha&e follo+in, components as may be applicable5

1. Nature and purpose of study statin, it as research

2. -uration of participation +ith number of participants

3. Procedures to be follo+ed

!. In&esti,ations: if any: to be performed

'. Anticipated ris4s and discomforts ade7uately described and +hether pro6ect in&ol&es more

than minimal ris4

). Benefits to participant: community or medical profession as may be applicable

. Policy on compensation

1. %teps ta4en for ensurin, confidentiality

11. No loss of benefits on +ithdra+al

12. Benefit sharin, in the e&ent of commerciali@ation



13. Contact details of PI or local PI(Co?PI in multicentric studies for as4in, more information

related to the research.

1!. Contact details of Chairman of the Ethics Committee for appeal a,ainst &iolation of ri,hts

1'. >oluntary participation

1). If test for =I> is to be done: counselin, for consent for testin, must be ,i&en as per

national ,uidelines.

1. %tora,e period of data ;biolo,ical sample as +ell< +ith choice offered to participant

re,ardin, future use of sample: refusal for stora,e and receipt of its results

A copy of the participant information sheet should be ,i&en to the participant for her( his

record. "he informed consent should be brief in content hi,hli,htin, that it is ,i&en of free

+ill or &oluntarily after understandin, the implications of ris4s and benefits and s(he could

+ithdra+ +ithout loss of routine care benefits. Assurance is ,i&en that confidentiality +ould

be maintained and all the in&esti,ations(inter&entions +ould be carried out only after consent

is obtained. Fhen the +ritten consent as si,nature or thumb impression is not possible due to

sensiti&e nature of the pro6ect or the participant is unable to +rite: then &erbal consent can be

ta4en after ensurin, its documentation by an unrelated +itness. In some cases ombudsman: a

third party: can ensure total accountability for the process of obtainin, the consent. Audio?

&isual methods could be adopted +ith prior consent and ade7uate precaution to ensure

confidentiality: but appro&al of Ethics Committee is re7uired for such procedures.

In most community based(ethno,raphic research it +ould be necessary to ha&e the consent of

the community: +hich can be done throu,h the >illa,e eaders: the Panchayat head: the

tribal leaders etc. +ho are considered to be ,ate 4eepers of the society( community.

Particularly in a country li4e India: +ith the le&el of po&erty and i,norance that is pre&alent:

it is easy to use inducements: especially financial inducements: to ,et indi&iduals and

communities to consent. %uch inducements are not permissible. =o+e&er: it is necessary to

pro&ide for ade7uate compensation for loss of +a,es and tra&el(other e9penses incurred for

participatin, in the study.

Fres or re50onsent(

Re?consent is ta4en in follo+in, conditions5

1. Fhen lon, term follo+?up or study e9tension is planned later.

!. Fhen there is a chan,e in procedures and site &isits.

1



'. Before dissemination(publication if there is possibility of disclosure of identity throu,h

data presentation or photo,raphs.

.,.,. Essential infor"ation for )ros)e0ti%e resear0 )arti0i)ants(

Before re7uestin, an indi&idual*s consent to participate in research: the in&esti,ator must

pro&ide the indi&idual +ith the follo+in, information in the lan,ua,e she or he is able to

understand +hich should not only be scientifically accurate but should also be adapti&e to

their social and cultural conte9t5

• Aims and methods of the research

• E9pected duration of the participation

• Benefits that mi,ht reasonably be e9pected as an outcome of research to the

participant or community or to others

• Any alternati&e procedures or courses of treatment that mi,ht be as ad&anta,eous to

the participant as the procedure or treatment to +hich s(he is bein, sub6ected

• Any foreseeable ris4 or discomfort to the participant resultin, from participation in

the study

• Ri,ht to pre&ent use of her( his biolo,ical sample at any time durin, the conduct of

the research

• E9tent to +hich confidentiality of records could be maintained ie.: the limits to +hich

the in&esti,ator +ould be able to safe,uard confidentiality and the anticipated

conse7uences of breach of confidentiality

• Responsibility of in&esti,ators

• Compensation of participants for participation in the study

• reedom of indi&idual(family to participate and to +ithdra+ from research any time

+ithout penalty or loss of benefits +hich the participant +ould other+ise be entitled

to

• Identity of the research teams and contact persons +ith address and phone numbers

• oreseeable e9tent of information on possible current and future uses of the

biolo,ical material and of the data to be ,enerated from the research and if the

material is li4ely to be used for secondary purposes or +ould be shared +ith others:

clear mention of the same

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• Publication: if any: includin, photo,raphs and charts.

"he 7uality of the consent of certain social and mar,inali@ed ,roups re7uires careful

consideration as their a,reement to &olunteer may be unduly influenced by the In&esti,ator.

.,.,1 Confi&entiality for Pros)e0ti%e resear0 )arti0i)ants(

"he in&esti,ator must safe,uard the confidentiality of research data: +hich mi,ht lead to the

identification of the indi&idual participants. -ata of indi&idual participants can be disclosed

under the follo+in, circumstances5

• only in a court of la+ under the orders of the presidin, 6ud,e or

• there is threat to a person*s life or

• if there is ris4 to public health it ta4es precedence o&er personal ri,ht to pri&acy and

may ha&e to be communicated to health authority.

"herefore: the limitations in maintainin, the confidentiality of data should be anticipated and

assessed and communicated to appropriate indi&iduals or authorities as the case may be.

.,.,2 Confli0t of Interest(

A set of conditions in +hich professional 6ud,ment concernin, a primary interest li4e

patient*s +elfare or the &alidity of research tends to be or appears to be unduly influenced by

a secondary interest li4e non?financial ;personal: academic or political< or financial ,ain is

termed as Conflict of Interest ;CI<. In all situations +here there is li4ely to be conflicts of

interest it must be ensured that the interest of the indi&iduals in&ol&ed in the study are

protected at any cost. In cases +here the NEC determines that a conflict of interest may

dama,e the scientific inte,rity of a pro6ect or cause harm to research participants: the

committee should ad&ise accordin,ly.

In&esti,ators should declare such conflicts of interest in the application submitted to NEC for

re&ie+. NEC need self?re,ulatory processes to monitor: pre&ent and resol&e such conflicts of

interest. "he NEC can determine the conditions for mana,ement of such conflicts in its %P

manual.

Prospecti&e participants in research should also be informed of the sponsorship of research:

so that they can be a+are of the potential for conflicts of interest and commercial aspects of

the research. %ponsorship of the research should also be informed to the audience +hen

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presentin, papers and should be mentioned +hen publishin, in popular media or scientific

6ournals.

Gndue inducement throu,h compensation for indi&idual participants: families and

populations should be prohibited. Gndue compensation +ould include assistance to related

person;s< for transport of body for cremation or burial: pro&ision for insurance for unrelated

conditions: free transportation to and fro for e9amination not included in the routine: free trip

to to+n if the participants are from rural areas: free hot meals: freedom for prisoners: free

medication +hich is ,enerally not a&ailable: academic credits and disproportionate

compensation to researcher ( team( institution. =o+e&er: in remote and inaccessible areas

some of the features mentioned abo&e may be a necessity and culture specific.

%i,nificant financial interest means anythin, of monetary &alue that +ould reasonablyappear to be a si,nificant conse7uence of such research includin, salary or other payments

for ser&ices li4e consultin, fees or honorarium per participant e7uity interests in stoc4s:

stoc4 options or other o+nership interests and intellectual property ri,hts from patents:

copyri,hts and royalties from such ri,hts. "herefore: the NEC should e9amine this on a case?

by?case basis: as some of these elements may be 6ustifiable for collectin, &ital data for

national use or necessary to find if some inter&entions may si,nificantly ha&e direct impact

on health policies.

.,.,9, International 0olla-oration/assistan0e in E%al3ation an& O)erational Resear0

Research in health areas has ,ained ,reater momentum only by the second half of the 2 th

Century: especially since the 1)s: the scope of international co?operation and collaboration

assumed such proportions as to ha&e e9ploitati&e connotations +ith commercial and human

dimensions. -ifferent le&els of de&elopment in terms of infrastructure: e9pertise: social and

cultural perceptions: la+s relatin, to intellectual property ri,hts etc.: necessitate an ethical

frame+or4 to ,uide such collaboration. "he same concerns are applicable e&en +hen there is

no formal collaboration bet+een countries: but the research is underta4en +ith assistance

from international or,ani@ations as sponsors ;$o&ernmental li4e National Institutes of

=ealth: G%A: non?$o&ernmental li4e Bill H #elinda $ates oundation: ord oundation or

others li4e F=: GNICE: GNAI-%: etc.<.

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.,.,:, S)e0ial Con0erns

1. $i&en the ma,nitude and se&erity of the health problems in different countries: capacity

buildin, to address ethical issues that arise out of collaborati&e research must be promoted on

a priority basis. %trate,ies should be implemented so that &arious countries and communities

can practice meanin,ful self?determination in health de&elopment and can ensure thescientific and ethical conduct of research.

2. "he collaboratin, in&esti,ators: institutions and countries can function as e7ual partners

+ith sponsors e&en +hen in a &ulnerable position by buildin, appropriate safe,uards.

Community representati&es should be in&ol&ed early enou,h +hile desi,nin, the protocol

and in a sustained manner durin, the de&elopment: implementation: monitorin, and

dissemination of results of research.

3. Careful consideration should be ,i&en to protect the di,nity: safety and +elfare of the

participants +hen the social conte9ts of the proposed research can create foreseeable

conditions for e9ploitation of the participants or increase their &ulnerability to harm. "he

steps to be ta4en to o&ercome these should be described and appro&al ta4en from concerned

Ethics Committee.

!. E&ery adult participant in the research should &oluntarily ,i&e informed consent. In case of

children: ,uardian should ,i&e the consent.

'. As different 4inds of research ;epidemiolo,ical studies: beha&ioural and social science

oriented research etc.< ha&e their o+n particular scientific re7uirements and specific ethical

challen,es: the choice of study populations for each type of study should be 6ustified in

ad&ance in scientific and ethical terms re,ardless of the place from +here the study

population is selected.

). "he nature: ma,nitude: and probability of all foreseeable harms resultin, from

participation in a collaborati&e research pro,ramme should be specified in the research

protocol and e9plained to the participants as fully as can be reasonably done. #oreo&er: the

modalities by +hich to address these: includin, pro&ision for the best possible nationally

a&ailable care to participants +ho e9perience ad&erse reactions to a &accine or dru, under

study: compensation for in6ury related to the research: and referral for psychosocial and le,al

support if necessary: need to be described.

. "he research protocol should outline the benefits that persons(communities(countries

participatin, in such research should e9perience as a result of their participation. Care should

be ta4en so that these are not presented in a +ay that unduly influences freedom of choice in

1!



participation. "he burden and the benefit should be e7ually borne by the collaboratin,

countries.

0. $uidelines: rules: re,ulations and cultural sensiti&ities of all countries participatin, in

collaborati&e research pro6ects should be respected: especially by researchers in the host

country and the sponsor country. "hese could be +ith reference to intellectual property ri,hts:

e9chan,e of biolo,ical materials ;human: animal: plant or microbial<: data transfer: security

issues: and issues of socially or politically sensiti&e nature. In this conte9t: it is essential for

researchers to follo+ the $I notification on E9chan,e of =uman Biolo,ical

#aterial for Biomedical ResearchJ issued on 1.11. and obtains appropriate re,ulatory

clearances as pre&alent in the country for international collaboration and EC appro&al from

all trial sites before the initiation of research.

. =I> testin, +as reco,ni@ed as different from other blood tests because it presented

serious: psycholo,ical ris4s such as family: discrimination in employment: and(or restricted

or no access to health care: insurance and housin,. "herefore: special protection for

confidentiality of =I> test results should perform.

1. >ulnerability is particularly important in conte9t of =I> related research. "hose infected

+ith =I> may be medically &ulnerable because of their infection. In addition: homose9uals:

in6ection dru, users: minorities: and +omen: +ho: for &arious reasons: may be at hi,her ris4

of =I> infection: are more li4ely to be socially and economically &ulnerable because of

historical attitudes and discrimination. Accordin,ly: in&esti,ators conductin, =I> related

research must pay particular attention to &ulnerability and ta4e steps to protect potentially

&ulnerable research participants.

1, Resear0er;s relations <it te "e&ia an& )3-li0ation )ra0ti0es(

Researchers ha&e a responsibility to ma4e sure that the public is accurately informed about

results +ithout raisin, false hopes or e9pectations. It should also not unnecessarily scare the

people. Researchers should ta4e care to a&oid tal4in, +ith 6ournalists or reporters about

preliminary findin,s as seemin,ly promisin, research that subse7uently cannot be &alidated

or could lead to misconcepts if reported prematurely. "herefore: it is important to a&oid

premature reports and publicity stunts. "he best safe,uard a,ainst inaccurate reportin, is for

the researcher to tal4 to media on condition that the reporter submit a full +ritten: rather than

oral &ersion: of +hat +ill be reported: so that it enables the researcher to ma4e necessary

corrections: if needed: prior to publication.

1'



In&esti,ator*s publication plans should not threaten the pri&acy or confidentiality of

participants. It is recommended that a clear consent for publication should be obtained

besides the consent for participation in research such consent should preferably be obtained

on t+o different occasions.

#aintenance of confidentiality +hile publishin, data should be ta4en care of. In case there is

need for publication(presentation of photo,raphs(slides(&ideos of participant ;s<: prior

consent to do so should be obtained. Identification features should be appropriately

camoufla,ed. "he same safe,uard should be obser&ed for &ideo co&era,e.

Fith re,ard to authorship: the International Committee of #edical Kournal Editors ;ICK#E<

has laid do+n criteria based on credit and accountability. nly those +ho ma4e substantial

contribution to the article and ta4e responsibility for the published matter can be co?authors.

Pla,iarism or falsification of data and authorship are important ethical issues in publications.

"he term 8misconduct in research* means fabrication: falsification: pla,iarism: selecti&e

omission of data and claimin, that some data are missin,: i,norin, outliers +ithout declarin,

it: ,ift authorship: not citin, others* +or4: not disclosin, conflict of interest: redundant

publication: and failure to ade7uately re&ie+ e9istin, research. "he Commission on Research

Inte,rity in G% created by G% Con,ress addresses the scientific: ethical: social and le,al

issues in&ol&in, scientific misconduct in research.

2, Eti0al Iss3es in E)i&e"iolo4i0al Resear0

Epidemiolo,y of =I>(AI-% and other infectious diseases are of prime importance in our

country. %uch studies are on lar,e scale and assist in impro&in, the public health: +hich

includes both patients and healthy people and communities. Epidemiolo,ical studies co&er

research: pro,ramme e&aluation and sur&eillance. Ethics in epidemiolo,ical studies is

multidimensional co&erin, clinical medicine: public health and the social milieu. In

Epidemiolo,ical research if some mista4es or aberrations ,et detected durin, the course of

conduct of such studies: repeatin, the +hole e9ercise +ill be e9pensi&e: time consumin, and

may not e&en be feasible. =ence utmost care needs to be ta4en for &arious aspects ? technical:

practical and ethical.

1)



$eneral ethical principles of respect for persons: duty to ma9imi@e possible benefits and

minimise possible harm are important considerations in ethical ,uidelines. At the same time it

is essential that all indi&iduals in an epidemiolo,ical research are treated ali4e 4eepin, in

mind the rules of distributi&e 6ustice. "he +elfare of the indi&idual has to be balanced a,ainst

the +elfare of the community and society at lar,e. "he C.I..#.% ( F.=. $uidelines for

Epidemiolo,ical Research assume that the indi&iduals or populations bein, studied are

capable of ,i&in, informed consent understandin, the implications of the study. Fith lar,e

se,ments of our population: ,i&en their le&el of education: the full understandin, in the sense

of industrialised countries may not be achie&able. =o+ the principle of do no harmJ is

ensured under such circumstances +ithout bein, paternalistic is a ma6or issue that has to be

ta4en into consideration in ethical ,uidelines.

In cohort or sur&ey techni7ues for incidence and pre&alence of &arious diseases: a ma6or issue

that has to be considered is ho+ much of inter&ention is 6ustified and +hether one is 6ustified

in +ithholdin, inter&entions. =ealth education or other inter&entions includin, non?health

inter&entions can be 7uite e9pensi&e. An alternate strate,y that may be follo+ed is to ma4e

curati&e therapy a&ailable to the population at their o+n re7uest. "his usually in&ol&es

runnin, a clinic: +hich is readily accessible to the population +ithout any other inter&ention.

=o+e&er: it is ,enerally considered unethical to +ithhold inter&ention or ser&ices.

%ur&eillance studies to obtain true =I> burden rates most li4ely ,i&e rise to ethical dilemmas

re,ardin, maintenance of confidentiality and pre&ention of sti,mati@ation. Fhere&er

applicable anonymisation could sol&e these problems +hen the information is re7uired to be

placed in public domain.

9, Distin0tion -et<een resear0 an& )ro4ra""e e%al3ation(

It is difficult to ma4e a distinction bet+een epidemiolo,ical research and pro,ramme

e&aluation. Fhene&er a pro,ramme e&aluation and sur&eillance is launched: the monitorin,

and e&aluatin, mechanisms should clearly be planned and cleared by NEC ;NAC Ethics

Committee< before initiation as is done in all other studies. It is not al+ays possible to 4no+

+hat +ill happen to the participants as une9pected results or undesirable e&ents can

sometimes occur. >ery often the benefits and ris4s of the research pertain not only to the

indi&idual participants: but also the community from +hich they are dra+n. "herefore: the

participation of local community representati&es in plannin,: conductin, and monitorin,

1



research is important to a&ert circumstances +hich may be detrimental to the participants*

+elfare. "his also helps in impro&in, the &ision of the researcher re,ardin, the ob6ecti&es and

the desi,n of study. "he inclusion of a community representati&e should be included in NEC

act on behalf of all participants in&ol&ed in a research study: Communities should be

informed of the research: possible outcomes ;positi&e and ne,ati&e<: and the results of the

research. Community representati&es and researchers can +or4 to,ether to ma4e sure that

research is conducted in the most appropriate +ay and the benefits if any: could be shared in

a reasonable or +or4able manner.

:, Co""3nity Parti0i)ation

A community can be defined as a ,roup of people sharin, the same location: beliefs: culture:

ideals: ,oals: a,e: ,ender: profession: lifestyle: common interests: ,eo,raphical locations or

settin,s or disease. Fhen research participants are dra+n from a specific community:members of that community can be in&ol&ed to discuss any concerns it may ha&e re,ardin,

the research. In different +ays such a dialo,ue can be facilitated. If an ethics committee does

not ha&e a member from the community: it may as4 a local community representati&e to be

the &oice for all participants. n the other had: community representati&es can formally 6oin

to,ether to form a ,roup termed as Community For4in, $roup: or Community Ad&isory

$roup: +hich ta4es part in the research at all sta,es of the study. In international studies:

particularly on issues in&ol&in, communities: representation from this body ensures that the

community*s health needs and e9pectations are addressed: informed consent is appropriate:

and access to research benefits is pro&ided throu,h research that is desi,ned and

implemented in the best interests of science and community. Community representation

should be in&ol&ed before: durin, and after the study. Before the study is initiated the

community is informed to see if it a,rees that the research addresses a need or problem

rele&ant to that community and to confirm that the desi,n is culture specific and brin,s some

benefits to research participants or the community. %ince some ris4 may be associated the

community representation is needed to assist in de&elopin, appropriate +ays to protect the

participants. -urin, the study: the association +ith community representati&es continues to

educate others about the research and to alert the researcher to ethical issues related to the

research. After the study is completed: community representati&es can help in ma4in, the

results 4no+n to the entire community. =o+e&er: application of research findin,s may ta4e a

lon, time: +hich the community representati&es should be made to understand. "he benefits

10



may be participants* and community*s access to inter&ention. Person for inter&ention

responsible and conditions under +hich this +ould be done: duration of a&ailability of

inter&ention: methods of impro&in, the 7uality of health care in the community and any

e9pected desirable beha&ioral chan,e in the community should be clearly e9plained to

community by the Ethics Committee or community representati&es.

=, Eti0al Iss3es in >3estionnaire ase& Resear0

A 7uestionnaire is a common research methods used in the field of epidemiolo,y: social

sciences: psycholo,y: etc. %uccess of research studies depends on the trust and

cooperation the researcher ,ained from the participants. "herefore: in order to implement

efficient and ethically appropriate 7uestionnaire based research: it is essential to establish

ethical standard that +ould ,o&ern this principle.

?, Eti0al Iss3es in Fo03s Gro3) Dis03ssion

Ethical considerations for focus ,roup discussion are the same as for most other methods

of social research. or e9ample: +hen selectin, and in&ol&in, participants: researchers

must ensure that full information about the purpose and uses of participant*s contributions

is ,i&en. Bein, honest and 4eepin, participants informed about the e9pectations of the

,roup and topic: and not pressurin, participants to spea4 is ,ood practice. A particular

ethical issue to consider in case of focus ,roups is the handlin, of sensiti&e material and

confidentiality ,i&en that there +ill al+ays be more than one participant in the ,roup.

Participants need to be encoura,ed to 4eep confidential +hat they hear durin, the

meetin, and researchers ha&e the responsibility to anonymise data from the ,roup.

@, Eti0al Iss3es in Internet ase& Resear0

"he fundamental tenets ,o&ernin, the protection of human sub6ects in research studies

apply to internet based research as +ell. "he comple9ity of internet research throu,h: for

e9ample: e?mail sur&eys: +eb based sur&eys or on?line discussion ,roups present

different challen,es that need to be addressed in accordance +ith the Ethics Committee.

"he ,eneral principles are applicable for internet based research as +ell. "he specific

,uidelines(issues should also be follo+ed +hile conductin, internet based research.

1



1. Identification of +ho +ill ha&e access to the data: ho+ lon, the data +ill be

protected ;secure protection of information durin, the study: remo&al and stora,e

of records follo+in, completion of the study: duration of stora,e is for a

minimum of 3 years by primary in&esti,ator: faculty ad&isor: or department and

accessible if re&ie+ of the data is necessary<.

2. %tatement affirmin, that +eb sur&eys are pass+ord protected usin, a secure

ser&er +ithout inclusion of identifyin, information.

3. Contact persons for 7uestions about the research.

!. %tatement that the participant has read the informed consent statement: all

7uestions has been ans+ered: and his(her +illin,ness to complete the

7uestionnaire or participate in the research implies consent.

'. Access to results +hereby a summary or abstract may be posted or sent &ia e?

mail.

"he re7uirement for +ritten documentation +ith participant*s si,nature in studies

in&ol&in, minimal ris4 may be +ai&ed by the NEC. "hese procedures may not apply to

research in&ol&in, children or other &ulnerable ,roups +ho are not: accordin, to federal

re,ulations: empo+ered to authori@e consent for themsel&es. Fhile the child may assent:

the parents or ,uardians must pro&ide consent. Fith internet use: the identity(a,e of the

participant is not easily determined. In ,eneral: as ris4 le&el increases for participants: the

use of the internet may not be ad&isable.

"he use of the Feb for recruitment of sub6ects: data collection: and data analysis may be

ad&anta,eous in securin, lar,er or more specific samples more efficiently and at a lo+er

cost. Careful attention must be ,i&en to the treatment and protection of research

participants and: specific to student research: research ad&isors must be &i,ilant about use

of on?line data analysis.

+, Pro0e&3re for Eti0al Re%ie< of Pro)osals

"he Committee should re&ie+ e&ery research proposal before the research is initiated. "he

Committee should e&aluate the possible ris4s to the participants +ith proper 6ustification: the

e9pected benefits and ade7uacy of documentation for ensurin, pri&acy: confidentiality and

the 6ustice issues. "he NECs member?secretary shall screen all the proposals for their

completeness and dependin, on the ris4 in&ol&ed.

2



All research proposals( protocols that in&ol&e &ulnerable population and special ,roups shall

be sub6ected to full re&ie+ by all the members. Fhile re&ie+in, the proposals: the follo+in,

situations may be carefully assessed a,ainst the e9istin, facilities at the research site for

ris4(benefit analysis5

a. Collection of blood samples by fin,er pric4: heel pric4 or &enipuncture5

i. from healthy adults and non?pre,nant +omen +ho +ei,h normal for their a,e and not more

than ' ml blood is dra+n in an 0 +ee4 period and fre7uency of collection is not more than

2 times per +ee4

ii. from other adults and children: +here the a,e: +ei,ht: and health of the participants: the

collection procedure: the amount of blood to be collected: and the fre7uency +ith +hich it

+ill be collected has been considered and not more than ' ml or 3 ml per 4,: +hiche&er is

lesser is dra+n in an 0 +ee4 period and not more than 2 times per +ee4

iii. from neonates dependin, on the haemodynamics: body +ei,ht of the baby and other

purposes not more than 1D of blood is dra+n +ithin !0 L 2 hours. If more than this

amount is to be dra+n it becomes a ris4y condition re7uirin, infusion(blood transfusion

b. Research in&ol&in, clinical materials ;data: documents: records: or specimens< that +ill be

collected solely for non?research ;clinical< purposes.

c. Collection of data from &oice: &ideo: di,ital: or ima,e recordin,s made for research

purposes.

d. Research on indi&idual or ,roup characteristics or beha&iour not limited to research on

perception: co,nition: moti&ation: identity: lan,ua,e: communication: cultural beliefs or

practices: and social beha&iour or research employin, sur&ey: inter&ie+: oral history: focus

,roup: pro,ram e&aluation: human factors e&aluation: or 7uality assurance methodolo,ies.

In the follo+in, situations: the #ember? %ecretary of the Committee may 7uic4ly re&ie+ the

protocols5

1. Re&ised proposal pre&iously appro&ed throu,h full re&ie+ by the committee

2. Continuin, re&ie+ of appro&ed proposals +here there is no additional ris4 or acti&ity

and is limited to data analysis.

++, S3-"ission of A))li0ation

"he researcher should submit an application in a prescribed format alon, +ith the study

protocol. "he protocol should include the follo+in,5

21



1. "he title +ith si,nature of Principal In&esti,ator ;PI< and Co?in&esti,ators as attestation for

conductin, the study.

2. Clear rationale and ob6ecti&es for underta4in, the study(inter&entions in human

participants in the li,ht of e9istin, 4no+led,e.

3. Recent curriculum &itae of the In&esti,ators indicatin, 7ualification and e9perience.

!. Participant recruitment procedures and brochures: if any.

'. Inclusion and e9clusion criteria for entry of participants.

). Precise description of methodolo,y of the proposed research: includin, sample si@e ;+ith

6ustification<: type of study desi,n ;obser&ational: e9perimental: pilot: randomi@ed:

lon,itudinal: cohort: cross?sectional etc.<: intended inter&ention.

. Procedure for see4in, and obtainin, informed consent +ith sample of participant(patient

information sheet and informed consent forms in En,lish and local lan,ua,es.

0. An account of stora,e and maintenance of all data collected durin, the research.

. Plans for publication of results ? positi&e or ne,ati&e ? +hile maintainin, the pri&acy and

confidentiality of the study participants.

1. A statement on probable ethical issues and steps ta4en to tac4le the situations.

11. All other rele&ant documents related to the study protocol.

12. -etails of undin, a,ency( %ponsors and fund allocation.

13. or international collaborati&e study details about forei,n collaborators and documents

for re&ie+ of =ealth #inistryMs %creenin, Committee;=#%C< or appropriate Committees

under other a,encies(authority li4e -ru, Controller $eneral of India ;-C$I<.

1!. A statement on conflict?of?interest ;CI<: if any.

+., De0ision "a6in4 )ro0ess

"he committee should be able to pro&ide complete and ade7uate re&ie+ of the research

proposals submitted to them. It should meet periodically at fre7uent inter&als to re&ie+ ne+

proposals: e&aluate annual pro,ress of on,oin, ones: re&ie+ serious ad&erse e&ent ;%AE<

reports and assess final reports of all research acti&ities in&ol&in, human bein,s throu,h a

pre&iously scheduled a,enda and modified +here&er appropriate. "he follo+in, points

should be considered +hile doin, so5

1. "he decision must be ta4en by a broad consensus after the 7uorum re7uirements are

fulfilled to recommend(re6ect(su,,est modification for a repeat re&ie+ or ad&ise appropriate

22



steps. "he #ember %ecretary should communicate the decision in +ritin, to the Principle

In&esti,ators.

2. If a member has conflict?of?interest ;CI< in&ol&in, a pro6ect then s(he should submit this

in +ritin, to the chairperson before the re&ie+ meetin,: and it should also be recorded in the

minutes.

3. If one of the members has her(his o+n proposal for re&ie+ or has any CI then s(he should

+ithdra+ from the NEC +hile the pro6ect is bein, discussed

!. A ne,ati&e decision should al+ays be supported by clearly defined reasons.

'. An NEC may decide to re&erse its positi&e decision on a study if it recei&es information

that may ad&ersely affect the ris4( benefit ratio.

). In case of premature termination of study: notification should include the reasons for

termination alon, +ith the summary of results conducted till date.

. %ub6ect e9perts may be in&ited to offer their &ie+s: but should not ta4e part in the decision

ma4in, process. =o+e&er: their opinion must be recorded.

0. #eetin,s are to be minuted +hich should be appro&ed and si,ned by the Chairperson( >ice

Chairperson(desi,nated member of the committee.

+1, Re%ie< )ro0ess

"he method of re&ie+ should be stated in the %P. "he ethical re&ie+ should be done in

formal meetin,s and EC should not ta4e decisions throu,h circulation of proposals. "he

committee should meet at re,ular inter&als and should not 4eep a decision pendin, for more

than 3 months: +hich may be defined in the %P.

Periodic re&ie+

"he on,oin, research may be re&ie+ed at re,ular inter&als of si9 month as may be specified

in the %P of the ethics committee. "he NEC also has the responsibility to re&ie+ appro&ed

pro6ects for continuation: ne+ information: ad&erse e&ent monitorin,: follo+?up and later

after completion if need be.

Interim re&ie+

"he NEC should decide the special circumstances and the mechanism +hen an interim

re&ie+ can be resorted to by a sub?committee instead of +aitin, for the scheduled time of the

meetin, li4e re?e9amination of a proposal already e9amined by the NEC or any other matter

+hich should be brou,ht to the attention of the NEC. =o+e&er: decisions ta4en should be

brou,ht to the notice of the main committee.

23



#onitorin,

nce NEC ,i&es a certificate of appro&al it is the duty of the NEC to monitor the appro&ed

studies: for +hich an o&ersi,ht mechanism should be in place. Actual site &isits can be made

especially in the e&ent of reportin, of ad&erse e&ents or &iolations of human ri,hts.

Additionally: periodic status reports must be as4ed for at appropriate inter&als based on the

safety concerns and this should be specified in the %P of the NEC.

Record 4eepin,

All documentation and communication of an NEC are to be dated: filed and preser&ed

accordin, to +ritten procedures. %trict confidentiality is to be maintained durin, access and

retrie&al procedures. "he follo+in, records should be maintained for the follo+in,5

i. Constitution and composition of the NEC

ii. %i,ned and dated copies of the latest the curriculum &itae of all NEC members +ith

records of trainin, if any

iii. %tandin, operatin, procedures of the NEC

i&. National and International ,uidelines

&. Copies of protocols submitted for re&ie+

&i. All correspondence +ith NEC members and in&esti,ators re,ardin, application: decision

and follo+ up

&ii. A,enda of all NEC meetin,s

&iii. #inutes of all NEC meetin,s +ith si,nature of the Chairperson

i9. Copies of decisions communicated to the applicants

9. Record of all notification issued for premature termination of a study +ith a summary of

the reasons

9i inal report of the study includin, microfilms: C-s and >ideo recordin,s.

It is recommended that all records must be safely maintained after the completion(termination

of the study for a period of at?least 3 years.

Administration

A full time secretariat and space for 4eepin, records is re7uired for a +ell functionin, of

NEC.

2!



%pecial Consideration5

Fhile all the abo&e re7uirements are applicable to research as a +hole irrespecti&e of the

specialty of research: there are certain specific concerns pertainin, to speciali@ed areas of

research +hich re7uire additional safe ,uards ( protection and specific considerations for the

NEC to ta4e note of. E9amples of such instances are research in&ol&in, children: pre,nant

and lactatin, +omen: &ulnerable participants and those +ith diminished autonomy besides

issues pertainin, to commerciali@ation of research and international collaboration. "he

obser&ations and su,,estions of NEC should be ,i&en in +ritin, in unambi,uous terms in

such instances.

"he procedure for obtainin, ethical clearance +ill in&ol&e5

• Bein, familiar +ith the NACP policy on research ethics.

• %ubmission of re7uest form for ethical clearance in the prescribed format for

appro&al to the Chair of the Committee.

• Alon, +ith the re7uest form: Research(Pro6ect Information %heet and Informed

Consent orm ;+here applicable< should be submitted.

• Informed Consent Process and Research(Pro6ect Information %heet5 "his has been

described in detail earlier.

An application for appro&al should be submitted to E&aluation and Research -i&ision at

NAC. Recei&ed application +ill then be re&ie+ed by the concerned officer of the

-i&ision: +ho +ill: if necessary: see4 clarifications from the applicant before ma4in, a

recommendation to the NAC Ethics Committee for Research.

"he Committee shall determine +hether or not the proposed pro6ect is acceptable on

ethical ,rounds.

• If the pro6ect is ethically acceptable: the Committee shall issue a +ritten ethical

clearance +hich shall include a 8Pro6ect Identification Number* and details of

those methods of obser&ation to ensure that the pro6ect continues to conform to

appro&e ethical standards.

• If the pro6ect is ethically acceptable +ith re&ision: the Principal In&esti,ator of the

pro6ect should re?submit an application for appro&al.

2'



• If the pro6ect is ethically unacceptable: the Committee shall ad&ise the application

in +ritin, of its concerns.

"he pro6ect shall not commence until such time as these concerns are addressed to

Committee*s satisfaction. "he Committee shall maintain a record of all proposed research

pro6ects +hich shall include the follo+in, items5

• Pro6ect Identification Number

• Name(s of Principal In&esti,ator(s

• "itle of the Pro6ect

• Ethical appro&al(non?appro&al +ith date

2)



A))en&i* A

NATIONAL AIDS CONTROL ORGANISATION

;#onitorin,: E&aluation and Research -i&ision<

APPLICATION FORM FOR ETHICAL CLEARANCE

SECTION +( DETAILS OF APPLICANT

NAME( Prof/Dr/Mr/Mrs/Miss/Ms

Professional stat3s

IF STUDENT/FELLO#

BTi06 te a))ro)riate 0o&e

ES/NO

De4ree A))li0a-leBMasters/M,Pil/PD

Prin0i)al In%esti4ator BNa"e$

Desi4nation$ Or4anisation$ Conta0t

&etails

Co5In%esti4ators BNa"e$ Desi4nation$

Or4anisation$ Conta0t &etails

Instit3tion/Or4ani7ation <ere

a))li0ant re4istere&/e")loye& an& f3ll

a&&ress

#eter "e"-er of NIIHAR ES/NO

If yes >3ote ID No

2



Please atta0 &etaile& C3rri03l3" Vitae of all In%esti4ators B<it s3-8e0t s)e0ifi0

)3-li0ation li"ite& to )re%io3s 9 years

SECTION .( PROECT DETAILS

+, TITLE OF PROECT in f3ll;do not abbre&iate<

.,Ty)e of St3&y ( Biomedical H Clinical Research1

%ocial %cience Research2 Epidemiolo,ical %tudy3

Policy #ana,ement %tudy!

1, Stat3s of Re%ie<( Ne+ Re&ised

2, S)onsor Infor"ation 51. Indian a< $o&ernment Central %tate Institutional

b< Pri&ate %pecify details

2. International $o&ernment Pri&ate GN a,encies

%pecify details

3. Industry National #ultinational

%pecify details

'. Is the proposal bein, submitted for

clearance from =ealth #inistry*s %creenin,Committee ;=#%C< for International

collaborationO

es(No

:, Conta0t A&&ress of S)onsor(

=, Total 3&4et ;INR<5

?, rief &es0ri)tion of te )ro)osal L Introduction: re&ie+ of literature: aim;s< H ob6ecti&es:

6ustification for study: methodolo,y describin, the potential ris4s H benefits: outcome

measures: statistical analysis and +hether it is of national si,nificance +ith rationale ;Attach

sheet +ith ma9imum ' +ords<5

@, S3-8e0t sele0tion(

i. Number of %ub6ects 5

ii. -uration of study 5

iii. Fill sub6ects from both se9es be recruited es No

i&. Inclusion ( e9clusion criteria ,i&en es No

20



&. "ype of sub6ects >olunteers Patients

&i. >ulnerable sub6ects ;"ic4 the appropriate response<

P=APre,nant +omen

Children

=R$rphan

Illiterate

any other ;specify<

+, Pri%a0y an& 0onfi&entiality

i. %tudy in&ol&es ? -irect IdentifiersIndirect Identifiers(coded

Anonymous(delin4ed

ii. Confidential handlin, of data by staff es No

++, Use of -iolo4i0al/ a7ar&o3s "aterials es No

i. Gse of blood es No

ii. Gse of body fluids es No

+., Consent ( QFritten ral Audio?&isual i. Consent form 5 ;tic4 the included elements<

Gnderstandable lan,ua,e Alternati&es to participation%tatement that study in&ol&es research Confidentiality of records

%ponsor of study Contact information

Purpose and procedures %tatement that consent is &oluntary

Ris4s H -iscomforts Ri,ht to +ithdra+Benefits Consent for future use of biolo,ical material

Compensation for participation Benefits if any on future commerciali@ation

Compensation for study related in6ury e,. ,enetic basis for dru, de&elopment

QIf +ritten consent is not obtained: ,i&e reasons5

ii. Fho +ill obtain consent O PI(Co?PI Nurse(Counsellor

Research staff

Any other ;specify<

+1, #ill any a&%ertisin4 -e &one for re0r3it"ent of S3-8e0ts

;posters: flyers: brochure: +ebsites L if so 4indly attach a copy<

es No

+2, Ris6s ! enefits(

i. Is the ris4 reasonable compared to the anticipated benefitsto sub6ects ( community ( countryO

es

No

2



ii. Is there physical ( social ( psycholo,ical ris4 ( discomfortO

If es$ #inimal or no ris4

#ore than minimum ris4 =i,h ris4

es No

Iii.Is there a benefit a< to the sub6ect O

-irect Indirect

b< Benefit to society

+9, Data Monitorin4

i. =as pro&ision been made for data monitorin, and

securityO

es No

ii. Is there a plan for interim analysis of dataO es No

iii. Is there a plan for reportin, of ad&erse e&entsO es No

+:, Is tere 0o")ensation for )arti0i)ation

If es$ #onetary In 4ind

%pecify amount and purpose5

es No

+=, Is tere 0o")ensation for "e&i0al 0are If es$ by %ponsor by In&esti,ator

by insurance by any othercompany

es No

+?, Do yo3 a%e 0onfli0t of interest

Bfinan0ial/nonfinan0ial

If es$ s)e0ify (

es No

Ce06list for atta0e& &o03"ents5

Pro6ect proposal L 1 Copies

Curriculum >itae of In&esti,ators Brief description of proposal Participant information sheet

Informed Consent form

In&esti,ator*s brochure for recruitin, sub6ects

Copy of ad&ertisements(Information brochuresCopy of 7uestionnaire

=#%C(-C$I(-B"(BARC clearance if obtained

Si4nat3re of A))li0ant

Co3ntersi4nat3re of PI/HOD(incase of student/fellow)

Pla0e(

Date(

10- naco ethical guidelines for operational research

Documents