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Communication of decisions of the 102 th Institutional Ethics Committee

IEC code: 2018-207 -EMP -107

Agenda Item No. 16

PGUBE{S4qt20ts

Date: 09-May-19

Title of project: Frequency of sleep abnormalities in patients with irritable bowel syndrome and its

relationship with symptom severity, quality of life and effect of Pharmacological

intervention to improve sleep on these parameter

Principat Investigator: Dr U C Ghosal Department: Gastroenterology

Name and Address of Institution: Sanjay Gandhi Postgraduate Institute of Medical Sciences,

Raebareli Road, Luckn ow, 2260 I 4

NewlRe-review project: New

Date, time and venue of meeting: 19-Jan-19 11.00 AM at Committee room of Guest house SGPGI

Dear Dr.

Institutional Ethics Committee reviewed and discussed your application to conduct the research

study during the IEC meeting held on l9-Jan-19

List of documents reviewed:

l Project Submission Form

2. Study Protocol

3. Case Report Form

4. Consent of Head of the PI's Department

5. Research Committee/Department committee /Doctoral Committee/Scientific Committee

Approval

6. Undertaking by the PI

7. Conflict of Interest Statement by PI

8. CV of investigator outside SGPGI or of the student

9. Participant Information document (PID) consent forms CF) in English and Hindi

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Communication of decisions of the 107 th lnstitutional Ethics Committee

IEC code: 201 8-207-EMP-107

Agenda Item No. 16

The following members of the Institutional Ethics committee (IEC) were present at the meeting

held on 19-Jan-19

Dr Chandishwar Nath Retd Chief Scientist CSIR-CDRI Lucknow - Chairman (Officiating)

Prof S.K Misra, Dean SGPGI - Member

Justice Vishnu Sahai Former Chief Justice Allahabad High Courl - Member

Shri Vijai Varma, Chairman Upbhokta Forum Lucknow - Member

Shri Sharat Pradhan Senior Journalist Lucknow - Member

Prof Manish Kumar Verma Deptt of Sociology BBAU, Lucknow - Member

Dr. Mohan Gurjar, Deptt. Of CCM, SGPGI, Lucknow - Member

Piof. Vinita Agrawal, Deptt. Of Pathology, SGPGI, Lucknow - Member Secretary

IEC has taken following decisions for the study/trial;

Scientific issues, ethical issues and PID, CF were discussed.

The committee has given the following suggestions to the PI:

l. If the drug 'Melatonin' is indicated and approved for therapy, what is the beneficial outcome

ofthis study?

2. Justiff the use of placebo?

3 . Mention the side-effects of the drug. Mention the provision of support and medical treatment

for study related adverse side-effects.

4. The study involves 'evaluation of sleep abnormalities'. Include a psychiatrist in the study.

5. Mention source of healthy controls.

6. Mention method of randomization.

7. The study will require CTRI registration before start of study.

8. Submit properly framed separate PID's for controls, patients and legally accepted relative

(LAR). Mnetion the collection of blood and stool also in the PID.

g. The departmental research committee meeting on2lll2}l9,however, the meeting minutes

PcttBf,,l3r-t4 12018

Date: 09-May-19

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Communication of decisions of the 107 th Institutional Ethics Committee

IEC code: 2018-207 -EMP -107

Agenda Item No. 16

signed on 301 1212018. Clarify.

Decision Major Modification. Kindly resubmit revised protocol and other documents.

PI advised to submit above correction within 4 weeks, failing which the project will not be

considered in next IEC meeting for ethical approval.

As per above recommendations of IEC, the project/trial with documents has been placed for the

reviewed by the following 3 - members committee.

1 . Dr. Chandishwar Nath, Member Scientist G and Chief Scientist, Division of Toxicology, CDRI,

Lucknow

2. Dr. Vinita Das Dept. of Obst. And Gynae, KGMU, Lucknow

3. Dr.Vinita Agrawal, Prof, Dept of Pathology, SGPGIMS, Lucknow

The 3- members has gone through the required documents suggested by IEC and following

decision has been taken,

'Decision:Approved.'The approval is valid until one year or duration of project whichever is later from the date

of sanction. You may make a written request for renewal / extension of the validity, along

with the submission of annual status report.Following points must be noted:

1 .lEC should be informed of the date of commencement of study (AN5-V2/SGSOP 06/V3) and annual

progress.

2.PI and other investigators should co-operate with IEC, which may monitor the trial from time to time.

3.The decision was arrived at through consensus. Neither PI nor any of proposed study team members was

present during the decision making of the IEC.

4.8.t the time of PI's retirernenVintention to leave the institute, study responsibility should be transferred to

a colleague after obtaining clearance from HOD and getting IEC concurrence and submitting status report,

including accounts details should be submitted to HOD, IEC and extramural sponsors.

5.The IEC functions in accordance with the GCP-CDSCO/ICMR/Schedule Y guidelines,{CH-GCP.

PGttBEt3ql t20t8

Date: 09-May-19

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Communication of decisions of the 107 th Institutional Ethics Committee

IEC code: 201 8-207-EMP-107

Agenda ltem No. 16

6.New information or any SAE, which could affect any study, must be communicated to IEC and sponsors'

The pI should report SAEs occurred for IEC approved studies within 7 days of the occurrence of the SAE' If

the SAII is ,Dcath., the Bioethics cell shoulcl receive the SAE reporting fbrm rvithin 24 hours of the

occurrence.

7.ln the events o1'any protocol ar.nendments, IEC must be infbrmed and the amendments should be

highlighted in clear tern.rs

g.An1, deviation/violation/waiver in the protocol must be informed to the IEC as detailed in ANI -V3/

SGSOP O9/V3.

9. Ilpro.iectidrug/rlevice trial initiation not done in next 6 rnonths from date of approval from IEC, further

extel]sion u'ill not be granted ancl it rvill require resubmissiot.t to tE'C'

We hcr.eb.v conflrm tl.rat the Institutional Ethics Committee is organized and operates as pel'amended

schedule Y (20rh .lan 2005), ICF{ GCP guidelines and applicable regulations.

Thanking You,

Your Sincerell'.

PGilBr-t311t20t8

Date: 09-May-19

t r.;'Nil.^tDrl vinita AgrYwal)

Member Secretary

IEC, SGPGI, Lucknow.