Вы находитесь на странице: 1из 9

Guidelines for constitution of an Institutional Committee for Stem Cell Research (IC-SCR)

The following guidelines must be followed while constituting an IC-SCR:


1. The Chairman shall have a biomedical qualification with a postgraduate (medical) / doctorate degree
(non-medical) and must have a minimum of ten (10) years experience after obtaining the postgraduate /
doctorate degree. The Chairman must be from outside the institution with no conflict of interest (COI).
2. Members from Legal, Ethics and Social Sciences must be from outside the institute and with no COI.
These members should have appropriate qualifications with demonstrable experience in the respective
fields and must have at least five (5) years of relevant experience.
3. Stem cell / cell biology experts must have a postgraduate (medical) / doctorate degree (non-medical)
with a minimum of five (5) years experience in the field of stem cell research after obtaining
postgraduate / doctorate degree. At least two stem cell experts preferably from outside the institution
should be inducted in the IC-SCR with no COI.
4. Member Secretary should be from the same institution and must not have any COI.
5. Any member having COI with a particular proposal must abstain from the discussion and decision
making process of that proposal.
6. The Head of the institution shall not be the member of the IC-SCR.
7. IC-SCR members must be familiar with the current bioethical guidelines and guidelines for stem cell
research.
8. The quorum should consist of the following members, without whom the decision should not be taken:
a. Chairman and Member Secretary
b. Experts from Law, Ethics and Social Sciences
c. At least one stem cell / cell biology expert with appropriate expertise and no COI
9. The group of institutions may have a common IC-SCR if:
a. It designates at least one person from each institute as a member with no COI
b. Provides details of that person to the NAC-SCRT
c. The designated person is present during the discussion of the proposals submitted by the institute
Guidelines for framing SOP for functioning of IC-SCR
The applicants must submit standard operating procedure (SOP) for functioning of IC-SCR including, but
not limited to, the following details:
1. Constitution and functioning of IC-SCR
2. Terms of reference of members
3. Detailed review and approval process
4. Frequency of meetings
5. Monitoring and follow-up of approved projects
6. Maintenance of records
Please read the following instructions
a.
b.
c.
d.
e.
f.
g.

Enclose latest CVs of all the IC-SCR members and SOP with the duly filled form.
Brief summary of all projects (ongoing / completed) must be submitted in the format provided.
Provide details of all investigators working in the field of stem cell research at the institution.

Provide valid e-mail ids for communication, failing which communications may be delayed.
Member Secretary must be responsible for all communications with the NAC-SCRT.
If there are any changes to be made after the submission, please contact the NAC-SCRT Secretariat.
Ensure that all details are complete and accurate to avoid delays in registration.

h. Soft copies of the application and all enclosures (in word format only) must be submitted online and a
printed copy, in original, must be sent to: The Member Secretary, NAC-SCRT Secretariat, ICMR
Headquarters, V. Ramalingaswami Bhawan, Ansari Nagar, New Delhi-110029
i. Soft copies sent in any other file format / scanned copies will not be accepted (Only Declaration and
Regulatory Approvals may be scanned).
The institute must ensure that its IC-SCR is always independent and appropriately competent to review the
proposals being submitted to them.

It is the responsibility of the IC-SCR to ensure that the research conducted under its ambit is scientific and
ethical.

Institutional Committee for Stem Cell Research (IC-SCR) - Registration


Section 1: Institution Details
All details are mandatory
1.

Name of the Institute

2.

Name and Designationof the


Head of the Institute

3.

Category of the Institute


(tick appropriate)

Research Institute

Clinic

Medical College

Cord Blood Bank

Hospital (Public)

Nursing Home

Hospital (Private)

Others
(Specify)___________

4.

Complete postal address


with pin code

5.

Phone No. with STD Code

6.

Fax No. with STD Code

7.

Email Id

8.

Email Id of Head of the Institute

Section 2: Details of IC-SCR Member Secretary


All details are mandatory
9.

Name

10.

Complete postal address


with pin code

11.

Phone No. with STD Code

12.

Fax No. with STD Code

13.

Mobile No.(10 digits only)

14.

Email Id

Section 3: Details of Stem Cell Research


15.

16
.

Source of stem cells

Type of research
Adult

Basic Sciences

Clinical Trials

Embryonic

Basic Sciences

Clinical Trials

Foetal

Basic Sciences

Clinical Trials

Cadaveric

Basic Sciences

Clinical Trials

iPSCs

Basic Sciences

Clinical Trials

Yes

No

Whether the institute is


conducting any stem cell therapy?
If YES, please provide the details
for the same

Section 4: IC-SCRComposition
* Must be from outside the institute
Date of constitution of IC-SCR: dd / mm / yyyy
Sl.
No
.

Name

IC-SCR
Designation

1.

Chairman*

2.

Legal Expert*

3.

Ethics Expert*

4.

Social Scientist*

5.

Stem Cell Expert*

6.

Stem Cell Expert*

7.

Member Secretary

8.
9.
10.

Area(s) of
expertise

Qualification(s)

Affiliation(s)

Section 5: Details of Basic Science Research Projects


Use separate sheet for each project
Attach IC-SCR/IECApprovals
Basic Science Research Project
Sl. No.
Current Status Ongoing / Completed (delete inapplicable)
Title
Funding Agency
Duration of the project
Name(s), Qualification(s), and
affiliation(s) of PI(s)
Name(s), Qualification(s), and
affiliation(s) of Co-PI(s)
Name(s), Qualification(s), and
affiliation(s) of CoInvestigator(s)
Objectives

Nature and source of cells

Adult / Embryonic / Foetal / Cadaveric / iPSCs (delete inapplicable)

Level of manipulation Minimal / Substantial / Major (delete inapplicable)


Brief Summary (limit to 250 words)

Section 6: Details of Clinical Trials


Use separate sheet for each trial
Attach IC-SCR/IEC/Regulatory Approvals
Clinical Trials
Sl. No.
Current Status Ongoing / Completed (delete inapplicable)
Title
Funding Agency
Is the trial conducted for Yes / No (delete inapplicable)
market authorisation of stem
cell product/therapy
CTRI Registration Id
Phase and duration
of the trial
(mention dates of start/completion)

Name(s), Qualification(s), and


affiliation(s) of PI(s)
Name(s), Qualification(s), and
affiliation(s) of Co-PI(s)
Name(s), Qualification(s), and
affiliation(s) of CoInvestigator(s)
Objectives
Nature and source of cells

Adult / Embryonic / Foetal / Cadaveric / iPSCs (delete inapplicable)

Level of manipulation Minimal / Substantial / Major (delete inapplicable)


No. of subjects recruited /
to be recruited
End-point parameters
Brief Summary (limit to 250 words)

Section 7: Details of Stem Cell Research Investigators


Sl.
No.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.

Name

Area(s) of
expertise

Qualification(s)

No. of stem cell


related publications

DECLARATION
We certify that the foregoing information is true and complete to the best of our knowledge and belief. We
also affirmthat the stem cell research conducted at this institute and functioning of this IC-SCR is in
compliance with the current national guidelines for stem cell research.

Chairman, IC-SCR
Signature with stamp

Head of the Institute


Signature with stamp

Date:

Date:

Place:

Place:

Checklist
Duly completed application form
SOP for functioning of the IC-SCR in prescribed format
Latest CVs of all the IC-SCR members
Summary of all stem cell related projects (ongoing/completed) in the prescribed format
Copies of regulatory approvals (IC-SCR/IEC/DCGI etc.) for all basic science research projects and
clinical trials (ongoing/completed)
Duly signed declaration

**********