Institutional Ethics Committee (Biomedical and Health Research)

All India Institute of Medical Sciences

Bilaspur – 174001, Himachal Pradesh

Annexure 1: AIIMS-BLS/IEC-H/SOP07/V1/ANX01
Project submission form for IEC review

Project submission form

(To be filled by IEC office)

IEC project number:
Date of submission:

A. Project details

1. Project title:
2. Principal investigator:
3. Department and designation:
4. Contact details
 Telephone number:
 Email:
 Fax:
5. Co-investigators:
6. Student researcher:
7. Project funded? Yes / No
8. If funded, funding source and sponsor/CRO
a. Intramural
b. Extramural
c. Clinical trial
9. Budget with details:
10. Student project? Yes / No
a. Name of the student researcher:
b. Contact details of student researcher (phone number, email):
c. Course enrolled in: (e.g. MD, MS, MCh, DM, PhD, MSc, SRF)
d. Year of admission:
e. Month and year of appearing for final examination:
f. Month and year of submitting dissertation:
g. Guide and co-guides (names, designation, address, phone number and email):
h. Is the research study intra-departmental or inter-departmental?
i. If the study is inter-departmental names of the collaborating departments:
j. Has consent been obtained from the concerned departments?
k. Total funds required for the study (in Rupees):
l. Source of funding:
m. Date of approval by the departmental PG monitoring committee:
11. Is the project collaborative? Yes / No
12. If collaborative, then provided details and names of institutes

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 Institutional Ethics Committee (Biomedical and Health Research)
All India Institute of Medical Sciences
Bilaspur – 174001, Himachal Pradesh

a. National:
b. International:
13. Study duration:
14. Study design:
a. Observational / interventional
b. Single centre / multicentre
15. Number of research participants:
16. Clearly defined inclusion and exclusion criteria: Yes / No
a. Inclusion criteria:
b. Exclusion criteria:
17. Sampling
a. Sampling population:
b. Sample size calculation:
c. Sampling technique:
18. Data collection methods including collection settings and periodicity
19. Any vulnerable subjects: Yes / No
20. Category of vulnerable subjects (please specify): e.g. pregnant, children, elderly, illiterate,
handicapped, terminally or seriously ill, mentally challenged, socioeconomically
backward, etc.
21. Special group subjects (please specify): e.g. captives, employees, students, nurses, armed
forces personnel, healthcare workers, etc.
22. Will advertisement be used for recruitment: Yes / No

B. Specimen collection (to be filled if any specimen will be collected)

1. Please specify the type, frequency and amount of samples that will be collected from the
participants e.g. blood, body fluids, tissue, etc.
2. Will foetal tissue or abortus be collected? Yes / No
 If yes, please provide details.
3. Will pre-existing, stored or left over samples from earlier be used? Yes / No
 If yes, please provide details.
4. Please specify how biological materials will be disposed?
5. Will any specimens be stored for bio-banking or future research? Yes / No
 If yes, please give details.
6. Will any participant samples be sent abroad? Yes / No
 If yes, please give details and the address of the international collaborators.
 Please specify the reasons for sending samples abroad:
o Facility unavailable in India
o Facility inaccessible in India
o Facility available but not being availed in India
 Reasons for not being availed?
 Have necessary clearances been obtained for sending samples abroad?

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 Institutional Ethics Committee (Biomedical and Health Research)
All India Institute of Medical Sciences
Bilaspur – 174001, Himachal Pradesh

C. Interventional study (to be filled if applicable)

1. Please specify what all the interventional study involves:

a. Drugs
b. Devices
c. Vaccines
d. Radiopharmaceuticals
e. Recombinant DNA/ Gene therapy
f. Stem cell
g. Indian/ alternative system of medicine
h. Other (please specify)
i. For drugs, devices and vaccines has a copy of the DCGI approval been enclosed?
Yes / No
j. For radiopharmaceuticals, has a copy of the BARC approval been enclosed? Yes /
No
2. Are the above items that will be employed in the study, approved and marketed, and in
which countries?
a. India
b. UK and Europe
c. USA
d. Other countries
e. Please specify approved indications ………………………………………………
3. Is the drug being employed, an investigational new drug? Yes / No; If yes:
a. Is the investigator’s brochure enclosed? Yes / No
b. Is preclinical study data available? Yes / No
i. If yes, please provide summary
c. Is clinical study data available? Yes / No
i. If yes, please provide summary
d. Which phase is the clinical study in?
i. Phase I
ii. Phase II
iii. Phase III
iv. Phase IV
v. Not applicable
e. If study is in phase I-III, will the drug/device be provided free? Yes / No
f. If study is in phase IV, will the drug/device be provided at a lower cost than
hospital pharmacy? Yes / No
g. Has DCGI permission been obtained? Yes / No
i. If yes, has a copy of the permission letter been enclosed? Yes / No
4. Data monitoring
a. Is there a plan for reporting of adverse events? Yes / No
i. If yes, the reporting will be done to:

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 Institutional Ethics Committee (Biomedical and Health Research)
All India Institute of Medical Sciences
Bilaspur – 174001, Himachal Pradesh

 Study sponsor
 IEC
 DCGI
b. Is there a plan for interim analysis of the data? Yes / No
i. If yes, please describe in brief the data monitoring and analysis plan
5. Methodology and study participants
a. Inclusion criteria:
b. Exclusion criteria:
c. Withdrawal criteria, if relevant, e.g. for trial-related therapy and follow-up, or a
prematurely terminated study to ensure safety of participants:
d. Rescue criteria, if applicable, e.g. starting symptomatic therapy, either to control
disease symptoms, or to circumvent the lack of efficacy of the drug under study,
or to rescue participants in placebo group:
e. Number of groups to be studied, with group definitions
f. Randomization details including, intervention details with standardization
techniques for drugs, devices, invasive procedures, non-invasive procedures and
other interventions.
6. Is there a provision for travel and treatment of participants due to study-related injuries?
Yes / No
a. If yes, the funds for above will be provided by:
i. Study sponsor
ii. Investigators
iii. Insurance company
iv. Other source (please specify)
7. Is the study trial registered with the Clinical Trial Registry of India? Yes / No
a. If yes, is a copy of the registration certificate enclosed? Yes / No

D. Risks and benefits

1. Does this study carry risk for the participant?

 Minimal risk
 More than minimal risk
 High risk
2. Is there any benefit for the participant?
 Direct
 Indirect
 None
3. Is there any benefit to the society?
 Yes
 No
4. Is the risk commensurate to the benefits?
 Yes

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 Institutional Ethics Committee (Biomedical and Health Research)
All India Institute of Medical Sciences
Bilaspur – 174001, Himachal Pradesh

 No

E. Privacy and confidentiality

1. What form of identifiers does the study employ?

 Direct identifiers (participant name, registration number)
 Indirect identifiers (study identifier)
 Anonymized identifiers
2. Will the participant and study data be handled confidentially?
 Yes
 No

F. Informed consent documents

1. Has the project sought waiver of consent?

a. If yes, please provide justification for seeking waiver
2. Type of informed consent that will be taken:
 Written
 Verbal
 Audio-visual
3. Language of informed consent:
 English
 Hindi
 Local language (please specify)
4. Does the study include children? Yes / No
5. If yes, which age group? …………………
6. Which of the following patient information and informed consent documents have been
submitted?
 For adult patients
 For adult controls / volunteers
 For parents / legally acceptable/authorized representative/guardian
 Assent form for children 7-18 years
7. Who will take the informed consent from participants?
Principal investigator
Co-investigators
Nurse
Counsellor
Research staff
Student
Other (please specify)

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 Institutional Ethics Committee (Biomedical and Health Research)
All India Institute of Medical Sciences
Bilaspur – 174001, Himachal Pradesh

G. Project archiving

1. Do the investigators require project documents and records to be archived longer than 5
years after the completion/termination of the project? Yes / No
2. If yes, for how many years? ………………….
3. Please give reasons for archiving more than 5 years

H. Ethical issues

Please identify and provide details of any ethical issues related to the proposed study.
…………………………………………………………………………………………………..
…………………………………………………………………………………………………..
…………………………………………………………………………………………………..

I. Brief summary of research proposal

Please provided a brief summary of the research proposal including the aim and objectives,
methodology, potential risks and benefits, and outcomes (maximum 500 words).

Signature of student researcher (if applicable)

(Name, designation, department, and date)

Signature of Principal investigator / Guide

(Name, designation, department with seal and date)

Signature of Co-investigator / Co-guide

(Name, designation, department with seal and date)

Signature of the Head of Department

(Name, designation, department with seal and date)

Signature of the Head of Department from collaborating institutions

(Name, designation, department with seal and date)

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 Institutional Ethics Committee (Biomedical and Health Research)
All India Institute of Medical Sciences
Bilaspur – 174001, Himachal Pradesh

Instructions for submission:

1. Submit two print and one electronic copy of the project, submission form and all other
study related documents, as per the submission checklist.
2. Submit the detailed project proposal comprising a short review of literature, study
justification, aim, objectives, sample size calculation, methodology, inclusion and
exclusion criteria, analysis and expected outcomes. Mention the source of participants,
including volunteers and controls.
3. Submit case report form
4. Submit a copy of recent, signed and dated curriculum vitae of the investigators and
student who have submitted the project / thesis proposal.
5. The participant information and informed consent documents should be in simple
language devoid of technical jargon.
6. Consider including the following in the participant information documents:
a. Statement that the study involves research
b. Statement that consent and participation are voluntary
c. Purpose and procedures
d. Alternatives to participation
e. Risk and discomforts
f. Consent for future use of biological specimens
g. Confidentiality of records
h. Right to withdraw from the study
i. Contact information of investigators
j. Free supply of drugs/treatment, as applicable
k. Compensation for study related injuries

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 Institutional Ethics Committee (Biomedical and Health Research)
All India Institute of Medical Sciences
Bilaspur – 174001, Himachal Pradesh

Annexure 2: AIIMS-BLS/IEC-H/SOP07/V1/ANX02
Form for consent of the Principal Investigator’s Head of Department

Consent of the Principal Investigator’s Head of Department

Date: ………………

I have reviewed the project entitled

“……………………………………………………………
……………………………………………………………………………………………….”
submitted by ………………………………………………….., principal investigator from
my department. I endorse the project and have no objection on its submission for
consideration by the institutional ethics committee. I concur with the investigators included in
the study.

Signature and date Name Department

[Note: to avoid conflict of interest, if the head of the department is himself/herself the
principal investigator, this form is not be submitted.]

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 Institutional Ethics Committee (Biomedical and Health Research)
All India Institute of Medical Sciences
Bilaspur – 174001, Himachal Pradesh

Annexure 3: AIIMS-BLS/IEC-H/SOP07/V1/ANX03
Form for Research review committee / Departmental research committee / Doctoral
committee / Scientific committee / MD-MS protocol review committee approval

Research review committee / Departmental research committee / Doctoral committee /

Scientific committee / MD-MS protocol review committee approval

The project entitled

“…………………………………………………………………………….
……………………………………………………………………………………………….”
with all its accompanying documents was reviewed by the Research review committee /
Departmental research committee/ Doctoral committee/ Scientific committee/ MD-MS
protocol review committee on (dd/mm/yyyy), at AIIMS, Bilaspur. The committee has granted
its approval on the scientific content of the project.

The proposal may now be reviewed by the institutional ethics committee for ethics approval.

Signature of the Committee Chairperson/ Head

Name:

Date:

[Note:
1. This form is not required for sponsor/CRO initiated drug/device trials.
2. Please attach a copy of the minutes of the research review committee / departmental
research committee / doctoral committee / scientific committee / MD-MS protocol review
committee.]

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 Institutional Ethics Committee (Biomedical and Health Research)
All India Institute of Medical Sciences
Bilaspur – 174001, Himachal Pradesh

Annexure 4: AIIMS-BLS/IEC-H/SOP07/V1/ANX04
Form for undertaking by the principal investigator

Undertaking by the principal investigator

Project title:

Name, designation and department of the principal investigator:

Other members of the research team:

Name and address of other institutions collaborating in the study:

Number of ongoing projects / clinical trials with the principal investigator:

 Number of sponsored clinical trials with active enrolments:
 Number of sponsored clinical trials with follow-up only:
 Total number of ongoing projects:

1. I confirm that I will initiate the above study only after obtaining all necessary
regulatory clearances.
2. I will not implement any research protocol deviation without prior approval from the
sponsor and intimation to the IEC.
3. I confirm that the co-investigators and other members of the study team have been
informed about their obligations and are qualified to meet them.
4. I will personally supervise the study and ensure that the requirements of obtaining
informed consent and other ethical requirements under national regulatory and ICMR
guidelines are adhered to.
5. I will maintain accurate and complete record of all cases in accordance with GCP
provisions and make them available for audit/inspection by the IEC, regulatory
authorities, sponsors or their authorized representatives.
6. I will inform the sponsors, IEC, head of Institute, and the Central Licensing Authority
of any unexpected or serious adverse event at the earliest and definitely within
fourteen calendar days of its occurrence. I will also inform the above authorities about
any serious adverse event leading to death at the earliest and within 14 calendar days
of the knowledge of its occurrence.
7. I will maintain confidentiality of the identity of all participating subjects and assure
security and confidentiality of study data.

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 Institutional Ethics Committee (Biomedical and Health Research)
All India Institute of Medical Sciences
Bilaspur – 174001, Himachal Pradesh

8. I and my colleagues will comply with statutory obligations, requirements and

guidelines applicable to such clinical studies.
9. I will inform the IEC if there is a change in the funding agency/status.
10. I will inform the IEC of the date of starting the study within 2 weeks of initiation of
the trial and submit annual progress reports and final report to the IEC Member
Secretary within 4 weeks of the due date.

Principal investigator
(Signature, name, designation, department, date)

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 Institutional Ethics Committee (Biomedical and Health Research)
All India Institute of Medical Sciences
Bilaspur – 174001, Himachal Pradesh

Annexure 5: AIIMS-BLS/IEC-H/SOP07/V1/ANX05
Form for undertaking by the student researcher’s Guide

Undertaking by Guide

Title of the study:

I undertake full responsibility and accountability for the planning and execution of the above
study, and for any adverse events that may occur during the course of the study. The data
collected during the study and all records pertaining to the study will be kept in my
safekeeping for a minimum duration of five years after the completion of the study.

Signature of the Guide

(Name, designation, department, seal, date)

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 Institutional Ethics Committee (Biomedical and Health Research)
All India Institute of Medical Sciences
Bilaspur – 174001, Himachal Pradesh

Annexure 6: AIIMS-BLS/IEC-H/SOP07/V1/ANX06
Form for conflict of interest declaration by the principal investigator

Conflict of interest declaration by the principal investigator

The Member Secretary

Institutional Ethics Committee (Biomedical and Health Research),
All India Institute of Medical Sciences,
Bilaspur – 174001, Himachal Pradesh

Project entitled:

Name of principal investigator:

Conflict of interest declaration

[ ] I hereby declare that I have no conflicts of interest related to my project.

[ ] I hereby declare that I have the following conflicts of interest related to my project:

Principal investigator
(Signature, name, date)

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 Institutional Ethics Committee (Biomedical and Health Research)
All India Institute of Medical Sciences
Bilaspur – 174001, Himachal Pradesh

Annexure 7: AIIMS-BLS/IEC-H/SOP07/V1/ANX07
Brief format for curriculum vitae of the principal investigator, co-investigator and/or
student researcher

Brief format for curriculum vitae of the principal investigator, co-investigator and/or
student researcher

1. Name:
2. Date of birth: (dd/mm/yyyy)
3. Study site affiliation: (e.g. principal investigator, co-investigator, coordinator, etc.)
4. Study site and institution address:
5. Phone (office):
6. Phone (mobile):
7. Email address:
8. Academic qualifications (most current first):
9. Professional experience/ academic appointments (most current first):
10. Brief summary of relevant clinical research experience:

Signature
Date:

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 Institutional Ethics Committee (Biomedical and Health Research)
All India Institute of Medical Sciences
Bilaspur – 174001, Himachal Pradesh

Annexure 8: AIIMS-BLS/IEC-H/SOP07/V1/ANX08
Guidelines for drafting participant/ legally acceptable guardian information documents

Guidelines for drafting participant / legally acceptable guardian information documents

1. Study title
 Is the title self-explanatory to a lay person? If not, an additional simplified title should
be included.
2. Invitation paragraph
 You should explain that the patient is being asked to take part in a research/trial study.
“You are being invited to take part in a research/trial study. Before you decide it is
important for you to understand why the research/study is being done and what it will
involve. Please take time to read the following information carefully and discuss it
with friends, relatives and your treating physician/family doctor if you wish. Ask us if
there is anything that is not clear or if you would like more information. Take time to
decide whether or not you wish to take part.”
3. What is the purpose of the study?
 The background and aim of the study should be given here.
4. Why have I been chosen?
 You should explain how and why the patient/volunteer was chosen and how many
other patients will be studied.
5. Do I have to take part?
 You should explain that taking part in the research/trial is entirely voluntary e.g. “It is
up to you to decide whether or not to take part. If you do decide to take part you will
be given this information sheet to keep and be asked to sign a consent form. If you
decide to take part you are still free to withdraw at any time and without giving a
reason. This will not affect the standard of care you receive.”
6. What will happen to me if I take part?
 You should say how long the patient will be involved in the research/trial, how long
the research/trial will last (if this is different), how often they will need to visit the
hospital/lab or a clinic (if this is appropriate) and how long these visits will be. You
should explain if the patient will need to visit the doctor (or clinic) more often than for
the usual treatment and if travel expenses are available. What exactly will happen e.g.
blood tests, x-rays, interviews etc.? Whenever possible you should draw a simple flow
chart or plan indicating what will happen at each visit. What are the patient’s
responsibilities? Set down clearly what you expect of them in the form of simple
instructions, for example asking them to come to the clinic at 8.00 am without having
eaten anything/on an empty stomach/fasting. You should explain simply and briefly
the research/trial methods you intend to use, for example:
 Randomized trial: Sometimes, because we do not know which way of treating
patients is best, we need to make comparisons. People will be put into groups and

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 Institutional Ethics Committee (Biomedical and Health Research)
All India Institute of Medical Sciences
Bilaspur – 174001, Himachal Pradesh

then compared. The groups are selected by a computer, which has no information
about the individual – i.e. by chance. Patients in each group then have a different
treatment and these are compared. This way, the chances of something happening as a
result of our choosing to put you in a specific group or bias is reduced. You should
tell the patients what chance they have of getting the study drug/treatment: e.g. a one
in four chance.
 Blind trial: In a blind trial you will not know which treatment group you are in. If the
trial is a double-blind trial, neither you nor your doctor will know in which treatment
group you are (although, if your doctor needs to find out he/she can do so). This is
done to ensure that the trial is carried out without a bias that may result from knowing
which group you are in, which can adversely affect the results.
 Cross-over trial: In a cross-over trial both the groups have the different treatments in
turn. There may be a break between treatments, a washout period, so that the effects
of the first drug or treatment are cleared from your body before you start the new
treatment.
7. What do I have to do?
 Are there any lifestyle restrictions? You should tell the patient if there are any dietary
restrictions. Can the patient drive? Drink? Take part in sport? Can the patient continue
to take his/her regular medication? Should the patient refrain from giving blood?
What happens if the patient becomes pregnant? Explain (if necessary) that the patient
should take the medication regularly and dangers of non-compliance.
8. What is the drug or procedure that is being tested?
 You should include a short description of the drug or device and give the stage of
development. You should also state the dosage of the drug and method of
administration. Patients entered into drug trials should preferably be given a card
(similar to an identify card) with details of the trial they are in. They should be asked
to carry it at all times.
9. What are the alternatives for diagnosis or treatment?
 For therapeutic research/trial the patient should be told what other treatment options
are available.
10. What are the side effects of taking part?
 For any new drug or procedure you should explain to the patients the possible side
effects. If they suffer these or any other symptoms they should report them next time
you meet. You should also give them a contact name and number to phone if they
become in any way concerned or in case of emergency. The known side effects
should be listed in terms the patient will clearly understand (e.g. ‘damage to the heart’
rather than ‘cardiotoxicity’; ‘abnormalities of liver tests’ rather than ‘raised liver
enzymes’). For any relatively new drug it should be explained that there may be
unknown side effects.
11. What are the possible disadvantages and risks of taking part?
 For studies where there could be harm to an unborn child if the patient were pregnant
or became pregnant during the study.

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 Institutional Ethics Committee (Biomedical and Health Research)
All India Institute of Medical Sciences
Bilaspur – 174001, Himachal Pradesh

 “It is possible that if the treatment is given to a pregnant woman it will harm the
unborn child. Pregnant women must not therefore take part in this study, neither
should woman who plan to become pregnant during the study. Women who are at risk
of pregnancy may be asked to have a pregnancy test before taking part to exclude the
possibility of pregnancy. Women who could become pregnant must use an effective
contraceptive during the course of this study. Any woman who finds that she has
become pregnant while taking part in the study should immediately inform the
investigator.”
 Use the pregnancy statement carefully. In certain circumstances (e.g. terminal illness)
it would be inappropriate and insensitive to bring up pregnancy.
 There should also be an appropriate warning and advice for men if the treatment could
damage sperm which might therefore lead to a risk of foetal damage.
 If future insurance status, e.g. for life insurance or private medical insurance, could be
affected by taking part this should be stated (if e.g. high blood pressure is detected). If
the patients have private medical insurance you should ask them to check with the
company before agreeing to take part in the trial. They will need to do this to ensure
that their participation will not affect their medical insurance.
 You should clearly state what will happen if you detect or find a condition of which
the patient was unaware. It is treatable? What are you going to do with this
information? What might be uncovered (e.g. high blood pressure, HIV status)?
12. What are the possible benefits of taking part?
 Where there is no intended clinical benefit to the patient from taking part in the trial
this should be stated clearly.
 It is important not to exaggerate the possible benefits to the patient during the course
of the study, e.g. saying they will be given extra attention. For example, “We hope
that both (all) the treatments will help you. However, this cannot be guaranteed. The
information we get from this study may help us to treat future patients with (name of
condition) better”.
13. What if new information becomes available?
 If additional information becomes available during the course of the research/trial you
will need to tell the patient about this. For example:
 “Sometimes during the course of a research project/trial, new information becomes
available about the treatment/drug that is being studied. If this happens, your
research/trial doctor will tell you about it and discuss with you whether you want to
continue in the study. If you decide to withdraw, your research/trial doctor will make
arrangements for your care to continue. If you decide to continue in the study, you
may be asked to sign an updated consent form. Also, on receiving new information
your research/trial doctor might consider it to be in your best interests to withdraw
you from the study. He/she will explain the reasons and arrange for your care to
continue.”
14. What happens when the research/trial study stops?

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 Institutional Ethics Committee (Biomedical and Health Research)
All India Institute of Medical Sciences
Bilaspur – 174001, Himachal Pradesh

 If the treatment will not be available after the research/trial finishes this should be
explained to the patient. You would also explain to them what treatment will be
available instead. Occasionally the company sponsoring the research/trial may stop it.
If this is the case the reasons should be explained to the patient.
15. What if something goes wrong?
 You should inform patients how complaints will be handled and what addresses may
be available. Is there a procedure in place? You will need to distinguish between
complaints from patients as to their treatment by members of staff (doctors, nurses
etc.) and something serious happening during or following their participation in the
trial, i.e. a reportable serious adverse event. You should incorporate following line in
PID “In case of study related injury or death, (name of CRO/ company), will provide
the complete medical care as well as compensation for the injuries or deaths”.
16. Will my taking part in this study be kept confidential?
 You will need to obtain the patient’s permission to allow restricted access to their
medical records and to the information collected about them in the course of the
study. You should explain that all information collected about them will be kept
strictly confidential.
 “If you consent to take part in the research/trial any of your medical records may be
inspected by the company sponsoring (and/or the company organizing) the
research/trial for purposes of analysing the results. They may also be looked at by
people from the company and from regulatory authorities to check that the study is
being carried out correctly. Your name, however, will not be disclosed outside the
hospital/clinic/laboratory”
 “All information collected about you during the course of the research/trial will be
kept strictly confidential. Any information which leaves the hospital/clinic/laboratory
will have your name and address removed so that you cannot be recognized from it.”
17. What will happen to the results of the research/trial study?
 You should be able to tell the patients what will happen to the results of the
research/trial. You might add that they will not be identified in any report/publication.
18. Who is organizing and funding the research/trial?
 The information should include the organization or company sponsoring or funding
the research/trial (e.g. Govt. agency, pharmaceutical company, NGO, academic
institution). The patient should be told whether he has to pay for drugs/tests, the
doctor conducting the research/trial is being paid for including and looking after the
patient in the study. The information regarding payment and compensation should be
included in the patient information documents.
19. Will the drug be made available after trial is over? (new drug requires continued
use, till it is marketed in India)
 Please explain to participant regarding the query of availability of study drug.
20. Who has reviewed the study?
 You may should mention that the IEC has reviewed and approved the study (you
should not however list the members of the committee).

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 Institutional Ethics Committee (Biomedical and Health Research)
All India Institute of Medical Sciences
Bilaspur – 174001, Himachal Pradesh

21. Contact for further information

 You should give the patient a contact address for further information. This can be
your name or that of another doctor/nurse involved in the study.
 Include the principal investigator’s details including name, address, and telephone
numbers; and the name and contact details of the IEC Member Secretary.

Remember to thank the participant for taking part in the study!

The participant information document should be dated and given a version number. It should
state that the participant will be given a copy of the information sheet and the signed consent
form.

Principal investigator
(Signature, name, date)

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 Institutional Ethics Committee (Biomedical and Health Research)
All India Institute of Medical Sciences
Bilaspur – 174001, Himachal Pradesh

Annexure 9: AIIMS-BLS/IEC-H/SOP07/V1/ANX09
Participant consent form

Participant consent form

Study title:
Study number:
Participant’s full name:
Participant’s father’s name:
Date of birth / age:
Address of the participant:
Education level:
Occupation: student/ self-employed/ service/ housewife/ other (please tick appropriate)

1. I confirm that I have read and understood the participant information document dated
(dd/mm/yyyy) for the above study and have had the opportunity to ask questions. I have
been explained the nature of the study by the investigator.
2. I understand that my participation in the study is voluntary and that I am free to withdraw
at any time, without giving any reason and without my medical care or legal rights being
affected.
3. I understand that the sponsor of the clinical trial/study, others working on the sponsor’s
behalf, the ethics committee and the regulatory authorities will not need my permission to
look at my health records both in respect of the current study and any further research that
may be conducted in relation to it, even if I withdraw from the study/ trial. However, I
understand that my identity will not be revealed in any information released to third
parties or published.
4. I agree not to restrict the use of any data or results that arise from this study provided such
a use is only for scientific purpose(s).
5. I permit the use of stored sample (tissue/blood) for future research. (Yes / No)
6. I agree to take part in the above study.

Signature (or thumb impression) of the participant / legally acceptable representative

Signatory’s name:
Date:

Study investigator
(Signature, name, date)

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 Institutional Ethics Committee (Biomedical and Health Research)
All India Institute of Medical Sciences
Bilaspur – 174001, Himachal Pradesh

Signature of the witness

Name of the witness:
Date:

Received a signed copy of the participant information document and consent form.

Signature (or thumb impression) of the participant / legally acceptable representative

Date:

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 Institutional Ethics Committee (Biomedical and Health Research)
All India Institute of Medical Sciences
Bilaspur – 174001, Himachal Pradesh

Annexure 10: AIIMS-BLS/IEC-H/SOP07/V1/ANX10

Child information document

Child information document

Study title:
………………………………………………………………………………………
…………………………………………………………………………………………………..

1. Introduction
 You have come to meet the doctor as you are suffering from
………………………....... You may be having symptoms like
……………………………………………………..
………………………………………………………………………………………….
 Describe briefly the purpose of this study
 If this is a randomized trial, details of both arms of the trial/study must be explained
in writing to the subject being enrolled.
 Disclose appropriate alternative treatments available, if any.
 We invite you to participate in this study.
2. What will you have to do?
 To participate in this research study, you will be examined by your doctor and if
found to fulfil pre-specified criteria, you will be eligible to be enrolled in this research
study.
 Since you are in the age group of 7-18 years we ask your accompanying parent /
guardian will also sign a similar form called as the parent informed consent form.
 List all the procedures, which will be employed in the study. Point out any that are
considered experimental/or otherwise, and explain technical and medical terminology
in simple, nontechnical & direct language.
 In addition, to record the same parameters daily your parent/guardian will also be
provided with a diary where they will enter the same findings accordingly. You will
have to tell them about your symptom and they will mark accordingly in the diary.
3. Risks and discomforts
 There is no foreseen significant risk/hazard to your health, if you wish to participate
in the study. If you follow the directions of the doctors in charge of this study and you
are injured due to any substance or procedure given under the study plan, the sponsor
will pay for the medical expenses for the treatment of that injury.
4. Benefits
 If you participate in the study you will receive
…………………………………………. If you appear to have any acute illness, you
will be offered free treatment for those visits in accordance with local standard

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 Institutional Ethics Committee (Biomedical and Health Research)
All India Institute of Medical Sciences
Bilaspur – 174001, Himachal Pradesh

medical care. You will not be offered free treatment for chronic diseases or conditions
not related to study procedures.
 Your participation in the study may help others, because this participation will help us
determine if the study drug/procedure is safe.
5. Confidentiality
 Your existing medical records may be accessed; personal health information about
you may be collected and processed by study investigators for the purpose of
performing the study.
 Information about you will be collected and stored in files with an assigned number,
and not directly with your name. All documents related to the study will only be
accessed by the study investigator, sponsor, the Ethics Committee and the Regulatory
authority.
 Your parent / guardian will have the right to access personal information about you at
any time with the study doctor and the right to correct this personal information. Your
parent / guardian can take away your authorization to collect process and disclose data
about you at any time.
6. Right to refuse or withdraw
 You do not have to take part in this research if you do not wish to do so. Refusing to
participate will not affect your treatment. You will still have all the benefits that you
would otherwise have got at this clinic/hospital. You may stop participating in the
research at any time you wish without losing any of your rights. Your treatment will
not be affected in any way.
 The study doctor may decide to withdraw you from the study if he/she considers it is
in your best interest.
 You will be informed of important new findings developed during the course of the
study so you will be able to consider your participation in the study in light of new
information.
7. Parents’ responsibilities
 It is the responsibility of your parent / guardian to come along with you to the hospital
during the study period for all the visits unless you withdraw or are prematurely
discontinued from the study. It is also your responsibility and your parent / guardian
to report any expected or unexpected reactions (side effects) that you notice during
the study period.
 It is also the responsibility of your parent / guardian to inform the doctor if you
consume any other medication apart from the study treatment.
 We expect your co-operation throughout the study.
8. Contact for further information
 You should give the participant a contact address for further information. This can be
your name or that of another doctor/nurse involved in the study.
 Include the principal investigator’s details including name, address, and telephone
numbers; and the name and contact details of the IEC Member Secretary.

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Institutional Ethics Committee (Biomedical and Health Research)
All India Institute of Medical Sciences
Bilaspur – 174001, Himachal Pradesh

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 Institutional Ethics Committee (Biomedical and Health Research)
All India Institute of Medical Sciences
Bilaspur – 174001, Himachal Pradesh

Annexure 11: AIIMS-BLS/IEC-H/SOP07/V1/ANX11

Child assent form

Child assent form

Study title:
Study number:
Child’s full name:
Child’s father’s name:
Date of birth / age:
Address of the participant:

I …………………………………………………….., exercising my free power of choice,

hereby give my consent for participation in the study entitled ………………………………
………………………………………………………………………………………………….
I have been informed, to my satisfaction, by the attending physician, about the purpose of the
study and the nature of the procedure to be done. I am aware that my parents/guardians do not
have to bear the expenses of the treatment if I suffer from any study/trial related injury, which
has causal relationship with the said study/trial drug. I am also aware of right to opt out of the
study/trial, at any time during the course of the study/trial, without having to give reasons for
doing so.

Signature of participant
Name of the participant:
Date:

Signature of the witness

Name of the witness:
Date:

Signature of the attending physician

Name of the attending physician:
Date:

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 Institutional Ethics Committee (Biomedical and Health Research)
All India Institute of Medical Sciences
Bilaspur – 174001, Himachal Pradesh

Annexure 12: AIIMS-BLS/IEC-H/SOP07/V1/ANX12

Document checklist

Document checklist

Instructions:

1. Please furnish two print copies and one electronic copy of the documents listed below
with your research project submission.
2. For non-interventional studies please submit only relevant documents.
3. Please assign page numbers to all the documents and enter the same in the checklist.
4. For drug and device trials please provide version numbers and effective dates for each
document.

Project title:

Principal investigator:

Type of project: Intramural/ Extramural / Student project / Investigator initiated /

Interventional trial

No Document Yes / No / Page no.

. Not applicable
1. Cover letter to Member Secretary / Chairperson
2. Project submission form
3. Research proposal
4. Amended research proposal, if applicable
5. Case report form
6. Consent of Principal Investigator’s Head of
Department
7. Administrative sanction from the head of the
Institute
8. Approval letter from research review committee,
doctoral committee, departmental research
committee, MD protocol review committee or other
scientific committee
9. Undertaking by principal investigator
10. Conflict of interest declaration by principal
investigator
11. Recent signed and dated curriculum vitae of the
investigators and student researcher
12. GCP training certificate (from within last 5 years)
of principal investigator, co-investigators and study

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 Institutional Ethics Committee (Biomedical and Health Research)
All India Institute of Medical Sciences
Bilaspur – 174001, Himachal Pradesh

No Document Yes / No / Page no.

. Not applicable
coordinators, if applicable
13. Research methodology training certificate (from
within 5 years) of principal investigator, co-
investigators, and study coordinators, if applicable
14. List of ongoing research studies currently with the
principal investigator
15. Participant information sheet and informed consent
forms in English and local vernacular language
16. Consent waiver form, if applicable
17. Back translations of the informed consent
documents and back translation certificates, if
applicable
18. Amendments to the informed consent documents, if
any
19. Investigator’s brochure (for drug/device trial)
20. Patient recruitment procedures including, project
advertisement, information brochure, notices, letters
to doctors etc. (for drug/device trial)
21. Clinical Trial Registry of India (CTRI) registration
(prerequisite for sponsored clinical trials; for other
trials registration can be done after IEC approval)
22. DCGI approval letter with list of approved institutes
(for sponsored drug/device trial)
23. Details of the funding agency/ sponsor and grant
received for the project (in project submission form
and clinical trial agreement)
24. Clinical trial agreement (CTA) between sponsors,
investigators, and heads of institutions (for
drug/device trial)
25. Insurance policy for study participants indicating
conditions of coverage, date of commencement, and
date of expiry of risk coverage. It is preferable to
have a full insurance policy rather than only an
insurance certificate (for drug/device trial)
26. Indemnity policy clearly indicating the conditions
of coverage, date of commencement and date of
expiry of risk coverage (for drug/device trial)
27. Material transfer agreement (MTA) and Health
Ministry’s Screening Committee (HMSC) approval
(for international transfer of biological materials)
28. Directorate General of Foreign Trade approval
(DGFT) (for export of study samples in clinical
trials)
29. Genetic Engineering Advisory Committee
(MoEF&CC and DBT-GEAC) approval (for
proposals involving recombinant DNA technology

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 Institutional Ethics Committee (Biomedical and Health Research)
All India Institute of Medical Sciences
Bilaspur – 174001, Himachal Pradesh

No Document Yes / No / Page no.

. Not applicable
and/or gene therapy)
30. Bhabha Atomic Research Centre (BARC) approval
(for studies involving radioisotopes, or ionizing
radiations)
31. Institutional stem cell research committee approval,
and NAC-SCRT registration and approval, if
applicable
32. Decision of other ethics committees from
collaborating institutions
33. Any other MoU or agreement for international
collaborations
34. Documentation of clinical trial registration, if
available
35. Any additional documents, as required by the IEC
36. Document checklist
37. IEC document receipt form

Principal investigator
(Signature, name, date)

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