PATIENT INFORMATION SHEET (PIS) 

The protocol must be accompanied by the Patient Information Sheet addressed to patient.  The Informed Consent Form to be used in the study should be signed by two witnesses.  While formulating the patient information sheet, investigator must provide the subjects with the following information in simple language, which can be understood by them. 

i)                    Aims and methods of the research

ii)                  Expected duration of the subject participation

iii)                The benefits to be expected from the research to the subject or to others

iv)                Any risk to the subject associated with the study

v)                  Maintenance of confidentiality of records

vi)                Provision of free treatment for research related injury

vii)              Compensation of subjects for disability or death resulting from such injury

viii)            Freedom of individual to participate and to withdraw from research at any time without penalty or loss of benefits to which the subject would otherwise be entitled.

ix)                Amount of blood sample to be taken should be mentioned in PIS in ml

x)                  Costs and source of investigations, disposables, implants and drugs / contrast media must be mentioned in the PIS.

xi)                Telephone number/contact number of the candidate and one of the investigator must be mentioned in the PIS.

(Students are requested to prepare the translation in simple Hindi on their own for both PIS should be enclosed herewith)