Patient Information Sheet (PIS)

The project must be accompanied by the Patient Information Sheet addressed to the patient.  While formulating the patient information sheet, investigator must provide the subjects with the following information in a simple language, which can be understood by them in English and Hindi.

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 in quantity in ml to be taken should be mentioned

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

xi)                Telephone number/contact number of Principle Investigator and Co investigator at the top of each page.

xii)              In case of drug trials:. 

                a) The chemical name of the drug, date of its manufacturing and batch number must be mentioned

                b) Initial Bio equivalent study of the drug / references should be provided