Informed Consent Form with Patient Information Sheet

[Guest guest]

Informed Consent of Participants:

For all biomedical research involving human participants, the investigator must obtain the informed consent of the prospective participant or in the case of an individual who is not capable of giving informed consent, the consent of a legal guardian. Informed consent protects the individual’s freedom of choice and respect for individual’s autonomy and is given voluntarily to participate in research or not. Adequate information about the research is given in a simple and easily understandable unambiguous language in a document known

as the Informed Consent Form with Participant/ Patient Information Sheet. The latter should have following components as may be applicable:

1. Nature and purpose of study stating it as research

2. Duration of participation with number of participants

3. Procedures to be followed

4. Investigations, if any, to be performed

5. Foreseeable risks and discomforts adequately described and whether project involves more than minimal risk

6. Benefits to participant, community or medical profession as may be applicable

7. Policy on compensation

8. Availability of medical treatment for such injuries or risk management

9. Alternative treatments if available

10. Steps taken for ensuring confidentiality

11. No loss of benefits on withdrawal

12. Benefit sharing in the event of commercialization

13. Contact details of PI or local PI/Co-PI in multicentric studies for asking more information related to the research or in case of injury

14. Voluntary participation

15. If test for genetics and HIV is to be done, counseling for consent for testing must be given as per national guidelines

16. Storage period of biological sample and related data with choice offered to participant regarding future use of sample, refusal for storage and receipt of its results

A copy of the participant/patient information sheet should be given to the participant for her/ his record.

Details of informed consent have already been covered in the earlier discussion.

Dr. Smita

The INTERNET now has a personality. YOURS! See your Homepage.