INFORMED CONSENT

 

1. Checklist for study Subject’s informed consent documents

1.1 Essential Elements:

1. Statement that the study involves research and explanation of the purpose of the research
2. Expected duration of the Subject’s participation
3. Description of the procedures to be followed, including all invasive procedures and
4. Description of any reasonably foreseeable risks or discomforts to the Subject
5. Description of any benefits to the Subject or others reasonably expected from research. If no benefit is expected Subject should be made aware of this.
6. Disclosure of specific appropriate alternative procedures or therapies available to the Subject.
7. Statement describing the extent to which confidentiality of records identifying the Subject will be maintained and who will have access to Subject’s medical records
8. Trial treatment schedule(s) and the probability for random assignment to each treatment (for randomized trials)
9. Compensation and/or treatment(s) available to the Subject in the event of a trial-related injury
10. An explanation about whom to contact for trial related queries, rights of Subjects and in the event of any injury
11. The anticipated prorated payment, if any, to the Subject for participating in the trial
12. Subject’s responsibilities on participation in the trial
13. Statement that participation is voluntary, that the subject can withdraw from the study at any time and that refusal to participate will not involve any penalty or loss of benefits to which the Subject is otherwise entitled
14. Any other pertinent information

 

  1.2 Additional elements, which may be required

     a.    Statement of foreseeable circumstances under which the Subject’s

participation may be   terminated by the Investigator without the Subject’s consent.

 

    b.  Additional costs to the Subject that may result from participation in the

                   study.

 

     c. The consequences of a Subject’s decision to withdraw from the research and

          procedures for  orderly termination of participation by Subject.

 

     d. Statement that the Subject or Subject’s representative will be notified in

a timely manner if  significant new findings develop during the course of the research which may affect the Subject’s willingness to continue   participation will be provided.

 

     e. A statement that the particular treatment or procedure may involve risks to the Subject (or to the embryo or fetus, if the Subject is or may become pregnant), which are currently   unforeseeable

 

     f.   Approximate number of Subjects enrolled in the study

 

2.      Format of informed consent form for Subjects participating in a clinical trial

 

Informed Consent form to participate in a clinical trial

Study Title:

Study Number:

 

Subject’s Initials: _______________         Subject’s Name:_______________

 

Date of Birth / Age: _________________  

 

		Please initial box (Subject)
(i)	I confirm that I have read and understood the information sheet dated ___ for the above study and have had the opportunity to ask questions.		[         ]
(ii)	I understand that my participation in the study is voluntary and that I am free to withdraw at any time, without giving any reason, without my medical care or legal rights being affected.		[         ]
(iii)	I understand that the Sponsor of the clinical trial, 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 trial. I agree to this access. However, I understand that my identity will not be revealed in any information released to third parties or published.		[         ]
(iv)	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)		[        ]
(v)	I agree to take part in the above study.		[         ]

                           

Signature (or Thumb impression) of the Subject/Legally Acceptable Representative:_____________                

 

 

Date: _____/_____/______

 

Signatory’s Name: ______________________________________________________

 

Signature of the Investigator: ____________________________                   Date: _____/_____/______

 

Study Investigator’s Name: __________________________________________________

 

Signature of the Witness ______________________               Date:_____/_____/_______     

 

Name of the Witness: _______________________________________________________

 

 Source : Schedule Y – APPENDIX V