compensation for participation

[Guest guest]

COMPENSATION FOR PARTICIPATION

Participants of a clinical trial may be paid for the inconvenience and time spent, and should be reimbursed for expenses incurred, in connection with their participation in research.

They may also receive free medical services. During the period of research if the participant requires treatment for complaints other than the one being studied necessary free ancillary care or appropriate referrals may be provided. However, payments should not be so large or the medical services so extensive as to make prospective participants consent readily to enroll in research against their better judgment, which would then be treated as undue inducement. All payments, reimbursement and medical services to be provided to research participants should be clearly stated in the protocol and approved by the IEC.

Care should be taken :

i. When a guardian is asked to give consent on behalf of an incompetent person,no remuneration should be offered except a refund of out of pocket expenses

ii. When a participant is withdrawn from research for medical reasons related to the study the participant should get the benefit for full participation

iii. When a participant withdraws for any other reasons s/he should be paid an amount proportionate to the amount of participation.

When appropriate, indicate any special incentive or treatment that subjects will receive through their participation in the study. If there is any type of remuneration, specify the amount, method of delivery, time, and reason why payment is required.

Research participants who suffer physical injury as a result of their participation are entitled to financial or other assistance to compensate them equitably for any temporary or permanent impairment or disability.

Obligation of the sponsor to pay

The sponsor whether a pharmaceutical company, a government, or an institution, should agree, before the research begins, in the a priori agreement to provide compensation for any physical or psychological injury for which participants are entitled or agree to provide insurance coverage for an unforeseen injury whenever possible.

An Arbitration committee could be set up by the institution to decide on the issue of compensation on a case-by-case basis for larger trials where such a step is feasible.

Dr Smita

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