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Comments and suggestions on CDSCO draft guidelines for determining compensation in case of clinical trial related injury or death

The ‘draft guidelines for determining the quantum of financial compensation to be paid in case of clinical trial related injury or death’ issued by the CDSCO (Central Drugs Standard Control Organization) on August 3, 2012, in general, are in the right direction. However, considering the way in which the third world populations are being exploited by the unscrupulous multinational pharmaceutical companies conducting drug trials, we need to protect the interests of our people through stringent and foolproof guidelines.

Dr Surinder Kumar Joshi

Some suggestions for making the compensation more judicious, and the system more effective, are given below.

I. Outline of the system of calculation of compensation as per the draft guidelines:

As per Para 5 of the draft the amount of compensation to be paid is to be decided by the ethics committee on the basis of the following formulae:

In case of trial related death

(a) Healthy participant                   C = A x B

(b) Diseased participant                 C1 = A x B (1-F/100)

In case of trial related injuries/disease

C2 = A x B (1-F/100) x D/100


‘A’ is the income of the deceased (Minimum to be at the rate fixed in the Minimum Wages Act) minus personal and living expenditure @50% in case of death and 40% in case of injury/disease;

‘B’ is the age of the participant. Value of ‘B’ is laid down in Annexure 1 (same as ‘Relevant Factor’ in Schedule IV to the Workmen’s Compensation Act); the value decreases as the age increases (For age 16 years = 228.54, for age 38 years = 189.56 and for age 65 years = 99.37);

‘F’ is the risk factor for seriousness and severity of the disease the subject was suffering from at the time of participation. To be decided by the investigator on a scale of zero to hundred, zero for healthy with no risk and 100 for fatality (maximum to be not more than 50); and

‘D’ is the percentage of permanent disability caused by the trial, to be decided by the doctor.

II. Inadequacies in the Guidelines

  1. In step 1, deduction of 50% (in case of death) as personal and living expenditure is not reasonable/realistic. It is too high.
  2. Rationale for deduction of 40% in case of trial related injury is not understandable. With disability/disease/injury, in fact the personal/living expenditure may be more than that of a healthy individual.
  3. Decision about the value of ‘F’ — the risk factor in Step 4 — is left to the investigator who may have a conflict of interest.
  4. Value of D — the percentage disability — is left to be decided by a single doctor.
  5. The draft does not include the compensation applicable in case of children, women (non-working) and elderly who may not be formally employed.
  6. There is no time limit laid down for payment of compensation.

III. Suggestions for improvement

1.     The trial must be started only after a detailed scrutiny of project documents and approval by the controlling authority (CDSCO/ICMR). Conduct of drug trials without approval should be a punishable offence inviting stringent punishments.

2.     The ETHICS COMMITTEE has a very crucial role and, therefore, the members must be professionals of proved integrity, professional standing and research experience. The composition of Ethics Committee (appointed by the institution conducting the trial) must be approved by the controlling authority (CDSCO/ICMR).

3.     In step 1, deduction of 50% (in case of death) as personal and living expenditure should be brought down to 25-30%.

4.     There should be no deduction (not more than 10% in any case) for personal/living expenditure (in Step 1) in cases of trial related injury.

5.     The value of ‘F’ the risk factor in Step 4 should be decided after approval by the Ethics Committee and the related documents should be submitted to the controlling authority (CDSCO/ICMR) for scrutiny.

6.     Value of D — the percentage disability — should be determined by a disability board of three doctors out of which at least one should be a specialist in the discipline related to the injury/disease caused.

7.      A procedure for working out the compensation in case of children, women and elderly, such as outlined below, may be included.

(a) For children:

The compensation for under 16 children may be calculated as applicable to 16 year old (the lowest slab in Annexure 1) and a reasonable amount (say @ Rs 12000-24000 per year) may be deducted (as expenditure on their upbringing for the period up to age 16 years) out of the total compensation admissible.

Example: For compensation in case of a child aged 12 years

Compensation = Amount of compensation for Age 16 – 12000 x 4 (the expenditure likely for upbringing from age 12 to age 16 years)         OR

Compensation as per pre-decided standard slabs of, say Rs 4 lakh for children under 10 years and Rs 6 lakh for those aged 10 to 16 years.

(b) For non-working women: Standard slabs of say Rs 10 lakh (age16-60) for death, and reduced proportionately by above formulae in case of injury/disease.

(c) For elderly (above 60 years): a standard slab of Rs 8 lakh for death and reduced proportionately for injury as per the formulae given above.

8.     At the time of awarding compensation, the individual may be alive and hence compensated as per the injury/disease/disability. In the event of death later but attributable to the trials, there must be a provision for enhancing the compensation as applicable in case of death.

9.     Cost of constant care: The cost of treatment (separate from the compensation) for trial related injury/disease/disability should also include the cost of constant care, where indicated. The treatment should be provided on cashless basis and the patient should have a choice of doctor/hospital convenient to the patient’s location.

10.    Compensation for psychological/emotional loss: The loss of a family member, especially mother/father, in the family means a major loss of psychological/emotional/advisory support which should also be compensated in financial terms by adding say another Rs 2 lakh to the amount calculated.   Or

Enhancement of the value of ‘F’ in Annexure 1 so that the minimum compensation paid for clinical drug trial related death is not less than Rs 10 lakh.

11.    The ethics committee, which is supposed to monitor the project from start to finish, should be submitting a regular report at fixed periodicity throughout the project.

12.    There should be a time limit of 4 weeks for payment of compensation and in case a delay is expected due to litigation, there should be a provision for interim compensation of 25% of the likely amount to prevent any hardship to the participants.

Dr S K Joshi
Hospital Administrator, Consultant and Visiting Faculty, Assessor for NABH Accreditation of Hospitals
Author of “Quality Management in Hospitals”, “Law and The Practice of Medicine”, “Safety Management in Hospitals”

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