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Table 8 Examples of ICP elements – cost and compensation

From: Ethical issues of informed consent in malaria research proposals submitted to a research ethics committee in Thailand: a retrospective document review

ICP Issues Raised by the REC

Type of request

C

E

R

P

Cost

 In the “cost” section, it is currently stated that “The pharmaceutical company will pay for appropriate treatment.” Who will make the decision regarding the appropriateness of the condition or the treatment for payment? Please explain.

X

X

X

 

 In the “cost” section, in relation to the costs the participant must pay, the researcher should add, “should there be an adverse incident related to the study procedure, the research team will be responsible for it.”

X

 

X

 

 It is currently stated, “The cost of treatment and laboratory according to the prescription of the hospital physician will be paid by yourself.” This should be more precisely stated “…., if such treatment and care are not related to the study.”

X

 

X

 

 Please state that the investigator will pay for treatment if the study participant shows no response to the study drug.

X

 

X

 

 Research-related injuries should cover the costs of potential life-long or long-term care for study-related injuries.

X

 

X

 

Compensation

 Please reconsider whether compensation is fair for participants staying at the hospital and participants attending a follow-up visit (100 Baht (3 US $) for all).

X

 

X

 

 Please reconsider the compensation provided to research participants; 150 baht per visit and 300 baht for an overnight stay is not likely to be appropriate.

X

 

X

 

 It is not clear whether compensation of 200 Baht for travel costs will be paid at the end of the study or per visit. Patients will have to return for follow-up twice.

X

 

X

 

 In the compensation section, please specify the amount(s) of money that will be provided to compensate participants.

X

 

X

 

 The rationale for compensation, which is stated as “for participation in this study” is inappropriate, because it appears to be an inducement. Please reconsider. Suggestion: it might better be “for time and travel”.

X

 

X

 

 In section C7 (compensation), it is currently stated that “Volunteers will receive a gift package… snack and insect repellent.” Please consider adding that this gift is a token of appreciation for participating in the study rather than compensation.

X

X

X

 

 Compensation provided to research participants: 100 Baht per visit is probably inappropriate, because participants may have to be off work the whole day. Please consider an amount of 300 Baht, which reflects the daily minimum wage.

X

 

X

 

 Why is the compensation for acute febrile patients 200 Baht, while healthy controls get 300 Baht? Please clarify.

X

 

X

 
  1. Note: C clarification, E elaboration, R revision, P paraphrasing