what is clinical research
the systematic attempt to improve health and well-being by identifying improved methods to prevent, treat and cure disease and illness
in particular what should informed consent provide
- understand the risks, potential benefits, procedures, and alternatives to the study in question
what is the first item on the ICH good clinical practices guidelines
states that the potential participants should understand ‘the study involves research’
the CIOMS guidelines first item
individuals understand they are being invited to participate in research
2 purposes that informed consent serves
- allows competent individuals to decide whether participation in research is consistent with their interests
- informed consent allows individuals to decide for themselves whether they will enroll in the study in question
participants should understand at least 3 aspects of participation in clinical research
- research contribution
- research relationship
- research impact
what is research relationship
the investigators will rely on participants efforts to gather the generalizable knowlede to benefit others
participants suffer from ‘therapeutic misconception’, what is this?
assuming that the relationship they have with the investigators is equivalent to the relationship patients have with their clinicians
what is wrong with the argument to anonymize samples?
it ignores the fact that individuals have an interest in the project
when should review committees consider waiving informed consent
- participation in study is minimal contribution
- participants have limited or no interaction with investigators
- participation has no or negligible impact on participants
suggestion
shorten consent forms
