Parental perceptions and attitudes about informed consent in clinical research involving children

Abstract

We interviewed 64 parents by questionnaire after completion of a clinical trial involving their children for their perceptions and attitudes about informed consent. The results show that only a small minority realized that drug trials are designed to assess not only efficacy but safety as well. More worrisome was the majority of parents who felt that drug trials conducted by hospitals are of no or low risks. Moreover, a significant minority offered the view that the strict informed consent procedures we followed were unnecessary because they would do what the doctor advised. Even more worrisome was the small percentage of parents who realized that a signed consent form was primarily meant to protect their rights, and only one-third of the parents knew of their right to withdraw their child unconditionally from the trial at any time. These findings suggest that there may be significant attitudinal barriers to parental understanding of the informed consent process.

Parents' Perceptions of Research With Newborns

“…This suggests that many parents have considerable trust in their physicians, and would depend on the physician to act with the infant's best interests in mind, which is consistent with previous studies 18 and underscores the vulnerability of parents to physician beliefs.…”

Parents' Perceptions of Research With Newborns

“…This suggests that many parents have considerable trust in their physicians, and would depend on the physician to act with the infant's best interests in mind, which is consistent with previous studies 18 and underscores the vulnerability of parents to physician beliefs.…”

The acceptability and impact of a randomised controlled trial of welfare rights advice accessed via primary health care: qualitative study

“…This occurred despite ethical committee approved information leaflets that were regarded as clear and a good reflection of participants' experiences in the trial. This has also been found in clinical research[ 4 ]. With the exception of two participants, no-one was unhappy about randomisation to the control condition which involved waiting six months for welfare rights advice.…”

Involving South Asian patients in clinical trials

“…Research examining informed consent suggests that even when trial recruiters adhere to strict informed consent procedures and ensure that 'simple language' is used, this does not guarantee that participants will fully understand the implications of participation. 98 The present findings indicate that in the case of Englishspeaking South Asian trial participants, similar issues around information provision and understanding might be in operation.…”

Parents' Perceptions of Research With Newborns

“…This suggests that many parents have considerable trust in their physicians, and would depend on the physician to act with the infant's best interests in mind, which is consistent with previous studies 18 and underscores the vulnerability of parents to physician beliefs.…”

The acceptability and impact of a randomised controlled trial of welfare rights advice accessed via primary health care: qualitative study

“…This occurred despite ethical committee approved information leaflets that were regarded as clear and a good reflection of participants' experiences in the trial. This has also been found in clinical research[ 4 ]. With the exception of two participants, no-one was unhappy about randomisation to the control condition which involved waiting six months for welfare rights advice.…”

Involving South Asian patients in clinical trials

“…Research examining informed consent suggests that even when trial recruiters adhere to strict informed consent procedures and ensure that 'simple language' is used, this does not guarantee that participants will fully understand the implications of participation. 98 The present findings indicate that in the case of Englishspeaking South Asian trial participants, similar issues around information provision and understanding might be in operation.…”

Parents' Perceptions of Research With Newborns

“…This suggests that many parents have considerable trust in their physicians, and would depend on the physician to act with the infant's best interests in mind, which is consistent with previous studies 18 and underscores the vulnerability of parents to physician beliefs.…”

The acceptability and impact of a randomised controlled trial of welfare rights advice accessed via primary health care: qualitative study

“…This occurred despite ethical committee approved information leaflets that were regarded as clear and a good reflection of participants' experiences in the trial. This has also been found in clinical research[ 4 ]. With the exception of two participants, no-one was unhappy about randomisation to the control condition which involved waiting six months for welfare rights advice.…”

Involving South Asian patients in clinical trials

“…Research examining informed consent suggests that even when trial recruiters adhere to strict informed consent procedures and ensure that 'simple language' is used, this does not guarantee that participants will fully understand the implications of participation. 98 The present findings indicate that in the case of Englishspeaking South Asian trial participants, similar issues around information provision and understanding might be in operation.…”