Quantifying the federal minimal risk standard: Implications for pediatric research without a prospect of direct benefit
Article Abstract:
The US federal regulations allow institutional review boards (IRBs) to approve pediatric research that does not offer a prospect of direct benefit only when the risks are minimal or when the risks are a minor increase over minimal risk. Data suggest that IRBs may be categorizing as greater than minimal risk many research procedures that qualify, under the federal regulations, as posing no greater than minimal risk to pediatric participants.
Publication Name: JAMA, The Journal of the American Medical Association
Subject: Health
ISSN: 0098-7484
Year: 2005
User Contributions:
Comment about this article or add new information about this topic:
How do institutional review boards apply the federal risk and benefit standards for pediatric research?
Article Abstract:
Different institutional review boards (IRBs) interpret the federal laws governing research on children differently, according to a survey of the chairpersons of 188 IRBs. The laws state that no study on children should be approved if it does not benefit the child and would expose the child to more than a minor increase over minimal risk of injury. Unfortunately, the laws are vague in defining what constitutes a benefit or a risk.
Publication Name: JAMA, The Journal of the American Medical Association
Subject: Health
ISSN: 0098-7484
Year: 2004
User Contributions:
Comment about this article or add new information about this topic:
Pediatric drug studies required by law
Article Abstract:
The US Food and Drug Administration now has the power to require pharmaceutical companies to test all drugs that will be given to children. Some doctors believe the FDA should create an expert panel to oversee this research. All researchers will have to follow strict guidelines to ensure that children will not be harmed by the drugs.
Publication Name: JAMA, The Journal of the American Medical Association
Subject: Health
ISSN: 0098-7484
Year: 2004
User Contributions:
Comment about this article or add new information about this topic:
- Abstracts: Michigan considers state ergonomics standard. No easy NRR determination for dual hearing protection
- Abstracts: Ensuring more holistic care for patients with dyspnoea. The Experience of being a suspended nurse. Risk awareness is a vital factor in fall prevention
- Abstracts: Making stepfamilies work. Discipline strategies that really work. The new face of fatherhood
- Abstracts: Network links doctors, disabled job seekers. Small practices can opt for simple, safe retirement plans
- Abstracts: Ethical considerations in publishing research involving human subjects. Demographic and prenatal factors of patients with cleft lip and cleft palate: a pilot study