Video Presentations About Research Designed for Parents
Children and Clinical Studies: The National Institutes of Health (NIH) has a wonderful web site with a host of information and video presentations about children in research. There are videos interviews with children and parents about deciding to take part in a study and information on questions to ask before deciding to take part. The NIH also has prepared a Newsletter that can be read online that outlines the information available on their web site.
NIH Division of Bioethics: For those who wish to learn more about the ethics of clinical research, the NIH Division of Bioethics has archived videos of past lectures going back to 2000. There are many topics that could be of interest to parents including talks on Ethical Issues in Research Involving Children; Risks and Benefits; and IRB Review.
References and Web Sites Related to Clinical Research
Federal Regulations Governing Clinical Research
- 45 CFR 46: The regulations that govern all research funded by the federal government; also known as the Common Rule.
- Belmont Report: An essential document which articulates the fundamental ethical principles which provide the foundation for the DHHS and FDA regulations. This is an essential document to read for all who conduct human subjects research.
- OHRP: OHRP's site contains resources and guidance germane to human subjects research and the regulatory process.
Food and Drug Administration
- Health Information Privacy: The Office of Civil Rights (OCR) website is an excellent resource for questions related to HIPAA as is the NIH's website on the HIPAA Privacy Rule.
- AAHRP: The Association for Accreditation and Human Research Protection Programs maintains standards and principles for IRB accreditation.
- Consent to Treatment and Confidentiality Provisions: The Juvenile Legal Center (JLC) has a nice summary of the rights of minors to in the state of Pennsylvania.
- Understanding Clinical Trials FAQ: This ClinicalTrials.gov (an NIH service) page contains helpful information about clinical trials in a Q-and-A format.