ERIC Number: ED540206
Record Type: Non-Journal
Publication Date: 2013
Pages: 23
Abstractor: As Provided
ISBN: N/A
ISSN: ISSN-1075-7031
EISSN: N/A
Preserving and Enhancing the Responsible Conduct of Research Involving Children and Youth: A Response to Proposed Changes in Federal Regulations. Social Policy Report. Volume 27, Number 1
Fisher, Celia B.; Brunnquell, Donald J.; Hughes, Diane L.; Liben, Lynn S.; Maholmes, Valerie; Plattner, Stuart; Russell, Stephen T.; Susman, Elizabeth J.
Society for Research in Child Development
For the first time in twenty years the U.S. Department of Health and Human Services (DHHS, 2009) is considering changes to federal regulations governing research. The Common Rule provides the basis for government regulations and Institutional Review Boards (IRB). Proposed changes will have a significant impact on Institutional Review Board evaluation of research involving infants, children and adolescents. For example, such a revision can serve to rectify or exacerbate often observed IRB inconsistencies and over-estimation of probable harms when applying "minimal risk" or "exempt" criteria to research involving minors. Proposed revisions may also affect the feasibility of research on adolescent risk that requires waiver of parental or guardian permission to be successfully implemented. Further, recommendations for a new category of "informational risk" based on current and emerging advances in analysis and storage of bio-specimens and information technologies for archival research will have significant influence on ethical procedures required for collection and storage of longitudinal and cross-sectional data. Given the importance of any rule change to the conduct of science related to children, the Society for Research in Child Development (SRCD) convened the SRCD Task Force on Proposed Changes to the Common Rule. The purpose of this report is to alert policymakers, scientists, and participant groups to proposed changes most relevant to research involving children and to provide recommendations for ensuring the responsible conduct of child and adolescent research in the final regulatory changes. (Contains 1 footnote.) [Commentaries by Kenneth D. Pimple and Noreen Yazejian & Barbara Davis Goldman are included. Commentaries are individually referenced.]
Descriptors: Behavioral Science Research, Research Design, Ethics, Federal Regulation, Change, Informed Consent, Adolescents, Children, Youth, Participation, Researchers, Personal Autonomy, Child Development, Risk, Research Administration, Health, Sexuality
Society for Research in Child Development. 2950 South State Street Suite 401, Ann Arbor, MI 48104. Tel: 734-926-0600; Fax: 734-926-0601; e-mail: info@srcd.org; Web site: http://www.srcd.org
Publication Type: Reports - Descriptive
Education Level: Elementary Secondary Education
Audience: N/A
Language: English
Sponsor: N/A
Authoring Institution: Society for Research in Child Development
Identifiers - Location: United States
Grant or Contract Numbers: N/A