Human Subjects and Clinical Trial Glossary Updates

Looking for the latest definition for terms relating to human subjects and clinical trials? The Glossary of NIH terms now contains definitions for Ancillary Study, Child, Clinical Trial Research Experience, Independent Clinical Trial, and Older Adult. Ancillary Study An ancillary study is an adjunctive or supplemental study to an ongoing study. An ancillary study may or may not be a clinical trial. Determine whether an ancillary study is a clinical trial by answering the four questions that define NIH clinical trials based on the information about the ancillary study alone, regardless of the clinical trial status of the parent trial. An ancillary clinical trial is a trial for which the answer to the four questions is ‘Yes’. An ancillary clinical trial to a larger clinical trial may be considered an independent clinical trial if it includes an additional intervention to patients or a sub-population of patients within the larger clinical trial. An example of an ancillary study that is not a clinical trial could be research which involves analyses of stored samples collected in an ongoing clinical trial but no additional intervention to the human subjects/patients. Child For the purposes of the NIH Policy and Guidelines on the Inclusion of Individuals Across the Lifespan as Participants in Research Involving Human Subjects, a child is defined as an individual under the age of 18 years. The intent of the NIH policy is to provide the opportunity for individuals, including ...
Source: NIH Extramural Nexus - Category: Research Authors: Tags: New Resources clinical trial glossary human subjects Source Type: funding