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 children and older adults, to participate in research studies when there is a sound scientific rationale for including them and participation is appropriate under existing Federal guidelines. Thus, children must be included in NIH-conducted or supported human subjects research unless there are scientific or ethical reasons not to include them.

For the purpose of providing consent for research participation, the definition of a child stated within the DHHS Regulations (45 CFR part 46, Subpart D, Sec. 402) should be applied. Please see the NIH Human Subjects website or 45 CFR 46, Subpart D for more information.

Clinical Trial Research Experience

The involvement of a student, postdoctorate, or early career faculty member in a clinical trial led by their mentor or other investigator, with the goal of obtaining clinical trial experience relevant to their research interests and career goals. A clinical trial research experience is one in which the participant is supervised by a more experienced investigator and is intended to prepare the participant to potentially lead an independent clinical trial in the future. The applicant can be part of the clinical trial team and can use the data generated during the clinical trial research experience in his/her proposed research project. NIH expects the mentor to assume overall responsibility of the trial including registering and reporting in clinicaltrials.gov and obtaining IRB approval.

Independent Clinical Trial

An independent clinical trial is one for which the researcher proposing the study has primary or lead responsibility for conducting and executing the trial. NIH policy permits individual career development awardees and individuals appointed to institutional career development awards to be involved in a range of clinical trial activities, including leading independent clinical trials. For NRSA trainees or fellows, however, NIH policy precludes leading an independent clinical trial as part of their training experience. Instead, NRSA trainees and fellows interested in clinical trials may gain clinical trial research experience by working on a trial led by their mentor or another investigator.

Older Adult

For the purposes of the NIH Policy and Guidelines on the Inclusion of Individuals Across the Lifespan as Participants in Research Involving Human Subjects, an older adult is defined as an individual 65 years of age or older.The intent of the NIH policy is to provide the opportunity for individuals, including children and older adults, to participate in research studies when there is a sound scientific rationale for including them, and their participation is appropriate.  Thus, older adults must be included in NIH-conducted or supported human subjects research unless there are scientific or ethical reasons not to include them.

For the full glossary of NIH terms and acronyms, visit the Glossary and Acronym List.

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One thought on “Looking for the Latest Definition for Terms Relating to Human Subjects and Clinical Trials?

  1. The definition of “older adult” should be revised to more clearly explain that the age range may be (i.e., is allowed to be) context specific.

    The definition of “older adult” should be driven by atheoretical science, not by an arbitrary scalar value reflecting chronology. I’m 61 years old, and still meet some criteria for being a child–just ask my wife. For neurodegenerative diseases, “older adult” should be defined by the risk of becoming clinically symptomatic–the age of peak incidence. Even for a “single” problem such as familial Parkinson’s disease, the age of onset often depends on the genetic defect, and even within a single protein defect, location can produce +/- 10 year variation. There seem to be enough examples of this biological variability to justify further consideration of the matter.

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