NOT-DE-14-001: Notice to Clarify Allowable Planning Activities for Behavioral and Social Interventions as Part of The NIDCR Clinical Trial or Biomarker Evaluation Study Planning Grant (R34)

Notice to Clarify Allowable Planning Activities for Behavioral and Social Interventions as Part of The NIDCR Clinical Trial or Biomarker Evaluation Study Planning Grant (R34)

Notice Number: NOT-DE-14-001

Key Dates
Release Date: November 19, 2013

Related Announcements
PAR-11-338

Issued by
National Institute on Dental and Craniofacial Research (NIDCR)

Purpose

The purpose of this Notice is to clarify the planning activities that are appropriate for the NIDCR Clinical Trial or Biomarker Clinical Evaluation Study Planning Grant (R34).

The current R34 Funding Opportunity Announcement states: “The Clinical Trial or Biomarker Clinical Evaluation Study Planning Grant is not designed for the collection of preliminary data (clinical or pre-clinical), or the collection of prospective data to support the rationale for a clinical trial or study”. However, the NIDCR recognizes that planning for a behavioral or social intervention study may require certain data collection activities to assess the feasibility and/or acceptability of the planned behavioral or social intervention and methods. For the purposes of this announcement, data collection to assess the feasibility and/or acceptability of a planned behavioral or social intervention and associated methods is allowable.

Examples of allowable activities include, but are not limited to:

Delivery of the planned behavioral or social intervention to a small number of participants, sufficient to determine the acceptability of the intervention to the target participants.

Delivery of the behavioral or social intervention in the target setting, with collection of data about feasibility of conducting the study in that setting.

Comparison of assessment measures delivered via different modalities, using a sample size adequate for understanding participant preference and performance.

Training of a sample of interventionists in the planned behavioral or social intervention, with assessment of fidelity in delivering the intervention after training.

Data collection instruments used during the R34 project period must be limited to those that assess feasibility and/or acceptability of a planned behavioral or social intervention. Collection of data for the purposes of determining efficacy or effectiveness of an intervention, whether on a small or large scale, is not an allowable activity for this funding opportunity announcement (FOA). Also, activities associated with developing new instruments, establishing reliability or validity of measures, and demonstrating calibration of examiners, are not allowable activities during the R34 planning grant.

The current FOA states that human subjects will not be involved during the R34 planning period. However, for applications leading to a behavioral or social intervention study, human subjects may be involved in the R34 project period for the purposes of establishing the acceptability of the behavioral or social intervention to the target population, the feasibility of delivering the behavioral or social intervention, as intended, and assessing acceptability and feasibility of data collection. Applications planning for a clinical trial or biomarker study that is not behavioral or social in nature are not permitted to involve human subjects during the R34 planning phase.

Inquiries

Please direct all inquiries to:

Melissa W. Riddle, PhD
National Institute of Dental and Craniofacial Research
Telephone: (301) 451-3888
Email: [email protected]
Website: http://www.nidcr.nih.gov/Research/DER/BSSRB.htm