# Presentation: 076868

## Additional Areas to Address

**Additional Areas to Address**

- Sally E. Eckert-Tilotta
*Scientific Review Administrator*

**US Department of Health and Human Services**
**National Institutes of Health**
**National Institute of Environmental Health Sciences **

**SBRP Applicant Information Meeting **
**October 29, 2003**
- Research Triangle Park
- North Carolina

## Required in Research Plan 

**Protection of Human Subjects from Research Risks (if appropriate)****- IRB approval not required for****  submission**
**Inclusion of Women, Minorities, and Children in Research (if appropriate)**

## Required in Research Plan (con’t)

**Care and Use of Vertebrate Animals in Research (if appropriate) ****- IACUC approval not required for****  submission**
**Sharing of Research Data**
**Quality Assurance Statement for Analytical Core(s)**

## Exempt Human Subjects Research

**Indicate applicable exemption in Section 4a on the cover page**
**Discuss in Research Plan Section E why exemption applies **

## Discuss Human Subjects Protection for Non-exempt Research

**Risks to the subjects**
**Adequacy of protection against risks**
**Potential benefits of the proposed research to subjects and others **
**Importance of the knowledge to be gained**

## Inclusion of Women, Minoritiesand Children

**Indicate inclusion of minorities, women, and children as subjects or why any category is excluded**
**Targeted/Planned Enrollment Table (PHS 398 Form) should be included for each study**

## Care and Use of Vertebrate Animals

**Detailed description of use**
**Justification of use, species, number**
**Describe veterinary care**
**Describe procedures for minimizing discomfort, stress, pain, and injury**
**Describe methods for euthanasia ****(if appropriate)**

## Essential  Elements

**Reviewers will include consideration of human subjects and animal use in the determination of the priority score of the project and application!**

## Sharing of Research Data

**Effective October 1, 2003**
**Applies to all grants with at least $500,000 direct cost in any one year**
**Instructions and policy on NIH website at http://grants.nih.gov/grants/policy/data_sharing/index.htm**

## Data Sharing — Policy

**Data should be made as widely and freely available as possible while safeguarding the privacy of participants, and protecting confidential and proprietary data**

## Data Sharing — Implementation

**Investigators are expected to include a plan for sharing final research data for research purposes, or state why data sharing is not possible.**
**Grantees are expected to implement the plan proposed in the application.**

## Data Sharing—Implementation (cont’d)

**Plan should be appropriate for the research data to be collected**
**Data sharing costs are allowable budget items**
**Reviewers will consider the reasonableness of the plan or rationale for not sharing research data**

## Quality Assurance Statement

**Only required if program includes a core that provides analytical, quantitative analysis**
**Not to exceed 2 pages**
**Must address 6 points in the RFA, namely:**
**	****	****- criteria for acceptable data quality**
**	****	****- sampling strategy/statistics**
**	****	****- custody of samples**
**	****	****- instrument calibration**
**	****	****- procedures for data reduction**
**	****	****- procedures for evaluation of success****  ****	****or external review**

## Resources for More Information

**PHS 398**
**http://grants1.nih.gov/grants/**
**funding/phs398/phs398.html**
**Human subjects...Section I C-8e**
**Vertebrate animals...Section I C-8f**
**Data sharing.....Section III M**

## Questions about Review

**Sally Eckert-Tilotta   ****	****919-541-1446**
**	****	****	****	****	****eckertt1@niehs.nih.gov**
**Janice Allen****	****	****	****919-541-7556**
**	****	****	****	****	****allen9@niehs.nih.gov**