# Presentation: 249804

## Sex/Gender and Minority Inclusion in NIH Clinical Research

**What Investigators Need to Know!**

## Overview 

**Review and Rationale of Policy**
**Recent Up-Dates & Implications**
**Definition of Clinical Research**
**OMB Standards**
**NIH-Defined Phase III Trials**
**Resources and Getting Help**

## NIH Policy on Inclusion of Women & Minorities in Clinical Research

**Why does NIH have this policy?**
**Mandated by Congress, 1993 PL 103-43**
**Ethical principal of justice and importance of balancing research burdens and benefits**

## Public Law PL 103-43

**Women and Minorities **_**must**_** be included in all clinical research studies**
**Women and Minorities **_**must**_** be included in Phase III clinical trials & the trial must be designed to permit valid analysis**
**Cost is **_**NOT**_** allowed as an acceptable reason for exclusion**
**NIH to support outreach efforts to recruit and retain women, minorities, and their subpopulations in clinical studies**

## NIH Policy on Inclusion

**NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research – Amended October, 2001**
**http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm**

## Updates to Inclusion Policy

**NIH Definition of Clinical Research**
**New OMB Standards for Data on Ethnicity and Race**
**Further Clarification about NIH-Defined Phase III Clinical Trials**

## NIH Definition of Clinical Research

** ****Patient-oriented research.****  **
**Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects.  **_**Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual**_**.  Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies;**

## NIH Definition of Clinical Research (continued)

**(2)  Epidemiologic and behavioral studies;**
**(3)  Outcomes research and health services**
**	****     ****research.**

## Instructions in PHS 398

**Best source of information for investigators**
_**[http://grants.nih.gov/grants/funding/phs398/phs398.html](http://grants.nih.gov/grants/funding/phs398/phs398.html)**_

## Instructions in PHS 398

**Section E: Human Subjects Research**
**Inclusion of Women**
**Inclusion of Minorities**
**Failure to include = Return Application Prior to Review**

## Instructions in PHS 398

**Inclusion of Women and Minorities Sections ****must**** include:**
**Subject Selection Criteria & Rationale**
**Rationale for Any Exclusions**
**Enrollment dates (start and end)**
**Outreach Plans for Recruitment**
**Proposed Composition Using New Tables**

## Reviewer Instructions

**Reviewers evaluate the Inclusion Plans**
**http://grants.nih.gov/grants/peer/hs_review_inst.pdf**
**Unacceptable plans ****must**** be reflected in the priority score**

## Funding Decisions

**Applications with Unacceptable Plans ****cannot**** be funded – ****must**** revise plans!**

## Update to NIH Policy for Inclusion

**New OMB Standards**
**OMB Directive 15 Issued 1997**
**Racial and Ethnic Standards for Federal Statistics and Administrative Reporting**
**Effective Date No Later Than **
**   ****January 1, 2003**

## Update to NIH Policy for Inclusion

**OMB Directive 15 Issued 1997**
**Collecting Data by Self-Report:**
**Two Separate Questions**
**Question 1****: Ask about Ethnicity**
**Question 2****: Ask about Race ****WITH OPTION**** to select more than one racial designation**

## NIH Policy for Inclusion

**OMB Directive 15 Issued 1997**
**Ethnic Categories:**
**Hispanic or Latino**
**Not Hispanic or Latino**
**Racial Categories:**
**American Indian or Alaska Native**
**Asian**
**Black or African American**
**Native Hawaiian or Other Pacific Islander**
**White**

## OMB Directive 15 1997

**Where can you find examples of data collection instruments that use the new OMB standards?**
**Many examples exist including:**
**PHS 398 Personal Data Form questions**
**2000 US Census questions**
**Do not use the 5/01 Inclusion Enrollment Table or Target Table to collect data from subjects**

## Additional Guidance on New Tables

**NIH Policy on Reporting Race and Ethnicity Data: Subjects in Clinical Research**
**http://grants.nih.gov/grants/guide/****notice-files/NOT-OD-01-053.html**

## Additional Guidance on New Tables

**New Application  or Competing Continuation Involving Collection of New/Additional Data**
**Must use new 5/01 Table**

## Additional Guidance on New Tables

**New Application  or Competing Continuation with No Plans to Collect New/Additional Data**
**May use Either:**
**New 5/01 Table**
**4/98 Version of the Inclusion Table**
**Use form appropriate for your data**

## Additional Guidance on New Tables

**Non-Competing Applications (Progress Reports) for grants that began before FY 2002**
**May use Either:**
**New 5/01 Table**
**4/98 Version of the Inclusion Table**
**Use form appropriate for your data**

## Slide 22

## Slide 23

## Update to NIH Inclusion Policy

**NIH-Defined Phase III Clinical Trials**
**Evidence must be reviewed to show whether clinically important sex/gender and race/ethnicity differences in intervention effect are expected **
**Plans for valid analysis must be included in the design**
**Results of analyses must be reported to NIH**

## Requirements for NIH-Defined Phase III Clinical Trials 

**Research plan must include one of the following:**
**Prior studies support ****significant differences**** between subgroups:**
**Need plans to conduct ****valid analyses to detect significant differences**** between sex/gender and/or racial/ethnic subgroups**** **
**For the purpose of this policy, **_**Significant Difference**_** is defined as a difference that is of clinical or public health importance based on substantial scientific data.  This is not the same as “statistically significant difference.”**

## Requirements for NIH-Defined Phase III Clinical Trial Applications

**OR:**
**Prior studies support ****no ****significant differences between subgroups:**
**Representation as subject selection criterion is not required; however, inclusion and analyses are encouraged**

## Requirements for NIH-Defined Phase III Clinical Trial Applications

**OR:**
**Prior studies ****neither support nor negate**** significant differences in intervention effect between subgroups:**
**Plans to conduct ****valid analyses**** of the intervention effect in sex/gender and/or racial/ethnic subgroups (Does not require high statistical power)**
**For the purpose of this policy, **_**Valid Analysis**_** means an unbiased assessment that does not require high statistical power and should be conducted for both large and small studies.**

## Reviewer Instructions for Phase III Clinical Trials

**Reviewers evaluate inclusion ****AND**** ****analysis plans**
**http://grants.nih.gov/grants/peer/hs_review_inst.pdf**
**Unacceptable plans ****must**** be reflected in the priority score**

## Funding Decisions for Phase III Clinical Trials

**Applications with Unacceptable Plans ****cannot ****be funded – ****must**** revise plans!**

## Requirements for NIH-Defined Phase III Clinical Trial Applications

**Progress Reports  need to include**
**Both:**
**Enrollment Table**
**Statement in text about progress in data analyses for sex/gender and ethnicity/racial effects.**

## Complying with the NIH Inclusion Policy

**Principal Investigators**
**Review Staff and Reviewers**
**Program Staff**
**Grants Management Staff**
**NIH Tracking and Inclusion Committee**
**Congress**
**Public**

## Monitoring Compliance with the NIH Inclusion Policy

**Annual Comprehensive Report: Monitoring Adherence to the NIH Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research**
_**[http://www4.od.nih.gov/orwh/inclusion.html](http://www4.od.nih.gov/orwh/inclusion.html)**_

## Resources and Getting Help

**PHS 398 Instructions**
_**[http://grants.nih.gov/grants/funding/phs398/phs398.html](http://grants.nih.gov/grants/funding/phs398/phs398.html)**_
**PHS 2590 Instructions**
_**[http://grants.nih.gov/grants/funding/2590/2590.htm](http://grants.nih.gov/grants/funding/2590/2590.htm)**_

## Resources and Getting Help

**Inclusion of Women and Minorities – Implementation Page**
**http://grants.nih.gov/grants/funding/women_min/women_min.htm**
**CONTACT PROGRAM STAFF!**