SexGender and Minority Inclusion in NIH Clinical Research

1
Sex/Gender and Minority Inclusion in NIH Clinical
Research

• What Investigators Need to Know!
• Presenter Miriam F. Kelty, PhD, National
  Institute on Aging, 2/2006

2
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

3
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

4
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

5
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/gui
  delines_amended_10_2001.htm

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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

7
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

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NIH Definition of Clinical Research (continued)

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

9
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

10
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

11
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

12
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 in PHS 398 to collect data from
  subjects

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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

14
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.

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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

16
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.

17
Instructions in PHS 398

• Best source of information for investigators
• http//grants.nih.gov/grants/funding/phs398/phs398
  .html

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Instructions in PHS 398

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

19
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

20
Instructions in the 398

• 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

21
Reviewer Instructions

• Reviewers evaluate the Inclusion Plans
• http//grants.nih.gov/grants/peer/hs_review_inst.p
  df
• Unacceptable plans must be reflected in the
  priority score

22
Reviewer Instructions for Phase III Clinical
Trials

• Reviewers evaluate inclusion AND analysis plans
• http//grants.nih.gov/grants/peer/hs_review_inst.p
  df
• Unacceptable plans must be reflected in the
  priority score

23
Funding Decisions

• Applications with Unacceptable Plans cannot be
  funded must revise plans!

24
Monitoring Progress

• Progress Reports must include Cumulative
  Enrollment
• Reported using the Enrollment tables

25
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.

26
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/N
  OT-OD-01-053.html

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Additional Guidance on New Tables

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

28
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

29
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

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Complying with the NIH Inclusion Policy

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

32
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

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Resources and Getting Help

• PHS 398 Instructions
• http//grants.nih.gov/grants/funding/phs398/phs398
  .html
• PHS 2590 Instructions
• http//grants.nih.gov/grants/funding/2590/2590.htm
  

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Resources and Getting Help

• Inclusion of Women and Minorities
  Implementation Page
• http//grants.nih.gov/grants/funding/women_min/wom
  en_min.htm
• CONTACT IC PROGRAM STAFF!