SexGender and Minority Inclusion in Clinical Research: Staff Training

1
Sex/Gender and Minority Inclusion in Clinical
Research Staff Training

• Policies
• And
• Procedures

2
Overview

• Review of Policy
• Definition of Clinical Research
• NIH-Defined Phase III Trials
• Exemptions vs. Exceptions
• Roles and Responsibilities of Program Staff
• Tracking Procedures
• Process
• Compliance
• Reports
• Resources

3
Review of the Inclusion Policy

• Why does NIH have an Inclusion Policy?
• Congressional mandate, 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
• Be included in Phase III clinical trials in
  numbers adequate for valid analysis
• Cost is NOT allowed as an acceptable reason for
  exclusion
• NIH support outreach efforts to recruit and
  retain women, minorities, and their
  subpopulations in clinical studies.

5
NIH Definition of Clinical Research

• In June 2001, NIH adopted the definition of
  clinical research as
• 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
• Epidemiologic and behavioral studies.
• Outcomes research and health services research.

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NIH-Defined Phase III Clinical Trial

• A broadly based prospective Phase III clinical
  investigation, usually involving several hundred
  or more human subjects, for the purpose of
  evaluating an experimental intervention in
  comparison to a standard or control intervention
  or comparing two or more existing treatments.
  Often the aim of such investigation is to provide
  evidence leading to a scientific basis for
  consideration of a change in health policy or
  standard of care.
• Note Very specific requirements for tracking.

7
NIH Policy for Inclusion OMB Standards for
Collecting Race and Ethnicity Information
(Directive 15, 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
• http//www.whitehouse.gov/omb/fedreg/ombdir15.html
  
• http//grants2.nih.gov/grants/guide/notice-files/N
  OT-OD-01-053.html

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What does NIBIB have to do?

• Peer Review of Inclusion
• Resolution of Unacceptable Codes
• Assign Tracking Exception Codes
• Evaluate target and enrollment data for
  compliance with the policy
• Enter target and enrollment data
• Create reports as requested by ORWH

11
Review Responsibilities

• Review staff
• Confirm inclusion plan is in the application
• Reviewers
• Evaluate inclusion plan
• Raise any concerns about the plan
• Assign U codes if there are concerns

12
Assignment of Gender Codes

• Reviewers designate inclusion plan as acceptable
  or unacceptable

13
Assignment of Minority Codes

• Reviewers designate inclusion plan as acceptable
  or unacceptable

14
Resolution of Unacceptable Codes

• Program staff responsibility
• Award cannot be made until the unacceptable plans
  are resolved
• Program staff will need to have discussion with
  PI
• PI needs to provide corrective actions in writing
• Program Officer determines if corrective actions
  are acceptable and signs off on letter from PI
• NIBIB Gender/Minority policy contact must also
  sign off on corrective actions
• Grants Management staff notified to lift code

15
Next Steps

• Determine Tracking Exception Code
• Evaluate Data for Compliance

16
Exemptions vs. Exceptions

• Exempt Human Subjects Research
• Six exemption categories
• Exemption 4. Research involving the collection or
  study of existing data, documents, records,
  pathological specimens, or diagnostic specimens,
  if these sources are publicly available or if the
  information is recorded by the investigator in
  such a manner that subjects cannot be identified,
  directly or through identifiers linked to the
  subjects.
• http//ohrp.osophs.dhhs.gov/humansubjects/guidance
  /45cfr46.htm46.102
• Exceptions to Gender/Minority Tracking (TEC)
• SS, DR, PR, SA, ET, NC, IC.

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Tracking Exception Codes

• SS small sample size (lt 10 subjects)
• small pilot studies that are easily identified
  by sample size.
• DR duplication of reporting
• study data should not be counted more than once.
• PR parent records
• parent record of grants where data are stored in
  protocols or subproject records.
• SA secondary analysis
• the analysis of study data being done more than
  once.
• ET early stage of technology development
• clinical research studies requiring the use of
  human subjects to develop improved
  technologies/methodologies
• NC not clinical research
• Studies involving human subjects, but not
  considered clinical research using the NIH
  definition.
• IC IC defined reason (comment field required)

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What do we do

• If tracking exception applies, put on competing
  checklist
• GM staff will enter into IMPAC II at time of
  award.
• If no tracking exception applies (i.e., code
  00), then

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Appropriate Target Data

• Program staff should determine if the target data
  is in compliance
• Points to consider in this decision
• Does the proposed number/proportions of women/men
  and different racial groups correspond to the
  population characteristics of the disease?
• Is there a compelling rationale proposed for
  exclusion?
• Is this a follow-up of a pre-existing cohort that
  provides unique information/opportunity?

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Post-Award Monitoring

• Monitoring Progress Reports
• Program Staff are responsible for
• Reviewing annual enrollment data to ensure the
  information has been provided and that the
  distribution is appropriate and on schedule.
• Progress Report Checklist
• Has the gender/minority information been
  provided, and is recruitment/retention
  appropriate and on schedule?
• Missing, Inappropriate or Inconsistent
  information
• Program staff should contact PI to discuss,
  resolve, and update table(s) if necessary.
• Include as a comment on checklist
• Supporting documents should be added to official
  grant file.
• GM has the authority to delay, withhold, or
  terminate an award that does not comply with the
  inclusion policy.
• Once data satisfactory to Program Officer, send
  to Tinera/Meredith for data entry in Population
  Tracking Module.

21
Summary

• Things to know
• Review of Quick Tips
• Major Take Home Points

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Things to know for tracking

• Tracking is done by protocol (i.e., study), NOT
  grant
• Unique protocol assignment method to ease
  querying the POP Track System
• Protocols will be set up at the time of the award
• Includes Protocol ID and Protocol Study Title
• The following must be known
• Are foreign populations involved?
• Is the protocol an NIH-defined Phase III clinical
  trial?
• E-snap Electronic Streamlined Non-Competing
  Application Process

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Gender/Minority Inclusion Quick Tip Reference

• Type 1 or 2
• ?
• Council Preparation resolve any Gender/Minority
  concerns on the application.
• ?
• Determine if Clinical Research
• ?
• Determine if there is an appropriate tracking
  exception code. If yes, assign TEC on competing
  checklist so IMPAC II record can be updated at
  the time of award.
• ?
• If no TEC applies, look for at least 1
  gender/minority Targeted/Planned Enrollment Table
  in the grant file and evaluate the target data
  for compliance.
• ?
• If there is no table, contact the PI and have
  him/her send you the table ASAP.
• ?
• Once the table is received, confirm that the
  recruitment plan is in compliance with the NIH
  policy.
• ?
• If the table is not in compliance, have a
  follow-up conversation with the PI to get the
  plan in compliance.
• ?
• If the table is in compliance, give to
  Tinera/Meredith for Data Entry into Population
  Tracking Module and send copy to official file.

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Gender/Minority Inclusion Quick Tip Reference
(cont.)

• Type 5
• ?
• Review Progress Report
• ?
• Verify if Exception to Tracking (i.e., code other
  than 00 check ICO)
• ?
• If Yes, do nothing further
• ?
• If No (i.e., code is 00), evaluate enrollment
  data for compliance
• ?
• If there is no table, contact the PI and have
  him/her send you the table ASAP.
• ?
• Once the table is received, confirm that the
  enrollment is in compliance with the NIH policy.
• ?
• If the table is not in compliance, have a
  follow-up conversation with the PI to get the
  table in compliance.
• ?
• If the table is in compliance, give to
  Tinera/Meredith for Data Entry into Population
  Tracking Module and send copy to official file.

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Major Take Home Points

• We have to perform tracking responsibilities in
  compliance with the NIH policy.
• TEC codes should not be assigned to avoid the
  process.
• Data should be evaluated before the award is
  issued.
• All actions must be done in a timely manner.

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Resources

• NIH Policy for Inclusion
• http//grants.nih.gov/grants/guide/notice-files/NO
  T-OD-02-001.html
• http//grants2.nih.gov/grants/guide/notice-files/N
  OT-OD-01-053.html
• Office of Management and Budget Definitions for
  ethnic and racial categories
• http//www.whitehouse.gov/omb/fedreg/ombdir15.html
  
• Sex/Gender and Minority Inclusion in Clinical
  Research Staff Training (Workbook and Power
  point slides)
• http//odoerdb2-1.od.nih.gov/oer/training/esa/sex_
  gender/sex_gender_agenda.htm
• Outreach Notebook For the Inclusion, Recruitment
  and Retention of Women and Minority Subjects in
  Clinical Research
• http//www4.od.nih.gov/orwh/outreach.pdf
• Guidance for the Principal Investigator
• http//www4.od.nih.gov/orwh/outreach.pdf
• NIH Grant/Contract Mechanisms Requiring
  Population Tracking
• http//impacii.nih.gov/popdoc/Mechamisms_Requiring
  _Pop_Tracking_03-05-04.pdf
• E-snap
• https//commonsdemo.era.nih.gov/commons-demo/