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Human Subject Protections Issues. Freda Yoder Division of Education and Development Office for Human Research Protections (OHRP) Department of Health and Human Services (DHHS) Community Networks to Reduce Cancer Health Disparities Pre-Application Conference, NIH - May 26, 2004.

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human subject protections issues
Human Subject Protections Issues

Freda Yoder

Division of Education and Development

Office for Human Research Protections (OHRP)

Department of Health and Human Services (DHHS)

Community Networks to Reduce Cancer Health Disparities

Pre-Application Conference, NIH - May 26, 2004

human subject protections issues1
Human Subject Protections Issues


  • Federal Regulations & Policy
  • Applicability of Regulations
  • Basic Protections Afforded by Regulations
federal regulations and policy
Federal Regulations and Policy
  • 45 CFR 46 - DHHS Policy for Protection of Human Research SubjectsOriginally adopted May, 1974, Revised January 13, 1981, Revised June 18, 1991
    • Basic protections – Subpart A
    • Additional protections for vulnerable populations in Subparts B-D
  • Federal Policy for the Protection of Human Subjects - “The Common Rule” June 18, 1991
    • Departments of Agriculture, Energy, Commerce, HUD, Justice, Defense, Education, Veterans Affairs, Transportation, and DHHS. NSF, NASA, EPA, AID, Social Security Administration, CIA, and the Consumer Product Safety Commission - FDA has its own regulations
additional dhhs protections
Additional DHHS Protections
  • Subpart B: Additional DHHS Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research (revised November 13, 2001)
  • Subpart C: Additional DHHS Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
  • Subpart D: Additional DHHS Protections for Children Involved as Subjects in Research
Applicability of

Federal Regulations

how determine applicability
How Determine Applicability?

Regulations apply to all non-exempthuman subject research conducted, supported, or otherwise subject to regulation by any Federal Department or Agency which takes appropriate administrative action to make the the policy applicable to such research

Three questions:

  • Does the activity involve Research?
  • Does the Activity involve Human Subjects?
  • Is the human subjects research Exempt?
does activity involve research
Does Activity Involve Research?

Research - a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge[46.102(d)]

does activity involve human subjects
Does Activity Involve Human Subjects?

Human Subject - a living individual about whom an investigator conducting research obtains

  • data through intervention or interactionwith the individual, or
  • indentifiable private information

[45 CFR 46.102(f)]

Private Information:

- Information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place

- Information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record)

Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects
is the human subject research exempt from federal policy
Is the Human Subject Research Exempt from Federal Policy?

46.101(b) lists the categories of exempt research and criteria for exemptions

Includes some research

  • conducted in educational settings involving normal educational practices …
  • involving educational tests, survey procedures, interview procedures, or observation of public behavior …*

* Generally not exempt for research with children

exempt categories continued
Exempt Categories - Continued

Includes some research

  • involving collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens …
  • and demonstration projects conducted by or subject to approval of [federal] Department or Agency heads … .
  • involving taste and food quality evaluation and consumer acceptance studies …
basic protections
Basic Protections
  • Institutional Assurance
  • Institutional Review Board (IRB) Review
  • Informed Consent, among others

The regulations contain three basic protections for human subjects:

basic protection institutional assurance
Basic Protection: Institutional Assurance
  • Each institutions engaged in covered research must provide written Assurance that it will comply with applicable regulations
  • In lieu of requiring submission of an assurance, other [Federal] Department or Agency heads shall accept the existence of an assurance on file with DHHS, and approved for Federalwide use
  • OHRP is the designated office for DHHS[46.103(a)]
Definition of Engagement:
  • Institutions become "engaged" in human subject research whenever their employees or agents
    • intervene or interact with living individuals for research purposes; or
    • obtain, provide, or access individually identifiable private information for research purposes.
  • Awardee institutions are automatically considered to be "engaged" in human subject research even where all activities involving human subjects are carried out by a subcontractor or collaborator – guidance at:
new federalwide assurance fwa
New Federalwide Assurance (FWA)
  • Simplified assurance system - separate procedure for IRB registration FWA filing
  • FWA applies to all federally conducted or supported research – one assurance ~ one institution
  • Institutions can elect to apply assurance to all research, regardless of source of support
  • Initial filings may be processed electronically
  • Procedures for submitting documents:
basic protection institutional review board review
Basic Protection:Institutional Review Board Review
  • Institutional Review Board (IRB):A committee charged with the review of human subject research to assure that the subjects’ rights and welfare are adequately protected
  • Why do we need IRB review?
    • No one can be objective about their own work
    • People underestimate the risks involved in things they are very familiar with
    • People overestimate the benefit of things that are important to them
required irb review
Required IRB Review
  • IRB must review and approval proposed research prior to the initiation of any research activity involving human subjects (Initial Review)
  • IRB must conduct review at interval appropriate to the degree of risk, but not less than once per year (Continuing Review)

- No grace period

- Criteria for IRB approval is same as initial review

  • IRB must review and approve changes to the research & informed consent prior to initiation
criteria for irb approval
Criteria for IRB Approval
  • Risks to subjects are minimized
  • Risks are reasonable in relation to anticipated benefits
  • Selection of subjects is equitable
  • Informed consent is sought from each subject or subject’s legally authorized representative, consistent with regulations
  • Informed consent is appropriately documented, consistent with regulations …continued
criteria for irb approval1
Criteria for IRB Approval

When appropriate:

  • data collection is monitored to ensure subject safety
  • privacy and confidentiality of subjects is protected
  • additional safeguards are included for vulnerable populations
basic protection informed consent
Basic Protection: Informed Consent

Informed consent is not a single event or just a form to be signed - rather, it is an educational process that takes place between the investigator and the prospective subject

Necessary elements of the consent process include:

  • full disclosure of the nature of the research and the subject's participation,
  • adequate comprehension on the part of the potential subjects, and
  • the subject's voluntary choice to participate.
Human Subject Research

is NOT a Right

It’s a Privilege

ohrp electronic access
OHRP Electronic Access