Download - 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 Issues
Outline Federal Regulations & Policy Applicability of Regulations Basic Protections Afforded by Regulations
Federal Regulations and Policy
45 CFR 46 - DHHS Policy for Protection of Human Research Subjects Originally 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
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 Applicability of
Federal RegulationsFederal Regulations
How Determine Applicability?
Regulations apply to all non-exempt human 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?
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?
Human Subject - a living individual about whom an investigator conducting research obtains– data through intervention or interaction
with 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?
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
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 Afforded by Basic Protections Afforded by Federal RegulationsFederal Regulations
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
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: http://ohrp.osophs.dhhs.gov/humansubjects/assurance/engage.htm
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:
http://ohrp.osophs.dhhs.gov/irbasur.htm
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
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
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 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
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
Web Site: http://ohrp.osophs.dhhs.gov
E-mail: [email protected]
Phone: (301) 496-7005