The Basics of Human Research Protections - PowerPoint PPT Presentation

About This Presentation
Title:

The Basics of Human Research Protections

Description:

Thanks to the Office of Human Research Protections for providing some text. ... on elected or appointed public officials or candidates for public office ... – PowerPoint PPT presentation

Number of Views:105
Avg rating:3.0/5.0
Slides: 52
Provided by: ecli
Category:

less

Transcript and Presenter's Notes

Title: The Basics of Human Research Protections


1
The Basics of Human Research Protections
  • Office of Research Oversight (ORO)
  • Veterans Health Administration
  • Department of Veterans Affairs

February 27, 2004
Thanks to the Office of Human Research
Protections for providing some slide text.
2
Outline
  • Ethical Principles
  • Federal Regulations
  • Resources

Office of Research Oversight (ORO)
2
3
Ethical Principles
Office of Research Oversight (ORO)
3
4
The Belmont Report
  • Ethical Principles and Guidelines for the
    Protection of Human Subjects of Research
  • The National Commission for the Protection of
    Human Subjects of Biomedical and Behavioral
    Research
  • April 18, 1979

Office of Research Oversight (ORO)
4
5
Ethical Principles Belmont Report
  • Respect for Persons
  • Individual autonomy
  • Protection of individuals with reduced autonomy
  • Beneficence
  • Maximize benefits and minimize harms
  • Justice
  • Equitable distribution of research risks and
    benefits

Office of Research Oversight (ORO)
5
6
Federal Regulations
Office of Research Oversight (ORO)
6
7
Federal Regulations and Policy
  • 45 CFR 46 Basic HHS Policy for Protection of
    Human Research Subjects
  • Originally adopted May 1974, Revised January 13,
    1981, Revised June 18, 1991
  • 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 HHS. NSF, NASA,
    EPA, AID, Social Security Administration, CIA,
    and the Consumer Product Safety Commission.

Office of Research Oversight (ORO)
7
8
Federal Regulations and Policy
  • Additional Protections Included in 45 CFR 46
  • Subpart B Additional Protections for Pregnant
    Women, Human Fetuses and Neonates Involved in
    Research
  • 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
  • VA follows if waivers from ORD permit inclusion
    of these populations.

Office of Research Oversight (ORO)
8
9
Food and Drug Administration
  • Regulations
  • Institutional Review Board 21 CFR 56
  • Informed Consent 21 CFR 50

Office of Research Oversight (ORO)
9
10
Differences in VA (38 CFR 16) FDA (21 CFR Parts
50 56) Regulations
  • Basic requirements for IRBs and for Informed
    Consent are congruent
  • Differences center on differences in
    applicability
  • VA regulations based on VA conduct/support of the
    research
  • FDA regulations based on use of FDA regulated
    product drugs, devices, or biologics

Office of Research Oversight (ORO)
10
11
Definitions
  • Research a systematic investigation designed to
    develop or contribute to generalizable
    knowledge.
  • Human Subject a living individual about whom an
    investigator conducting research obtains
  • data through intervention or interaction with the
    individual, or
  • identifiable private information
  • (FDA has different definitions)

Office of Research Oversight (ORO)
11
12
Exempt Research
  • Some research is exempt from federal
    regulations six categories of research
  • VHA facilities (not investigators) determine
    whether proposed research qualifies as exempt
    under VA regulations

Office of Research Oversight (ORO)
12
13
Exempt Research
  • Research that is exempt includes
  • Normal educational practices
  • Educational tests, surveys, interviews, or
    observation of public behavior unless identified
    and sensitive
  • Research using existing data, documents, records,
    pathological specimens, or diagnostic specimens,
    if publicly available or unidentifiable
  • continued

Office of Research Oversight (ORO)
13
14
Exempt Research
  • Research on elected or appointed public officials
    or candidates for public office
  • Evaluation of public benefit service programs
  • Taste and food quality evaluation and consumer
    acceptance studies

Office of Research Oversight (ORO)
14
15
Basic Protections
  • The regulations contain three basic protections
    for human subjects
  • Institutional Assurances
  • Institutional Review Board (IRB) Review
  • Informed Consent

VA also requires Research and Development
Committee review by policy.
Office of Research Oversight (ORO)
15
16
Institutional Assurances
Office of Research Oversight (ORO)
16
17
Assurances
  • Documentation of institutional commitment to
    comply with the Common Rule for
    Federally-supported research
  • OR
  • ALL human subject research
  • Principal method of compliance oversight
  • Federalwide Assurance

Office of Research Oversight (ORO)
17
18
Assurances
  • Required from each VHA facility engaged in the
    research

Office of Research Oversight (ORO)
18
19
Engagement
  • Institutions become engaged in human subject
    research whenever their employees or agents
  • intervene or interact with living individuals for
    research purposes or
  • obtain, release, 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

Office of Research Oversight (ORO)
19
20
Institutional Review Board Review
Office of Research Oversight (ORO)
20
21
IRB Review
  • Institutional Review Board (IRB) A committee
    charged with the review of human participants
    research to assure that the rights and welfare of
    human participants are adequately protected. VA
    IRBs are subcommittees of the RD Committee.
  • Why do we need IRB review?
  • No one can be objective about his/her own work
  • People underestimate the risks involved in
    research interventions with which they are quite
    familiar
  • People overestimate the benefit of things that
    are important to them

Office of Research Oversight (ORO)
21
22
Institutional Review Board (IRB)
  • Membership
  • At least five members of varying backgrounds
  • Sufficiently qualified
  • Not solely of one profession
  • Both men and women
  • At least one non-scientist
  • At least one non-affiliated member
  • Expertise on vulnerable populations
  • Outside consultants

Office of Research Oversight (ORO)
22
23
IRB Responsibilities
  • Review and approve, require modifications, or
    disapprove all covered research
  • Require that informed consent is in accordance
    with regulations
  • Require documentation of informed consent or may
    waive documentation in accordance with
    regulations
  • Notify investigators in writing of decisions
  • Conduct continuing review of research no less
    than once per year

Office of Research Oversight (ORO)
23
24
IRB Review
  • IRB review and approval must precede initiation
    of research involving human subjects (Initial
    Review)
  • IRB must review and approve changes to the
    research prior to initiation
  • In VA, RD Committee must also approve all
    research before it commences.

Office of Research Oversight (ORO)
24
25
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
  • Informed consent is appropriately documented
  • continued

Office of Research Oversight (ORO)
25
26
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

Office of Research Oversight (ORO)
26
27
Full Review
  • Convened meeting no mail reviews (telephone
    participation okay under some circumstances)
  • Quorum
  • Majority of IRB present
  • At least one non-scientist present
  • Approval by majority of those present
  • Members with conflict of interest should be
    absent during discussion and vote
  • Should the quorum fail during a meeting, no
    further votes can be taken unless the quorum can
    be restored

Office of Research Oversight (ORO)
27
28
Continuing Review
  • Continuing review is to be conducted at intervals
    appropriate to the degree of risk, but not less
    than once per year
  • Continuing review must be substantive and
    meaningful
  • The criteria for IRB approval is the same as for
    initial review

Office of Research Oversight (ORO)
28
29
Expedited Review
  • An IRB may use expedited review for
  • Research on list of eligible categories IF
    minimal risk
  • Minor changes in previously approved research
  • Carried out by IRB chair or one or more
    experienced IRB members
  • Reviewers can exercise all of the authorities of
    the IRB except disapproval
  • All IRB members must be informed of research
    approved under expedited review

Office of Research Oversight (ORO)
29
30
Expedited Review
  • Research activities that (1) present no more than
    minimal risk to human subjects, AND (2)
    involve only procedures listed in one or more
    categories published in the expedited review
    list
  • The categories in the list apply regardless of
    the age of subjects, except as noted
  • May not be used where identification of the
    subjects and/or their responses would reasonably
    place them at risk

Office of Research Oversight (ORO)
30
31
Expedited Review
  • May not be used for classified research involving
    human subjects
  • The standard requirements for informed consent
    (or its waiver, alteration, or exception) apply
    regardless of the type of reviewexpedited or
    convenedutilized by the IRB.
  • First seven categories pertain to both initial
    and continuing IRB review.

Office of Research Oversight (ORO)
31
32
Expedited Review
  • Eligible research categories
  • Clinical studies of drugs and medical devices
    where IND or IDE not required or device has been
    approved for marketing and is used as such
  • Collection of blood samples by finger stick, heel
    stick, ear stick, or venipuncture with
    restrictions on age, weight, and amount
  • Prospective collection of biological specimens
    for research purposes by noninvasive means
  • Collection of data through noninvasive procedures
    routinely employed in clinical practice

Office of Research Oversight (ORO)
32
33
Expedited Review
  • Eligible research categories
  • Research involving materials (data, documents,
    records, or specimens) that have been collected,
    or will be collected solely for non-research
    purposes
  • Collection of data from voice, video, digital, or
    image recordings made for research purposes
  • Research on individual or group characteristics
    or behavior or research employing survey,
    interview, oral history, etc. methodologies

Office of Research Oversight (ORO)
33
34
Expedited Review
  • Eligible research categories
  • Continuing review of research previously approved
    by the convened IRB with no further direct
    subject participation
  • Continuing review of research (not under IND or
    IDE) where the IRB has determined and documented
    at a convened meeting that the research involves
    no greater than minimal risk and no additional
    risks have been identified

Office of Research Oversight (ORO)
34
35
Informed Consent
Office of Research Oversight (ORO)
35
36
Informed Consent
  • Beyond the
  • Consent Form

Office of Research Oversight (ORO)
36
37
The Consent Process
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 or enrolled subject.
Necessary elements of the consent process includ
e
  • Full disclosure of the nature of the research and
    the subjects participation
  • Adequate comprehension on the part of the
    potential subjects, and
  • The subjects voluntary choice to participate

Office of Research Oversight (ORO)
37
38
Basic Elements
  • Research
  • Purpose
  • Duration
  • Procedures
  • Risks
  • Benefits
  • Alternatives
  • Confidentiality
  • Compensation for Injury
  • Whom to Contact
  • Right to Refuse or Withdraw

Office of Research Oversight (ORO)
38
39
Additional Elements
  • Risks related to pregnancy
  • Anticipated reasons for termination from the
    study
  • Costs
  • Consequences of withdrawal
  • New findings
  • Number of subjects

Office of Research Oversight (ORO)
39
40
Comprehension
  • Informed consent is not valid unless the
    consenter understands the information that has
    been provided.
  • The investigator must consider the nature of the
    proposed subject population, the type of
    information to be conveyed, and the circumstances
    under which the consent process will take place
    in determining the appropriate way to present the
    information.

Office of Research Oversight (ORO)
40
41
Voluntary Consent
  • To be valid, consent must be freely given free
    from all forms of coercion.
  • In addition to overt coercion, the investigator
    needs to be sensitive to more subtle forms of
    coercion, such as social pressure, requests from
    authority figures, and undue incentives for
    participation.

Office of Research Oversight (ORO)
41
42
Documentation of Consent
Documentation of legally effective informed
consent usually involves the use of a written
consent form signed by the subject or the
subjects legal representative.
  • The consent form is merely the documentation of
    informed consent and does not, in and of itself,
    constitute informed consent.
  • The fact that a subject signed a consent form
    does not mean that s/he understood what was being
    agreed to or truly gave his/her voluntary
    consent.
  • Informed consent is a process that is documented
    by a signed consent form.

Office of Research Oversight (ORO)
42
43
IRB Waivers
Office of Research Oversight (ORO)
43
44
IRB Waiver Informed Consent
The IRB may approve a waiver of some or all of
the consent requirements provided that
  • The research involves no more than minimal risk
    to subjects
  • The waiver will not adversely affect the rights
    and welfare of subjects
  • The research could not practicably be carried out
    without the waiver and
  • Whenever appropriate, the subjects will be
    debriefed provided with additional pertinent
    information after they have participated in the
    study.

Office of Research Oversight (ORO)
44
45
IRB Waiver Documentation of Consent
The IRB may waive the requirement for written
documentation of consent in cases where
  • The principal risks are those associated with a
    breach of confidentiality concerning the
    subjects participation in the research and the
    consent document is the only record linking the
    subject with the research
  • OR
  • The research presents no more than minimal risk
    and involves procedures that do not require
    written consent when performed outside of a
    research setting.

Office of Research Oversight (ORO)
45
46
Vulnerable Populations
Office of Research Oversight (ORO)
46
47
Subpart C -- Prisoners
  • HHS issued special protections in 1978
  • No Exemptions allowed
  • Definition of a prisoner
  • Additional duties of the IRB

Office of Research Oversight (ORO)
47
48
Subpart D -- Children
  • Definition of a child
  • Permission
  • Assent
  • IRB duties

Office of Research Oversight (ORO)
48
49
VHA Handbook 1200.5 Requirements for the Protecti
on
of Human Subjects in Research July 15, 2003
Office of Research Oversight (ORO)
49
50
Resources
Office of Research Oversight (ORO)
50
51
Electronic Resources
  • OHRP Website http//ohrp.osophs.dhhs.gov
  • IRB Registration Assurance Filing
  • Quality Improvement Program
  • Policy Guidance
  • Compliance Oversight
  • Educational Materials/Workshops
  • ORO Website http//www.va.gov/oro/
  • OROs Regional Office locations and contact
    information
  • OROs Central Office contact information
  • ORD Website http//www.va.gov/resdev/
  • PRIDEs Website http//www.va.gov/resdev/fr/PRIDE

Office of Research Oversight (ORO)
51
Write a Comment
User Comments (0)
About PowerShow.com