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Roles & Responsibilities. Melody Lin, Ph.D. December, 2012. Objectives. Research Suspensions Roles & Responsibilities Writing the informative consent form. Government Shutdowns. Massachusetts Eye and Ear Infirmary UCLA VA Health Sys. Greater Los Angeles

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roles responsibilities

Roles & Responsibilities

Melody Lin, Ph.D.

December, 2012

  • Research Suspensions
  • Roles & Responsibilities
  • Writing the informative consent form
government shutdowns
Government Shutdowns
  • Massachusetts Eye and Ear Infirmary
  • UCLA
  • VA Health Sys. Greater Los Angeles
  • Rush Presbyterian St Luke’s Med Ctr.
  • University of Illinois Chicago
  • Duke University Med Ctr.
  • Univ. Texas Medical Branch Galveston
  • University of Oklahoma Tulsa
  • Johns Hopkins University
research involving human subjects
Research Involving Human Subjects
  • Human Research Suspended at Major Institutions
    • Deficient Informed Consent
    • Inadequate Initial and Continuing IRB Review
    • Multiple Areas of Concern
  • Death in Gene Transfer Research
    • Conflicts of Interest
    • Unreported Deaths and Injuries
  • Media Attention – Congressional Hearings – Distrust
research involving human subjects1
Research Involving Human Subjects

“The Integrity of Research


Public Confidence in Research”

HHS Secretary, Donna Shalala, May 2000

good clinical practice
Good Clinical Practice
  • GCP is a System of Shared Responsibilities
    • Clinical Investigators
    • Institutions/Institutional Review Boards
    • Industry (Sponsors/Monitors)
    • Government Regulators
ensuring shared responsibility
Ensuring Shared Responsibility
  • Attention to ambiguities in the lines of responsibility
    • Investigator/subinvestigator
    • Sponsors/contractors
    • Institutions/Institutional Review Boards
  • Suspension cases have brought attention to inadequacies in the “culture” of institutions
human subject protections
Human Subject Protections





Research Team






basic protections afforded by regulations
Basic Protections Afforded by Regulations

Institutional Assurance

IRB Review


institutional assurance
Institutional Assurance

“Each institution engaged in research which is covered by this policy and which is conducted or supported by a Federal Department or Agency shall provide written assurance ... that it will comply with the requirements set forth in this policy.” §46.103(a)

See OHRP guidance on engagement in research:

institutional assurance cont d
Institutional Assurance, cont’d
  • Approved by OHRP
  • Terms of Assurance
  • Federalwide Assurance (FWA)
  • Method of compliance oversight for OHRP
  • Generally recognized by other federal departments & agencies
  • Registering IRB and filing Federalwide Assurance (FWA):
who is covered by an institution s assurance
Who is covered by an Institution’s Assurance?
  • Employees and agents, including students, involved in the conduct of research covered by the FWA.
institutional responsibilities
Institutional Responsibilities
  • Institutions have full responsibility for all research involving human subjects covered by their Assurance
  • All requirements of 45 CFR 46 must be met for all HHS-conducted or supported research
roles and responsibilities authorized institutional official
Roles and Responsibilities:Authorized Institutional Official
  • Legal Signatory for Institution (e.g. Assurance)
  • Overall Organizational Responsibility
  • AdequatePlacement of IRB within Institutional Structure
  • Adequate resources for IRB (staff, computers, office space, etc.)
  • Enforce Institutional Culture of Respect and Compliance

eg: Oversight and Monitoring of Research

  • OHRP primary contact
investigator responsibility 1
Investigator Responsibility #1

Design and implement ethical research, consistent with ethical principles

the belmont report
The Belmont Report

Three Basic Ethical Principles:

  • Respect for Persons
    • Individual autonomy
    • Protection of individuals with reduced autonomy
  • Beneficence
    • Maximize benefits and minimize harms
  • Justice
    • Equitable distribution of research costs and benefits
u s federal regulations and policy
U.S.Federal Regulations and Policy
  • 45 CFR 46 - Basic DHHS Policy for Protection of Human Research Subjects adopted May, 1974, Revised January 13, 1981, Revised June 18, 1991
    • Additional protections for vulnerable populations in Subparts B-D, 1983
  • 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.
food and drug administration
Food and Drug Administration


  • IRB - 21 CFR 56
  • Informed Consent - 21 CFR 50
hhs vs fda regulations
HHS vs. FDA Regulations
  • Basic requirements for IRBs and for Informed Consent are congruent
  • Differences center on differences in applicability
    • HHS regulations based on federal funding of research
    • FDA regulations based on use of FDA regulated product: drugs, devices, or biologics
investigator responsibility 3
Investigator Responsibility #3
  • Ensure that all research human subjects is
    • Submitted to and approved by the appropriate IRB
irb review
IRB Review
  • To assure that the rights and welfare of human subjects 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
investigator responsibility 4
Investigator Responsibility #4
  • Comply with all applicable IRB
    • Policies
    • Procedures
    • Decisions
    • Conditions
    • Requirements
irb decision matrix




Privacy & ConfidentialityProtection of subjects (especially vulnerable populations)

Informed consent

Surrogate consent


IRB Decision Matrix

Subject selection



Risk/Benefit Analysis

Experimental Design

Qualifications of PI

J. Cooper, Albany Medical Center

investigator responsibility 5
Investigator Responsibility #5
  • Implement research as approved
  • Obtain prior IRB approval for changes
investigator responsibility 6
Investigator Responsibility #6
  • Obtain informed consent and assent
    • in accord with rules
    • As approved by the IRB
informed consent

Informed Consent

Beyond the Consent Form

the consent process
The Consent Process

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

The basic 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.
investigator responsibility 7
Investigator Responsibility #7
  • Document informed consent and assent
    • In accord with rules
    • As approved by the IRB
documentation of consent
Documentation of Consent
  • Factors that improve readability include the following:
    • Technical terms should be replaced with simple language;
    • Use active tense rather than passive tense verbs ("We did" rather than "It was done");
    • Write shorter sentences and
    • Make clear the links of
      • logical sequences
      • cause-and-effect
      • We will do this because what happened
documentation of consent1
Documentation of Consent
  • Format can help comprehend and remember complex material. Good format uses:
    • headings
    • indents
    • bolded type
    • lists
    • extra spacing between sub-topics
    • repetition
    • reasonable-size type
    • plenty of margins and empty space in general
investigator responsibility 8
Investigator Responsibility #8
  • Report progress
    • Of approved research to the IRB
    • As often and in the manner prescribed by the IRB
continuing review
Continuing Review

An IRB shall conduct continuing review at intervals appropriate to the degree of risk, but not less than once per year…

21 CFR 56.109(e) 45 CFR 46.109(e)

investigator responsibility 9
Investigator Responsibility #9
  • Report to the IRB
    • Any injuries
    • Adverse Events
    • Unanticipated problems

Involving risks to subjects or others

investigator responsibility 10
Investigator Responsibility #10


  • Signed consent documents
  • IRB research records

At least 3 years after completion of the research activities

research team
Research Team
  • “The PI should have available an adequate number of qualified staff…” ICH-GCP [4.2.3]
    • Pharmacist
    • Subinvestigator
    • Site coordinator/study nurse
    • Referring physician(s)
    • Back-up team
    • Other specialists
    • Laboratory technician
research team cont d
  • Issues to consider:
    • Availability
    • Qualifications and training
    • Understanding of ICH-CGP and local regulations
  • The PI can delegate activities, but remains the responsible leader of the team. This delegation must be documented.
  • Make contingency plans for:
    • Sabbaticals
    • Staff leaving the institution
    • Medical leave
    • Vacations
    • Equipment breakdown
training your team
Training Your Team

ICH-GCP & applicable regulations

Their responsibilities

Trial activities

IP handling

Safety reporting

Confidentiality obligations

Protocol requirements

IRB submission

Training must be documented!

informative informed consent
“Informative” Informed Consent

What PI need to:

  • Know about IC
  • Do to create an “informative” Informed Consent Form
need to know
Need to Know!

IC is

  • a process – not just a form
  • is necessary to conduct ethical research
  • ensuring respect for persons through thoughtful consent for voluntary participation
need to know cont d
Need to Know! (cont’d)
  • IC is government regulated
    • 45 CFR 46 116, 117
    • 21 CFR 50 and 56
  • International norm
    • ICH-GCP
need to know cont d1
Need to Know! (cont’d)
  • The IRB is responsible for ensuring regulations are being followed
    • Review the Informed Consent form, is it … ?
      • Clear, easy-to-read, accurately reflects the project
    • Review the process of obtaining Informed Consent
      • Who, what, where, when and how …
need to do
Need to Do!
  • Meet the regulatory requirements
    • Eight mandatory elements of informed consent
    • Six additional elements when appropriate
  • Apply the local requirements
    • Follow the instructions!
      • SOP (IRB policies & procedures)
required elements of consent 8

Whom to contact

Compensation/ treatment for research related injury

Right to refuse or withdraw

Required Elements of Consent (8)
  • Research
    • Purpose
    • Duration
    • Procedures
  • Risks/discomforts
  • Benefits
  • Alternatives
additional elements 6
Additional Elements (6)

Unforeseen risks to subject (fetus)

Anticipated reasons for termination from the study by PI


Consequences of withdrawal by participant

New findings

Number of subjects

writing the consent form
Writing the Consent Form

Write in 2nd person

Not valid unless the subject understands the information that has been provided

The PI must consider subject population, type of information, and circumstances under which the consent will be obtained

writing the consent form cont d
Writing the Consent Form (cont’d)

Avoid technical terms

Simple sentences

Translation is required when English is not participants’ primary language


ALL changes to the consent form must be submitted to the IRB for review and approval, no matter how small!

Update version date when submitting for amendments

informed consent forms

Use complicated terms

Write above an 8th grade level

Put or leave unnecessary information in the form

Forget “Respect” for subjects

Informed Consent Forms


  • Write simply
  • Use small words
  • Include details
  • Describe timeframes
  • Use standardized language
  • Define risks
  • Define acronyms

Research suspensions

Qualified PI and their Responsibilities

Writing the informative Consent Form