Responsible Conduct of Research: Institutional Review Board

Report
Responsible
Conduct of
Research:
Institutional
Review
Board
Office of Regulatory Research Compliance
Objectives:

To provide an overview of the Office of Regulatory
Research Compliance and the role of
institutional review committees;

To describe role and function of the Institutional
Review Board and the human subjects
protection program;

To discuss the IRB review process and the
responsible conduct of research involving
human participants.
ABOUT THE OFFICE OF
REGULATORY RESEARCH
COMPLIANCE
About The Office of Regulatory
Research Compliance (ORRC)
Location: The Office of Regulatory
Research Compliance (ORRC)
1840 Seventh Street, NW
HURB-1, Suite 309
Washington, DC 20001
202-865-8597(O)
202-232-5286 (Fax)
Regulatory Committee Chairs
Medical IRB
• Thomas O. Obisesan, MD, MPH
• Chief, Section of Geriatrics, HUH
Non-Medical
IRB
• Broderick Eribo, PhD
• Associate Professor, Biology Dept.
IACUC
• Thomas Heinbockel, PhD
• Associate Professor, Anatomy Dept.
IBC
RMC
• Stanley Tai, PhD
• Associate Professor, Microbiology Dept.
• Allan Johnson, PhD
• Associate Dean, CNAHS
Function of the ORRC

ORRC supports HU in promoting ethical conduct of
research and educating faculty and students about
human subjects protections, responsible conduct of
research, animal care regulations, and bio-safety.

ORRC has oversight of all research approved by an
institutional review committee to ensure regulatory
compliance and the protection of all human and animal
participants involved in research.
Objectives:
 To provide an overview of the Office of Regulatory Research
Compliance and the role of institutional review committees;

To describe the role and function of the Institutional Review Board
(IRB) and the human subjects protections program;

To discuss the IRB review process and the responsible conduct of
research involving human subjects.
SPECIAL NOTE!
NO HUMAN SUBJECTS
RESEARCH, ANIMAL RESEARCH,
OR RESEARCH INVOLVING
BIOAGENTS AND RADIATION
CAN BEGIN UNTIL IT HAS
RECEIVED APPROVAL BY AN
INSTITUTIONAL REVIEW
COMMITTEE.
ETHICAL FOUNDATION
OF
HUMAN RESEARCH
PROTECTION
 Belmont Report
 Ethical Principles
ETHICAL
PRINCIPLES
The “Belmont Report,” formally known as
the Ethical Principles and Guidelines for
the Protection of Human Subjects of
Research, was written in 1979 by the
National Commission for the Protection of
Human Subjects of Biomedical and
Behavioral Research.
ETHICAL
PRINCIPLES
The Belmont Report identified the following three fundamental ethical
principles that must be carefully considered to ensure the ethical practice
of research involving human participants:
Respect for Persons
Justice
Beneficence
Respect for Persons
• Participants have a right to informed consent.
• Treat participants as autonomous agents capable of making
an independent decision to enter into the research study
voluntarily.
• Additional provisions must be taken to protect participants
that have a diminished capacity to act as an autonomous
agent (children, prisoners, etc.).
• Researcher should design procedures and safeguards which
minimize the risk of invasion of privacy and assure
confidentiality of data.
Justice
• No individual or group of participants should unduly bear
the risks of research nor inequitably receive its benefits.
• Fair distribution of risks and benefits of research.
• Equitable selection of subjects..
• IRB has the responsibility of reviewing any requests by
researchers to exclude selected subject populations.
Beneficence
• Do no harm.
• Refers to the responsibility of the researcher to maximize
possible benefits and minimize possible risks.
• The benefits should outweigh the risks..
• IRB has separate applications for studies with “minimal
risk” and “greater than minimal risk”.
REGULATORY
FOUNDATION
OF
HUMAN RESEARCH
PROTECTION




History
Regulations
Policies
HIPAA
History

Significant recent events in research
experimentation since the Hippocratic
Oath.
The Tuskegee
Syphilis Study
The Nuremberg
Code
The Milgram
Study
Declaration of
Helsinki
The Beecher
Article
The Syphilis Study
Expose
1932
1947
1963
1964
1966
1970s
The Code follows
the Nazi
experiments
(1930s-40s)
Yale psychologist
Stanley Milgrim
conducted a study
to test this theory
of obedience.
“Ethics and
Clinical Research
Article” published
citing 22 examples
of human research
being conduct not
complying with
Nuremberg
Article appears in
the New York
Times in 1972 that
caused the
Tuskegee study to
be shut down.
History (cont.)
The National
Research Act
The Belmont
Report
Consolidated
HHS/FDA
Regulations
CIOMS Guidelines
The Common Rule
(45 CFR 46)
National Bioethics
Advisory
Committee
1974
1978-79
1981
1982
1991
1995
HHS and FDA
attempted to
consolidate their
regulations
International
Ethical Guidelines
for Biomedical
Research
Involving Human
Subjects prepared
by the Council of
International
Organization for
Medical Science
Federal law that
established the
requirement of
human subjects
research review by
IRBs
* Recent findings on Guatemala and Henrietta Lacks.
What regulations govern human
subjects research?

Department of Health and
Human Services (DHHS)

Food and Drug
Administration (FDA)

Sponsors

Howard University Policies
What regulations govern human
subjects research? (cont.)
All research involving
human subjects must
adhere to DHHS
regulation 45 CFR 46,
also known as the
COMMON RULE,
unless the requirement
is waived by the IRB.
DHHS
45 CFR 46
COMMON
RULE
45 CFR 46:
The Common Rule


The Common Rule is a federal policy regarding Human Subjects
Protection. The main elements include:
(1)
requirements for assuring compliance by research institutions;
(2)
requirements for researchers’ obtaining and documenting informed
consent;
(3)
requirements for Institutional Review Board (IRB) membership,
function, operations, review of research, and recordkeeping.
Revisions under consideration affecting informed consent, security
and data collection.
http://www.hhs.gov/news/press/2011pres/07/20110722a.html
What is HIPAA?

The Health Insurance Portability
and Accountability Act, commonly
known as HIPAA, is another piece
of legislation that impacts the
conduct of human subjects
research.

Establishes national standards for
the protection of private health
information know as Protected
Health Information (PHI).

PHI is defined as any individually
identifiable health information that
is created or maintained by a
Covered Entity (CE) department.
HIPAA applies when:
An investigator working in a Non CE department receives
PHI from a CE department.
An investigator working in a CE department creates,
receives and/or discloses PHI for research purposes.
The IRB is responsible for reviewing proposed HIPAA
authorization forms, de-identification forms, and requests
to waive the authorization process for research projects.
ROLE OF THE IRB
Basic IRB Member
Responsibilities
 Conduct Protocol Review
 Applying Discipline Expertise and Regulatory
Knowledge
 Attend Meetings
 Review Allegations of Noncompliance
 Maintain Confidentiality
IRB REVIEW PROCESS




Types of Protocol Submission
Types of Protocol Review
Criteria for Approval
Criteria for Exemption; Expedited Review;
Full Board Review
 Points to Consider
(2 weeks)
(4-6 weeks)
(2-3 weeks)
Types of Protocol Submission
Examples of protocol submission:
1.
2.
3.
4.
5.
6.
Initial Review
Continuation Review
Revisions/Modifications/Amendments
Unanticipated Problems/Adverse Events
Alleged or Reported Noncompliance
Closures
Mechanisms of IRB Review:
Exempt
Expedited
Full
• Research must meet the federal criteria for
exempt review otherwise protocol will be
forwarded for other either expedited or full
board review
• Outcome of the review may include any of the
following: 1) approval; 2) request for
additional information; 3) request for changes;
4) request that the review be conducted by the
Full IRB.
• Four possible outcomes: (1) approval; (2) minor
revisions/additional information required (APPROVAL
WITH ADMINISTRATIVE REVIEW); (3) major
revisions/additional information required (TABLED);
and (4) Disapproval
What criteria must be met for
research to be approved?
Based upon the
criteria for
research approval
set forth in the
federal regulations
45 CFR Part
46.111, 50 CFR
56.111 and 38
CFR 16.111, the
IRB should
determine that all
of the following
conditions exist:
• Risks to subjects are minimized
• Risks to subjects are reasonable in relation to anticipated
benefits, if any, to subjects
• Selection of subjects is equitable.
• Informed consent will be sought from each prospective subject
• Informed consent will be appropriately documented
• For greater than minimal risk, clinical research, or an NIH
funded/FDA regulated clinical trial, the research plan makes
adequate provision for monitoring the data collected to ensure
the safety of subject.
• There are adequate provisions to protect the privacy of subjects
and to maintain the confidentiality of data.
• Where any of the subjects are like to be vulnerable to coercion
or undue influence, additional safeguards have been included
in the study to protect subjects.
Criteria for Exemption = 6:
*Only the IRB can make the official determination that your project is exempt based upon 45 CRF 46.101
1
2
• Research conducted in educational settings involving normal educational practices on
instructional strategies and teaching effectiveness
• Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey
procedures, interview procedures or observation of public behavior with certain conditions
3
•Research that is not exempt under paragraph b2 of this section, if: (i) the human subjects are elected or appointed
public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the
confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
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.
5
6
•Research and demonstration projects conducted by or subject to the approval of department or agency heads, and
which are designed to study, evaluate, or otherwise examine certain conditions
•Taste and food quality evaluation and consumer acceptance studies
Criteria for Expedited Review

Expedited reviewers must determine the following:

Do the research activities meet the definition of “minimal risk” and do
they fit within the federally mandated expedited categories?

Do the research activities meet the eight federal criteria for IRB
approval?

“Minimal risk” is defined as “the probability and magnitude of harm or
discomfort anticipated in the research are not greater in and of
themselves from those ordinarily encountered in daily life or during the
performance of routine physical or psychological examination or tests.”
EXPEDITED REVIEW DOES NOT MEAN PUT A RUSH ON MY
REVIEW BECAUSE A GRANT DEADLINE IS COMING UP!!!
Criteria for Full Board Review
•
Research that does meet the criteria for exempt or
expedited review must be submitted to the IRB for a
review at a convened meeting at which a quorum of
the members are present.
•
Medical IRB meets twice a month and the
Nonmedical IRB meets at least once a month.
•
Research involving “greater than minimal risk” must
go before the Full Review process.
TYPICAL REVIEW
TIMELINES
REVIEW TYPE
EXEMPT
EXPEDITED
RISK
ASSESSMENT
LOW OR LESS
MINIMAL
MINIMAL
APPROVAL
TIMELINE*
2 Weeks*
2-3 Weeks*
FULL BOARD
MORE THAN
MINIMAL
CONVENED FULL BOARD
Review 4-6Weeks*
*APPLICATIONS THAT REQUIRE REVISIONS MAY TAKE LONGER.
Points to consider: How long?
Exempt Review:
2 weeks
Expedited Review:
2-3 weeks
Full Board Review:
4-6 weeks
Most proposals submitted require some form of
revision. Submission of additional information will
add time to your review and approval.
Online CITI Training Module
https://www.citiprogram.org
IRB CHECKLIST
Form B-1 (always required)
Request for Expedited Review. Typed letter on letterhead signed by the PI.
Request for Exemption (Form D-1). Note: One or both, depending on nature
of the research
Conflict of Interest Forms for all Investigators
Certificate of completion of education in the protection of human research
participants (required)
Informed consent document(s)
Signed copy of The Principal Investigator’s Assurance Form
Any recruitment notices or advertisements
Any survey instruments, psychological tests (other than standard,
commercially available instruments), interview forms, or scripts to be used in the
research
Investigator’s qualifications (CV, biographical sketch)
Formal research protocol, if available.
Grant application, if applicable.
SUBMIT ONE APPLICATION. TWO ADDITIONAL COPIES ARE NO
LONGER REQUIRED!
FORMS
Applications forms are available online at:
http://www.howard.edu/orrc
Questions and Answers
The Office of Regulatory
Research Compliance
Location:
The Office of Regulatory Research
Compliance (ORRC)
1840 Seventh Street, NW
HURB-1, Suite 309
Washington, DC 20001
202-865-8597 (Office)
Yonette F. Thomas, PhD
Associate Vice President for Research Compliance

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