Transcript Where Do I Find Information?

Research Involving
Human Subjects
Institutional Review Board
(IRB)
Judette Haddad, PhD, CIP
History and Ethical principles
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Nuremberg Code 1947
Declaration of Helsinki 1964
National Research Act 1974
Belmont Report 1979
 Respect for person- Informed consent
 Beneficence- Favorable benefit-risk ratio
 Justice- Selection of subjects
Public Heath Services Act 1985
Human Subject Protection Regulations
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DHHS Regulations
 45 CFR part 46- Subparts A, B, C, D, & E
FDA Regulations
 21 CFR part 50, Protection of Human Subjects
 21 CFR part 56, Institutional Review Boards
 21 CFR part 312, Investigational New Drug
Application
 21 CFR part 812, Investigational Device Exemptions
OU Federal Wide Assurance
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All research involving the participation
of human subjects must be submitted
for review by the IRB (Institutional
Review Board for the Protection of
Human Subjects).
DHHS Definition
45 CFR 46.102(d)
 Research means a systematic investigation,
including research development, testing and
evaluation, designed to develop or contribute
to generalizable knowledge.
DHHS Definition
(cntd)
45 CFR 46.102(f)
 Human subject means a living individual
about whom an investigator (whether
professional or student) conducting research
obtains
(1) Data through intervention or
interaction with the individual, or
(2) Identifiable private information.
DHHS Definition
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(cntd)
Private Information:
 Information about behavior that occurs in a setting in
which the individual can reasonably expect that no
observation or recording is taking place
 information that has been provided for specific
purposes, other than research, where the individual
can reasonably expect that it will not be made public
(e.g., a medical record.) [45 CFR 46.102(f)].
 Protected Health Identifiers (PHI)
DHHS Definition
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(cntd)
Coded Private Information or Biological Specimens
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DHHS Office of Human Research Protection (OHRP)
policy considers private information or specimens
to be individually identifiable when they can be
linked to specific individuals either directly or
indirectly through coding systems.
DHHS OHRP guidance states that only a
knowledgeable person or entity is authorized to
determine if coded specimen or data constitute
research. An investigator cannot make that
determination.
Institutional Review Board
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IRB is a review committee established to help protect
the rights and welfare of human research subjects.
Authority of the IRB:
 Approve, disapprove, or modify research
 Conduct continuing reviews
 Observe and verify changes
 Suspend or terminate approval
 Observe the consent process and research
procedures
Review Categories
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Exempt
Expedited Review
Full board Review
Depends on the Risk Level (physical,
psychological, social and economic risk)
What is “minimal risk”?
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Minimal risk means that the probability and
magnitude of harm or discomfort anticipated
in the research are not greater in and of
themselves than those ordinarily encountered
in daily life or during the performance of
routine physical or psychological
examinations or tests.
Review Categories
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(cntd)
May be “Exempt”
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Projects that present no more than “minimal
risk” to the participants and do not
compromise the privacy of the participants or
confidentiality of the data
Fits 1 of 6 categories
Reviewed by IRB Chair or a designated
member
Common in Educational Research- No
identifiers
Review Categories
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May be “Expedited”
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(cntd)
Projects that present no more than
“minimal risk” to the participants, and for
minor changes in approved research
Has to fit 1 of 7 categories
Reviewed and approved by 1 or 2 IRB
Committee Members
Common in Educational Research for data
collection methods that use audio/visual
data collection- Retain identifiers
Review Categories
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(cntd)
Full Board Review
 Projects involving more than minimal risk
 Full Committee meets once per month (Applications
must be received at least 10 days before the next
meeting date)
 Researcher are invited to present the research
 Committee members ask the researcher questions
regarding the research and participation of human
subjects
 Vote is taken (in the absence of the researcher) and
recommendations are made
Review Categories
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(cntd)
Continuing Review
 Annually for Expedited or Full Board approved
applications.
 Email notifications sent two month prior to
approval expiration date.
 Must complete the Continuing Review Form
and attach a copy of the consent form.
 Same type of review as the original
application with some exceptions.
Review by Institution
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Research that has been approved by an
IRB may be subject to further
appropriate review and approval or
disapproval by officials of the institution.
However, institutional officials may not
approve the research if it has not been
approved by an IRB.
Criteria for IRB Approval of
Research
1. Risks to subjects are minimized
 sound research design which do not
unnecessarily expose subjects to risk,
 using procedures already being performed
on the subjects for diagnostic or treatment
purposes.
2. Risks to subjects are reasonable in relation to
anticipated benefits, and the importance of
the knowledge that may result.
3. Selection of subjects is equitable.
Criteria for IRB Approval of
Research (cntd)
4. Informed consent is sought.
5. Informed consent is appropriately documented.
6. Plans for monitoring the data collected to
ensure the safety of subjects.
7. adequate provisions to protect the privacy of
subjects and to maintain the confidentiality of
data.
8. additional safeguards to protect vulnerable
population (children, prisoners, pregnant women,
mentally disabled persons, or economically or
educationally disadvantaged persons).
IRB Requirements
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IRB must review:
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Qualification of the PI and collaborators
Full description about conflicts of interest
A complete description of the proposed research
Provisions for the adequate protection of rights
and welfare of subjects
Compliance with pertinent federal and state
laws/regulations and institutional policies
HIPAA Requirements
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Health Insurance Portability and Accountability Act
 Mandated standards for storage and transmission of
healthcare information
HHS- The Privacy Rule & Security Rule
 The research must be HIPAA compliant
 HIPAA language requirement in consent form
 PHI- Protected Health Information- 18 identifiers
 Authorization, Limited Data Set (16 ids) and Data Use
Agreement
De-identified Health Information- No restrictions
Informed Consent Process
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It is a process and not just a form.
It includes:
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Recruitment materials
Verbal instructions (in person or via video,
DVD)
Written materials
Q & A session(s)
Documentation of consent by signature
Informed Consent Process
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(cntd)
Participants must understand the nature of
the research.
Participants must be able to knowledgeably
and voluntarily decide whether or not to
participate.
Participants must understand the risks and
benefits of participation.
The IRB must determine that informed
consent will be properly obtained.
Elements of Informed Consent
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Eight Basic Elements
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Research, Purpose, Procedures (experimental),
Expected duration
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Risks and discomfort
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Benefit
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Alternatives procedures (Treatments)
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Confidentiality of records
6.
Medical treatment in case of research related
injury
7.
Contact Info: Research Qs, Rights Qs, Injury Qs
8.
Participation is Voluntary
Elements of Informed Consent
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(cntd)
Additional elements, as appropriate
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Unforeseeable Risk (embryo or fetus)
Participation may be terminated by researcher
Additional cost to subjects
Consequences of early withdrawal by subjects
Significant new findings that may affect wiliness
to continue participation
Approximate number of participants
Elements of Informed Consent
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Voluntary
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(cntd)
Consent if voluntary, free of coercive elements
Right to refuse or withdraw with no penalty
Unjustifiable pressures occur when persons in
authority urge a course of action for a subject
Coercion is likely whenever possible sanctions are
involved (implied or actual)
Undue influence occurs through an offer of an
excessive, unwarranted, inappropriate or improper
reward
Consent process may not involve the use of
“exculpatory language”
Elements of Informed Consent
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Comprehension
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Organized
Ample time for consideration
Opportunities for questions
Lay language appropriate for subject
(cntd)
Waiver or Alteration of Consent
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The IRB may approve a waiver or alteration of the
consent process provided:
1.
The research involves no more than minimal risk to
the subjects;
2.
The waiver or alteration will not adversely affect the
rights and welfare of the subjects;
3.
The research could not practicably be carried out
without the waiver or alteration; and
4.
Whenever appropriate, the subjects will be provided
with additional pertinent information after
participation.
Important Components of
Protection
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Minimizing Risk
Maintaining Confidentiality
Maintaining and Destroying Records
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Maintained for at least 3 years after the
completion of the study and then destroyed in a
manner that will protect the identity of human
subjects.
Reporting Adverse Events Related to
Research
Approved Research
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Research must be conducted as approved by
the IRB.
Any changes to original application must also
be approved before implementation.
Report changes to the IRB via modification
form found in the document library of IRBNet
IRB approval is valid for a maximum of one
year – a “Continuing Review Form” must be
submitted to extend the research beyond one
year.
How to Apply
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Submit an application via IRBNet accessible through
the Human Subjects (IRB) link on the ORA website.
All sections of the forms must be completed.
The application must include conflict of interest
disclosures and CITI training completion reports for
all key personnel, as well as the PI Assurance Form.
All research must be conducted or sponsored by an
OU faculty member.
Non-tenured track professors and staff members may
obtain a “Special Permission” to sponsor research.
What Happens?
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For research falling within the categories of exempt
or expedited review, review may be approved within
2-3 weeks.
For research review by the full committee, the
primary reviewer may contact you with questions or
clarifications regarding the review. You may be asked
to attend the meeting if additional clarifications are
needed.
If approved by the majority of IRB members
attending the meeting, you will be notified in writing
within a few days.
Faculty Responsibilities
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All investigators conducting research involving
human subjects must:
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Be familiar with Oakland University IRB Guidelines
on the ORA website.
Complete CITI Training.
Faculty training is available periodically
throughout the year.
Faculty must inform students with whom they
are working to read OU Guidelines and
complete CITI training.
Faculty Responsibilities
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(cntd)
Faculty must approve a student application
before it can be reviewed by the IRB.
All research must be exempted or approved
before it can be conducted.
Research must be conducted as described in
the approved or exempted application.
Research applications must be submitted
through IRBNet.
Where Do I Find Information?
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Most information on guidelines, procedures, and
submitting research applications can be found at
http://www2.oakland.edu/research
Contact Dr. Judette Haddad (Compliance Officer)
at [email protected] or 370-4898.
Contact Dr. Chris Stiller (IRB Chair) at
[email protected] or 370-4047.
Contact Dr. Rebecca Sandborg (Director of
Regulatory Support) at [email protected] or
370-2708.
Tips: Before you Apply
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Log in the IRBNet for a user name and password.
Be familiar with the questions that are asked on the
application.
Write the major components of the application
(Abstract, Protocol, Consent Form(s), Instruments).
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Use the “suggested language” on the consent form
template.
Include other items given to subjects such as survey
questionnaire or advertisements.
Allow ample time for the review process to take
place.
CITI Training
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Collaborative Institutional Training Initiative
https://www.citiprogram.org
Register- Choose OU as Participating Institution
Four Routes:
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Undergraduate Student
Graduate Students
Faculty and Staff
IRB Members
Mandatory Starting January 2011
CITI Course in Basic Human
Subject Research
Undergraduate Students
1. Oakland University
2. Research Misconduct 1-1215
3. Students in Research – SBR
CITI Course in Basic Human Subject ResearchOU Maters Final Projects or Theses, and Doctoral
Dissertations
Oakland University
2.
Belmont Report and CITI Course Introduction
3.
Defining Research with Human Subjects – SBR
4.
Assessing Risk in Social and Behavioral Sciences – SBR
5.
Informed Consent – SBR
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Privacy and Confidentiality – SBR
7.
Records-Based Research
8.
Internet Research – SBR
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Research and HIPAA Privacy Protections
10. Research Misconduct 1-1215
11. Data Acquisition, Management, Sharing and Ownership 1-1308
12. Conflicts of Interest and Commitment 1-1622
If Applicable:
1.
Research with Children– SBR
2.
Research with Prisoners – SBR
3.
Vulnerable Subjects - Research Involving Pregnant Women and
Fetuses in Utero
1.
CITI Course in Basic Human Subject ResearchOU Faculty Modules
Oakland University
2.
Belmont Report and CITI Course Introduction
3.
Defining Research with Human Subjects – SBR
4.
Assessing Risk in Social and Behavioral Sciences – SBR
5.
Privacy and Confidentiality – SBR
6.
HIPAA and Human Subjects Research
7.
Data Acquisition, Management, Sharing, and Ownership
8.
Informed Consent – SBR
9.
Conflicts of Interest in Research Involving Human Subjects
10. Records-Based Research
11. Internet Research – SBR
If Applicable:
1.
Research with Children – SBR
2.
Research with Prisoners
3.
Vulnerable Subjects – Research Involving Pregnant Women and
Fetuses in Utero
1.
Questions?
[email protected]