research involving human subjects institutional review board (irb)
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Research Involving Human Subjects
Institutional Review Board (IRB)
History and Ethical principles
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
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
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 (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 (cntd)
Coded Private Information or Biological Specimens 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 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 Exempt Expedited Review Full board Review Depends on the Risk Level (physical,
psychological, social and economic risk)
What is “minimal risk”? 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 (cntd)
May be “Exempt” 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 (cntd)
May be “Expedited” 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 (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 (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
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
IRB must review: 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 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
It is a process and not just a form. It includes:
Recruitment materials Verbal instructions (in person or via video, DVD) Written materials Q & A session(s) Documentation of consent by signature
Informed Consent Process (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
Eight Basic Elements1. Research, Purpose, Procedures
(experimental), Expected duration2. Risks and discomfort3. Benefit4. Alternatives procedures (Treatments)5. Confidentiality of records6. Medical treatment in case of research
related injury7. Contact Info: Research Qs, Rights Qs,
Injury Qs8. Participation is Voluntary
Elements of Informed Consent (cntd)
Additional elements, as appropriate1. Unforeseeable Risk (embryo or fetus)2. Participation may be terminated by
researcher3. Additional cost to subjects4. Consequences of early withdrawal by
subjects5. Significant new findings that may affect
wiliness to continue participation6. Approximate number of participants
Elements of Informed Consent (cntd)
Voluntary 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 (cntd)
Comprehension Organized Ample time for consideration Opportunities for questions Lay language appropriate for subject
Waiver or Alteration of Consent
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; and4. Whenever appropriate, the subjects will be
provided with additional pertinent information after participation.
Important Components of Protection
Minimizing Risk Maintaining Confidentiality Maintaining and Destroying Records
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 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
Amendment/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 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.
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? 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 All investigators conducting research
involving human subjects must: 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 (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?
Most information on guidelines, procedures, and submitting research applications can be found at http://www2.oakland.edu/research
Contacts: Dr. Judette Haddad (Regulatory Compliance
Coordinator) at haddad@oakland.edu or 248-370-4898.
Dr. Paul Schauert, PhD (IRB Administrator) at schauert@oakland.edu or 248-370-4329
Dr. Rebecca Sandborg (Director of Regulatory Support) at sandborg@oakland.edu or 248-370-2708.
Dr. Chris Stiller (IRB Chair) at cstiller@oakland.edu or 248-364-8661
Tips: Before you Apply 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).
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
Collaborative Institutional Training Initiative https://www.citiprogram.org Register- Choose OU as Participating
Institution Three Learner Groups:
Faculty Students and Faculty Advisor IRB Members
Mandatory Starting January 2011
Questions?
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