Research Involving Human Subjects Institutional Review Board (IRB)

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Research Involving Human Subjects Institutional Review Board (IRB)

Transcript of Research Involving Human Subjects Institutional Review Board (IRB)

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Research Involving Human Subjects

Institutional Review Board (IRB)

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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

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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

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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).

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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.

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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.

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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)

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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.

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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

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Review Categories Exempt Expedited Review Full board Review Depends on the Risk Level (physical,

psychological, social and economic risk)

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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.

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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

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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

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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

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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.

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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.

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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.

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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).

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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

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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

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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

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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.

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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

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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

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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”

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Elements of Informed Consent (cntd)

Comprehension Organized Ample time for consideration Opportunities for questions Lay language appropriate for subject

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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.

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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

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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.

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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.

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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.

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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.

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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.

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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 [email protected] or 248-370-4898.

Dr. Paul Schauert, PhD (IRB Administrator) at [email protected] or 248-370-4329

Dr. Rebecca Sandborg (Director of Regulatory Support) at [email protected] or 248-370-2708.

Dr. Chris Stiller (IRB Chair) at [email protected] or 248-364-8661

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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.

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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

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Questions?