an overview of the irb georgia tech office of research integrity assurance

AN OVERVIEW OF THE IRB

Georgia Tech Office of Research Integrity Assurance

WHAT IS THE IRB?The IRB is a Board charged with reviewing and overseeing human research subjects in order to:

1. Protect the rights and welfare of research subjects, and

2. Ensure compliance with established ethical standards and federal, state, and local regulations and policies.

Constituted in accordance with federal law: Minimum of five members Community representation Scientific and non-scientific members Adequate expertise to review the proposed work Consultants, when needed

IRBs have the authority to approve, disapprove, and require modifications to human subjects research.

IRB staff: handle administrative details, do not vote on protocols (with the exception of designated reviewers).

WHY DOES THE IRB EXIST?

THE NUREMBURG TRIALS

1947 - The Nuremberg Trials: Twenty-six Nazi physicians are tried at Nuremberg, Germany, for research atrocities performed on prisoners of war.

• Charges arose from medical experimentation on concentration camp prisoners

• This results in the Nuremberg Code: first international document to advocate voluntary participation and informed consent.

TUSKEEGEE

1940s - 1972: A series of research abuses starts in Tuskegee, Alabama. 

• Researchers tested 400 poor black males for latent syphilis and studied its natural course

• Recruited with promise of “special free treatment” for “bad blood”. No consent was obtained.

• They were not informed of the true nature of their disease and were denied treatment even after a treatment was found in 1947. The abuses are revealed in 1972.

• Study halted in 1972: 28-100 men died from advanced syphilis

WILLOWBROOK STATE SCHOOL 1963-1966

• Mentally handicapped, institutionalized children.

• Children were infected with live Hepatitis in order to develop a vaccine.

• Used as a requirement for admission to the facility, therefore parent permission was coerced. Parents who wanted care for their children may not have had other options.

THE DECLARATION OF HELSINKI1964: Principles established by the World Medical Association to guide physicians conducting medical research

Differentiated between therapeutic and non-therapeutic research:• Therapeutic research gives patients the opportunity to receive an experimental treatment that might have beneficial results.

• Non-therapeutic research is conducted to generate knowledge for a discipline, and might have positive results in future patients.

IRB CREATION

1974 National Research Act Required regulations for protection of human subjects

Informed consentLead to the creation of Institutional Review Boards

Created National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

•1979: The Belmont Report: Published by The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Ethical Principles and Guidelines for the Protection of Human Subjects of Research -- a guide for U.S. research with human subjects. 

•1981: the Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) issued regulations based on the Belmont Report.

• DHHS issued Code of Federal Regulations (CFR) Title 45 (public welfare), Part 46 (protection of human subjects). • The FDA issued CFR Title 21 (food and drugs), Parts 50 (protection of human subjects) and 56 (Institutional

Review Boards).

In 1991, the core DHHS regulations were formally adopted by more than a dozen other Departments and Agencies as the Federal Policy for the Protection of Human Subjects, or "Common Rule" .

MORE REGULATIONS

THE COMMON RULE

1. Defines regulated research

2. Provides regulatory authority for IRB review

3. Establishes requirements for IRB review

4. Identifies criteria for IRB approval of research

5. Creates additional protections for children and other vulnerable populations

THE BELMONT REPORT

Respect for Persons Individuals should be treated as autonomous agents (allow them to choose for themselves)

Provide extra protections to those with diminished autonomy (prisoners, children, cognitively impaired, etc.).

Beneficence First, do no harm Second, maximize possible benefits and minimize risks

Justice Fair selection of research subjects Fair sharing of burdens and benefits of the research

THE BELMONT REPORT APPLIED TO

HUMAN SUBJECTS RESEARCH Respect

Informed consent process Respect for privacy

Beneficence Good research design Favorable risk/benefit ratio

Justice Equitable selection of subjects

HUMAN SUBJECTS RESEARCH Research is “a systematic investigation designed to contribute to

generalizable knowledge.”

Typically Includes: Interviews, surveys, chart reviews, epidemiological studies, observational studies

Typically does NOT include: Training others on how to use a device, provided activities do not include data

collection/analysis

Designed to be Generalizable? Can be difficult to define, but typically designed to be generalizable if:

Aims to draw conclusions about people or practices beyond a specific individual or internal program

HUMAN SUBJECTS RESEARCH A Human Subject is a living individual about whom an investigator obtains:

1. Data through intervention or interaction; or

2. Identifiable private information Identifiable if identity can be ascertained (e.g. 18 HIPAA identifiers) Private means a reasonable expectation that no recording is taking place, and

information is used for intended purposes

Typically does NOT include human subjects: Analysis of deidentified dataset Research with deidentified samples

Exception for FDA definition, in which it is a clinical investigation involving human specimens

Deceased individuals

SOME EXAMPLES…DEIDENTIFIED DATASET

Analyzing data collected previously, stripped of all possible identifiers

Neither study team nor any collaborators have identifiers or a linking code

Yes, it’s research; but No human subjects because no interaction/no intervention/no identifiable info.

NOTE ON “DEIDENTIFIED”

To the IRB, deidentified means:No one on study team has access to identifiers at any timeTypically national-level databases may appear “deidentified” but administrators state that re-identification is technically possible May require separate data use agreement The IRB will often review these

RETROSPECTIVE CHART/RECORD REVIEW

Involves reviewing charts or records, or portions thereof, from specific, prior time period.

Yes, it’s research; and Yes with human subjects because the data will be identifiable

SURVEYS May be online surveys or in-person, designed to

gather and analyze data to investigate a question

What if it’s anonymous? Still involves human subjects, because it meets the interaction

element, whether it has identifiable information doesn’t matter It might, however, have an impact on the type of IRB review it

has

Yes, it’s research; and Yes with human subjects.

TYPES OF IRB REVIEW Exempt Does not mean that the research does not need IRB review Exempt research must be initially reviewed by the IRB Research that meets specific federal review criteria and falls into one (or more) of the 6

Exempt categories

Research that involves the following does not qualify for Exempt review: Minors Prisoners FDA-regulated research

Examples: • Focus group about the experience of a community program• Surveying teachers or nurses about a technique • Interviewing or surveying managers about a management style

A note: only the IRB can make an exempt determination

TYPES OF IRB REVIEW Expedited No more than minimal risk The identification of subjects will not reasonably place them at risk of criminal or civil liability or be damaging to their financial standing, employability, insurability, etc., AND appropriate protections will be implemented so that risks related to a breach of confidentiality are no greater than minimal.

The research is not classified Must fit into one (or more) of the 9 Expedited categories Must be renewed annually

Examples:

•Noninvasive procedures such as MRI, moderate exercise, blood draw of certain amounts from healthy volunteers

•Collection of sensitive data (drug use, criminal record, etc.)

•Some surveys and questionnaires

TYPES OF IRB REVIEW Full Board Unless otherwise determined to be Exempt or Expedited research, this research must be reviewed by a fully convened IRB

Usually more than minimal risk studies

Examples: multi-center clinical trials, medical device studies, some studies involving vulnerable populations.

RISK CATEGORIES

Minimal risk: The risks of harm are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests

More than minimal risk: Risks exceed, either in probability or magnitude, those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests

INFORMED CONSENT REQUIRED ELEMENTSIT’S A TEACHING TOOL - NOT A LEGAL DOCUMENT.

1. Statement that it is research

2. Purpose & procedures

3. Anticipated risks & benefits

4. Compensation/costs

5. Confidentiality

6. In case of injury

7. Subject rights

8. Appropriate reading level

WHEN CAN INFORMED CONSENT BE WAIVED? Waiver of Documentation of Consent

1. When the only record linking subjects and research is the ICF and a breach of confidentiality could cause harm to subjects AND

2. When research is no more than minimal risk and involves no procedures for which consent is normally required outside of the research context

The IRB requires either a consent ‘script’ (i.e., to verbally obtain consent, such as over the phone) or a consent letter that does not require the subject to sign, such as for an online survey. 

Waiver of Consent

The study involves no more than minimal risk; 1. The waiver will not adversely affect the rights and welfare of the participants;

2. The research can not practicably be carried out without the waiver; AND

3. Whenever appropriate, the participants will be provided with the additional pertinent information after their participation in the research.

THE IRB APPLICATION PROCESS

New protocol

application created in IRBWise

Sign-off by PI

Sign-off by departmen

t and submitted

Received by ORIA

ORIA staff will review

and if necessary, return for changes.

Forwarded for IRB review

IRB Determina

tion (approve,

disapprove, request changes,

etc)

GET IN TOUCH! Melanie Clark, CIP Associate Director

melanie.clark@gtrc.gatech.edu404-894-6942

Kelly Winn, CIP Research Associate

kelly.winn@gtrc.gatech.edu404-385-2175

Martha Patterson, CIP Compliance Officer

martha.patterson@gtrc.gatech.edu404-894-6944