DO NO HARM

IRRB Presentation

Purposes

Responsibilities

Processes

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IRRB Purposes

Assure that research follows ethical principles and guidelines.

Assist the investigator in examining ethical implications of their research.

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Nuremberg Code

Voluntary consent of the human subject absolutely essential.

Risk should never exceed benefits.

The Doctors Trial

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Belmont ReportPractice - Interventions that enhance

well-being of an individual and are likely to be successful.

Research - Activities designed to contribute to generalizable knowledge and/or interpretive understanding.

The Belmont Report

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Basic Ethical Principles

Respect for Persons - informed consent

Beneficence - do no harm

Justice - fair distribution of burdens & benefits

The Tuskegee Syphilis Study U.S. Dept of Health and Human Services Office for Human Research Protections

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Federal Definition of “Human Research Subject”

A living individual about whom an investigator (whether professional or student) conducting research obtains:

• Data through intervention or interaction with individual, or

• Identifiable private information.

Title 45, Part 46

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When does research not meet federal definition?

Study of private information about dead people;

Study of public information about living persons;

Observation of public behavior;

Study of publicly available information in which persons are not identifiable.

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Federal Requirements

Institutions conducting research will create:

A statement of ethical principles,An institutional research review board

(IRRB),Written procedures for conducting reviews of

research and reporting actions to investigators.

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IRRB Actions

Review and approve or disapprove all research activities.

Require informed consent and documentation of informed consent.

Notify investigators of its decision in writing.

Conduct continuing review of research at appropriate intervals.

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Elements of Informed Consent(Sample forms available at NLU)

Purpose of the research

Participants’ right to see your study

Contact for further information Advisor’s/chair’s address, telephone, and e-mail Affiliation with the university

Signatures—you and the participant

Two copies: for you and the participant

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Informed Consent(Do no harm!)

Participant must…

Be informed, and Give consent

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Be Informed

Who do I contact for information?

What is the purpose of the study?

How will data be used?

How long will my participation take?

Answer these questions:

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Be Informed (cont.)

How will confidentiality be protected?

Who will have access to transcripts, field notes?

What are the risks and benefits?

How will you report the research findings?

Answer these questions:

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Give Consent

Participation is voluntaryRight to withdrawFree of coercion and undue influenceConsent of parent or guardian when requiredConsent cannot be assumed, but must be

explicit and written

Include the following elements:

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Who Applies?

Those engaged in research:

Faculty and staffDoctoral Students: DissertationMasters Students: ThesisIDS Students: Action Research

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Who Does Not Apply?

Students conducting research as part of a class

Faculty and staff collecting institutional data for self study and accreditation

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Designated Category

Exempt

Expedited

Full Review

Criteria Standards

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Disposition of Application

Sent to Office of the ProvostChecked for completenessReviewedDatabase updatedProposal filedResearcher notified

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THANK YOU!

For additional information:

Visit

NLU IRRB Home page

or contact the

Office of the Provost

(312) 261-3683