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Institutional Review Board Review of Research Involving

Human ParticipantsOffice of Research Compliance

Northern Illinois UniversityDivision of Research & Graduate Studies

Lowden Hall 301

Sandra Arntz 815-753-8524 or sarntz@niu.eduJeanette Gommel 815-753-8588 or jgommel@niu.edu

www.orc.niu.edu

Rev. July 2008

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What is an IRB?

Charged with safeguarding the rights and welfare of human subjects.

Duties include establishing institutional policy and reviewing all research activities conducted by persons affiliated with NIU that involve the use of human subjects.

Membership includes NIU faculty researchers, SPS, nonscientists, and community members.

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Definitions

Research: – means a systematic investigation designed to develop or

contribute to generalizable knowledge. Research encompasses work that is conducted on or off campus, and includes questionnaires, interviews, tests, observations, surveys, and other experimental methodologies.

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 (information that is not publicly available).

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Definitions (continued)-Intervention includes both physical procedures by which data are

gathered (blood draw) and manipulations of the subject or the subject’s environment.

-Interaction includes communication or interpersonal contact between investigator and subject (for example, interviews, focus groups, surveys – including mailed and on-line).

-Private information includes 1) information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, 2) information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (medical record, GPA), or 3) information provided specifically in response to data collection (responses to a survey).

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How do I know if my project needs review?

Meets definition of “research”

+

Meets definition of “human subject(s)”

+

Conducted under auspices of an “assured” institution

=

Review Needed

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A Word About Student Projects: Educational exercises do not need IRB review if:

– The information will not be shared outside the class Educational exercises may be reviewed by the IRB if:

– The project involves a risky or sensitive topic IRB review is definitely needed:

– For thesis/dissertation projects– For projects disseminated outside the classroom

Even when IRB review may not be necessary, instructors are encouraged to discuss research ethics and IRB review procedures with their classes.

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IRB Review Process at NIU

Complete application form; use lay terminology. Prepare appropriate informed consent process; attach any form(s) to

be used or application for waiver if applicable. Append any survey, interview questions/topics or other instruments

to be used. Provide any recruitment/introductory materials. Departmental Review

– Departmental Reviewer is expected to:• Review protocols for ethical considerations and scientific merit.• Be knowledgeable about regulations governing research • Be responsible for thorough review of complete application and

initial determination of review category.

– Investigator, Advisor (for student projects), and Departmental Reviewer complete and initial checklist, sign application form, and forward to ORC.

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IRB Review Process at NIU (cont.)

Administrative Review (lowest risk level)– Exempt status reviewed and ratified by IRB Chair– Usually 7-10 day turnaround (often less)

Sub-committee Review (minimal risk level)– Reviewed by at least two IRB members– Usually 7-10 day turnaround (often less)

Full Review (minimal or greater risk level)– Reviewed at a convened meeting of the IRB – IRB meets 2nd & 4th Wednesday of each month.– Application deadline is 10 days before meeting date.

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Consent vs. Consent Forms The consent form is merely the documentation of informed

consent and does not, in and of itself, constitute informed consent. Informed consent is a process which is documented by a signed

consent form. The fact that a subject signed a consent form does not mean that

s/he understood what was being agreed to or truly gave voluntary consent.

Comprehension– Informed consent is not valid unless the consenter understands the

information that has been provided.– It is the responsibility of the investigator to do what s/he can to enhance

each prospective subject’s comprehension of the information.

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Informed Consent General Requirements

– Available from our website at www.grad.niu.edu/orc– Three types:

• Consent (adults age 18 or over)• Assent (minors under age 18)• Permission (parents/guardians)of minors or legally authorized

representative for adult with diminished capacity

Documentation– Investigator required to maintain signed consent

documents for 3 years after conclusion of the study. Waiver

– Of requirement to document informed consent– Of requirement to obtain informed consent

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Required Elements of Consent

Research– Purpose– Duration– Procedures

Risks or Discomforts– Reasonably foreseeable

(not every conceivable) Reasonably Anticipated

Benefits– To participant– To others

Alternatives Confidentiality Compensation for

injury Whom to contact

– Questions about study– Questions about rights

Right to refuse or withdraw without penalty or prejudice

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Anonymity vs. Confidentiality: Anonymous:

– Identifiers of any kind not used (name, code number, sometimes demographics)

– No one anywhere could ever link subject with responses

Confidential:– Identifiers link participants with data– Address how sensitive information is protected

Confidentiality issue with group situations

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Use of Date-Stamped Informed Consent Documents Consent documents for projects qualifying for

Expedited or Full Review are required to bear IRB approval stamp.

Stamp will be valid one year from date of review. Only consent forms bearing the approval stamp

may be photocopied for distribution to participants. When applying for continuation of approval

beyond one year, provide an unstamped consent form with Continuation Application.

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Continuing Review

For Sub-committee and Full Review Projects Must occur at least annually

– Not more than 365 from date of original review.– Not more than 30 days before expiration date

ORC sends out Application for Continuation of Approval

If approval of continuation not finalized before expiration date then approval lapses and data collection must stop.

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Investigator Responsibilities

Protecting the rights and welfare of human research participants and for complying with all applicable provisions of the institution’s Assurance

Must be familiar with:– The ethical principals of human subject research,– The requirements of the federal regulations,– Applicable state law,– The institution’s Assurance– Institutional policies and procedures for the protection

of human subjects

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Investigator Responsibilities (cont.)

Conducts all research according to the IRB approved protocol and complies with all IRB determinations.

Ensures that each potential subject understands the nature of the research and of the subject’s participation and takes appropriate steps to gain that comprehension

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Investigator Responsibilities (cont.)

Provides a copy of the IRB-approved informed consent document to each subject at the time of consent, unless the IRB has specifically waived this requirement.

Retains all signed consent documents according to the institutional policies, but at least three years beyond the completion of the research

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Investigator Responsibilities (cont.)

Promptly reports proposed changes in previously approved human subject research activities to the IRB.

Does not initiate changes without IRB review and approval, except where necessary to eliminate apparent immediate hazards to the subjects.

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Investigator Responsibilities (cont.)

Reports progress of approved research to the IRB, as often as and in the manner prescribed by the IRB on the basis of risks to subjects, but not less than once per year.

Promptly reports to the IRB any unanticipated problems involving risks to subjects or others.