Welcome to Institutional Review Board Page. The purpose of this web page
is to provide resources and reference materials to Medical staff, nurse
staff and students completing human subject research.
All Altru research involving human participants and conducted by medical
personnel or students must be reviewed following Altru Health System IRB
procedures, and
must be approved prior to the initiation of research activity and contact with potential human participants. There are no exceptions
to this policy.
If you have any questions regarding the IRB forms, you may contact Marie-Laure
Reese, IRB Reliance Specialist at
701.780.6161 or email
mreese@altru.org.
What is an IRB?
All types of research involving the use of human subjects, which would
include the studies mentioned previously, are regulated by a federally
mandated mechanism called an Institutional Review Board (IRB). Federal
law and regulations from the Department of Health and Human Services (DHHS),
as well as the Food and Drug Administration (FDA), require that all research
studies involving human subjects must have IRB approval before being conducted.
The responsibilities of the IRB fall into two main categories: initial
review and continuing review of research involving human participants.
The IRBs review and approve the research plan before the research can be
carried out. This review encompasses the research protocol, the informed
consent document, any advertisements, and other relevant information.
The IRBs seek to ensure that (a) any risks participants may incur are
warranted in relation to the anticipated benefits; (b) informed consent
documents and the consent process clearly conveys the risks and the research;
(c) the rights and welfare of the subjects are maintained; (d) advertisements
are not misleading; and (e) the selection of participants is equitable
and justified.
The continuing review process occurs at least annually. In addition to
the continuing review, protocol changes and reports of adverse events
are reviewed to ensure that the risk-benefit ratio of the research has
not changed and remains acceptable.
How are IRB's Organized?
Federal regulations require that IRBs have at least five members with varying
backgrounds. At least one member must have primarily scientific interests,
one must have primarily nonscientific interests, and one must be otherwise
unaffiliated with the institution in which the IRB resides.
The 3 Types of Review
1. Exempt Some research activities are exempt from annual review by the federal policy
for the protection of human subjects when the involvement of human subjects
falls within one or more certain categories such as research conducted
in established or commonly accepted educational settings; involving normal
educational practices; using educational tests, surveys, interviews, or
observation of public behavior; research involving the collection or study
of existing data, documents, records, or specimens; research designed
to study public benefit or service programs, taste and food quality evaluation
and consumer acceptance studies.
Requirements
Submit the original of the Human Subjects Review Form along with the consent
form, questionnaire, and supporting documentation to
IRB, Office 101, Altru 860 Columbia,
860 S. Columbia Rd,
Grand Forks, ND 58201.
2. Expedited Some research studies can receive IRB approval through expedited review.
This means that certain categories of research do not require review before
the entire Board. One or more designated members (often the chair) reviews
the study proposal and approves or disapproves. The IRB may use an expedited
review procedure only if the research involves no more than minimal risk,
it fits one of the categories identified by federal regulations as appropriate
for expedited review, or it involves a minor change in a previously approved study.
Requirements
Submit the original of the Human Subjects Review Form along with the consent
form, questionnaire, and supporting documentation to
IRB, Office 101, Altru 860 Columbia,
860 S. Columbia Rd,
Grand Forks, ND 58201.
3. Full Board Review: Projects where there is a physical risk or potential for injury or harm
to the subject’s dignity or well being require a FULL BOARD review
before the entire Institutional Review Board.
The Altru IRB Board meets at least once a month, in the 3rd Friday of the
month. The IRB deadline is always two weeks prior the meeting, in the
1st Friday of the month.
Requirements
Submit the original and (15) copies of the Human Subjects Review Form along
with copies of the consent form, questionnaire, and supporting documentation
to the IRB for distribution to the members. Send everything to:
IRB, Office 101, Altru 860 Columbia,
860 S. Columbia Rd,
Grand Forks, ND 58201
by the deadline (1st Friday of the month).
Students must send their study to both Altru and UND IRB. The student,
later on, will have to submit changes, continuing review or termination/completion,
to both IRB's.
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