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Tip Sheet Volume
6:3
Compliance: Human Subjects Research
ISU follows federal guidelines for
human subject protection and has established university policies for all
human subjects research conducted on campus, regardless of the funding
source. In addition to traditional biomedical and clinical studies, human
subjects research includes social and behavioral research such as surveys,
exercise and nutrition studies, learning experiments, etc. The following
information provides a brief overview of procedures for performing
research involving human subjects.
Approval
The Institutional Review Board (IRB) is a committee
that, prior to data collection, must review and approve all research
involving human subjects, even if the research falls within the Exempt or
Expedited categories of the federal regulations. New IRB approval is also
required for additional use of data that was collected under a prior
approval or for a purpose other than research.
Informed Consent
Informed Consent documents and other information given to the subjects
should —
- Be written in simple terms that the subjects can understand. This is not
the place to rely on abbreviations and scientific jargon for getting your
message across.
- Include contact information for the Principal Investigator (PI), major
professor and/or supervising faculty member for a student project, in case
a subject may have additional questions about the research. The IRB
contact information is required in the event a subject(s) has questions
about his/her rights of research or a research-related injury.
- Be given to both parents and minors if applicable. Parental consent is
required for research involving minors. The assent of the minor is
obtained to demonstrate respect for the minor’s right to know what he/she
is volunteering for.
A template for the Informed Consent Document is available at the Office of
Research Compliance web site (see web site below).
Proposals
In the proposal to the IRB committee, provide a
clear description of the research procedures. For example, in a proposal
that involves a survey handed out in classes, clearly indicate the type of
questions in the survey, how long the survey will take, whether or not
students will receive credit for participation, who will be handing out
and collecting the survey, whether or not the survey will be anonymous and
how the survey will be transmitted to the PI, if the PI is not physically
present in the room at time of collection.
Electronic
Data Collection
Confidentiality is an important consideration when collecting data using
e-mail or an on-line form (web site). Please consult with your departmental
systems support personnel to ensure the confidentiality of data collected
electronically. You must also address how you will ensure confidentiality in
the application for approval.
Reminder: The required forms,
complete instructions, training modules, and policies and procedures are
available at http://www.compliance.iastate.edu, the Office of Research
Compliance web site.
For questions regarding human
subjects, please contact: Ginny Austin-Eason, IRB Administrator,
austingr@iastate.edu
or 294-4566.
If you have any questions about this tip sheet please contact:
Lisa Lorenzen, 2810 Beardshear, Phone: (515) 294-0926, Email:
llorenze@iastate.edu
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