Frequently Asked Questions ~ Human Subjects Research
What is an IRB and what is its purpose?
The IRB is a group of individuals who review proposed research involving human subjects
to ensure that the rights and safety of human participants in research are protected
in accordance with federal regulations set forth by the Department of Health and Human
Who must apply to the IRB?
All human research conducted at, by, or under the auspices of Fredonia, whether funded
or not must be reviewed and approved before the research begins. This includes research
conducted by the administrators, faculty, staff, and students of our institution.
Where can I get an application?
Applications may be obtained from the Office of Sponsored Programs at E230 Thompson
Can applications be sent through e-mail?
Yes, applications may be sent via email to firstname.lastname@example.org. The signature page must be either faxed to (716) 673-3802, mailed, or delivered
to E230 Thompson Hall prior to commencement of the research project.
What if I have questions about completing the application?
Please call the Office of Sponsored Programs at (716) 673-3528. We will be happy
to assist you in completing your application and answer any questions you have about
the review process.
How long does it take for an IRB review?
Expedited studies may take up to three weeks and full committee reviews are usually
complete within a month of submission. Time may be somewhat shorter or longer, depending
on the time of year, availability of the HSRC members and volume of reviews.
How will I know if my application has been approved?
Receipt of an official notification via email from the Human Subjects Administrator
indicates the investigator(s) may proceed with the study, including a reminder to
comply with Part D of the Campus Policies on the Use of Human Subjects.
What is the meaning of "expedited" review?
This simply means that the research will be reviewed, at least initially, by less
than the full IRB. It does not necessarily mean that the review process will be faster,
or that the review will be less rigorous than one completed by the full committee.
If my research is exempt, why do I have to submit information to the Human Subjects
The researcher or investigator is not allowed to make his or her own assessment of
whether the research is exempt; only the Human Subjects Administrator or HSRC can
make that determination. You need to submit enough information to the Human Subjects
Administrator so that it can make an informed decision about exemptions.
For research with school-age children, do both the parent and the child have to give
Parental consent is required, and the children must also give their assent to participate.
For very young children, this process could involve a brief description of the activity
culminating with asking the child's willingness to participate. A short written consent
form in simple language or with symbols or graphics is appropriate for most children;
older children should be given a more extensive written consent form that is closer
in format and language to the one given to the parents.
When is it possible to withhold information about the purpose of the research or to
give misleading information about the purpose of the research?
Only when this would NOT affect the willingness to participate in the research, and
the misinformation or withheld information is provided afterward. It is not appropriate
to withhold information that would affect willingness to participate merely because
such information might influence how participants respond during the research.
What should a researcher do if changes are requested when an application is reviewed?
If very extensive changes are needed, the application should be revised and resubmitted
by the deadline for the committee's next meeting. If less extensive changes are requested,
the researcher should submit one copy of the portions of the application in which
the changes are located. Normally, such changes can be approved by the chair of the
committee or Human Subjects Administrator without waiting for the full committee to
meet. If only very minor changes are requested, approval may be given on condition
that the researcher sends confirmation of making the requested changes to the committee
chair. The report of the committee's review will specify which type of response is
wanted from the researcher. This report will usually come in an e-mail message from
the Human Subjects Administrator, and generally within 10 days after the committee's
meeting. Researchers should respond to a request for changes as quickly as possible,
and at least within 60 days of the request for changes. It may be necessary to submit
a new application if the researcher's response is not received within that time period.
In what situations does a researcher need to contact the IRB after research has been
If the researcher wants to make any significant changes in the research or encounters
any unanticipated problems, the HSRC must be notified.
How long does an approval last?
The maximum approval period is one year.
What does a researcher need to do if the project has not been completed when the approval
If a project continues beyond one year and the investigator/instructor has not made
any significant changes in the procedures outlined in the original protocol, a memorandum
requesting re-approval is all that must be submitted. A request for an extension of
a project must be made 10 days before the former approval date of the project. Otherwise,
a new protocol and review will be required. Any significant change requires a new
review by the HSRC.
How long does a researcher need to keep records of the research?
Researchers must keep documents showing informed consent for three years after the
conclusion of the research. Some agencies that sponsor research may have a longer
What fundamental principles in the 1979 Belmont Report have become basic guidelines
for conducting human subjects research?
Respect for persons (autonomy), beneficence, and justice. The Belmont Report became
the framework for federal policies on human subjects research and thus continues to
be an important document.
What factors do IRB members consider when reviewing my research proposal?
Among the issues to be considered are:
- how participants are approached (i.e., recruited) to be in the study;
- what procedures are used to obtain consent from prospective participants or their
legally authorized representatives;
- whether free and informed consent has been achieved;
- the safeguards in place to protect participants who may be vulnerable to coercion
or undue influence;
- the procedures used to protect participants' privacy;
- the nature of the physical, psychological, social, and legal risks;
- the steps the researcher has taken for protecting against and minimizing potential
- whether the researcher has identified benefits to the subjects and benefits to society;
- avoidance of needless deception;
- appropriate contact information is included on consent forms; and,
- obtaining written cooperative agreements from off-campus research sites.
Do I need any special training to use human participants in research?
All key personnel listed on forms submitted for HSRC approval must complete training
campus mandated CITI training (www.citiprogram.org) on the protection of human research participants before a protocol will be approved.
Data collection and contact with human subjects cannot start until training has been
Key Personnel includes the principal investigator, co-principal investigators, supervising
faculty member, and any other individuals who will have contact with the participants
or the participants' data.
Do student research/academic projects require HSRC review and approval?
Yes, if human subjects are involved and the work meets the definition of research.
Student researchers must have a faculty sponsor for each research project.
If I have other questions, where can I look for answers?
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