- INTRODUCTION
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Federal guidelines require that particular information be reviewed in each request to use human subjects in research. You
can facilitate the review of your request by providing all requested information using the forms and templates provided.
This includes using the section headings provided in the application narrative of the application form and the consent
form.
Please remember that individuals outside of your particular field will read your request. Therefore, please write for an intelligent (faculty
colleague) audience who is unfamiliar with your topic and research methods. Imagine that you are writing a "cookbook" to train an
undergraduate student to conduct the study and provide that level of detail when describing the procedures and practices of
your proposed study.
The purpose of the Committee on the Use of Human Research Subjects (Committee or IRB) is to protect human research subjects. The
three basic ethical principles governing human subject research are defined in the Belmont Report. These principles are
(1) respect for the persons, (2) beneficence, and (3) justice. If you have particular questions in applying these
principles, please contact the Committee's staff for guidance.
- SUBMISSION DEADLINES
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The investigator must receive Committee approval prior to subject recruitment and initiation of research involving human
subjects. Therefore, it is advisable to initiate your request well in advance of the anticipated starting date. Approval of
a research protocol cannot be granted retroactively under any circumstances.
- Upon receipt of a Research Exemption Request or Application Form requesting Expedited Review, the Committee Chair and
Associate Chair review the request. The principal investigator is notified within five (5) working days concerning the
status of the application. Is more information needed? Are there human subject protection issues to be resolved? After
all issues are resolved investigators are notified of the Committee's action on their application or Research Exemption
Request.
- After an Application requesting Expedited Review has been approved, it is distributed to two (2) additional Committee
members for a post-review. This post-review helps to ensure a complete and thorough review of the application.
- Applications requiring Full Committee Review must be received at least ten working days prior to the next scheduled
Full Committee meeting. Currently, the Committee meets on the last Tuesday of the month (with the exception of November
and December in which case the first Tuesday in December constitutes the November-December meeting). The Committee's
practice is to circulate applications requiring Full Review to all Committee members prior to the meeting. Questions,
comments or concerns raised by members are transmitted to the principal investigator for response prior to the meeting.
To the extent possible, all necessary additional information is made available to the Committee prior to the meeting. To
allow for questions raised at the meeting to be promptly addressed, the investigator should plan to attend the Committee
meeting. See Meetings and Deadlines
- In addition to Committee approval, all research using human subjects, including Research Exemption Requests, must also
be approved by a Purdue University representative, the Assistant Vice Provost for Research Compliance or the Vice
Provost for Research. This may occasionally add several days to the review process.
- WRITING YOUR APPLICATION
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An application to use human research subjects should stand on its own, without reference to any attending grant application
or previous human subjects application. The application should be written so that Committee members who are unfamiliar
with the investigator's field of research can evaluate the recruitment, informed consent, study procedures, and the
potential risks to subjects. If you are employing procedures that have been approved in a previous application, please
describe the procedures in full and reference the prior application by study title and reference number assigned by the
Committee.
- RESEARCH EXEMPTION
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Some minimal risk research projects do not need to be reviewed by the Committee on the Use of Human Research Subjects.
However, the Committee, not the investigator, must make the determination that the proposed research project falls into one
of the federal research exemption categories. To receive this determination, an investigator must submit a Research
Exemption Request.
Federal guidelines state what may be Exempt from review. The Committee may place more restrictive standards on the
research if it is deemed appropriate to protect human subjects. To determine if the proposed study qualifies for an Exempt
determination please review the Exempt Categories in our Research Exemption Request Guidelines.
- EXPEDITED REVIEW
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Some research that presents no more than minimal risk to a subject may be approved by Expedited Review. Your research must
meet this definition first to be considered for Expedited Review. Minimal risk means that the probability and magnitude of
harm or discomfort anticipated are no greater than those ordinarily encountered in daily life or during the performance of
routine physical or psychological tests.
To qualify for expedited review the research must meet the definition of minimal risk and fall into one of the seven (7)
categories listed by the federal regulations. These categories can be found in the Application Guidelines under "Expedited
Review".
The Committee retains the authority to place additional restrictions on the research and require that it receive Full
Committee review.
- FULL COMMITTEE REVIEW
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Research not qualifying for Exempt or Expedited review may be reviewed by the Full Committee at its monthly meeting. This
includes research that involves more than minimal risk; is not listed in the regulations as qualifying for exempt or
expedited review; and any research which involves fetuses, pregnant women, prisoners, or groups who may have diminished
capacity to provide consent or who may be at high risk.
The investigator submits an application for Full Review. As previously described above in the Submission Deadlines
section, copies of the application are distributed to Committee members prior to the meeting. Our office then compiles the
Committee members' comments and concerns and forwards them to the investigator for a response. It is preferred the
investigator responds to the Committee's comments before the Committee meeting. Additionally, investigators whose
applications are being reviewed are requested to attend the meeting to respond to any last minute concerns. After the
meeting the Committee chair will contact the investigator regarding the Committee's decision.
- APPROVAL
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Once an expedited or full review application has been approved, the investigator will receive a copy of an Approval Form.
The Approval Form states the date of the application's review, the type of review, the approval date and expiration date.
Most often, the expiration date is 365 days after the date of review. However, occasionally the expiration date may be for
a shorter duration. Similarly, after a Research Exemption Request is deemed to be exempt, the investigator receives a copy
of the Research Exemption Request form signed by the Committee chair. For exempt research there is no actual expiration
date provided the investigator keeps the protocol active in our office.
- CONTINUING REVIEW
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Federal regulations require continuing review of approved protocols. Before the expiration date of the protocol,
investigators receive a Surveillance Form for Approved Protocols (Surveillance Form) requesting information about the
protocol. The questions range from number of subjects tested to changes in the protocol and a report of research
findings. It also informs the Committee if the protocol is on-going or has been terminated. If the protocol is on-going
the Surveillance Form requests the submission of currently used recruitment and consent documents plus current approvals
from all other institutions where the research is being conducted. A request for additional materials may accompany the
Surveillance Form depending on the protocol in question. These materials must be submitted to our office by the requested
due date indicated on the Surveillance Form to ensure timely renewal of a protocol's approval. Without these documents,
the Committee cannot complete continuing review on a protocol and it's approval will expire. If the approval expires, no
further recruitment or testing of human subjects can take place.
In the case of protocols approved via Full Committee Review, the protocols must be reviewed at the Full Committee meeting
in order to renew approval. This places additional time constraints on the protocol and necessitates a timely response
from investigators. Protocols approved via Expedited Review can be reviewed for renewed approval in our office.
Although exempt research has no actual expiration date, investigators are required to update our office of the status of
their project by completing a Surveillance Form for Exempt Protocols. The Surveillance Form asks about changes to the
research protocol and if the protocols is on-going or has been terminated. As with the other types of review, the
investigator will receive the Surveillance Form from our office before the anniversary date of the Committee chair's
signature on the original Research Exemption Request form.
If your protocol is a funded project, please note that failure to submit the completed Surveillance Form and requested
materials will result in expiration of your approval AND any remaining funds related to the protocol will be frozen. Even
if you are no longer recruiting or testing subjects, you are required to keep your protocol's approval active if you intend
to continue to draw funds for that protocol. This applies to Exempt protocols as well.
- REVISION OF A PREVIOUSLY APPROVED PROTOCOL
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If you wish to revise your protocol after it has received initial approval, you must submit a completed Revision of
Protocol Form plus any additional materials related to the revision such as revised consent forms, advertisements,
recruitment letters, etc. This form is required all protocols regardless of the type of review they underwent (Exempt,
Expedited or Full).
When completing the form, please keep in mind the actual form itself is intended to be a one-page summary of your
revision(s). If you have several revisions or a particularly lengthy revision, please summarize the revision on the
Revision of Protocol Form and then attach a complete explanation of the revision.
For revision requests of protocols initially approved via Exempt or Expedited Reviews, you need only submit the signed
Revision of Protocol Form plus one copy of all additional materials. The revision will receive an in-office review.
If the protocol received Full Review, please submit the signed Revision of Protocol Form and additional materials plus 25
copies of the complete packet. The revision request will be reviewed at the next Full Committee meeting provided it is
received in our office by the submission deadline.
