Guide for Human Subjects Research
Human Subjects Resources
Developing Your Request for Review
What are the Categories for Review?
Determination of Research Activity Applicability Under Human Research Protections
Approvals of Request for Review
Continuation of Research
Changes in Protocol After Review
Informed Consent & Definition
Elements of Informed Consent
Assessment of Risks
Informed Consent Process With Children
Tips for Creating an Informed Consent Document
Issues of Special Concern
Support and Assistance
Campus Policies On Human Subjects
GUIDE FOR HUMAN SUBJECTS RESEARCH
Please allow adequate time for preparation and submission of your proposal. It is important that you present all information in a clear and concise manner. Keep in mind that members of the review committee may not be familiar with your topic of research, materials, and procedures. The Human Subjects Research Application may be accessed in Word (105 KB) or as a fillable PDF (201 KB)
All applications must be submitted both in hard copy and digitally. Submit applications via email to Human.Subjects@fredonia.edu or campus mail to the Grants & Sponsored Programs Office, Reed Library 127A. It is important to note that, if your application is submitted via e-mail, a signed Cover Sheet must be sent to the OSP. If you have a proposal requiring HSRC full review, applications must be received by Thursday of the week before the meeting in order to be handled at the next meeting, although the HSRC does make all attempts to review all applications beforehand.
In addition, if any researcher needs assistance, the Human Subjects Administrator and members of the HSRC will meet to advise investigators. Where desired, especially with time-sensitive student research, the HSRC will pre-review a request for review, providing guidance where necessary.
Your application will be reviewed under one of three categories:
CATEGORY I - Exempt Research (No IRB review required)
Many exempt projects can be conducted without full or expedited review, but require the filing of a memorandum with the Human Subjects Administrator IRB one week before data collection begins. Investigators who feel their projects fall under this category must contact the Human Subjects Administrator for determination of exemption. Investigators may not make the determination of exemption.
Research that may be considered exempt include the following:
CATEGORY II - Research Activities Subject to Expedited Review
Research that does not meet the criteria for Category I and involves no more than minimal risk to the subject is appropriate for expedited review. Minimal risk is defined as "the risks of harm, anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests" (—Title 45, Part §46.110). Projects that may receive expedited review include the following:
Ordinarily, it takes at least two weeks to complete an expedited review, and longer if you submit during academic breaks. The Fredonia HSRC tries to move more quickly than this. The expedited review is done by rotation of campus Human Subjects Review Committee members, excepting reviews by members of protocols within their own departments. The selected reviewer submits concerns or issues to the HSA who notifies the investigator.
CATEGORY III - Research Activities Subject to Full HSRC Review
Projects requiring full HSRC review are those:
- that do not meet the criteria for Category II because subjects will be exposed to more than minimal risk (e.g., use of invasive techniques or unusual therapeutic techniques such as hypnosis).
- research requiring the use of deception.
- projects requiring the use of subjects from populations in need of special protection (e.g., prisoners, individuals with disabilities, the elderly, pregnant women, and children).
- activities that induce stress at greater levels than that of daily life.
It is often very difficult to determine if an activity requires review and approval by the HSRC without significant discussions with someone who has extensive knowledge about the regulations and institutional policies. Questions concerning the classification of a study into one of these categories should be directed to the Human Subjects Administrator (Dr. Kathleen Gradel) at 673.3528 or via email @ Human.Subjects@fredonia.edu. Aspects of the project that may be difficult can be discussed and alternative actions suggested. At this point, the research often can be designed in a way that will facilitate approval.
If your project requires expedited or full review, you must submit an application for review to the HSRC. If the concerns/objections warrant, a full HSRC review may be conducted. Full HSRC review includes a formal meeting where HSRC members review the request for the regulations and, if the investigator is present, may ask questions about the need for using human subjects. Investigators may amend their proposal in response to concerns of IRB members. The HSRC will then vote to either approve or disapprove the proposed project.
In order for the research needing expedited or full committee review to be approved, the approval of a majority of members of the HSRC is needed. Criteria for approval are the following:
- risks to human subjects are minimized and are reasonable in relation to study benefits;
- the study is well designed;
- selection of participants is equitable;
- the research is in compliance with the special considerations of vulnerable populations; such as children, pregnant women, prisoners, the elderly, and economically disadvantaged;
- all elements of the informed consent process have been met;
- the privacy of participants is protected and the data are kept confidential;
- the rights of participants, including freedom from coercion, are protected.
Receipt of an official notification via letter or email from the Administrator of Research Services indicates the investigator(s) may proceed with the study.
Approved protocols are valid for a period of one year. 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 at least 10 days prior to the previous year’s approval date. Any significant change requires a new application for review by the IRB.
Signed informed consent forms must be retained by the investigator/instructor for a period of not less than three years following the termination of the project.
At any point during the project, problems arising from the use of human subjects must be reported to the Human Subjects Administrator.
Within thirty (30) days of the conclusion of data collection on an approved project, a memorandum must be filed with the Human Subjects Administrator indicating project termination and specifying any difficulties that occurred with the use of human subjects.
Changes in protocol after approval
ANY changes in your study protocol that occur after the final approval is received must be communicated to the HSRC prior to implementing the change. Significant changes in protocol that impact the protection of human subjects will necessitate re-evaluation by the committee.
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FORMS AND TEMPLATES
Online Forms » (application, exemplars, child assent/consent, adult informed consent, parental consent)
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TRAINING HUMAN SUBJECTS RESEARCH
Go to the CITI Course at www.citiprogram.org to complete Fredonia's required Human Subjects Training.
(CITI = Collaborative Institutional Training Initiative)
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