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My research involves human subjects, how do I apply?
There are three categories of application: exemption, expedited review, and full review. You should apply for the category that best fits your research.
Exemption: Research is considered exempt if it falls under the following categories:
1. Typically involves data already collected or that is publicly available, or that involves educational procedures, etc. conducted in normal educational settings.
2. Cognitive tests, etc. are exempted only provided that there is no possible means of identifying subjects, etc., or the releasing of this information could not cause harm to the subjects.
3. If Federal regulations require complete confidentiality, it is exempt.
4. If it is food research, it is exempted provided it involves wholesome foods or additive levels below federal standards
Exempt research does not require informed consent, but it does require application to the IRB. Even though your research is exempt, you must file for exemption by filling out Form 1 (Application for IRB Review) and Form 3 (application for exemption). You should fill out each form electronically and submit them to irb@uah.edu. Additionally, you must print out hard copies, sign them, and forward them to the committee chair, Dr. William Wilkerson in the Philosophy Department, Morton Hall 332a. The form has a checklist you can follow on its final page.
Research in which you will be collecting data from subjects for more than one year will need to renew its application after a year. You can do this with Form 5.
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Expedited review: Research is subject to expedited review if it falls under one of the following categories:
1. Clinical study of drug where:
a. Investigation of new drug is not required.
b. Research on medical devices where exemption is not required or device is cleared.
2. Collection of blood samples by finger, heel, ear or venipuncture
a. From healthy adults weighing at least 100 pounds. Not to exceed 550 ml in 8 week period.
b. From adults and children considering weight, height and age. Not to exceed lesser of 50 ml or 3 ml per kg in 8 week period.
c. In all cases no more frequently than 2 times per week.
3. Prospective collection of biological specimens for research purposes by noninvasive means. (Eg., hair, nails, teeth, saliva, excretions, etc.)
4. Collection of data through non-invasive procedures, excluding x-rays and microwave devices. (Eg, weighing, MRI, EEG, Ultrasound, etc.) If data collection devise are new or are being tested for purposes other than their approved use, your research cannot be given expedited review
5. Research involving materials that have been collected solely for nonresearch purposes (eg. Data, records, specimens).
6. Collection of data from voice, video, digital or image recordings made for research purposes.
7. Research on individual or group characteristics behavior or research employing survey, interview, oral history, focus group, program evaluation, human factors or quality assurance. (May include research on perception, cognition, motivation, identity, language, cultural beliefs, social behavior, communication.)
8. Continuing research already approved by the IRB where:
a. Research is permanently closed to new subjects, subjects have completed research interventions, research remains active only for long-term follow up.
b. No subjects have been enrolled and no additional risks identified.
c. Remaining research activities are limited to data analysis.
9. Continuing research not involving new drug or device, where 2-8 do not apply, but the IRB has concluded at a convened meeting that research involves no greater than minimal risk.
The vast majority of research at UAH falls under this category. Generally, if you are not engaged in testing new medical treatments or devices, and you can safeguard the anonymity of your subjects, your research will fall under this category. It is very easy to file for expedited review. The full IRB committee does not need to meet to discuss your application, although the committee will look at your application. Approval generally comes within 1 week.
To apply for expedited review, you must fill out Form 1 (Application for IRB review) and Form 2 (Application for expedited review). Additionally, you will need to obtain informed consent from your subjects, and you will need to submit a sample of your consent letter. See the consent form guidelines. There are some circumstances in which the requirement for consent can be waived; they are explained on the guidelines form.
Research involving minors (person under the age of 19) or prisoners is subject to special regulation, you must fill out either Form 6 (for minors) or Form 7 (for prisoners) and include it with your application.
Research in which you will be collecting data from subjects for more than one year will need to renew its application after a year. You can do this with Form 5.
You should fill out each form electronically and submit them, along with supporting materials, to irb@uah.edu. Additionally, you must print out hard copies, sign them, and forward them to the committee chair, Dr. William Wilkerson in the Philosophy Department, Morton Hall 332a. The form has a checklist you can follow on its final page.
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Full Review. Research that does not fall under expedited or exempted review, but involves human subjects, must undergo a full review by the convened IRB committee. There are many criteria which guide the IRB in a full review, and they include: minimizing of risks and maximizing of overall benefit, equitable selection of subjects, procedures for obtaining and documenting informed consent, data monitoring provisions, privacy and confidentiality of the subject and safeguards for vulnerable subjects.
Applicants for full review must fill out Form 1 (Application for IRB review) and Form 4 (Full Review). Additionally, you will need to obtain informed consent from your subjects, and you will need to submit a sample of your consent letter. See the consent form guidelines. There are some circumstances in which the requirement for consent can be waived; they are explained on the guidelines form.
Research involving minors (person under the age of 19) or prisoners is subject to special regulation, you must fill out either Form 6 (for minors) or Form 7 (for prisoners) and include it with your application.
Research in which you will be collecting data from subjects for more than one year will need to renew its application after a year. You can do this with Form 5.
You should fill out each form electronically and submit them, along with supporting materials, to irb@uah.edu. Additionally, you must print out hard copies, sign them, and forward them to the committee chair, Dr. William Wilkerson in the Philosophy Department, Morton Hall 332a. The form has a checklist you can follow on its final page.
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