UAH

How do I apply

How do I apply for IRB approval?

There are three categories of application: exemption from review, expedited review, and full review. You should apply for the category that best fits your research. 

Exemption from Review. Research is considered exempt from review if it does not involve any minors (persons under 19 years of age in Alabama) or prisoners, it is not classified, and it falls under at least one of the following five categories: 

  1. Your project (a) involves only the collection or study of information about a person that exists prior to development of your research project proposal, and (b) either this information is publicly available or, while not publicly available, will be recorded in a way that guarantees anonymity of the person.
    • Information about a person is anonymous if (i) it is not possible to identify the person either directly or through identifiers that link the person with their responses, and (ii) disclosure of the person's responses outside the research project would not place the person at risk of criminal or civil liability, and (iii) disclosure of the person's responses outside the research project would not damage the person's financial standing, employability, or reputation.
  2. Your project (a) is conducted only in established or commonly accepted education settings, and (b) studies only normal educational practices.
    • Established or common education settings include (but are not limited to) schools, colleges, and possibly other sites at which educational activities regularly occur.
    • A project studies a normal educational practice if it studies regular and special education instruction strategies, if it studies the effectiveness of instructional techniques or curricula or classroom management methods, or if it compares techniques or curricula or classroom management methods.
  3. Your project (a) involves only educational tests, surveys, procedures, interviews, or public observation of behavior, and (b) either the information you expect to obtain about participants will be anonymous or, while not anonymous, pertains to elected or appointed officials or candidates for public office.
  4. Your project (a) is conducted or approved by the head of a public department or agency, and (b) is designed only to study or evaluate (i) public benefit or service programs or (ii) procedures for obtaining benefits or services under public benefit or service programs or (iii) possible changes or alternatives to public benefit or service programs or (iv) possible changes or alternatives to procedures for obtaining benefits or services under public benefit or service programs or (v) possible changes in methods or levels of payment for benefits or services under public benefit or service programs.
  5. Your project (a) involves only an evaluation of taste and food quality or a food consumer acceptance study, and (b) the foods intended to be consumed in your project are either wholesome and additive-free or approved by the Environment Protection Agency or approved by the Food Safety and Inspection Service of the U.S. Department of Agriculture or deemed to contain safe levels of food ingredients, agricultural chemicals, and/or environmental contaminants.
      • 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 from Review).
      • You must complete all forms, electronically sign, save as pdf files,  and email them to Dr. Pam O'Neal , IRB Chair, at irb@uah.edu.
  6. If your research requires collecting data for more than one year after the date of your IRB approval, you will need to renew your application prior to the end of that year. You can do this by submitting Form 5 (Application for Renewal).

 


Expedited review. The vast majority of research at UAHuntsville falls under this category. The primary factors that determine whether your research qualifies for expedited review are whether your project involves testing new medical treatments or devices, and whether you can safeguard the anonymity of your subjects. See immediately below for more specific conditions. 

If your research satisfies each of the following four conditions, then it qualifies for expedited review: 

  1. Your research is not confidential.
  2. Your project presents no more than minimal risk to participants.
    • Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance or routine physical or psychological examinations or tests.
  3. Either (a) identification of the participants and/or their responses would unreasonably place them at risk of criminal or civic liability or be damaging to the subjects' financial standing, employability, insurability, or reputation and would not be stigmatizing; or (b) your project implements reasonable and appropriate protections so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
  4. Your research involves only the projects on the "safe-to-expedite" list, which includes all and only the following research projects:
    • Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, memory, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
    • Collection of data from voice, video, digital, or image recordings made for research purposes.
    • Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required.
    • Research on medical devices for which an investigational device exemption application (21 CFR Part 812) is not required.
    • Research on medical devices that are cleared/approved for marketing and being used in accordance with their cleared/approved labeling.
    • Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture from healthy, nonpregnant adults who weigh at least 110 pounds, such that the amount of blood drawn does not exceed 500 ml in an eight week period and collection of blood does not occur more frequently than twice per week.
    • Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture from adults or those under 19 years of age, such that the amount of blood drawn does not exceed the lesser of 50 ml or 3 ml per kg in an eight week period and collection of blood does not occur more frequently than twice per week.
    • Prospective collection of biological specimens for research purposes by noninvasive means.
    • Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves, such that any medical devices employed are cleared/approved for marketing and the research is not intended to evaluate the safety and effectiveness of a medical device.
    • Research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis).

Continuing research already approved by the IRB qualifies for expedited review if it satisfies each of the following three conditions:

  • Research is permanently closed to new subjects, subjects have completed research interventions, or research remains active only for long-term follow-up.
  • No subjects have been enrolled and no additional risks identified.
  • Remaining research activities are limited to data analysis.

Although the full IRB committee does not need to meet to discuss applications that qualify for expedited review, the committee will review your application. Approval generally comes within two weeks during the Fall and Spring semesters. See "How Does IRB Work?" for details on the review process.

To apply for expedited review, you must fill out Form 1 (Application for IRB Review) and Form 2 (Application for Expedited Review).

Additionally, you must obtain informed consent from your subjects, and you must submit a sample of your consent form. See "On Informed Consent" for guidance.

There are some circumstances in which the requirement for consent can be waived. Consult the Waiver of Informed Consent to determine if your research qualifies.

Research involving minors (persons under the age of 19) or prisoners is subject to special regulation, and requires that you submit either Form 6 (for minors) or Form 7 (for prisoners) with your application.

You must complete all forms, electronically sign, save as pdf files, and email them to Dr. Pam O'Neal , IRB Chair, at irb@uah.edu.

If your research requires collecting data for more than one year after the date of your IRB approval, you will need to renew your application prior to the end of that year. You can do this by submitting Form 5 (Application for Renewal).


Full Review. Research involving human subjects that is classified, or that does not fall under expedited or exempted review, must undergo a full review by the convened IRB committee. 

Many criteria guide the IRB in a full review, including: 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 participants, 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 must obtain informed consent from your subjects, and you must submit a sample of your consent form. See "On Informed Consent" for guidance.

There are some circumstances in which the requirement for consent can be waived. Consult the Waiver of Informed Consent to determine if your research qualifies.

Research involving minors (persons under the age of 19) or prisoners is subject to special regulation, and requires that you submit either Form 6 (for minors) or Form 7 (for prisoners) with your application.

You must complete all forms, electronically sign, save as pdf files, and email them to Dr. Pam O'Neal, IRB Chair, at irb@uah.edu.

If your research requires collecting data for more than one year after the date of your IRB approval, you will need to renew your application prior to the end of that year. You can do this by submitting Form 5 (Application for Renewal).