IRB Form 1 - Research Exempt from Review

Back to Human Subjects Research Homepage

IRB Form 1

(Please include a project description with this form)

Checklist for Human Subjects Research that is Exempt from IRB Review

Before performing Human Subjects Research at Swarthmore you must read and understand Swarthmore's Guidelines for Human Subjects Research.

Please submit 2 copies of the following to the Human Protections Administrator

A copy of this document with the information about the principal investigator and research project filled out and the check lists completed.
brief description of your research project.
A description of the aspects of the research involving Human Subjects.
A copy of any consent forms. These forms must have an expiration date of no more than one year from the beginning of the project.

Name of Principal Investigator:	_________________________________________
Title of Principal Investigator:	_________________________________________
Title of Research Project:	_________________________________________
Signature of Principal Investigator:	_________________________________________
Date:	_________________________________________

If this is student research it requires a faculty or staff sponsor.

Name of Sponsor:	_________________________________________
Title of Sponsor:	_________________________________________
Signature of Sponsor:	_________________________________________
Date:	_________________________________________

Use the following checklist to ensure that your research is exempt from IRB review:

Part A (all items must apply). Put a check mark near all items that apply to your research.

__ 1. The research does not involve as subjects prisoners, fetuses, pregnant women, the seriously ill, or mentally or cognitively compromised adults.

__ 2. The research does not involve the collection or recording of behavior which, if known outside the research, could reasonably place subjects at risk of criminal or civil liability or be damaging to the subject’s financial standing, employability, or reputation.

__ 3. The research does not involve the collection of information regarding sensitive aspects of subjects’ behavior (e.g., drug or alcohol use, illegal conduct, sexual behavior).

__ 4. The research does not involve subjects under the age of 18 (except as they are participating in projects that fall under categories 1, 3, 4, and/or 5 in Part B). Category B 2 studies that include minors should be submitted for expedited review.

__ 5. The research does not involve deception.

__ 6. The procedures of this research are generally free of foreseeable risk to the subject.

__ 7. The research does not require a waiver from informed consent procedures.

Part B (at least one item should apply). Put a check mark near all items that apply to your research.

__ 1. Research conducted in established or commonly accepted educational settings and involving normal educational practices (e.g., research on regular and special education instructional strategies, research on instructional techniques, curricula, or classroom management methods).

__ 2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, where information is recorded anonymously (i.e., so that the human subject cannot be identified, directly or indirectly through identifiers linked to the subject). [NB: All survey/interview/observational research in which elected or appointed public officials or candidates for public office serve as subjects is exempt, whether or not data collection is anonymous.]

__ 3. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens. These sources must be either publicly available or the information must be recorded anonymously (i.e., in such a manner that subjects cannot be identified, directly or through identifiers linked to the subject).

__ 4. Research (including demonstration projects) conducted by or subject to the approval of federal department or agency heads, and designed to study, evaluate, or otherwise examine (i) public benefit or service programs (e.g., social security, welfare, etc.); (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.

__ 5. Research involving taste or food quality evaluations or consumer acceptance studies, where the tested products are wholesome foods without additives, or foods which contain additives at or below levels found to be safe by the FDA or approved by the EPA of the Food Safety and Inspection Service of the U.S. Department of Agriculture.

Back to Human Subjects Research Homepage