Pepperdine University
Graduate and Professional Schools Institutional Review Board (GPS IRB)
Reviewer Guidelines: EXEMPT RESEARCH
Introduction
Please use this form in completing your review of the exempt research application. Federal guidelines have designated six categories of human subjects’ research that qualify for exempt status. These categories are described in the appendix of this form. Research that qualifies for exemption must pose little if any risk to human subjects. Please note that it is Pepperdine University’s policy that all human subjects’ research, including research that is ultimately determined to be exempt from further IRB review, have an informed consent procedure in place.
As you read through the exempt application, please check “Yes”, “No”, or “N/A” for each item in the checklist. Any item marked “No” may raise human subjects concerns that will need to be addressed or may require a higher level of review before approval for exempt status is given. There are spaces throughout the reviewer form for you to make additional comments that may clarify or expand upon items marked “No” on the checklist.
Please email an electronic copy of your completed checklist to or mail a hard copy to Jean Kang, Manager GPS IRB, Pepperdine University GSEP, 6100 Center Drive 5th Floor, Los Angeles, CA 90045.
Thank You!
Pepperdine University
Graduate and Professional Schools Institutional Review Board (GPS IRB)
Reviewer Guidelines: EXEMPT RESEARCH
Instructions: Please fill in the IRB application information for the protocol that you are reviewing. The checklist below can be used as a guide when reviewing applications submitted as Exempt. Items #1-9 should be checked “YES”, “NO”, or N/A. A “No” to any of these items requires clarification from the investigator and may result in application for exempt status being denied (i.e., research would require application for expedited or full review).
Principal Investigator (s):IRB Protocol #:
Title:
Faculty Advisor
(if applicable):
School/Program: / Psy.D. Education GSBM SOL SPP
Administration Other:
IRB Reviewer:
Date:
Item # / Application Item / Issue/Items to Check / YES/NO/NA
1. / Summary of Proposed Research, goals, objectives / o Is description of proposed research understandable? / Y N N/A
o Are goals/objectives clearly stated? / Y N N/A
2. / Category of research activity qualifying for exemption / o Is one of 6 exempt categories clearly listed?
o Which category is listed?
(categories can be found in Appendix B of Investigator’s Manual: 45 CFR 46 101(b)) / Y N N/A
3. / Nature of human subjects’ participation / o Subjects are NOT members of a protected/vulnerable group are subjects (e.g., prisoners, pregnant women, fetuses or products of labor & delivery, decisionally impaired individuals) / Y N N/A
o Study DOES NOT involve deception / Y N N/A
o If study involves observation of children, the investigator DOES NOT participate in the activities being observed / Y N N/A
4. / Why should protocol be considered exempt? / o Procedures involve no or minimal risk (see definition below) / Y N N/A
o Subjects are not placed at risk for criminal, civil, financial, employability or loss of reputation. / Y N N/A
5. / Explain how records will be kept / o Are reasonable safeguards in place for protecting subject identities if information is recorded in a manner that could identify participants (i.e., non-anonymous data) such as locked files for hard copies, password protected computer files, etc. / Y N N/A
6. / Data recorded so subjects can be identified? / o Is explanation provided of who will have access to keys linking data to specific identifiable individuals? Does this seem restricted to only necessary personnel? / Y N N/A
o If mental health/health questionnaires used, is a procedure described for referring participants for follow-up assistance if illness/risk indicated? / Y N N/A
o Is plan in place for how record of participants’ names/codes will be handled once study is complete? / Y N N/A
7. / Copies of data collection tools / o Are copies of any measures, forms, questionnaires, surveys, flyers, etc. that participants will see included? / Y N N/A
o Are copies of any scripts of information to be given to participants included? / Y N N/A
o Are copies of any data collection forms/database formats included? / Y N N/A
o Are all relevant bulleted points summarized application under item #7 (i.e., research being conducted to fulfill course/thesis requirements, purpose of study, anonymity/confidentiality statement) included in any relevant data collection tool? / Y N N/A
o Is an informed consent form included that contains elements listed in (45 CFR 46 116 (a)(1-8))
OR
a Waiver/Alteration of Informed Consent Form
Application completed? / Y N N/A
8. / Permission from cooperating institutions / o Are letters of permission from cooperating institutions included that specify investigator is permitted to recruit subjects from site? / Y N N/A
9. / HIPAA / o Does investigator explain if HIPAA is applicable? / Y N N/A
o If HIPAA applies, are copies of the covered entity’s HIPAA Authorization and Revocation of Authorization forms attached to the application?[1] / Y N N/A
o Is Application for Use or Disclosure of PHI Without Authorization form included if investigator plans to disclose PHI without authorization? / Y N N/A
Consent Document Required Elements (from 45 CFR 46.116) / YES/NO/NA
o Statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental. This information should be stated in lay language. / Y N N/A
o A description of foreseeable risks or discomforts to subjects / Y N N/A
o A description of any benefits to the subject or to others which may reasonably be expected from the research / Y N N/A
o (A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject) – May not be applicable / Y N N/A
o Statement describing the extent, if any, to which confidentiality or records identifying the subject will be maintained / Y N N/A
o Statement that participation is voluntary, and that refusal to participate or discontinuing participation at any time will involve no penalty or loss of benefits to which the subject is otherwise entitled. / Y N N/A
o An explanation of whom to contact for answers to pertinent questions about the research (e.g., investigator, dissertation chairperson) and research subjects’ rights (IRB chairperson) / Y N N/A
Minimal risk definition: “The probability and magnitude if 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 of routine physical or psychological examinations or test” (45 CFR 46.102(i)).
Reviewer Decision:
Please check one:
Approve Exemption - As submitted the protocol is exempt from further IRB review.
Approved with Minor Modifications (Provisionally Approve) – The principle investigator must make minor modifications before final GPS IRB exemption can be given (list comments below).
Approved with Major Modifications (Clarifications Needed) - Substantive revisions and/or requested information must be made to the application before final GPS IRB exemption can be given (list comments below).
Reviewer Comments:
Categories of Exempt Research According to the Code of Federal Regulations 45 CFR 46.101 (b) 2
1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:
a. Research on regular and special education instructional strategies
OR
b. Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures[2], interview procedures or observation of public behavior, unless:
a. Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects;
AND
b. Any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if:
a. The human subjects are elected or appointed public officials or candidates for public office;
OR
b. Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
4. Research, involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
5. Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine:
a. Public benefit or service programs
b. Procedures for obtaining benefits or services under those programs
c. Possible changes in or alternatives to those programs or procedures
d. Possible changes in methods or levels of payment for benefits or services under those programs.
6. Taste and food quality evaluation and consumer acceptance studies, if:
a. Wholesome foods without additives are consumed
OR
b. A food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
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[1] If the covered entity does not provide such forms, investigator can use those in Section X of the Pepperdine University’s Protection of Human Participants in Research: Policies and Procedures Manual.
[2] The exemption at 45 CFR 46.101 (b)(2), for research involving survey or interview procedures or observations of public behavior, does not apply to research with children, Subpart D, except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed.