1. Purpose
This SOP describes the process for the review and approval of protocols exempt from
IRB review and approval.
2. Overview
Federally funded research activities that meet all applicable criteria set forth
by the regulations (45 CFR 46.104) and involve no greater than “minimal risk” may
qualify for exemption from IRB review. Additionally, non-federally funded research
activities that meet all applicable criteria set forth by the WVU IRB may qualify
for exemption from IRB review. An exemption must be determined by the IRB, (or
designee), not an individual investigator. The exemption categories are described
below. The IRB (or designee) may rule a proposal as exempt if it fits into one
(or more) of the exemption categories and is no greater than minimal risk. However,
the WVU IRB may determine that there are research protocols that may pose ethical
concerns and are reviewed as with any other new protocol application.
All exempt reviews conducted by WVU IRB designated members meet the requirements
of a limited IRB review by ensuring that when appropriate, the research plan includes
adequate provisions to protect the privacy of participants and to maintain the
confidentiality of the data.
WVU retains the authority to suspend or terminate IRB approval of research approved
with a limited review.
WVU IRB does not utilize broad consent. Exemption categories intended for research
using broad consent are not applied at WVU.
Exempt protocols are communicated to the IRB at the next convened meeting after approval
of the project.
3. Procedures
3.1.1 Pre-Submission
The PI should determine if the research project qualifies for Exempt submission
by reviewing Section 4 (Scope of this Policy) of this SOP.
- The PI should complete the required training.
- The PI should determine the regulatory requirements for the project and the data
that will be collected or used during the project. Locate and complete the
required forms and guidance on the WVU OHRP website, such as HIPAA Waivers,
Data Intake Forms, and Consent documents.
- The PI should review the required provisions for vulnerable or disadvantaged
populations, as directed in Section 5 (Vulnerable Populations).
- The PI should create the Informational Cover Letter (if applicable) on the WVU
OHRP website.
3.1.2 Submission
The PI should submit the completed Exemption application using the WVU
electronic IRB system, and upload the following documents as applicable:
- Recruitment materials (cover letter, recruitment script, flyer, etc.)
- Informational Cover Letter (if applicable)
- Surveys, questionnaires, and data collection instruments
- Letter(s) of permission from each non-WVU site
- Verification of current human subject protection training for all members of
the research team, including the faculty advisor
- Research Data Use and Protection Certification
3.1.3. WVU IRB Review: A WVU IRB Chair (or designee) reviews all requests
for research submitted under the Exempt submission type and determines whether
the application meets the criteria for inclusion.
3.1.4. WVU IRB Determinations: The reviewer may require additional protections
for participants or require that the application be submitted or reviewed using
an alternative submission type. Determinations made by the reviewer will be communicated
with the Principal Investigator via the WVU electronic IRB system.
3.1.5. WVU IRB Acknowledgement: The acknowledgement of the Exempt application
serves as formal documentation of the reviewer’s determination. Exempt protocols
are granted a five (5) year approval period.
3.1.6. Amendments to Exempt Protocols: Amendments must be submitted as
new application if the researcher discovers the following:
- Modifications that increase risk to participants - modifications that increase
risk to participants must be submitted for review and approval before implementing
the change.
- Funding Changes - federal funding awarded, or funding from WVCTSI.
- If an amendment causes the protocol ineligible for Exemption, the amendment
must be submitted as a new application in WVU+kc. Additional Human Subjects
Protection (HSP) Training may be required. Please refer to the WVU OHRP
website for guidance on additional training based on the type of protocol
submitted in WVU+kc.
3.1.7. Continuing Review: Acknowledged Exempt protocols are granted a
five (5) year approval period. To extend the approval period beyond the initial
five (5) year period, a new initial application must be submitted for review and
approval for acknowledgement by the WVU IRB.
3.1.8. Reporting Requirements: Approved protocol applications must follow
the reporting requirements outlined in SOP 031: Research Related Event Reporting.
4. Scope
4.1.1. Exemption for research involving survey or interview procedures does not apply
to research in children. Research involving observations of public behavior in
children when the investigator does not interact with the children being observed,
is considered exempt.
4.1.2. Exemption for research does not apply to prisoners as research participants.
IRB review is required (See SOPs 013: Vulnerable Populations, 018: Expedited Review,
and 019: Full Review).
4.1.3. Research activities not regulated by the FDA in which the only involvement
of human participants will be one or more of the following categories are exempt
from IRB review, but require institutional review:
Research conducted in established or commonly (standard practice) accepted educational
settings, involving normal educational practices, such as:
- Research on regular and special education instructional strategies; or
- Research on the effectiveness of or the comparison among instructional techniques,
curricula, or classroom management methods.
4.1.4. Research involving the use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures or observation of public
behavior if AT LEAST ONE of the following criteria are met:
- Information obtained is NOT recorded in such a manner that human participants
can be readily ascertained (identified), directly or through identifiers linked
to the participants;
- Any disclosure of the human participants’ responses outside the research would
NOT reasonably place the participants at risk of criminal or civil liability
or be damaging to the participant’s financial standing, employability, or reputation;
or
- The information obtained is recorded by the investigator in such a manner that
the identity of the human participants can readily be ascertained, directly
or through identifiers linked to the participants, and an IRB conducts a limited
IRB review to make the determination required by 46.117(a)(7).
4.1.6. 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 Section 4.3.2, ONLY IF:
- The human subjects are elected or appointed public officials or candidates for
public office; or
- Federal statute(s) require(s) without exception that the confidentiality of the
personally identifiable information will be maintained throughout the research
and after the research is complete.
Research involving benign behavioral interventions in conjunction with the collection
of information from an adult subject through verbal or written responses (including
data entry) or audiovisual recording if the subject prospectively agrees to the
intervention and information collection and at least one of the following criteria
is met:
- The information obtained is recorded by the investigator in such a manner that
the identity of the human subjects cannot readily be ascertained, directly
or through identifiers linked to the subjects;
- Any disclosure of the human subjects’ responses outside the research would not
reasonably place the subjects at risk of criminal or civil liability or be
damaging to the subjects’ financial standing, employability, educational advancement,
or reputation; or
- The information obtained is recorded by the investigator in such a manner that
the identity of the human subjects can readily be ascertained, directly or
through identifiers linked to the subjects, and an IRB conducts a limited IRB
review to make the determination required by §46.111(a)(7).
-
For the purpose of this provision, benign behavioral interventions are brief in duration,
harmless, painless, not physically invasive, not likely to have a significant
adverse lasting impact on the subjects, and the investigator has no reason
to think the subjects will find the interventions offensive or embarrassing.
Provided all such criteria are met, examples of such benign behavioral interventions
would include having the subjects play an online game, having them solve puzzles
under various noise conditions, or having them decide how to allocate a nominal
amount of received cash between themselves and someone else.
-
If the research involves deceiving the subjects regarding the nature or purposes
of the research, this exemption is not applicable unless the subject authorizes
the deception through a prospective agreement to participate in research in
circumstances in which the subject is informed that he or she will be unaware
of or misled regarding the nature or purposes of the research.
4.1.8. Research involving the collection or study of secondary data, documents, records,
pathological specimens, or diagnostic specimens, if at least one of the criteria
below are met (please note, this includes retrospective and prospective collection
of secondary data):
- The identifiable private information or identifiable biospecimens are publicly
available;
-
Information, which may include information about biospecimens, is recorded by the
investigator in such a manner that the identity of the human subjects cannot
readily be ascertained or through identifiers linked to the subjects, the investigator
does not contact the subjects, and the investigator will not re-identify subjects;
- The research involves only information collection and analysis involving the
researcher’s use of identifiable health information when that use is regulated
under 45 CFR parts 160 and 164, subparts A and E, for the purposes of “health
care operations” or “research” as those terms are defined at 45 CFR 164.501
or for “public health activities and purposes” as described under 45 CFR 164.512(b)
[Note that HIPAA does not apply to biospecimens, so this provision applies
only to the secondary use of identifiable private health information (which
can include information obtained from specimens)]; or
- The research is conducted by, or on behalf of, a Federal department or agency
using government-generated or government-collected information obtained for
nonresearch activities, if the research generates identifiable private information
that is or will be maintained on information technology that is subject to
and incompliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C.
3501
[Note: This category is unlikely to be used. If you believe that it is applicable,
please contact WVU OHRP for assistance.]
Note: This category does not apply to FDA regulated research.
4.1.9. Research protocols involving the collection of data from medical records may
qualify as exempt from review under the secondary collection category (4.1.7 above)
provided that the following criteria are met:
- While this category involves secondary research for which consent is not required,
the IRB could request the researcher to obtain informed consent or request
a waiver of informed conset for prospectively collected data under sub-category
(iii). Informed consent would not apply to category (i) publicly available
data, or (ii) researcher agrees not to record identifiers or re- identify/re-contact
subject. However, the IRB may ask the researcher to justify why informed consent
is not practicable for prospective collections under category (iii) A HIPAA
Waiver of Authorization should be submitted for both review types (exempt and
expedited). Waiver of Informed Consent will need to be submitted for medical
records research not qualifying for exempt category four (see 4.1.7 above).
Research and demonstration projects which are conducted by or subject to the approval
of federal department or agency heads, and which are designed to study, evaluate,
or otherwise examine:
- Public benefit or service program;
- Procedures for obtaining benefits or services under those programs;
- Possible changes in or alternatives to those programs or procedures; or
- Possible changes in methods or levels of payment for benefits or services under
those programs
- The program under study must deliver a public benefit (e.g., financial or medical
benefits as provided under the Social Security Act) or service (e.g., social,
supportive, or nutrition services provided under the Older American Act).
-
The research demonstration project must be conducted pursuant to the specific federal
statutory authority, there must be no statutory requirements of IRB review,
the research must not involve significant physical invasions or intrusions
upon the privacy of participants, and the exemption must be invoked only with
authorization or concurrence by the funding agency.
4.1.11. Taste and food quality evaluation and consumer acceptance protocols:
- If wholesome foods without additives are consumed; or
- If 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 containment
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.
4.1.12. The following categories of clinical investigations are exempt from the requirements
of IRB review:
- Emergency use of a test article provided that such emergency use is reported
to the IRB within five (5) working days. Any subsequent use of the test article
at the institution is subject to IRB review. [21 CFR 56.104(c)]
- Taste and food quality evaluations and consumer acceptance protocols, if wholesome
foods without additives are consumed or if 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 of the Food a Safety and Inspection Service of the U.S. Department
of Agriculture. [21 CFR 56.104(d)]
5. References
WVU Policies:
SOP 013: Vulnerable Populations
SOP 018: Expedited Review
SOP 019: Full Review
SOP 031: Research Related Event Reporting
Federal Regulations:
21 CFR 56.104 (c) (d)
45 CFR 46.104
