Reviewer Worksheet:EXEMPT DETERMINATION
Study IDStudy Title
Principal Investigator
Submission Type
Chair or Designee / Date of Review
REVIEWER CONFLICT OF INTEREST
Do you have any conflicts of interest related to this study that could prevent you from☐ Yes ☐ No
providing an independent review or that may lend itself to the perception of a COI?
SUMMARY & RECOMMENDATIONS
Determination:☐ Meets All Criteria for Exemption
☐ Minor Revisions
☐Major Revisions
☐Disapprove – Forward to Administrator
☐ Project is Not Exempt – Forward for Expedited Rev
☐ Project is Not Exempt – Forward for Full Board Rev
☐ Project is Not Human Subjects Research
☐ Project is HSR but OSU is Not Engaged
Exempt Category(ies): ☐1 ☐2 ☐3 ☐4 ☐5 ☐6check all that apply
FLEX Category(ies): ☐ A ☐ B check if applicable__Data Security Level
Funding:Grant/Contract matches protocol:Discrepancies explained and justified:
ANCILLARY REVIEWS
Biosafety☐ Approved ☐ Requested revisions ☐ Pending☐ N/A
Radiation Safety☐ Approved ☐ Requested revisions ☐ Pending☐ N/A
Conflict of Interest☐ Approved ☐ Requested revisions ☐ Pending☐ N/A
Office of Info. Security☐ Approved ☐ Requested revisions ☐ Pending☐ N/A
Registrar☐ Approved ☐ Requested revisions ☐ Pending☐ N/A
Human Resources☐ Approved ☐ Requested revisions ☐ Pending☐ N/A
Export Control☐ Approved ☐ Requested revisions ☐ Pending☐ N/A
Office Comments: [e.g., verification date, notes to PI for email, notes for file about the review, indicating that study involves international research, etc.]
Verified that changes were made to correct version using compare documents: __ yes ___ no __ n/a
Information for Exempt Notice:[e.g., waivers, explanation of revisions, notes to PI]
Stamp consent document(s): ☐ Yes, stamp the consent document(s)
☐ No, do not stamp the consent document(s)
International Research: ☐Yes, this study involves international research
☐No, this study does not involve international research
RESEARCH DETERMINATION / YES / NO / N/A / COMMENTSDoes the study meet the definition of research? / ☐ / ☐ / ☐
Does the study meet the definition of human subjects? / ☐ / ☐ / ☐
Is OSU engaged in research? / ☐ / ☐ / ☐
DETERMINATION OF EXEMPT CATEGORY
Exemption Categories / Applies / N/ACategory 1: Research conducted in established or commonly accepted educational settings, involving normal educational practices. / ☐ / ☐
If the research involves any of the following, Category 1 does not apply:
- Surveys, questionnaires, or deception
Category 2: Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior. / ☐ / ☐
If the research involves either of the following, Category 2 does not apply:
- 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.
- If the study presents a risk not articulated above, such as the risk of causing distress to the subject, the HRPP may determine that review of the study by an expedited or full board procedure is appropriate. Example: An anonymous online survey about suicidal ideation.
- Research with children involving surveys, interviews or participant observation AND the investigator is participating in the activities being observed.
- Please note: studies eligible for Flex Initiatives may fall into exempt category FLEX A. For more information, see FLEX section below
For VA Research, Category 2 does not apply if both of the following are true:
- Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects, and
- Any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of loss of insurability
Applies / N/A
Category 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 Category 2, 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 thereafter.
Applies / N/A
Category 4: Research involving the collection or study of EXISTING data, documents, records, pathological specimens, or diagnostic specimens, if: / ☐ / ☐
- The sources are publicly available or
- The information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects
- Please note: studies eligible for Flex Initiatives may fall into exempt category FLEX B. For more information, see FLEX section below
Category 4 will only apply if all of the data exists prior to the start of the research.
Applies / N/A
Category 5: Research and demonstration projects which are designed to study, evaluate, or otherwise examine public benefit or service programs, if: / ☐ / ☐
- The projects are conducted by or subject to the approval of Federal Department or Agency heads, and,
- There is no statutory requirements for IRB review, and
- The research does not involve significant physical invasions or intrusions upon the privacy of subjects and,
- The exemption is invoked with authorization or concurrence by the funding agency
Category 6: Taste and food quality evaluation and consumer acceptance studies, if: / ☐ / ☐
- Wholesome foods without additives are consumed; or
- 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
Is the research eligible for exemption under one or more of the above categories? / Y☐ / N☐
If the study cannot be exempt, does it qualify for FLEX A or B? FLEX eligibility is N/A if study is exempt under federal categories.
FLEX ELIGIBILITY / YES / NO or N/A
The research activities present no more than minimal risk to Human Subjects. / ☐ / ☐
If “no’, this study is not eligible for FLEX initiatives
FLEX EXCLUSIONS / YES / NO
The research has federal funding or a plan for future federal sponsorship (e.g., proof of concept studies for federal RFPs, pilot studies intended to support a federal grant application, training and program project grants, no-cost extensions) / ☐ / ☐
The research is funded or otherwise regulated by a federal agency that has signed on to the Common Rule, including all agencies within the Department of Health and Human Services / ☐ / ☐
The research is regulated by the FDA / ☐ / ☐
There is an NIH-issued or pending Certificate of Confidentiality / ☐ / ☐
The study involves prisoners or parolees as subjects / ☐ / ☐
There are contractual obligations or restrictions that require the application of the Common Rule or which require annual review by an IRB / ☐ / ☐
The research is federally classified research / ☐ / ☐
The research is a clinical investigation / ☐ / ☐
If “yes” to one or more of the exclusions, this study is not eligible for FLEX initiatives
Yes / No
Is the study eligible for FLEX? / ☐ / ☐
If “yes” please complete the FLEX initiative section below
FLEX Exempt Categories / Applies / N/A
FLEX A: Research not otherwise excluded from Flex initiatives, that does not conform to a specific exempt category under 45 CFR 46 and involves one or more of the following:
- Educational tests, surveys, questionnaires, interviews, focus groups and observation of public behavior involving minors; this includes observations of children when the researchers is participating in the activities being observed
- Adults and/or minors performing activities or tasks that supplement or inform procedures in FLEX A(1) above. Examples of such activities or tasks include but are not limited to computer programming; mind or concept mapping; participation in a game (real or virtual); journaling; watching and responding to visual or auditory stimulation (e.g., videos, music, pictures, etc.); usability or software testing; or the use of eye-tracking technology; engaging in minimal risk physical tasks such as walking, riding, driving, or exercise.
[Flex category A is similar to exempt category 2, but expanded to include tasks and applicable to children; observations of children when the researcher is participating in the activities being observed removes the restriction dictated by Subpart D. Note: Observation of minors in school is not considered “public” because the researcher needs permission from school officials to observe students.]
FLEX B:Research not otherwise excluded from Flex initiatives and involves the collection or study of existing or prospectively accumulating data, documents, records, or biological specimens that exist or will exist for research or non-research purposes. Such data may be individually identifiable, so long as a breach of confidentiality would not pose more than a minimal risk to the research subjects.
Examples include:
- DMV records (if not already publicly available)
- Fishing or boating licenses (if not already publicly available)
- Marriage, divorce, and real estate transactions
- Datasets from previously approved minimal risk research
Excluded from this category are individually identifiable medical, mental health, school, and employment records, as a breach of confidentiality involving this information is not considered to be minimal risk and therefore does not meet the FLEX criteria. If the data is pre-existing and will be abstracted or recorded in such a manner that subjects cannot be identified, directly or indirectly, through variables linked to the subjects, an exemption under category 4 may be more appropriate.If biological specimens, whether identifiable or deidentified, will be used to determine the safety or efficacy of an investigational medical device, the study is regulated by the FDA and therefore not eligible for FLEX.
[Flex category B is similar to exempt category 4 and expedited category 5 – adds individual identifiers and prospective collection to category 4]
Is the research eligible for one of the FLEX exempt categories? / Y☐ / N☐
For initial reviews, address these criteria as they apply to the entire protocol. For project revisions and minor changes, address only how the criteria apply to the changes.
WORKSHEET
IDENTIFICATION AND RECRUITMENT OF SUBJECTSYES / NO / N/A / COMMENTS
- Do recruitment materials include all of the following required elements?
Name of the PI
Clear statement that this is research or a study
Contact information for interested individuals / ☐ / ☐ / ☐
CONSENT
- OBTAINING INFORMED CONSENT
The consent process discloses, as appropriate:
That the activity involves research or a study / ☐ / ☐ / ☐
The purpose / ☐ / ☐ / ☐
The duration of the subject’s participation (optional) / ☐ / ☐ / ☐
The procedures/activities / ☐ / ☐ / ☐
Identification of experimental procedures / ☐ / ☐ / ☐
Any risks and benefits (optional if no risk or benefit) / ☐ / ☐ / ☐
Any alternatives (such as alternate class activity) / ☐ / ☐ / ☐
That enrollment and all activities are voluntary / ☐ / ☐ / ☐
Contact information for the PI and HRPP (if appropriate) / ☐ / ☐ / ☐
Funding Source / ☐ / ☐ / ☐
SPECIAL OR VULNERABLE POPULATIONS
- CHILDREN
Does the study involve children? If “no”, skip this section. / ☐ / ☐
ASSENT / YES / NO / COMMENTS
Is assent being obtained from all children? / ☐ / ☐
Are the procedures for obtaining assent appropriate for the age and ability of the children (generally verbal assent up to 7 years and written for 8 years and older)? / ☐ / ☐
- INTERNATIONAL RESEARCH
Does this study involve international research? If “no”, skip this section. / ☐ / ☐
Does the HRPP need to obtain outside consultation with regard to the local context? / ☐ / ☐
Document consultation: / ☐ / ☐
- STUDENTS
Does the study specifically target students? If “no”, skip this section. / ☐ / ☐ / ☐
Is targeting this population scientifically justified or permitted under the policy (e.g. extra credit as mechanism for compensation, student subject pool)? / ☐ / ☐
Does the recruitment plan comply with the OSU IRB policy in that it emphasizes voluntariness, confidentiality, and permits self-identification of study interest? / ☐ / ☐
If students are being recruited to participate by investigators who are also the class instructor(s), should an exception be granted to permit direct recruitment? Note: Exceptions may be granted if the purpose of the research is directly connected to students in a particular class. / ☐ / ☐ / ☐
Do the investigators ensure that students know they may choose not to participate in the research and that their decision will not affect their grade, class standing, or relationship with any instructor? / ☐ / ☐
Is extra credit offered as compensation to students? / ☐ / ☐
If yes, is an alternative means of earning equivalent extra credit for an equivalent commitment of time and effort made available for those who cannot or choose not to participate in the research? / ☐ / ☐ / ☐
Does the research use class time? / ☐ / ☐
If yes, does the investigator explain how participation in the research would be a learning experience to the students, AND how the research is relevant to the course? / ☐ / ☐ / ☐
Is an alternative activity provided for students who choose not to participate? / ☐ / ☐ / ☐
Are investigators using education records in research, such as class assignments, grades, student evaluations, etc.? / ☐ / ☐
If yes, Registrar approval is required. Is there an approved internal data request form for this study? / ☐ / ☐ / ☐
Is it clear who will be providing the records (i.e. Registrar’s Office, Class instructor, other)? / ☐ / ☐ / ☐
Is written consent being sought from participants? Such consent may be written or obtained electronically within an authenticated environment, such as MyOSU. Please see the FERPA decision trees for additional guidance.
Relevant Regulation: FERPA 34 CFR 99.30
In addition to the usual elements consent information must include:
- Signature and Date*
- Specify the records that may be disclosed;
- State the purpose of the disclosure; and
- Identify the party or class of parties to whom the disclosure may be made (i.e. researchers, external collaborators, etc.)
(1)Identifies and authenticates a particular person as the source of the electronic consent; and
(2)Indicates such person's approval of the information contained in the electronic consent. / ☐ / ☐ / ☐
If K-12, does the project involve survey, analysis, or evaluation involving a PPRA topic? Please see the PPRA decision tree for additional guidance / ☐ / ☐ / ☐
If yes, PPRA consent requirements apply.
Relevant Regulation: PPRA 34 CFR 98
If PPRA is applicable:
- Prior written consent of the parent or guardian or adult/ emancipated student must be obtained (34 CFR 98.4 (b)(2))
- Materials must be available for inspection by the parents or guardians of the children (34 CFR 98.3 (a))
- EMPLOYEES
Does the study specifically target employees? If “no”, skip this section. / ☐ / ☐ / ☐
Is targeting this population scientifically justified? / ☐ / ☐ / ☐
If use of OSU employee data is planned, has Human Resources approved the use of this data? / ☐ / ☐ / ☐
Does the recruitment plan comply with the OSU IRB policy in that it emphasizes voluntariness, confidentiality, and permits self-identification of study interest? / ☐ / ☐ / ☐
- CONFLICT OF INTEREST
Does any member of the study have a conflict of interest? If “no”, skip this section / ☐ / ☐
Are there adequate procedures in place to manage any conflict of interest? / ☐ / ☐
Is the conflict disclosed to subjects as part of the consent process? / ☐ / ☐
- DECEPTION
Does the study involve deception? If “no”, skip this section. If yes, the study cannot fit into exempt category 1, but may qualify for exemption under another category. / ☐ / ☐
Does the study design meet all of the criteria for a waiver of consent? / ☐ / ☐
Investigator has provided all of the following:
Justification for the deception / ☐ / ☐
A description of the manner of deception and how the deception will take place / ☐ / ☐
An explanation as to why deception is necessary to this protocol / ☐ / ☐
A description of whether the deception results in any increased risk to participants / ☐ / ☐
An indication of whether the deception may affect a subject’s willingness to participate in research / ☐ / ☐
A description of the post-study debriefing that includes offering the participant the option to withdraw their data from the study. If an exception to the requirement for a debriefing is requested, the study must be reviewed by the full board. / ☐ / ☐
A description of any previous use of deception in similar research and a summary of any actual harms or reactions from participants to the use of deception / ☐ / ☐
A description of alternatives to deception that were considered and an explanation as to why these alternatives were rejected / ☐ / ☐
- FUNDING
If funded, does the funding source or site of research have additional regulations or rules that need to be followed? / ☐ / ☐
- FOODS
Does the study involve giving or providing food or a food ingredient to subjects?
If no, skip this section. / ☐ / ☐
Will the food or food ingredient be purchased from a store or provided by a restaurant or catering?
Has GMP or USP/Food Grade certificates been provided? / ☐ / ☐
Does the study adequately address the potential for allergic reactions? / ☐ / ☐
Is there an adequate plan for the storage, preparation, handling, and distribution of all foods? / ☐ / ☐
Does the study involve alcohol?
If “no”, skip the rest of this section. / ☐ / ☐
If yes, are subjects expectorating all alcohol?
If “no”, cannot be exempt. / ☐ / ☐
COMMENTS AND STIPULATIONS
Date:
Comments:
Stipulations:
☐ All of the stipulations were resolvedDate:
OSU IRB FWA0000039201HRPP Form | v. date March 2017