II2 FO1 Application for Exempt Research

II2 FO1 Application for Exempt Research
Version Date
UNR Protocol Number:
To determine if the proposed research may meet the criteria for exempt review, check the box indicating “Yes” or “No” for each of the questions below. / Yes / No
Does this research present greater than minimal risk* to participants?
*Minimal Risk: 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 of routine physical or psychological examinations or tests.
Are you conducting research with prisoners?
Are the prospective participants your students or employees?
Will incomplete disclosure or deception be used in this study?
Are you recording data in such a way that participants can be identified and might disclosure of participants’ responses outside the research place them at risk?
Are you videotaping participants?
Note: If you checked “Yes” to any of these questions, your study may not meet the criteria for exempt review. If you have questions, please contact the Office of Human Research Protection. Otherwise, please complete the Protocol Application for the Involvement of Human Subjects.

SECTION I: General Information

1.Study Title

2.Duration of Study

State the anticipated time frame for this study, in months, not exceeding 36 months. Be sure to include sufficient time for data analysis. NOTE: Applications for exempt research are not renewable.

3.Categories for Exempt Research

Read each of the following statements carefully and check the category that applies to the proposed research.

Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special educational instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. [45CFR46.101(b)(1)]

Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless the following two conditions exist:(i) information obtained is recorded in such a manner that the human subjects can be identified, directly or indirectly through identifiers linked to the subjects; and(ii) any disclosure of subjects’ responses outside the research could reasonably place subjects at risk of criminal or civil liability or be damaging to subjects’ financial standing, employability or reputation.[45CFR46.101(b)(2)]

NOTE:This exemption does not apply to research involving children unless the research is limited to observation of public behavior when the investigators do not participate in the activities being observed.

All research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey or interview procedures or observation of public behavior that is not exempt under categories 2 or 3 above, (i) if the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. [45CFR46.101(b)(3)]

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.[45CFR46.101(b)(4)]

NOTE: To qualify for this exemption all of the data, documents, records, or specimens must be in existence before the project begins.

Research and demonstration projects which are conducted by or subject to the approval of Department of Health and Human Services (DHHS), and which are designed to study, evaluate, or otherwise examine:(i) public benefit or service programs; (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. [45CFR46.101(b)(5)]The research or demonstration project must be conducted pursuant to specific federal statutory authority, must have no statutory requirement that an IRB review the project, and must not involve significant physical invasions or intrusions upon the privacy of the subjects.

NOTE:Demonstration projects can only be exempted with funding agency authorization or concurrence.

Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) 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 or the Food Safety and Inspection Service of the U.S. Department of Agriculture. [45CFR46.101(b)(6)]

4.Type of Study

(Check all that apply)

Faculty Research

Graduate Research

Comprehensive Project

Thesis

Dissertation

Undergraduate Research

VA Research

Other, specify:

5.Contact Information

Note for all student researchers: Complete items5 a. and 5.b., and obtain your advisor’s signature in Section X: Assurances.

5.a.Principal Investigator

Name:
Mailing Address:
Department:
Email: / Phone: / Fax:
Researcher completed CITI

5.b.Faculty Advisor(Complete only for student-initiated research. All student research requires a faculty member to serve as the Faculty Advisor.)

Name
Mailing Address:
Department:
Email: / Phone: / Fax:
Researcher completed CITI

5.c.Contact Person(Complete only if an investigator, student, or staff member other than the Principal Investigator is to serve as the primary point of contact for all correspondence.)

Name
Mailing Address:
Department:
Email: / Phone: / Fax:

6.Performance Sites

6.a. Study Locations (Check all that apply)

UNR Campus

VASierra Nevada Health Care System (VASNHCS)

Other, list:

6.b. If the study will take place at a non-University or non-VASNHCS location, you must provide written documentation that the site has given its permission for the study to take place.Is written documentation from all performance sites attached?

No, this application cannot be approved until the UNR OHRP is in receipt of written documentation of permission from all sites.

Yes, attach documentation.

SECTION II: Funding

1.Is the proposed research funded?

No, skip to Section III

Yes, complete items 1.a-1.c

1.a. Funding Agency and Sponsor Information

Funding Source / Name of Sponsor
Federal
State of Nevada
Local Government
Industry
Internal Funding
Private/Other

1.b. Grant/Contract Information

Principal Investigator of Grant/Contract:
Grant/Contract Title:
Grant Number:
Grant/Contract Status (e.g., pending, awarded):

Note: For all sponsored research, provide two copies of the grant application, with budget or contractswith statement of work and budget.

SECTION III: Participants

1.Anticipated Total Number of Participants

2.Justification of Sample Size

Describe how the proposed sample size is appropriate for achieving the anticipated results.

3.Participant Population(s)

Check each participant population that may be enrolled.

Adult Volunteers

UNR Students

Children

Other, specify:

4.Inclusion/Exclusion Criteria

List the inclusion and exclusion criteria. Justify any proposed exclusionsthat are based on age, race, or gender.

5.Recruitment Procedures

5.a.State who will be recruiting participants.

5.b.Describe where and when recruitment will take place.

5.c.State what potential participants will be told during recruitment.

5.d.Indicate which types of recruitment materials will be used to invite potential participants to be in the study and attach copies. (Check all that apply.)

SONA post / flyers
letters / emails
scripts / mass media advertisements
social media (e.g., Facebook) / list serves or online posts
other (describe):

SECTION IV: Informed Consent

Informed consent is a process that begins with the initial contact and continues throughout the study; informed consent is not simply the act of signing a consent form.

1.Consent Process

1.a. List the persons who will obtain informed consent/parental permission from participants/parents, and assent from dependents. NOTE: Anyone listed in this section must also be listed in Section IX.

1.b. Explain when and where informed consent/assent will be obtained from participants/parents (e.g., clinic visit, via mail, public event, classroom).

1.c. State how much time participants/parents will be given to make a decision about participation. (NOTE: Potential participants need adequate time to consider participation.)

1.d. Describe the steps that will be taken to ensure that consent is obtained in a language that participants/parents will easily understand.

2.Documentation of Consent

Unless a waiver or alteration of consent, or a waiver of documentation of consent is being requested, list and attach the forms that will be used to obtain written consent from each sample population (i.e. adult consent form, parental permission form, surrogate consent form, and assent form for children aged 12-17 years). If an assent script will be used for children aged 7-11 years list and attach a copy of it.

Sample forms with instructions are available on the forms page of the UNR OHRP website.

Under specific circumstances, a waiver or alteration of the consent process, or a waiver of signed consent may apply. See below for details. If neither waiver will be requested, skip to Section V.

3.Waiver or alteration of the Consent Process = Informed consent will not be obtained from participants.

If requesting a waiver or alteration of the consent process,complete questions 3.a-3.d.

3.a.Does the study pose more than minimal risk to participants?

Yes  If yes, this waiver does not apply.

3.b.Will the waiver adversely affect participants’ rights and welfare?

Yes  If yes, this waiver does not apply.

3.c.Would the research be feasible without the waiver?

No  If no, explain why it would not be feasible:

Yes  If yes, this waiver does not apply.

3.d.If appropriate, explain how the participants will be given additional pertinent information about the study after their participation:

4.Waiver of Signed Consent = Participants are not required to sign a consent form.The investigator may instead provide participants with a written statement regarding the research, e.g. an information sheet.

Review the information below to determine if a waiver of signed consent may apply to this research. Note: Either Category 1 or Category 2 must be true.

Category 1

The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern.

False

True, explain:

Category 2

The research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside of the research context.

False

True, explain:

Attach information sheet, when applicable.

SECTION V: Research Plan

1.Introduction

Briefly summarize the previous research that led to the plan for this project and provide references when appropriate.

2.Purpose

In lay language, state the rationale for the study, the research hypothesis, and the goals of the proposed study as these relate to the research questions; include the importance or value of the knowledge this study is likely to generate.

3.ResearchDesign

Describe the research design.

4.Study Procedures

Describe what participants will experience during their participation in the study.Includethe sequence of procedures andthe time commitment for participants.

5.Study Materials

Describe the purpose of all questionnaires, assessment instruments, and data collection logs that will used and attach a copy of each.

6.Compensation

Will any compensation be given to participants (including extra credit)?

No, skip to Section VI.

Yes If yes, see note immediately below, and complete 6.a. and 6.b.

NOTE: The UNR Controller’s Office requires identifying information to issue checks, cash, or gift certificates to participants when funds originate from UNR-administered grants or contracts. Studies providing compensation to participants via UNR-administered grants or contracts may not be exempt.

6.a. Describe the type and amount ofcompensationthat will be given to participants (e.g., cash, checks, gift cards, free services, gifts, extra credit).

6.b. State when compensation will be given.

SECTION VI: Risks and Benefits

1. Risks and Inconveniences

Are there any known risks or inconveniences to participants?

No, skip tonumber 2, Benefits.

Yes

1.a. Describe any anticipated risks or inconveniences participantsmay experience.

1.b. Describe the steps that will be taken to minimize any risks the study might pose.

2.Benefits

2.a. Describeanticipated direct benefits to individual participants, if any.

2.b. Describe anticipated benefits to science, society, or a specific class of individuals.

3.Risk/Benefit Analysis

Describe how risks to participants are reasonable in relation to anticipated benefits.

SECTION VII: Privacy and Confidentiality

1.Privacy = The right of individuals to controlaccess to their person, behavior, andviewpoints.

How will the investigators protect the privacy of participants at the time of recruitment,and duringand after participation? NOTE: Consider the timing and place of the research procedures.

2.Confidentiality = Howthe informationresearchers obtain about participantsis handled to ensure that the information will not be disclosed other than as described in this application.

2.a. Describe procedures for protectingthe confidentiality of participant data. Includethe specific location where data will be stored, length of the storage period, and what will happen to the data after the storage period elapses. NOTE: Consent forms, data, and master code sheets must be stored separately.

2.b. State who will have access to the data, includinginvestigators, research assistants, advisors, external agencies (e.g., study sponsors, collaborating institutions, DHHS), and the University of Nevada, Reno Biomedical or Social Behavioral Institutional Review Board.

2.c. If data will be coded, explain all coding procedures, including when master code sheets will be destroyed. NOTE: Personal identifiers or portions of personal identifiers (e.g., social security number, date of birth, mother’s maiden name) can not be used for coding purposes.

3.HIPAA Authorization

If you are collecting protected health information from a University covered entity, including the VA, please review IRB procedure “II3D PR1 Authorization for ResearchUses and Disclosures of Protected HealthInformation.” You may be required to submit an Authorization to Use, Create and Share Health Information for Research Purposes form or aHIPAA IRB Waiver of Authorization Form, both of which are available on the Investigator Forms page of our website.

For further information about HIPAA and research, go to the National Institutes of Health website:HIPAA Privacy Rule, Information for Researchers).

Attach HIPAA document(s) if appropriate.

SECTION VIII: Financial Conflict of Interest

1.Disclosure of Financial Interests

Do any investigators (or their spouses or dependent children) have financial or non-financial interests that may affect subject protection or the integrity of the proposed research?

Yes, describe the interests:

Section IX: Study Personnel

1. Co-Investigators

Name:
Mailing Address:
Department:
Phone: / Fax: / Email:
Researcher completed CITI
Name:
Mailing Address:
Department:
Phone: / Fax: / Email:
Researcher completed CITI
Name:
Mailing Address:
Department:
Phone: / Fax: / Email:
Researcher completed CITI
Name:
Mailing Address:
Department:
Phone: / Fax: / Email:
Researcher completed CITI
Name:
Mailing Address:
Department:
Phone: / Fax: / Email:
Researcher completed CITI

2.Research Team Members

Name / Department / Institution / Role / CITI Training
Completed
Completed
Completed
Completed
Completed
Completed
Completed

Section X: Assurances

1. Principal Investigator Assurance

I hereby certify that the study procedures described in the attached protocol have been designed, to the best of my ability and knowledge, to protect human subjects engaged in research in accordance with the standards set by University of Nevada, Reno, the United States Department of Health and Human Services, the Department of Veterans Affairs (when appropriate), and any other sponsoring federal agency.

I agree to accept responsibility for the scientific conduct of the research involving human subjects and to provide information and/or progress reports to the University of Nevada, Reno Institutional Review Board as required. I verify that all responsible investigators are appropriately credentialed to do the services provided and the work undertaken in this protocol.

I further certify that my participation and the participation of any co-investigators does/do not, in any way, violate the University of Nevada, Reno policy on conflicts of interest.

Principal Investigator / Date
(Non-students only)
or
Faculty Advisor / Date
(Required for student-initiated research)

2.Student Principal Investigator Assurance

[NOTE: Applications from student principal investigators require the signature of a faculty advisor.]

Student Principal Investigator / Date

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