How to Submit:

All research using human subjects must be approved by the institution. Certain categories of research (i.e. “exempt research”) do not require convened IRB review and approval. Exempt research is subject to institutional review and must be approved by an IRB Chair, Vice Chair, or the Director, UNR Office of Human Research Protection. A Statement of Exemption applies to research that presents very low or no risk of harm to human subjects. Approval for exempt research will be based upon the criteria specified in the federal regulations at 45 CFR 46.101b (see Exempt Categories).

Filing a Statement of Exemption does not apply if the subjects are members of a “vulnerable population”, i.e. children (except for research involving observations of public behavior when the investigator does not participate in the activities being observed), prisoners, fetuses, pregnant women, persons who are cognitively impaired, human in vitro fertilization, or persons who are economically or educationally disadvantaged.

Students may assume roles as Principal Investigators conducting exempt research as long as they have a faculty sponsor who will serve as co-investigator and faculty advisor on the study.

Investigator note: Exempt research, once approved, is non-renewable. The duration of study for exempt research is limited to the number of months specified on the approved application but no longer than 36 months from the date of approval.

To submit an exemption:

One complete original, including:

1. an Exemption Application signed and dated by the Principal Investigator and/or faculty advisor,

2. all recruitment materials (e.g., letter of invitation, recruitment script, flyer),

3. consent form (when appropriate),

4. HIPAA waiver of authorization or de-identification form (when appropriate),

5. all surveys, questionnaires, instruments, etc.,

6. letter(s) of permission from each non-University and/or non-VA Sierra Nevada Health Care System site(s) of performance

7. if sponsored, one copy of the grant application(s) and/or contract

8. verification of current human research protection training for all members of the research team, including the faculty advisor

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Initial Review of New Protocols

Expedited Initial Review:

Research activities that present no more than minimal risk to human subjects, and involve only procedures listed in one or more categories authorized by 45 CFR 46.110 and 21 CFR 56.110 (see Expedited Review Categories), may be reviewed through the Expedited Review* procedure. Activities must not be deemed to be of minimal risk simply because they are included within these categories. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects. Under an expedited review procedure, the review may be carried out by the IRB Chair or by one or more reviewers (e.g. a subcommittee of the IRB) designated by the Chair or the UNR OHRP from among members of the IRB.

There is no deadline to submit an expedited review.

To submit a new protocol for Expedited Review:

One complete original, including:

1. a Protocol Application completely filled-out with all required signatures;

2. an Expedited Review Checklist

3. Supplemental forms for research involving Vulnerable Populations;

4. all recruitment materials (e.g., letter of invitation, recruitment script, flyer),

5. consent/parental permission/assent form(s) (when appropriate),

6. HIPAA authorization, waiver of authorization, or de-identification form (when appropriate),

7. all surveys, questionnaires, instruments, etc. (in the case of standardized instruments, provide two copies),

8. letter(s) of permission from each non-University site of performance,

9. if sponsored,

ü copy of the grant application(s) and/or contract

ü fully-executed OSPA transmittal(s)

10. verification of current human research protection training for all members of the research team

Plus 3 copies of the complete original

Full-Board Initial Review:

If the research involves greater than minimal risk, the Full-Board will review the protocol at a convened meeting. Board meetings for the UNR Biomedical IRB are held once per month, and once per month for each of the two UNR Social Behavioral IRBs. The deadline to submit to full-board meetings is approximately two weeks prior to the meeting. (see Schedule for Full-Board meetings)

To submit a new protocol for Full-Board Initial Review:

One complete original, including:

1. a Protocol Application completely filled-out with all required signatures

2. Supplemental forms for research involving Vulnerable Populations;

3. all recruitment materials (e.g., letter of invitation, recruitment script, flyer),

4. consent/parental permission/assent form(s) (when appropriate),

5. HIPAA authorization, waiver of authorization, or de-identification form (when appropriate),

6. all surveys, questionnaires, instruments, etc. (in the case of standardized instruments, provide two copies),

7. letter(s) of permission from each non-University site of performance,

8. verification of current human research protection training for all members of the research team

Required number of copies of the complete original for the IRB reviewing the research:

Biomedical IRB – 12 copies

Social Behavioral IRB – Panel A – 12 copies

Social Behavioral IRB – Panel B – 12 copies

If sponsored,

1. two copies of the grant application(s) and/or contract with scope of work

2. fully-executed OSPA transmittal(s)

If industry-sponsored,

1. two copies of the sponsor protocol

2. two copies of the Investigator’s Brochure

3. Form FDA 1572

4. sponsor Financial Disclosure form.

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Protocol Modification

Expedited Review of Protocol Modification:

A proposed modification that presents no more than minimal risk to human subjects, and involves only procedures listed in one or more categories authorized by 45 CFR 46.110 and 21 CFR 56.110 (see Expedited Review Categories), may be reviewed through the Expedited Review procedure. Activities must not be deemed to be of minimal risk simply because they are included within these categories. Inclusion on this list merely means that the modification is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects. Under an expedited review procedure, the review may be carried out by the IRB Chair or by one or more reviewers (e.g. a subcommittee of the IRB) designated by the Chair or the UNR OHRP from among members of the IRB.

There is no deadline to submit an expedited review.

To submit a protocol modification for Expedited Review:

One complete original, including:

1. a protocol modification form completely filled-out, dated and signed by the Principal Investigator,

2. a memorandum, signed and dated by the Principal Investigator, explaining the requested modification,

3. an updated Protocol Application [or Description of Study if this was used for the original submission] (and sponsor protocol, when appropriate), which includes the proposed modification(s) highlighted and a version date and pagination in the footer,

4. any additional recruitment materials (e.g., letter of invitation, recruitment script, flyer),

5. revised consent/parental permission/assent form(s) (when appropriate), which include the proposed modification(s) highlighted and a version date and pagination in the footer,

6. new HIPAA authorization, waiver of authorization, or de-identification form (when appropriate),

7. any additional surveys, questionnaires, instruments, etc. (in the case of standardized instruments, provide two copies),

8. any letter of permission from each additional non-University site of performance,

If additional sponsors will be added,

1. copy of the grant application(s), and

2. fully-executed OSPA transmittal(s)

Plus 3 copies of the complete original,

One clean copy (without highlighting) of the revised consent/parental permission/assent form(s) for re-certification (when appropriate).

Full-Board Review of Protocol Modification:

If the research involves greater than minimal risk, the Full-Board will review the protocol modification at a convened meeting. Board meetings for the UNR Biomedical IRB are held once per month, and once per month for each of the two UNR Social Behavioral IRBs. The deadline to submit to full-board meetings is approximately two weeks prior to the meeting. (see Schedule for Full-Board meetings)

To submit a protocol modification for Full-Board Review:

One complete original, including:

1. a protocol modification form completely filled-out, signed and dated by the Principal Investigator,

2. a memorandum, signed and dated by the Principal Investigator, explaining the requested modification,

4. any additional recruitment materials (e.g., letter of invitation, recruitment script, flyer),

5. revised consent/parental permission/assent form(s) (when appropriate), which include the proposed modification(s) highlighted and a version date and pagination in the footer,

6. new HIPAA authorization, waiver of authorization, or de-identification form (when appropriate),

7. any additional surveys, questionnaires, instruments, etc. (in the case of standardized instruments, provide two copies),

8. any letter(s) of permission from each additional non-University site of performance,

Required number of copies of the complete original for the IRB reviewing the research:

Biomedical IRB – 12 copies

Social Behavioral IRB – Panel A – 12 copies

Social Behavioral IRB – Panel B – 12 copies

One clean (without highlighting) copy of the revised consent/parental permission/assent form(s) for re-certification (when appropriate),

If additional sponsors will be added,

1. two copies of the grant application(s), and

2. fully-executed OSPA transmittal(s)

If industry-sponsored,

1. two copies of the revised sponsor protocol (when appropriate)

2. two copies of the revised Investigator’s Brochure (when appropriate).

To submit a protocol closure for Full-Board Review:

One complete original, including:

1. a protocol modification form completely filled-out, signed and dated by the Principal Investigator,

2. a final report.

Required number of copies of the complete original for the IRB reviewing the closure:

Biomedical IRB – 12 copies

Social Behavioral IRB – Panel A – 12 copies

Social Behavioral IRB – Panel B – 12 copies

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Continuing Review (Renewal)

Approved research is subject to continuing IRB review at least yearly, or more frequently if specified by the IRB [45 CFR 46.109(e)], but not sooner than 30 days prior to the protocol termination (expiration) date. This review must take place BEFORE the approval expiration date; any lapse in approval will result in suspension of subject recruitment/enrollment and, if the research is DHHS-sponsored, notification of the funding Agency. The approval date and the termination (expiration) date are clearly noted on all IRB certifications sent to the PI and must be strictly adhered to.

As a courtesy, the UNR OHRP will send a first and second notice (i.e. the Research Status Report and Request for Continuation) of the continuing review to the Principal Investigator in advance of the protocol expiration date. It is the responsibility of the Principal Investigator to meet the deadline indicated on the Research Status Report and Request for Continuation. Please allow sufficient time for development and review of renewal submissions. By federal regulation, no extension to that date can be granted.

To submit a continuing review for Full-Board Review:

One complete original, including:

1. a Research Status Report and Request for Continuation form completely filled-out (both pages), signed and dated by the Principal Investigator,

2. a research plan for the upcoming review period,

3. a copy of the approved Description of Study (if no modification is proposed), which includes a version date and pagination in the footer,

4. a copy of the approved consent/parental permission/assent form(s) (when appropriate and if no modifications are proposed),

(Please do not update the revision date in the footers of the approved consent/parental permission/assent form(s) if no modifications are proposed.)

5. required number of copies of the complete original for the IRB reviewing the research:

Biomedical IRB – 12 copies

Social Behavioral IRB – Panel A – 12 copies

Social Behavioral IRB – Panel B – 12 copies

6. one clean (without highlighting) copy of the approved consent/parental permission/assent form(s) for re-certification,

7. verification of current human research protection training for all members of the research team

If any modification will be proposed at the time of continuing review, the request for modification must be prepared according to the instructions for submitting a Full-Board Review of Protocol Modification and attached to the request for continuation.

To submit a protocol closure at the time of continuing review for Full-Board Review:

One complete original, including:

1. a Research Status Report and Request for Continuation form completely filled-out (both pages), signed and dated by the Principal Investigator, and

2. a final report.

Required number of copies of the complete original for the IRB reviewing the closure:

Biomedical IRB – 12 copies

Social Behavioral IRB – Panel A – 12 copies

Social Behavioral IRB – Panel B – 12 copies

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HIPAA-required Documents

Effective April 14, 2003, the Health Information Portability and Accountability Act (HIPPA) becomes law. Any esearch that is derived from a "covered entity" within the University of Nevada, Reno must comply with this law. Presently, the covered entities of UNR are designated as the following:

· University of Nevada School of Medicine and its affiliated practice groups, MedSchool Associates South, MedSchool Associates North, and NFPRP (Mojave Health);

· Psychological Service Center;

· Counseling and Testing;

· CEP-Downing Counseling Clinic;

· Student Health Center;

· Pharmacy

[Please be advised that changes may be necessary in response to new federal guidance or University policy. When changes are made this site will be revised and announcements regarding those changes will be posted on the OHRP website in this section.]

Existing IRB-approved Studies

To continue to collect protected health information (PHI)* after the Health Insurance Portability and Accountability Act (HIPAA) implementation date on April 14, 2003, investigators must modify this existing study and obtain IRB approval.

1. If your current project has an IRB approved consent form, you must also obtain an authorization to use PHI from all subjects enrolled after April 14, 2003. Submit a protocol modification application to the IRB and complete the following:

- Prepare an authorization form, using the authorization template;

- Attach a memorandum to the protocol modification application.

2. If your current protocol does not have an approved consent form, complete either the De-identification Form, if applicable, or request a waiver of authorization by completing the Waiver of Authorization Form.