Application for Exemption from Irb Review

OHR-18

09/2014

page1

APPLICATION FOR EXEMPTION FROM IRB REVIEW

STUDY TITLE: ______

PRINCIPAL INVESTIGATOR: ______

DEPT.:______TELEPHONE#/E-MAIL:______

Instructions: Check off the documents below that you have included with your exempt application (OHR-18).

OHR-18 – For all exempt studies

Grant, if applicable.

Other relevant materials,if applicable (questionnaires, brochures, advertisements, etc.).

OHR-3 – If you are requesting a waiver of subject authorization to collect PHI.

OHR-5 – If de-identified health information is being collected.

OHR-8/HIPAA Authorization - If subject authorization will be obtained to collect PHI.

No identifiers or health information are being collected. HIPAA authorization/OHR-3/OHR-5 not required.

***Please see the OHR-5 for a list of identifiers.***

SECTION 1:

Research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from IRB review. Please check those items that apply to your research.

____(1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) 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, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) 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.

(Note 1: Audio, video and/or digital recording removes a study from consideration for exemption. The study should be submitted as expedited or full.)

Note 2: In order for research involving children as participants to be exempt, the procedures must be limited to observation of public behavior where the investigators do not participate in the activities being observed and educational tests.Surveys or interviews of children do not qualify for exemption.)

____(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: (i) 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.

____(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.

(Note: In order to meet this category, tissue and/or data must exist at the time the research is proposed to the IRB.)

____(5) Research and demonstration projects which are conducted by or subject to the approval of federalDepartment or Agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Federal 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.

(Note: In order to meet this category, the research must: 1) be conducted pursuant to specific federal statutory authority; 2) not involve significant physical invasions or intrusions upon the privacy interests of participant; 3) have authorization or concurrence by the funding agency.)

*These categories are taken from 45 CFR 46.101(b)

SECTION 2:

Please attach a brief summary (in lay language) of your research, and a justification for why it fits the exemption criteria you have chosen. Give definitions for all acronyms used.If research involves interaction with participants, please address the following items:

How, where, and according to what time-frame will participants be approached and consented? (Be sure to consult, adapt and include in your application the appropriate consent template [OHR-8, OHR-8E, OHR-8F, etc.]).
How will privacy of participants be maintained?
Explain criteria for participant selection. (Selection should be equitable, unless there is a justifiable scientific reason for exclusion of certain populations.)

(These items are adapted from the TJUH patient bill of rights document at

SECTION 3:

Does the research involve prisoners as participants? YES ⁯ NO ⁯
Is the research FDA-regulated (i.e., involving an FDA-regulated drug or device)?

YES ⁯ NO ⁯

CERTIFICATION OF CONFLICTS OF INTEREST (See TJU Policy 107.03, Conflicts of Interests for Employees” attachment 2 for more detailed information)

THIS CERTIFICATION MUST BE COMPLETED AND ALL THE REQUIRED SIGNATURES MUST BE OBTAINED BEFORE THIS PROTOCOL/RESEARCH PROJECT MAY BE ADMINISTRATIVELY PROCESSED.

Each Investigator and all Key Personnel must answer the following questions in relation to this proposal. The TJU ID# requested can be found in the box on the left side of your pay stub. For non-Jefferson employees, this section should be left blank.

Principal and Co-Investigators & Key Personnel:

Copy this section as necessary to accommodate all personnel on study.

Name:______

Do you have a current Conflicts of Interest Disclosure on file with the University?

_____Yes

_____No

_____Not Sure

Do you or an immediate family member have any financial interests as defined in the TJU Conflicts of Interest Policy 107.03?

_____Yes

_____No

Do you or an immediate family member have a significant financial interest that may pose a conflict of interest as defined in the TJU Conflicts of Interest Policy 107.03?

_____Yes

_____No

If you checked “yes” to question 2 or 3 above, describe the financial interest below and any steps planned to prevent the financial interest from interfering with the design, conduct, or reporting of the research, including interfering with the protection of participants. Attach separate sheet if needed.

Check appropriate boxes in the table below.

Significant financial interest in the sponsor or subcontractor, i.e., paid consultancy, stock, stock options, ownership, etc.
Intellectual property rights (patents, pending patents, copyrights, trademarks, licensing agreement, royalties)
Honoraria, speaker’s fees, paid authorship
Gifts
Trips
Service on Board
Paid expert testimony
Compensation for employment (by other than TJU/TJUH)
Other
None

How do you plan to manage the conflict?

Reduce ______Manage _____Eliminate _____

If you identified a potential conflict of interest on this form that is not known to the TJU COI Committee, contact Janyce Lingo at 215-503-0758 or .

If you are a TJU employee or faculty member, or a TJUH employee you must have submitted an up-to-date Disclosure of Conflicts of Interest to University Counsel. If you have not, please complete an on-line Disclosure that can be accessed via the Pulse homepage or a hard copy that may be obtained on the Office of University Counsel website. If you are not a TJU employee, TJUH employee, nor a TJU faculty member, you must file a Disclosure Statement for Non TJU/TJUH Employees Conducting Research indicating either the nature of the conflict of interest, if any, or certifying that you do not have a conflict of interest in a financially interested company with regard to this proposal.

RELATIONSHIP(S) WITH OTHER ENTITIES

The Principal Investigator must complete the following:

Other than the entity paying for the study or as disclosed in the protocol, will any OTHER ENTITY(S):

1. Require and/or receive reports or other information regarding this study? [ ] Yes [ ] No

If yes, list entity (s) ______

2. Be identified in any reports submitted to the FDA or other regulatory agencies? [ ] Yes [ ] No

If yes, list entity(s) ______

3. Be given access to study data?[ ] Yes [ ] No

If yes, list entity(s) ______

4. Be given attribution in any publication or presentation regarding this study? [ ] Yes [ ] No

If yes, list entity(s) ______

The IRB must be notified in writing by the PI should any of the answers to the above change.

The OHR-18 must be signed by all Key Personnel participating in the project and their department Chairpersons and Administrators. The Principal Investigator agrees to accept responsibility for the conduct of the project. All Key Personnel certify that, to the best of their knowledge, all information provided is correct and in compliance with University policies.

Please type all names below signature lines. Copy signature lines as needed to accommodate all personnel.

Principal InvestigatorChairmanAdministratorDate

Co- InvestigatorChairmanAdministratorDate

Key PersonnelChairmanAdministratorDate

______

Dean, Jefferson School of Health Professions (for JSHP applications only)