ࡱ> a V bjbjjj >"?b?b@x""&&&8^|&Xn H$$$$&DEED  $0)EPC&DEE0$$YJLJLJLERR$$ JLE JLJL i"$08FLbo0kFk&k@JLEEE00IEEEEEEEkEEEEEEEEE"B d:    Application to the RESEARCH COMMITTEE and IRB for Approval of a Research Project Exempt from IRB Review This form is for new proposals in which the only human involvement is in one or more categories exempt from review by the IRB. Exempt research must be approved by The Dean of Research and Chair of the IRB. The 911 Investigator of Record (the principal investigator or 911 co-investigator if the PI is not a member of the full time 911 faculty) is responsible for completing and submitting this application. Project Title:  FORMTEXT      Project PersonnelNUHS Contact Person (Check one):  FORMCHECKBOX  NUHS Investigator of Record  FORMCHECKBOX  Project Principal InvestigatorName, academic/professional degree(s):  FORMTEXT       Phone number:  FORMTEXT       Email:  FORMTEXT       Date of most recent IRB approved training for Protection of Human Subjects from Research Risk  FORMTEXT       Signature and Date: (Check one)  FORMCHECKBOX  Co-Investigator  FORMCHECKBOX  Faculty Sponsor (required when PI is student or non-full time faculty)Name, academic/professional degree(s): FORMTEXT       Phone number:  FORMTEXT       Email:  FORMTEXT       Date of most recent IRB approved training for Protection of Human Subjects from Research Risk  FORMTEXT       Signature and Date:For additional investigators, attached a sheet with contact information, signature and date of IRB training Background: 1. Does this study involve research (a systematic investigation designed to develop or contribute to generalizable knowledge)?  FORMCHECKBOX  Yes.  FORMCHECKBOX  No. STOP. This project does not require review 2. Does this study involve human subjects (a living individual about whom a researcher obtains data through intervention or interaction with the individual or identifiable private information)?  FORMCHECKBOX  Yes.  FORMCHECKBOX  No. Stop. This project does not require IRB review. Complete the Research Committee application.  Background (continued): 3. Does this study fall into at least one of the following categories of exempt IRB review [45 CFR 46.104(d)]? Educational practice: Research conducted in established or commonly accepted educational settings that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special instructional strategies, and research on the effectiveness of, or the comparison among, instructional techniques, curricula or classroom management methods. Survey, Tests, Interviews or Observations: Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met: (A) information obtained is recorded in such a manner that human subjects cannot be identified, directly or through identifiers linked to the subjects; (B) 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, or reputation; (C) 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 for privacy and confidentiality protection.. Benign Behavioral Interventions Research involving benign behavioral interventions with adults who prospectively agree when information collection is limited to verbal or written responses (including data entry) or audiovisual recording and at least one of the following criteria is met: (A) The information recorded cannot readily be linked to the subjects;(B) Any disclosure of the human subjects' responses 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 (C) If identifiable information is recorded by the investigator, IRB conducts a limited IRB review for privacy and confidentiality protection. Secondary research Secondary research uses of identifiable private information or identifiable biospecimens, for which consent is not required if at least one of the following criteria is met: (A)The identifiable private information or identifiable biospecimens are publicly available; (B) 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 directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects; (C) Investigators use is regulated under HIPAA as health care operations or research or public health activities and purposes; or (D) Research is conducted by, or on behalf of, a Federal department or agency using data collected or generated by the government for nonresearch purposes, and the information is protected by federal privacy standards. Public benefit and service programs research and demonstration projects Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department: (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 (iv) changes in methods of payment for benefits under those programs. Food Research Taste and food quality evaluation, and consumer acceptance studies with i) wholesome foods that do not contain additives, or ii) food which will be consumed that contains a food ingredient at or below the level found to be safe and for a use 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. Storage/Maintenance of identifiable private information or biospecimens Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review Use of private information or biospecimens for secondary research Secondary research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met: (A) Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained and (B) IRB conducts a limited IRB review and makes the determination  FORMCHECKBOX  Yes, Indicate which category(s)  FORMTEXT        FORMCHECKBOX  No, STOP. This project does not qualify as Exempt Research. Complete the Research Committee application and IRB New Project Application (Form B). Please indicate the anticipated duration of the project:  FORMTEXT start date to  FORMTEXT completion date.  FUNDING: Please use the table below to identify what funds may be needed for the success of the project. If you are seeking outside funding, please include study budget. CategoryCostConsultant Fees (statistician) FORMTEXT      Research Assistants (FWS) FORMTEXT      Equipment FORMTEXT      Supplies FORMTEXT      Travel FORMTEXT      Publishing/Poster Fees FORMTEXT      Other Costs:  FORMTEXT       FORMTEXT      TOTAL  FORMTEXT      It is recommended that you discuss funds with your Cost Center Manager (Department Chair) prior to starting the project TIME COMMITMENT: Time commitment for each study personnel should be approved by their cost center manager (Department Chair, Dean, Director etc.) Cost center manager name:  FORMTEXT       FORMTEXT Name of study personnel  FORMTEXT Role in Study (PI, co-investigator, etc)  FORMTEXT Amount of time dedicated to research (hr/wk or %) I approve the time commitment requested to work on this project once the project has met all requirements and received all necessary approvals to begin. Signature and Date:For additional investigators, please attach approved time commitment from their cost center managers.  PROMOTING OBJECTVITY IN RESEARCHIs this project seeking any funding from Public Health Services (example: NIH, NSF, HRSA, etc.)?  FORMCHECKBOX  No, PHS funding is NOT being sought. Do any investigators, or family members thereof (spouse, dependent children) have a significant financial interest ($5000 compensation in the past 12 months, including salary, consulting, honorarium, or 5% ownership of company) with the project sponsor?  FORMCHECKBOX  No.  FORMCHECKBOX  Yes. Attach a description of the significant financial interest and present a plan for managing the conflict, minimizing its effect on the design, conduct, or reporting of the research, and maintaining the rights and welfare of the research participants.  FORMCHECKBOX  Yes, PHS funding is being sought. Have any investigators disclosure been determined to be a financial conflict of interest (FCOI) under the 911 Financial Conflict of Interest in Research policy?  FORMCHECKBOX  No. Dean of Research has initialed section XI of the Research Committee application indicating that FCOI review was completed.  FORMCHECKBOX  Yes. Attach a copy of the FCOI management plan signed by the Dean of Research with this application. DESCRIPTION OF THE EXEMPT RESEARCH Write a description of the project. Include: 1 Project background (include a literature review) and purpose/aim/hypothesis of the study.  FORMTEXT       2. A description of the procedures/methods.  FORMTEXT       3. Describe what data will be collected and how it will be collected.  FORMTEXT       4. How do you plan to analyze the data (such as inferential or descriptive statistics, etc.)?  FORMTEXT       Include copies of Research Instruments (Surveys, Questionnaires, Tests, Interview Guides, etc.) PARTICIPANTS [if not relevant, check this box  FORMCHECKBOX ]1 Who is being included and who is being excluded in the project  FORMTEXT      2. Anticipated number of participants:  FORMTEXT      3. Will there be opportunity for equal representation of : Gender?  FORMCHECKBOX  Yes  FORMCHECKBOX No Racial/ethnic groups?  FORMCHECKBOX  Yes  FORMCHECKBOX No If you answered  No for either of the above questions, please explain.  FORMTEXT       4. Indicate who will participate in the research (e.g, NUHS students/faculty/staff, community members, patients.  FORMTEXT       How and where will participants be approached?  FORMTEXT       Attach copies of all recruiting materials Who will approach or contact the participants (name and role in the project, such as investigator, instructor, research assistant, etc,) ?  FORMTEXT       INFORMED CONSENT [if not relevant, check this box  FORMCHECKBOX ]Describe the methods you plan to use in order to obtain informed consent from the participants in the project. If you are requesting an alteration or waiver of consent, please explain why. If you cannot obtain an informed consent from a participant, please explain why it cannot be obtained.  FORMTEXT       Attach a copy of the consent document or the information statement supplied to participants. PROVISIONS TO MAINTAIN CONFIDENTIALITY OF IDENTIFIED DATA [if not relevant, check this box  FORMCHECKBOX ]1 Who will have access to data (name and role in the project, such as investigator, instructor, research assistant, etc,)?  FORMTEXT      2. Will data be made available to anyone other than the principal investigator and research staff? 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Where will the data be stored and for how long?  FORMTEXT       4. Who will be the supervisor of the data?  FORMTEXT       If not the PI, how will that person (method and frequency report the security of the data to the PI?  FORMTEXT       Investigator s Assurance: I certify that the information provided in this application is complete and correct. I understand that as NUHS Primary Investigator, I have ultimate responsibility for the protection of the rights and welfare of human subjects, for the conduct of the study, and the ethical performance of the project. I agree to comply with all 911 policies and procedures, as well as with all applicable federal, state, and local laws regarding the protection of human subjects in research, including, but not limited to, the following: the project will be performed by qualified personnel, no changes will be made in the protocol or consent form until approved by the 911 IRB, legally effective informed consent will be obtained from human subjects if applicable, and as appropriate, adverse events will be reported to the IRB in a timely manner. I further certify that the proposed research is not currently underway, and will not begin until approval has been obtained. I have read and understand the 911 Policy The Protection of Human Subjects from Research Risk concerning protocols.  Signature 911 Primary Investigator (Print) Name Date Faculty Sponsors Assurance By my signature as sponsor on this research application, I certify that the student or guest investigator is knowledgeable about the regulations and policies governing research with human subjects and has sufficient training and experience to conduct this particular study in accord with the approved protocol. In addition, I agree to meet with the investigator on a regular basis to monitor study progress. Should problems arise during the course of the study, I agree to be available, personally, to supervise the investigator in solving them. I assure that the investigator will promptly report any significant or adverse effects to the IRB in a timely manner. If I will be unavailable, on sabbatical leave or vacation for example, I will arrange for an alternate faculty sponsor to assume responsibility during my absence, and I will advise the Dean of Research by letter of such arrangements. I certify that the proposed research is not currently underway, and will not begin until approval is obtained. I certify that the investigator and myself have read and understand the 911 Policy The Protection of Human Subjects from Research Risk concerning exempt protocols.  Signature Faculty Sponsor* (Print) Name Date * The faculty sponsor must be a full time member of the 911 faculty. The faculty member is considered the responsible party for legal and ethical performance of the project.   Dean of Research and Chair of IRB Signatures* Project Title: As Dean of Research, I acknowledge that this research is in keeping with the standards set by our University and I assure that the 911 Primary Investigator has met all University requirements for approval of this research.  Signature Dean of Research or Designee Print Name and Date As Chair of the 911 IRB, I have reviewed this project and find that it meets the criteria of exempt research as described by the 911 policy Protection of Human Subjects from Research Risks and the Code of Federal Regulations.  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