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Northeastern Ohio Universities College of Medicine
Institutional Review Board (IRB) Application
FOR USE WITH PROJECTS INVO...
A. Are you applying for full board review? (Please Review Guidelines for Protection of Human Subjects in Research)
Yes: Th...
B. Qualifications for expedited IRB review. The Research must present NO more than MINIMAL RISK and at least one of the
fo...
Drug - experimental
ECG
Electrical stimulation
Device - approved, but non-approved use
Device - experimental
Fetal tissue
...
Methods:      
Clinical Relevance:      
Page 5 of 4 Revised August 2010
Methods:      
Clinical Relevance:      
Page 5 of 4 Revised August 2010
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Application for Projects Involving Biomedical Research Studies

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Application for Projects Involving Biomedical Research Studies

  1. 1. Northeastern Ohio Universities College of Medicine Institutional Review Board (IRB) Application FOR USE WITH PROJECTS INVOLVING BIOMEDICAL RESEARCH Office of Research and Sponsored Programs Directions: Your application must include a completed, signed, printout of this form, together with your proposed consent form, protocol, questionnaires, and any appendices that might be helpful to the IRB’s consideration. Answer ALL questions. If a questin does not apply to your study, please write N/A in the appropriate space. Refer to Guidelines for Protection of Human Subjects in Research for directions in completing this form and submitting your application. Please submit 1 hardcopy to: Trish Wilson, Research Coordinator, IRB Office, Room G-235, NEOUCOM Rootstown Campus or electronically to paw@neoucom.edu. If you are sending this application electronically, you must scan the application so that the PI’s signature is displayed. Type signatures will not be accepted. Applications requiring full board review must be received 14 days prior to the scheduled full board meeting. If your project includes behavioral research or the use of surveys, you are using the incorrect form. The time required for exempt or expedited review depends on the availability of the IRB reviewers and the availability of the investigator to make any necessary corrections. The time required for exempt or expedited review depends on the availability of the IRB reviewers and the availability of the investigator to make any necessary corrections. We can not guarantee a review for exemption or an expedited review in less than two weeks. Please plan accordingly. It is in the best interest of the investigator to submit a complete application that contains all parts. Any missing items or lack of clarification of important information in the proposal can cause delays. First person listed below must be a NEOUCOM faculty member who will serve as the Principal Investigator for this study. Only 1 person may be named as a principal investigator. 1. Study Personnel (names, degrees) Dept./Section/Location Telephone Email Status                         Principal Investigator                                                                                                 Ia. Person to Contact Regarding this Application: Telephone FAX Location and Room #                         2. TITLE OF PROTOCOL       3. PROJECT PERIOD: From       to       4. FUNDING SOURCE (name of sponsor or funding agency):       __________________________________________________________________________________________________________________ A. Is the sponsor a for-profit corporation? (double click on the appropriate box) No Yes: Provide an indemnity agreement. 5. PRINCIPAL INVESTIGATOR ASSURANCE: “I have read NEOUCOM’s Guidelines for Protection of Human Subjects in Research. In addition, all study personnel listed above have completed the required on-line training in human subjects research. I understand it is my responsibility, as Principal Investigator, to assure the accuracy of the description of research in this application and for insuring the research is conducted as approved by the NEOUCOM IRB.” Principal Investigator: _________________________________________ Date:___________________ Student’s Signature if a student project: ___________________________ Date: __________________ (All student projects must have a faculty member as PI) To answer “yes” or “no” to the following questions, double-click on the appropriate box . 6. REQUIRED INFORMATION: ( If completing form electronically, double click on boxes to check) Page 1 of 4 Revised August 2010
  2. 2. A. Are you applying for full board review? (Please Review Guidelines for Protection of Human Subjects in Research) Yes: The entire application must be completed, excluding section VII No: Are you applying for an exemption from the IRB? Yes: You must complete the entire application including section VII part A No: Are you applying for an expedited IRB review? Yes: You must complete the entire application including section VII part B B. Are investigation drugs, biologics, or devices used in this study? No Yes: FDA IND/IDE #       C. Will personnel and resources from another department be involved in this study? No Yes: Letter of agreement must be attached if not listed as co-investigator. D. Are non-NEOUCOM Consortium institutions involved? No Yes: Letter of agreement must be attached. Please attach Co-Investigator’s memo “Intent to Collaborate”. Will part or all of the study be conducted at that site? No Yes E. Will subjects be exposed to any ionizing radiation? No: Radiation Safety Committee (RSC) review not required. Yes: Will participants in this study receive direct medical benefits? No: RSC review REQUIRED. Yes: Is the proposed use and/or combination of uses of radiation/radioactive materials normally considered to be routine? (Examples: X-ray, nuclear medicine scan, and conventional radiotherapy) No: RSC review REQUIRED. Yes: Will subjects participating in the study receive a greater radiation dose than patients undergoing routine treatment for the same medical condition? No: RSC review not required. Yes: RSC review REQUIRED. F. Are hazardous materials (carcinogens, mutagens, toxic substances, infectious agents, etc.) used in this study? No Yes: Letter of approval from Biosafety Committee required. G. Do any of the investigators have a potential conflict of interest in the performance of this study? No Yes: Attach explanatory statement. H. Will subjects be recruited using advertising material or form letters? No Yes: Attach sample copy. I. Is the study being submitted to any Federally Funded Institute or Agency for sponsorship? No Yes: PHS policy requires assurance that the composition of the proposed study population benefits all persons at risk of the condition under study. The gender and racial/ethnic composition, together with a rationale for inclusion/exclusion, should be described in the funding proposal and in Section VII, which follows. J. What is the length of participation for the research subjects and the total number of visits required to complete the study? Length of study participation for subjects       Total Number of Visits       K. Have all Investigators and Co-Investigators completed a training course for conducting Human Subjects Research within the last 3 years? If not, please complete the on-line training course located at http://phrp.nihtraining.com/users/login.php. Please list below the date of certification. If a certificate is currently not on file with the IRB, please attach to this application. Principal Investigator:       Date of certification:       Co-Investigators:       Date of certification:       Co-Investigators:       Date of certification:       Co-Investigators:       Date of certification:       7. REASON FOR EXEMPT OR EXPEDITED REVIEW: (Exempt does not mean exempt from IRB review. Exempt refers to exempt from 45CFR46 requirements. Only the IRB can exempt your protocol from these requirements. ) A: The study is exempt research because: *Research on special education instructional strategies, comparison of techniques, or classroom management methods. *Research involving educational testing, survey or interview procedures or observation of public behavior. *Research involving existing data, documents or pathological specimens IF the sources are publicly available or subjects cannot be identified through any type of identifiers. *Research or demonstration projects that are designed to evaluate or otherwise study procedures of public benefit or service programs Taste and food quality food evaluations and consumer acceptance studies. Page 2 of 4 Revised August 2010
  3. 3. B. Qualifications for expedited IRB review. The Research must present NO more than MINIMAL RISK and at least one of the following boxes must be checked. Expedited review is at the IRB’s discretion and may be waived at any time by the IRB. Research on drugs for which an Investigational new drug application is not required Collection of blood samples by finger, ear, venipuncture or heel stick from subjects who meet the criteria. Collection of biological specimens by non-invasive means. Collection of biological data through non-invasive procedures (i.e. ECG, BMI) Research on individual or group behavior or characteristics of individuals (i.e. surveys with no identifiers) Collection of data from voice, video, digital, or image recordings made for research purposes Research on individual or group characteristics or behavior, surveys, interviews or oral history that have identifiers at any point of the research Continuing review of research previously approved by the convened IRB and the following are true: enrollment is closed, no additional risks have been identified or remaining research activity is data analysis The study of data (chart reviews), documents, records, pathological specimens, or diagnostic specimens. C. Eligible for waiver of consent (IRB’s can choose to waive consent but are not required to) Yes No (c) An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either: (1) That 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; or (2) That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context. 8. USE OF HEALTH INFORMATION: Does the study involve the use of health information? Health information is defined as: * any information pertaining to the past, present, or future physical or mental health or condition of an individual; * any information pertaining to the provision of health care to an individual; or * any information pertaining to the past, present, or future payment for the provision of health care to an individual. No Yes: You are required to complete a HIPAA Application for the use of health information along with this IRB Application. HIPAA applications can be found at http://www.neoucom.edu/DEPTS/GRAN/forms.html. 9. DESCRIPTION OF HUMAN SUBJECTS: A. Subjects: Number Age Range Healthy (normal) subjects             Patients             Vulnerable Populations             B. Classification of subjects (check all that apply): Abortuses Adults Cognitively impaired Comatose Female Fetuses Healthy Institutionalized Male Minorities Minors (< 18 yrs) Patients Physically handicapped Pregnant women Prisoners International Subjects Traumatized (Emotional) Traumatized (Physical) Students (Any type) Other (list):       C. Source of subjects:       D. Criteria for inclusion of subjects:       E. Criteria for exclusion of subjects:       F. Inducement being offered to the subjects (includes reimbursement for travel or any merchandise from sponsor):       10. SUBJECT-RELATED PROCEDURES: A. Location of subject-related procedures: B. List of subject-related procedures (check all those that apply): Biopsy Blood drawing Data bank, data archives, or medial records Diet alteration Drug - approved, but non-approved use Placebo(s) Proton beam Radiation Radioisotopes Randomization Page 3 of 4 Revised August 2010
  4. 4. Drug - experimental ECG Electrical stimulation Device - approved, but non-approved use Device - experimental Fetal tissue Filming, video, or voice-recording Interview Observation Physical exercise or activity Physical manipulation Specimens – anonymous Specimens – discard Stem Cells Surgical or autopsy tissue Survey Task Test, pen/pencil/computerized Treatment Underwater weighing Urine or fecal sample Other (describe):       11. RISK: A. List the risks that might result from the experimental aspects of the study. When the subjects are patients, clearly identify the risks that would be in addition to routine therapy.       B. Give an estimate of the magnitude of risks the subject assumes by entering this study: C. State plan for preventing or minimizing these risks.       12. BENEFIT: A. State the expected benefits to the subjects.       B. State the expected benefits to humanity.       13. CONFIDENTIALITY: A. Will the investigator(s) be able to identify the subjects by appearance, name, or data? No Yes: Please state what steps will be taken to insure confidentiality of the subjects: 14. USE OF HEALTH INFORMATION: A. Does the study involve the use of health information? Health information is defined as: a) any information pertaining to the past, present, or future physical or mental health or condition of an individual; b) any information pertaining to the provision of health care to an individual; or c) any information pertaining to the past, present, or future payment for the provision of health care to an individual. No Yes: You are required to complete a HIPAA Application along with this IRB Application. HIPAA applications can be found at http://www.neoucom.edu/DEPTS/GRAN/forms.html. DESCRIPTION OF STUDY ABSTRACT: Objectives:      Research Plan:       Page 4 of 4 Revised August 2010
  5. 5. Methods:       Clinical Relevance:       Page 5 of 4 Revised August 2010
  6. 6. Methods:       Clinical Relevance:       Page 5 of 4 Revised August 2010

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