ࡱ> 683457 bjbjUU %H7|7|Ψl<<<8=,,>$]\?TH(|H|H|HcK~LM`ܣޣޣޣޣޣޣ$ 3dMJ|cKMMAT|H|HkATATATMl|H|HܣATMܣAT"ATcX |HP? _ph7<iO:-0]&iOATMarshall University HUMAN RESEARCH PROTECTION PROGRAM IRB Research (Protocol) Application Form IRB #2 (Social/Behavioral) PART I Principal Research Investigator Personal Information A copy of your CV or resume must be submitted with this application. Name ______Nega Debela______ Degree(s) _Ph.D.,M.Sc., M.Ed., B.Ed.,BA.____________________ Address _____100 Angus E Peyton_____South Charleston_ _________ __WV____25303_______ Street City State Zip Phone ____(304)7468931___ Fax __(304) 746-1942___ E-Mail _debela1@marshall.edu__________ Department _____GSEPD____________________________________________ Is this student generated research? Yes  FORMCHECKBOX  No  FORMCHECKBOX  If Yes, please give the students name: _Lee Ann Hvizdak______________________________ Complete Page 13(Attachment C) Please be advised that STUDENTS are not permitted to serve as a Principal Investigator. They may be listed as Co-Investigators only. Professional Applicable Licenses: State ______ Number ____________ Exp. Date ________ Restrictions? Yes  FORMCHECKBOX  No  FORMCHECKBOX  N/A  FORMCHECKBOX  State ______ Number ____________ Exp. Date ________ Restrictions? Yes  FORMCHECKBOX  No  FORMCHECKBOX  N/A  FORMCHECKBOX  Board Certifications and Expiration dates (if applicable) _________________________________________________________ Have you ever had any privileges or license suspended or removed? Yes  FORMCHECKBOX  No  FORMCHECKBOX  If yes, where? _____________________________________________ Are you or any member of your research staff under sanction by any state licensing board? Yes  FORMCHECKBOX  No  FORMCHECKBOX  Have you or any of your research staff ever been under sanction? Yes  FORMCHECKBOX  No  FORMCHECKBOX  If yes, explain. Do you have an academic appointment at Marshall University? Yes  FORMCHECKBOX  No  FORMCHECKBOX  If so, indicate level (e.g., Professor, Assoc. Professor, etc.): __Professor_________________________ Research Experience: Have you been a Principal Investigator in the last 5 years? Yes  FORMCHECKBOX  No  FORMCHECKBOX  How many years have you been conducting research in any capacity? __10_______ Years Have any of your studies been suspended or terminated? Yes  FORMCHECKBOX  No  FORMCHECKBOX  N/A  FORMCHECKBOX  If yes, submit explanation. Have you or any member of your research staff been under sanction for unethical behavior in research activities? Yes  FORMCHECKBOX  No  FORMCHECKBOX  If yes, submit explanation. List your two most recent IRB approved studies on which you were principal or co-investigator. ______ 198282-2 HYPERLINK "https://www.irbnet.org/release/study/study.jsp?ctx_id=0&spk_id=270186" Attitudinal Study of 4-H Volunteers  198725-3 HYPERLINK "https://www.irbnet.org/release/study/study.jsp?ctx_id=0&spk_id=270501" How do teachers use technology in the cl...  _____________________________________________________ Conflict of Interest: (All possible conflicts of interest must be revealed.) Immediate family means spouse, children, parents, in-laws, and siblings. Interest related to the research means an interest in the sponsor of the research or a product or service being tested. 1. Do you and your immediate family members in the aggregate own more than five percent (5%) of $10,000 (whichever is less) ownership interest in any private or public corporation, partnership, proprietorship, trust, joint venture and every other business interest, including real estate used for income, and specific stocks or an interest of any amount in a non-publicly traded company that an independent observer might reasonably determine could affect or compromise, or appear to affect or compromise research? Moreover, has an ownership arrangement been entered into where the value of the ownership interests will be affected by the outcome of the research? Yes  FORMCHECKBOX  No  FORMCHECKBOX  2. Do you and your immediate family members, in the aggregate, receive more than $100 in gifts and/or $10,000 in honoraria, from any entity such that, to an independent observer, your research could be affected? For example, are the things of value from an entity that has a financial interest that, to an independent observer, could be related to your research? (Gifts and/or honoraria may be due to lecturing, travel, service on an advisory board, or for any other purpose not directly related to the reasonable costs of conducting the research) Moreover, has a compensation arrangement been entered into where the amount of compensation will be affected by the outcome of the research? Yes  FORMCHECKBOX  No  FORMCHECKBOX  3. Do you and/or your immediate family members, in the aggregate, receive more than $10,000 in salary, consulting fees, wages or retainers from any entity other than the Marshall University, and are the circumstances such that, to an independent observer, your research could be affected? For example, are the things of value from an entity that has financial interests that, to an independent observer, could be related to your research? Moreover, has a compensation arrangement been entered into where the amount of compensation will be affected by the outcome of the research? Yes  FORMCHECKBOX  No  FORMCHECKBOX  4. Do you or any member of your immediate family occupy any of the following positions: officer, director, associate, partner, member or proprietor of any corporation, sole proprietorship, partnership, or limited liability company or any other business venture, and are the circumstances such that, to an independent observer, your research could be affected? For example, is the position with an entity that has any financial interest that, to an independent observer, could be related to your research? Yes  FORMCHECKBOX  No  FORMCHECKBOX  5. Do you and/or your immediate family members, in the aggregate, receive royalty income or have a right to receive future royalties under a patent license or copyright, where your research is related to the licensed technology or work; or have other intellectual property interest where your research is related to the licensed technology or work? Yes  FORMCHECKBOX  No  FORMCHECKBOX  6. Do you or any member of your immediate family receive non-royalty payments or entitlements to payments in connection with the research that are not directly related to the reasonable costs of research (enrollment bonuses, milestone payments, etc)? Yes  FORMCHECKBOX  No  FORMCHECKBOX  7. Do students, interns, fellows, or other trainees under your supervision or mentorship participate in research projects in which your and/or your immediate family have a significant financial interest? Yes  FORMCHECKBOX  No  FORMCHECKBOX  (If YES, to any above question, you must submit a Significant Financial Interest Disclosure Form to the Office of Research Integrity. This form can be found on the ORI website.) Research Staff: (Co-Investigators and other research staff) Note: Attachment C must be completed for each person on this list. Name _Lee Ann Hvizdak _________________ Position __student__________________________ Name _________________________________ Position __________________________________ Name _________________________________ Position __________________________________ Name _________________________________ Position __________________________________ Is there an adequate number of qualified staff? Yes  FORMCHECKBOX  No  FORMCHECKBOX  N/A  FORMCHECKBOX  Is there a process to ensure that all persons assisting with the research are adequately informed about the protocol and their research-related duties and functions? Yes  FORMCHECKBOX  No  FORMCHECKBOX  N/A  FORMCHECKBOX  If on-site data collection is done: Will you be on the premises whenever data are collected? Yes  FORMCHECKBOX  No  FORMCHECKBOX  N/A  FORMCHECKBOX  If no, what supervision will be provided on site? ___co-investigator_____________________________ _________________________________________________________________________________________ Will you be on the premises whenever follow-up is done? Yes  FORMCHECKBOX  No  FORMCHECKBOX  N/A  FORMCHECKBOX  If no, who will conduct the follow up data collection? Name _________________________ Degree(s) ________ Position ______________________________ Is any special training required to do the data collection required in this study? Yes  FORMCHECKBOX  No  FORMCHECKBOX  If yes, explain. ______________________________________________________________________ __________________________________________________________________________ List external sites where the research will be conducted (e.g., schools, business, and health care facilities) and subject to the review of the Marshall University IRB. For each site indicate: The name of the site Whether the site has an IRB Whether the site has granted permission for the research to be conducted (attach approval letters) Contact information for the site If the site has an IRB, has the IRB approved the research or do they plan to defer to the MU IRB? _The research site is Enslow Middle School. EMS does not have an IRB. Principal, Mr. Ryan McKenzie, granted permission for the research to be conducted. Contact information for the site is 2613 Collis Ave., Huntington, WV 25702. 304-528-5121. _________________________________________________________________________ _________________________________________________________________________________________ _________________________________________________________________________________________ Is this a multi-center study? Yes  FORMCHECKBOX  No  FORMCHECKBOX  If yes, are you the lead investigator of this study, or is Marshall University the lead site in this study? _________________________________________________________________________________________ If yes, describe the management and communication among sites of information obtained in this research that may be relevant to the protection of research participants, such as: Unanticipated problems involving risks to participants or others Interim results Protocol modifications _________________________________________________________________________________________ _________________________________________________________________________________________ PART II Description of the Research Protocol: Title _One to One Technology Initiative ___ ____________________________ __________________________________________________________________________________________ Does the research present more than minimal risk? Yes  FORMCHECKBOX  No  FORMCHECKBOX  (Note: Minimal risk means that 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.) If yes, describe the provisions for monitoring the data collected to ensure the safety of participants. _________________________________________________________________________________________ _________________________________________________________________________________________ Will you have adequate facilities? Yes  FORMCHECKBOX  No  FORMCHECKBOX  Will you have sufficient time to conduct and complete the research? Yes  FORMCHECKBOX  No  FORMCHECKBOX  Will you have the availability of medical or psychological resources that participants might require as a consequence of the research? Yes  FORMCHECKBOX  No  FORMCHECKBOX  N/A  FORMCHECKBOX  Sponsored Studies: (Submit a copy of the grant application or grant proposal) Federal Department or Agency (if any) _____________________________________________________ (Note: If this is a Federally Funded study the grant application or proposal must be approved by the IRB in accordance with 45CFR46.103(f). Sponsor Contact Person (if applicable): ____________________________________________ Phone: _____________________ Fax: _________________ E-Mail: __________________ Study Subjects and Procedures Total number of anticipated subjects __4_ (Minimum # __2______ Maximum # __4_____) Age of subjects: (Minimum age__18+_______ Maximum age __NA______) Sex of anticipated subjects:  FORMCHECKBOX  Male  FORMCHECKBOX  Female  FORMCHECKBOX  Both male and female Does the study exclude pregnant women or women of child bearing age? Yes  FORMCHECKBOX  No  FORMCHECKBOX  N/A  FORMCHECKBOX  If yes, please identify the rationale. ______________________________________________________ _________________________________________________________________________________________ Will all subjects be legally competent? Yes  FORMCHECKBOX  No  FORMCHECKBOX  N/A  FORMCHECKBOX  Will all subjects be mentally capable? Yes  FORMCHECKBOX  No  FORMCHECKBOX  N/A  FORMCHECKBOX  Will any subjects be chronically ill? Yes  FORMCHECKBOX  No  FORMCHECKBOX  N/A  FORMCHECKBOX  Will any subjects be in pain? Yes  FORMCHECKBOX  No  FORMCHECKBOX  N/A  FORMCHECKBOX  Does the research include subjects likely to be vulnerable to coercion or undue influence? Yes  FORMCHECKBOX  No  FORMCHECKBOX  If yes, describe the adequate additional safeguards included in the protocol to protect their rights and welfare. ________________________________________________________________________________________ ________________________________________________________________________________________ Recruitment: From where will you draw your subjects? Teachers at Enslow Middle School_______________________ Will subjects be drawn from your own patient base? Yes  FORMCHECKBOX  No  FORMCHECKBOX  N/A  FORMCHECKBOX  Will you be in contact with the subjects personal physician? Yes  FORMCHECKBOX  No  FORMCHECKBOX  N/A  FORMCHECKBOX  Will advertisement on any media be necessary? Yes  FORMCHECKBOX  No  FORMCHECKBOX  (Note: The IRB must review any recruitment materials to subjects along with information on their placement and the type of targeted audience.)  FORMCHECKBOX  Radio  FORMCHECKBOX Print  FORMCHECKBOX  TV  FORMCHECKBOX Other _______________ Are there any finders fees involved in recruitment? Yes  FORMCHECKBOX  No  FORMCHECKBOX  N/A  FORMCHECKBOX  If yes, explain _____________________________________________________________________________ _________________________________________________________________________________________ Justify in the abstract that you will have access to a population that will allow recruitment of the required number of participants within the proposed recruitment period. Submit a copy of any recruitment materials that will be utilized, including letters to other individuals soliciting subjects for the study. Informed Consent: How will informed consent be obtained? ___Interview consent and anonymous consent_____________ If a form is used, submit a copy. Will the Principal Investigator conduct the consent? Yes  FORMCHECKBOX  No  FORMCHECKBOX  N/A  FORMCHECKBOX  If no, who and describe his/her informed consent training. _____Lee Ann Hvizdak completed CITI course____________________________________________________ What steps will be taken to minimize the possibility of coercion or undue influence? _There will not be any interviews in public places, privacy will be protected, and signed informed consent will be used. Survey participants will be asked to place completed surveys in a locked box placed in the main office. Surveys will be picked up after 48 hours. ________________________________________________________________________________________ How long will the potential subject have to decide to take part in the study? ___one day for interview participants and 48 hours for survey participants. _________________ How will comprehension of informed consent be assessed? ___ask questions of informed consent. Is the participant able to read, write, and understand? __________________________ Will any of the subjects have their primary language other than English? Yes  FORMCHECKBOX  No  FORMCHECKBOX  N/A  FORMCHECKBOX  If yes, is there an experienced translator available? Yes  FORMCHECKBOX  No  FORMCHECKBOX  N/A  FORMCHECKBOX  Languages: __________________________________________ Will the consent form be translated? Yes  FORMCHECKBOX  No  FORMCHECKBOX  N/A  FORMCHECKBOX  If yes, into what language(s)? _____________________________ What additional safeguards will be in place to protect any vulnerable subjects (children, prisoners, pregnant women, cognitively impaired or mentally disabled participants, economically or educationally disadvantaged, elderly or non-English speaking)? Describe: __I do not plan to interview any vulnerable subjects. _____________________________________________________________________________ ________________________________________________________________________________ Confidentiality: Where will the signed consent form(s) be filed? ____Locked in co-investigators home office_________________ Please indicate where a copy of the subjects informed consent will be filed. Mark all that apply.  FORMCHECKBOX  N/A  FORMCHECKBOX  Research Protocol  FORMCHECKBOX  Pharmacy Service  FORMCHECKBOX  Investigators file  FORMCHECKBOX  Study Subjects Medical Record  FORMCHECKBOX  Other_in a locked file at home___________________ Who will have access to the research record(s) besides your research staff and the agencies already authorized access such as FDA auditors, other federal auditors, and Study Coordinator?  FORMCHECKBOX  No One  FORMCHECKBOX  Sponsors monitor  FORMCHECKBOX  Others, specify___________________________ Where will subjects records be stored during the study? _Locked in co-investigators home office______________ Where will subjects records be stored after completion of study? __In the principal investigators office______ Does the consent contain the required HIPAA Privacy Rule documentation for the release authorization of protected health information for research purposes or, if requesting a waiver of authorization, has justification for IRB Waiver approval been submitted? Yes  FORMCHECKBOX  No  FORMCHECKBOX  N/A  FORMCHECKBOX  Are subjects forms coded to protect privacy? Yes  FORMCHECKBOX  No  FORMCHECKBOX  N/A  FORMCHECKBOX  If yes, where is the key to the code stored? __locked in a file at home_____________________ (Do not use the subjects Social Security Number as an identifier.) Who has access to the code key? ___no one___________________________ If no, what method of protecting identifiers will be utilized? Describe: ________________________ ________________________________________________________________________________________ Privacy: Describe the provisions included in the protocol to protect the privacy interests of participants. _______________ ____Interviews will take place in a room behind closed doors_________________________________________ Monetary Issues: Subject payment: Are subjects paid for participation in the study? Yes  FORMCHECKBOX  No  FORMCHECKBOX  Are subjects reimbursed for expenses? Yes  FORMCHECKBOX  No  FORMCHECKBOX  Is there a completion bonus? Yes  FORMCHECKBOX  No  FORMCHECKBOX  Subject Charges: Will subjects pay for any part of their participation in the study such as: Qualifying examinations Yes  FORMCHECKBOX  No  FORMCHECKBOX  N/A  FORMCHECKBOX  Follow-up visits Yes  FORMCHECKBOX  No  FORMCHECKBOX  N/A  FORMCHECKBOX  Investigational drugs Yes  FORMCHECKBOX  No  FORMCHECKBOX  N/A  FORMCHECKBOX  Investigational devices Yes  FORMCHECKBOX  No  FORMCHECKBOX  N/A  FORMCHECKBOX  Concomitant drugs Yes  FORMCHECKBOX  No  FORMCHECKBOX  N/A  FORMCHECKBOX  Laboratory tests Yes  FORMCHECKBOX  No  FORMCHECKBOX  N/A  FORMCHECKBOX  Will subjects third party carrier be charged for any research-related procedure? Yes  FORMCHECKBOX  No  FORMCHECKBOX  N/A  FORMCHECKBOX  Estimated cost to subject $ ________________ ______________________________________________________________________________________ Abstract: (All of the below listed items must be addressed in the abstract and attached separately) Please submit an abstract of the proposed work (<500 words) providing a complete description of the following: (Abstract must be written in lay terms): The Purpose of the Research: The Scientific or Scholarly Rationale: The Procedures to be Performed: A Description of What Procedures Were Being Performed Already for Diagnostic or Treatment Purposes (if applicable): The Risks and Potential Benefits of the Research: Complete Inclusion/Exclusion Criteria ______________________________________________________________________________________ PART III Training Principal investigators, other investigators, study coordinators, technicians, and other individuals involved with the proposed research are responsible for completion of all required orientation, education, and training identified by the Director, the Office of Research Integrity (ORI) BEFORE submitting the proposal to the IRB. All Co-Investigator(s) and research staff must complete ATTACHMENT C prior to the submission. Everyone involved with the research is held accountable for protecting the rights and safety of human subjects. IRB Mandatory Education/Training : Belmont Report Please read the  HYPERLINK "http://ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htm" Belmont Report as it forms the basis of the Marshall University Human Research Protection Program (HRPP). Human Subject Assurance Training Go to  HYPERLINK "http://www.citiprogram.org" http://www.citiprogram.org. This website contains the CITI Educational course. You must first "Register for the Course" to establish a Username and Password. If you have already established an account, log on to access the educational modules. Once the basic course has been completed then you will be required to complete a refresher course annually. Marshall University Human Research Protection Program - Standard Operating Procedures You are responsible for reading and abiding by the Standard Operating Procedures. (available on the web site at http://www.marshall.edu/research/ori). Part IV TYPE of REVIEW REQUESTED: To qualify for Exempt or Expedited review, the study must pose no more than minimal risk to human subjects. Minimal risk is defined as the situation in which the probability and magnitude of harm or discomfort in the research are not greater in and of themselves than those encountered in daily life or during the performance of routine physical or psychological examinations or tests. (Select only one category) Exempt  FORMCHECKBOX  (Complete Exempt Checklist on page 10 and 11) Expedited  FORMCHECKBOX  (Complete Expedited Checklist on page 12 and the Expedited Protocol Assessment Form) Convened  FORMCHECKBOX  (Include the Initial Protocol Assessment Form) The IRB Chairman or his designee will make the final determination if the protocol meets the criteria for exempt or expedited, as requested. If the protocol does not meet the criteria, it will be presented before a full convened IRB for review. PART V  CERTIFICATION AND ASSURANCES: This certification verifies that I have completed all training required for the submission of this protocol: 1) Read, understand, and will abide the Belmont Report, 2) completion of the CITI Educational Course Modules, and 3) review of the Marshall University HRPP Standard Operating Procedures. I am responsible for the conduct of this research protocol, including the co-investigator(s) and other research staff. I have certified that all co-investigator(s) and other research staff have completed the training requirements and signed the Attachment C. I hereby certify that: The information contained in this document is accurate and correct. I will carefully follow the approved research and submit ALL changes to the IRB for consideration BEFORE incorporating them into the study. I will notify the IRB of: any deviations from the approved research taken in an emergency to protect the subject from harm. any unanticipated problem, or serious, unusual, or unanticipated adverse event. I or my designee will abide by the informed consent process with each subject and document this process on the approved consent form, allowing each subject adequate time before the study to decide voluntarily to participate in this study. I will protect the rights and welfare of each subject to the best of my ability.  SUBMISSION INFORMATION: In preparation for submission of the initial protocol information to ORI, the following information must be submitted for the appropriate category of review required: Complete packets include: Initial Application, study protocol, abstract, PI/Co-PI/ Research Staff CVs, and (if applicable) consents/assents, advertising materials, surveys, Initial Assessment Form, Expedited Assessment Form, sponsor contract, Attachment C Forms. ALL REQUESTED DOCUMENTATION MUST BE SUBMITTED 30 DAYS PRIOR TO THE NEXT SCHEDULED IRB MEETING. ATTACHMENT A EXEMPT CHECKLIST Determining Eligibility for Exempt Status: In order for a study to be eligible for Exempt Status ALL of the following MUST apply: The research presents no more than minimal risk to participants. Selection of participants is equitable. If the research involves interactions with participants: The circumstances of consent minimize coercion and undue influence. Participants will be informed of: That the study involves research. A description of the procedures. That participation is voluntary. Whom to call with questions. Provisions for protecting the privacy interests of participants are adequate. If private identifying data are recorded: Provisions for maintaining the confidentiality of data are adequate ALL of the research activities are described in one or more of the following checked categories (1-6). If ANY aspect of the research does not fall within at least one of these categories, the research IS NOT eligible for exempt status. 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. The research does not involve prisoners as participants. The research is not FDA-regulated.   FORMCHECKBOX 2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, ethnography 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. If the research is VA-regulated, If any disclosure of the human participants responses outside the research could reasonably place the participants at risk of loss of insurability, information obtained is recorded in such a manner that human participants can be identified, directly or through identifiers linked to the participants. The research does not involve prisoners as participants. If the research involves children as participants, the procedures do not involve any of the following: Survey procedures. Interview procedures. Observation of public behavior where the investigators participate in the activities being observed. The research is not FDA-regulated.   FORMCHECKBOX 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 question #2 above, if: i) The human subjects are elected or appointed public officials or candidates for public office; or ii) Federal statues(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. The research does not involve prisoners as participants. The research is not FDA-regulated.   FORMCHECKBOX  4. Research involving the collection or study of existing data, documents, records, 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 links to the subjects. The data must already exist for a study that fall into this category. IF the data are not now in existence (e.g. they are yet to be collected), the study may not be exempted. The data, documents, records, and specimens exist at the time the research is proposed. The research does not involve prisoners as participants. The research is not FDA-regulated.   FORMCHECKBOX 5. Research and demonstration projects which are conducted by or subject to the approval of Department or Agency heads, and which are designed to study, evaluate, or otherwise examine: i) Public benefit or service program; ii) Procedures for obtaining benefits or services under those programs; iii) Possible changes in or alternatives to those programs or procedures; or possible changes in methods or levels of payment for benefits or services under those program. The program under study delivers a public benefit (e.g., financial or medical benefits as provided under the Social Security Act) or service (e.g., social, supportive, or nutrition services as provided under the Older Americans Act). The research is conducted pursuant to specific federal statutory authority. There is no statutory requirement that an IRB review the research. The research does not involve significant physical invasions or intrusions upon the privacy of participants. The federal funding agency concurs that this exemption category applies. The research does not involve prisoners as participants. The research is not FDA-regulated.   FORMCHECKBOX 6. 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 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 US Department of Agriculture. The research does not involve prisoners as participants.  FORMCHECKBOX   Research proposals that do not meet the criteria for an exempt review may qualify for an expedited review, or will be presented before a full convened board. Protocols that do meet the criteria for an exempt review will be so reported and documented at the next IRB meeting.  ATTACHMENT B EXPEDITED CHECKLIST Initial Review of a New Protocol: The following criteria apply to all categories: The research presents no greater than minimal risks to subjects The research includes reasonable and appropriate protections so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal, if the identification of the participants or their responses will reasonably place them at risk of criminal or civil liability or be damaging to their financial standing, employability, insurability, reputation, or be stigmatizing. The research is not classified The research fits into one (or more) of the following categories 1) Clinical studies of drugs and medical devices only when condition (a) or (b) is met. Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.) Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling. FORMCHECKBOX  2) Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows: From healthy, non-pregnant adults who weigh at least 110 pounds: For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and no more frequently than 2 times per week; or From other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and no more frequently than 2 times per week. FORMCHECKBOX  3) Prospective collection of biological specimens for research purposes by noninvasive means. Examples: (a) Hair and nail clippings in a non-disfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization. FORMCHECKBOX  4) Collection of data through noninvasive procedures ( not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject's privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual. FORMCHECKBOX  5) Research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for non-research purposes (such as medical treatment or diagnosis). FORMCHECKBOX 6) Collection of data from voice, video, digital, or image recordings made for research purposes. FORMCHECKBOX 7) Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. FORMCHECKBOX Protocols that do meet the criteria will be so reported and documented at the next IRB meeting. Protocols that do not meet the criteria for an expedited review will be presented before a full convened board.  ATTACHMENT C CO-INVESTIGATORS/RESESARCH STAFF INFORMATION AND CERTIFICATION A copy of your CV or resume must be submitted. NAME: _Lee Ann Hvizdak__ ______________________ PHONE: _304-374-6657_______________ POSITION: __teacher____________ EMAIL: _lhvizdak@access.k12.wv.us_ ______ Research Experience: Have you served as a co-investigator, principal investigator, or as research staff member of any other IRB approved study? Yes  FORMCHECKBOX  No  FORMCHECKBOX  If yes, list your two most recent IRB approved studies in which you have been involved. ____________ ______________ Did you participate in the development of either this protocol or device? Yes  FORMCHECKBOX  No  FORMCHECKBOX  Conflict of Interest: (All possible conflicts of interest must be revealed.) Immediate family means spouse, children, parents, in-laws, and siblings. Interest related to the research means an interest in the sponsor of the research or a product or service being tested. 1. Do you and your immediate family members in the aggregate own more than five percent (5%) of $10,000 (whichever is less) ownership interest in any private or public corporation, partnership, proprietorship, trust, joint venture and every other business interest, including real estate used for income, and specific stocks or an interest of any amount in a non-publicly traded company that an independent observer might reasonably determine could affect or compromise, or appear to affect or compromise research? Moreover, has an ownership arrangement been entered into where the value of the ownership interests will be affected by the outcome of the research? Yes  FORMCHECKBOX  No  FORMCHECKBOX  2. Do you and your immediate family members, in the aggregate, receive more than $100 in gifts and/or $10,000 in honoraria, from any entity such that, to an independent observer, your research could be affected? For example, are the things of value from an entity that has a financial interest that, to an independent observer, could be related to your research? (Gifts and/or honoraria may be due to lecturing, travel, service on an advisory board, or for any other purpose not directly related to the reasonable costs of conducting the research) Moreover, has a compensation arrangement been entered into where the amount of compensation will be affected by the outcome of the research? Yes  FORMCHECKBOX  No  FORMCHECKBOX  3. Do you and/or your immediate family members, in the aggregate, receive more than $10,000 in salary, consulting fees, wages or retainers from any entity other than the Marshall University, and are the circumstances such that, to an independent observer, your research could be affected? For example, are the things of value from an entity that has financial interests that, to an independent observer, could be related to your research? Moreover, has a compensation arrangement been entered into where the amount of compensation will be affected by the outcome of the research? Yes  FORMCHECKBOX  No  FORMCHECKBOX  4. Do you or any member of your immediate family occupy any of the following positions: officer, director, associate, partner, member or proprietor of any corporation, sole proprietorship, partnership, or limited liability company or any other business venture, and are the circumstances such that, to an independent observer, your research could be affected? For example, is the position with an entity that has any financial interest that, to an independent observer, could be related to your research? Yes  FORMCHECKBOX  No  FORMCHECKBOX  5. Do you and/or your immediate family members, in the aggregate, receive royalty income or have a right to receive future royalties under a patent license or copyright, where your research is related to the licensed technology or work; or have other intellectual property interest where your research is related to the licensed technology or work? Yes  FORMCHECKBOX  No  FORMCHECKBOX  6. Do you or any member of your immediate family receive non-royalty payments or entitlements to payments in connection with the research that are not directly related to the reasonable costs of research (enrollment bonuses, milestone payments, etc)? Yes  FORMCHECKBOX  No  FORMCHECKBOX  7. Do students, interns, fellows, or other trainees under your supervision or mentorship participate in research projects in which your and/or your immediate family have a significant financial interest? Yes  FORMCHECKBOX  No  FORMCHECKBOX  (If YES, to any above question, you must submit a Significant Financial Interest Disclosure Form to the Office of Research Integrity. This form can be found on the ORI website.) CERTIFICATION AND ASSURANCES: By submission of this attachment you hereby certify that: The information contained in this document is accurate and correct. You have completed all training required for the submission of this protocol: 1) Read, understand, and will abide the Belmont Report, 2) completion of the CITI educational course modules, and 3) review of the Marshall University HRPP Standard Operating Procedures. You will protect the rights and welfare of each subject to the best of your ability.     Revised 1-12-2010 Page  PAGE 2 of  NUMPAGES 15 z{:; 9:YZqyPQ_`ahiwʻʲʦʲʚʻʻʲvʲjOJQJU5>*OJQJ\5OJQJ\@6@jtOJQJUjOJQJUjOJQJU >*OJQJCJOJQJaJOJQJ OJQJ\5CJOJQJaJ56OJQJ56>*OJQJ 5OJQJ>*CJ$CJCJ *6_z{[\;<~:YZ !] ]`"]"άZ! 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