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New Project 1 New Project 1 Document Transcript

  • NEW PROJECT<br />HUMAN SUBJECTS REVIEW SUMMARY FORM<br />INSTRUCTIONS<br />Please read the following instructions carefully. Improper submission may result in delayed review. Additional information may be found in the Investigator’s Guide to Human Subjects Review (call the Office of Academic Affairs, 626-6434, for a hard copy).<br />All forms must be typewritten or word-processed. If using a typewriter, please use additional pages<br />as needed to provide details requested on page 2 of form. If using a downloaded form, sections on page 2 will expand as text is entered. <br />(2)For all projects, the following items must be submitted for IRB review:<br />____One copy of the signed Human Subjects Review Summary Form (following pages). <br />Pages 1-2 are required. Pages 3-4 may be used to indicate whether the investigator believes the project is eligible for expedited or exempt status. Final determination of project status is made by the IRB Chair. <br /> Signatures of investigator, department chair and faculty supervisor (if a student<br /> project) are required. (If signatures are missing, all materials will be returned.)<br />____One copy of the Information Summary and Consent Document.<br />____One copy of any interview scripts, letters, questionnaires, or other stimuli to be used in the study.<br />____One copy of any advertisement(s) for recruiting subjects.<br />____One copy of letter(s) of agreement from any outside agency, company, clinic, etc. involved in this project.<br />For funded or potentially funded projects, in addition to items checked above:<br />____One copy of the grant research plan (excluding budget pages) or the pharmaceutical protocol.<br />____If multiple funding sources are being sought, provide all funding information requested on page 1 of the Human Subjects Review Summary Form for each source (use additional separate page if necessary). Include a copy of the research proposal sent to each funding agency. A cover letter of explanation to the Human Subjects Office is helpful.<br />NEW PROJECT<br />HUMAN SUBJECTS REVIEW SUMMARY FORM<br />FOR REVIEW BY: FORMCHECKBOX HSIRB-01<br />Principal Investigator: FORMTEXT _Meri StilesPhone/Pager: FORMTEXT _802-626-4825SSN: FORMTEXT _NOT NEEDEDDegree(s): FORMTEXT _Ph.D MSW E-Mail: FORMTEXT _meri.stiles@lsc.vsc.eduDepartment: FORMTEXT Psychology and Human ServicesCampus Address: FORMTEXT Vail 417Contact Person for Questions: FORMTEXT _Meri StilesPhone/Pager: FORMTEXT 802-626-4825Campus Address: FORMTEXT _ Vail 417E-Mail: FORMTEXT _meri.stiles@lsc.vsc.eduProject Title: FORMTEXT _The Relationship Between College Student Substance Misuse and Subgroup AffiliationAnticipated Number of Subjects: FORMTEXT _35Anticipated Gender Breakdown: M: FORMTEXT _20 F: FORMTEXT _15Check if this project involves special populations: FORMCHECKBOX _ Minors (under 18) Ages: FORMTEXT       FORMCHECKBOX _ Pregnant Women/Fetuses FORMCHECKBOX _ Cognitively Impaired FORMCHECKBOX _ PrisonersCheck and describe if this project involves either: FORMCHECKBOX Existing Data/Records: FORMTEXT       FORMTEXT       FORMCHECKBOX Pathology/Diagnostic Specimens: FORMTEXT       FORMTEXT      <br />FDA INFORMATION: FORMCHECKBOX Not Applicable or:<br /> FORMCHECKBOX Investigational New Drug (IND)Name: FORMTEXT      Number: FORMTEXT       FORMCHECKBOX Investigational Device Exemption (IDE)Name: FORMTEXT      Number: FORMTEXT       FORMCHECKBOX Biologic ProductName: FORMTEXT      Number: FORMTEXT      <br />FUNDING INFORMATION: FORMCHECKBOX _ No Funding or:<br />Project Sponsor(s): FORMTEXT _LSC Board of Visitors FORMCHECKBOX _External Sponsor and/or FORMCHECKBOX _ Internal GrantDSP Sequence Number(s): FORMTEXT _     Grant/Contract Application Date(s): FORMTEXT _12/08 - 8/09Funding Agency Number(s): FORMTEXT _     Project Director: FORMTEXT Meri Stiles FORMCHECKBOX _ Part of a Training, Center, or Program Project Grant <br />Assurance<br />The undersigned assure that the protocols involving human subjects described in this application are complete and accurate, and are consistent with applicable protocols submitted to external funding agencies. All protocol activities will be performed in accordance with Lyndon State College, State, and Federal regulations. No activities involving the use of human subjects will be initiated without prior review and approval by the College's Institutional Review Board.<br />______________________________________________________________________________________________<br />Signature of Principal InvestigatorDateSignature of DEO (Department Chair)Date<br />For Student Projects:<br />______________________________________________________________________________________<br />Signature of Supervising FacultyDateIRB Approval SignatureDate<br />FOREXPEDITED per 45 CFR 46.110(b) ________, Category ________IRB ID NUMBER:IRBEXEMPT per 45 CFR 46.101(b) ________USEWAIVER of SIGNED CONSENT per 45 CFR 46.117(c) ________ONLYWAIVER of ELEMENTS of CONSENT per 45 CFR 46.116 ________VULNERABLE POPULATION PROTECTION per 45 CFR ____________<br />NEW PROJECT<br />HUMAN SUBJECTS REVIEW SUMMARY FORM<br />INVESTIGATORS<br />[List all personnel (name and degree) involved in this project.]<br /> FORMTEXT _Meri Stiles, Ph.D., MSW<br />ABSTRACT<br />[Provide a concise summary of this project without providing extensive experimental details.]<br /> FORMTEXT _This research will gather data on Lyndon State College student perceptions on the connection between group affiliations and substance use behaviors. <br />RESEARCH PLAN<br />[Include sufficient information for evaluation of this project independent of any other document. Describe how subjects will be identified and approached to participate. Describe study procedures and methods for maintaining confidentiality.]<br /> FORMTEXT _Students will be recruited to the study through flyers and email requests to participate in a focus group of 5-7 members. The focus groups will take place in a private setting on campus and will be audio-taped. Potential participants will be screened for eligibility (LSC student and 18 years of age). Eligible participants will be consented into the study and be provided a copy of their signed consent. Study participant names will never appear in the transcript and the consent forms will be kept separate from the transcripts and audio-tape in the investigator's locked office. The audio-tape will be destroyed after it is transcribed by the investigator. The transcription and analysis will be kept as a password protected file on the investigator's personal computer. Participants will never be identified when data from this study is reported.<br />SCREENING PROCESS (if applicable, otherwise leave blank)<br />[Describe any screening procedures (e.g., diagnostic tests) for determining subject eligibility.]<br />Estimated number of subjects to be screened: FORMTEXT _50<br />Estimated number of subjects to be enrolled: FORMTEXT _35<br />RISKS<br />[Consideration should be given to physical, psychological, emotional, legal, social, or financial risks, and any other risks.]<br /> FORMTEXT _A potential risk of this study is that students may react to questions about substance use. <br />PROCEDURES TO MINIMIZE RISKS<br /> FORMTEXT _If the study raises any personal concerns counseling services will be made available to participants at the Brown House on the LSC campus. The contact information for the Brown House counseling is on the consent form. <br />BENEFITS<br />[Describe potential benefits to study participants and/or mankind. Compensation is not a benefit.]<br /> FORMTEXT The analysis of this data may provide information for the design of a substance use harm reduction program for the college community.<br />ALTERNATIVE PROCEDURES (for treatment/therapy/device projects only, otherwise leave blank)<br /> FORMTEXT _     <br />REGISTRY PROJECTS<br />[To be considered a registry: (1) the individuals in the registry must have a common condition, (2) the individuals in the registry might be contacted in the future (3) the names/data of the individuals in the registry might be used by investigators other than the one maintaining the registry.]<br /> FORMCHECKBOX _ This project establishes a registry. Registry name: FORMTEXT _     <br /> FORMCHECKBOX _ This project uses an existing registry. Registry name: FORMTEXT _     <br />LEVEL OF REVIEW - requested<br /> FORMCHECKBOX Exempt: This project is exempt because data collection will be anonymous and the research is FORMDROPDOWN <br />Forward original application to IRB at Office of Academic Affairs, Vail 365.<br /> FORMCHECKBOX Expedited: This project is eligible for expedited review because it involves FORMDROPDOWN <br />Forward original application plus 3 copies to the Office of Academic Affairs, Vail 365.<br /> FORMCHECKBOX Full: Forward original application plus 5 copies to the Office of Academic Affairs, Vail 365.<br />REQUEST FOR EXEMPTION FROM CONTINUING/ANNUAL REVIEW<br />While all projects involving human subjects must undergo initial review, some research is exempt from continuing/annual review. Annual reporting will be required. At the time of initial review, the IRB determines whether the project is exempt from continuing/annual review. The IRB retains the right to require full board review when warranted by the nature of the research and/or inclusion of vulnerable subject populations. <br />Criteria for Exemption from Continuing/Annual Review<br />Research activities that (1) present no more than minimal risk to human subjects, and (2) involve publicly available information, or data recorded in such a manner that subjects cannot be identified, and (3) involve only procedures listed in one or more of the following categories, may be exempt from continuing/annual IRB review. <br />If you believe your project meets criteria for exemption from continuing/annual review, please check all categories below that apply.<br /> FORMCHECKBOX Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as research on regular and special educational instructional strategies, or research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.<br /> FORMCHECKBOX Research involving the use of educational tests, survey procedures, interview procedures or observation of public behavior.<br /> FORMCHECKBOX Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior not otherwise exempt under the above two categories if the human subjects are elected or appointed public officials of candidates for public office; or federal statutes require without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.<br /> FORMCHECKBOX Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens.<br /> FORMCHECKBOX Research to evaluate or otherwise examine public benefit or service programs; procedures for obtaining benefits or services under those programs; possible changes in or alternatives to those programs or procedures or possible changes in methods or levels of payments for benefits or services under those programs.<br /> FORMCHECKBOX Taste and food quality evaluation and consumer acceptance studies.<br /> FORMCHECKBOX Research using tissues from cadavers.<br />REQUEST FOR EXPEDITED REVIEW<br />Expedited review is permitted for certain kinds of research involving no more than minimal risk and may be reviewed by the IRB chair or a designated voting member. The IRB retains the right to require full board review when warranted by the nature of the research and/or inclusion of vulnerable subject populations. <br />Criteria for Expedited Review<br />Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure. Standard requirements for informed consent (or its waiver, alteration, or exception) apply. The activities listed are not necessarily minimal risk. Inclusion on the list merely means that the activity is eligible for expedited review when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.<br />If you believe your project meets criteria for expedited review, please check all categories below that apply.<br /> FORMCHECKBOX Research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required.<br /> FORMCHECKBOX Collection of blood samples by finger stick, heel stick, ear stick or venipuncture as follows: (a) from healthy, nonpregnant adults, who weigh at least 110 pounds. For these subjects, amounts drawn may not exceed 550 ml in an 8 week period and no more than 2 times per week; or (b) from other adults and children, considering age, weight, and health, 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/kg in an 8-week period and no more than 2 times per week. <br /> FORMCHECKBOX Prospective collection of biological specimens for research purposes by noninvasive means. Examples: (a) hair and nail clippings, in a nondisfiguring manner; (b) deciduous teeth at the time of exfoliation; (c) permanent teeth if patient care indicates a need for extraction; (d) collection of excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or 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) collection of both supra- and subgingival dental plaque and calculus, provided the collection procedure 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. <br /> FORMCHECKBOX 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, electroencepha- lography, thermography, detection of naturally occurring radioactivity, electroretinography, echography, ultrasound, 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.<br /> FORMCHECKBOX Research involving materials (data, documents, records or specimens) that have been collected,<br />or will be collected solely for non-research purposes (such as medical treatment or diagnosis). <br /> FORMCHECKBOX Collection of data from voice, video, digital or image recordings made for research purposes.<br /> FORMCHECKBOX 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. <br />