ࡱ>    # (bjbjFnFn  $h$h+b b DDDXXX8$XHQn (H^^^)))PPPPPPP$SlV\PD)")))P^^Q!!!)p8^D^P!)P!!G\,N^+L&PQ0HQQLfVVLNNVDN))!)))))PP 4)))HQ))))V)))))))))b X :  Office of Research and Creative Scholarship Institutional Review Board (269) 471-6361 Fax: (269) 471-6246 E-mail:  HYPERLINK "mailto:irb@andrews.edu" irb@andrews.edu պAV, Berrien Springs, MI 49104-0355 Application for Approval of Human Subjects Research Please complete this application as thoroughly as possible. Your application will be reviewed by a committee of պAV IRB, and if approved it will be for one year. Beyond the one year you will be required to submit a continuation request. It is the IRBs responsibility to assign the level of review: Exempt, Expedited or Full. It is your responsibility to accurately complete the form and provide the required documents. Should your application fall into the exempt status, you should expect a response from the IRB office within 2 weeks; Expedited within 2 weeks and a Full review 4-6 weeks.  HYPERLINK "http://www.andrews.edu/services/research/research_compliance/institutional_review/" http://www.andrews.edu/services/research/research_compliance/institutional_review/ Please complete the following application: 1. Research ProjectTitle: Will the research be conducted on the AU campus? ___ Yes ___ No If no, please indicate the location(s) of the study and attach an institutional consent letter that references the researchers study.  What is the source of funding (please check all that apply) ___ Unfunded ___ Internal FundingSource: ___ External FundingSponsor/Source:Grant title:Award # / Charging String: If you do not know the funding/grant information, please obtain it from your department 2. Principal Investigator (PI)First Name: Last Name: Telephone: E-mail:  ___ Yes I am a student. If so, please provide information about your faculty advisor below.First Name: Last Name: Telephone: E-mail: Advisors signature: Department: Program: 3. Co-investigators (Please list their names and contact information below)First Name: Last Name: Telephone: E-mail: First Name: Last Name: Telephone: E-mail: First Name: Last Name: Telephone: E-mail: First Name: Last Name: Telephone: E-mail: 4. Cooperating InstitutionsIs this research being done in cooperation with any institutions, individuals or organizations not affiliated with AU? ___ Yes ___ No If yes, please provide the names and contact information of authorized officials below. Name of Organization: Address: First Name: Last Name: Telephone: E-mail: First Name: Last Name: Telephone: E-mail Have you received IRB approval from another institution for this study? ___ Yes ___ No If yes, please attach a copy of the IRB approval. 5. Participant RecruitmentDescribe how participant recruitment will be performed. Include how and by whom potential participants are introduced to the study (please check all below that apply) ___ AU directory ___ Postings, Flyers ___ Radio, TV ___ E-mail solicitation. Indicate how the email addresses are obtained: ___ Web-based solicitation. Specify sites: ___ Participant Pool. Specify what pool: ___ Other, please specify:Please attach any recruiting materials you plan to use and the text of e-mail or web-based solicitations you will use. 6. Participant Compensation and CostsAre participants to be compensated for the study? Yes ___ No ___ If yes, what is the amount, type and source of funds?Amount:Source:Type:Will participants who are students be offered class credit? ___ Yes ___ No ___ NAAre other inducements planned to recruit participants? ___ Yes ___ No If yes, please describe.Are there any costs to participants? ___ Yes ___ No If yes, please explain. 7. Confidentiality and Data SecurityWill personal identifiers be collected? ___ Yes ___ No Will identifiers be translated to a code? ___Yes ___ NoWill recordings be made (audio, video)? ___ Yes ___ No If yes, please describe. Who will have access to data (survey, questionnaires, recordings, interview records, etc.)? Please list below. 8. Conflict of Interest Do you (or any individual who is associated with or responsible for the design, the conduct of or the reporting of this research) have an economic or financial interest in, or act as an officer or director for, any outside entity whose interests could reasonably appear to be affected by this research project: ___ Yes ___ No If yes, please provide detailed information to permit the IRB to determine if such involvement should be disclosed to potential research subjects. 9. ResultsTo whom will you present results (highlight all that apply) ___ Class ___ Conference ___ Published Article ___ Other If other, please specify: 10. Description of Research SubjectsIf human subjects are involved, please highlight all that apply: ___ Minors (under 18 years) ___ Prison inmates ___ Mentally impaired ___ Physically disabled ___ Institutionalized residents ___ Anyone unable to make informed decisions about participation ___ Vulnerable or at-risk groups, e.g., poverty, pregnant women, substance abuse population 11. RisksAre there any potential damage or adverse consequences to researcher, participants, or environment? These include physical, psychological, social, or spiritual risks whether as part of the protocol or a remote possibility. Please highlight all that apply (Type of risk): ___ Physical harm ___ Psychological harm ___ Social harm ___ Spiritual harm 12. Content SensitivityDoes your research address culturally or morally sensitive issues? ___ Yes ___ No If yes, please describe: 13. Please provide (type in or copy - paste or attach) the following documentation in the boxes below: Protocol : Survey instrument or interview protocol: Institutional approval letter (if off AU campus): Consent form (for interviews and focus groups): Participants recruitment documents: National Institute of Health certificate of training completion  Principal Investigators Assurance Statement for Using Human Subjects in Research ______ I certify that the information provided in this IRB application is complete and accurate. _____ I certify that co-investigators have approved application for IRB submission. ______ I understand that as Principal Investigator, I have ultimate responsibility for the conduct of IRB approved studies, the ethical performance of protocols, the protection of the rights and welfare of human subjects, and strict adherence to the studys protocol and any stipulation imposed by պAV Institutional Review Board. ______ I will submit modifications and / or changes to the IRB as necessary prior to implementation. ______ I agree to comply with all պAVs policies and procedures, as well as with all applicable federal, state, and local laws, regarding the protection of human participants in research. ______ My advisor has reviewed and approved my proposal.      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