ࡱ>  bjbj?? <UU0c 86 q/4&, , , , !%|(@-------,1W4.Q)!!Q)Q).*, , /****Q)d, , -*Q)-**T--us)$l--5/<q/t-,'5*'5-*-$Q)Q)Q)..*Q)Q)Q)q/'5Q)Q)Q)Q)Q)Q)Q)Q)Q) :   WESTFIELD STATE UNIVERSITY INSTITUTIONAL REVIEW BOARD Application for use of human subjects in research The aim of the ɫƵ (WSU) IRB is to protect the dignity, rights and welfare of human subjects in research conducted by faculty, staff, students and others as required in accordance with the federal regulations (45 CFR 46). The following information must be provided regardless of funding status. Research in which data are collected through the involvement of human subject participation may not be conducted in the absence of ɫƵ IRB approval. Your completed application should be submitted electronically along with copies of supporting documents which should include consent forms, surveys, questionnaires, etc.) to the WSU IRB ( HYPERLINK "mailto:irb@westfield.ma.edu" irb@westfield.ma.edu). Determination of how your protocol will be reviewed (e.g., Exempt, Expedited or Full Committee) is made by the WSU IRB after you have submitted your application. Please identify the type of review you are requesting. While the WSU IRB reserves the right to review any protocol at a full committee review, those studies which typically require such review are indicated below. Please visit the WSC IRB portal channel for full committee/submission deadlines and/or additional information or contact the committee chair at  HYPERLINK "mailto:irb@westfield.ma.edu" irb@westfield.ma.edu. When approval is issued, an email will be sent to the principal investigator and if requested an approved consent form and approval letter will be sent to the principal investigator. Please do not collect data until you receive the approval notice.Applicant InformationPrincipal Investigator:  FORMTEXT      Phone: FORMTEXT      Email: FORMTEXT      Position at WSU (faculty/student):  FORMTEXT       (if student, please indicate Faculty Advisor below) Dept.:  FORMTEXT       Campus mail code (or other mailing address if needed):  FORMTEXT       WSU Faculty Advisor:  FORMTEXT      Dept.:  FORMTEXT      Email:  FORMTEXT      Co-Investigator(s) (if applicable):  FORMTEXT      Dept.:  FORMTEXT      Email:  FORMTEXT       FORMTEXT      Dept.:  FORMTEXT      Email:  FORMTEXT       FORMTEXT      Dept.:  FORMTEXT       Email:  FORMTEXT      Project Type:  FORMCHECKBOX  Research  FORMCHECKBOX  Thesis Publication  FORMCHECKBOX Teaching  FORMCHECKBOX  Class Project  FORMCHECKBOX  Other (specify):  FORMTEXT      Project Period: From:  FORMTEXT       To:  FORMTEXT      Location of Research:  FORMTEXT      Project Title:  FORMTEXT      FUNDING Information: Project is: unfunded  FORMCHECKBOX  funded  FORMCHECKBOX  (if funded, please complete the following):  FORMCHECKBOX  to be funded (pending) Funding Agency Name: 1.  FORMTEXT       2. FORMTEXT       Sponsor program name:  FORMTEXT       Contract/Grant No. (If applicable):  FORMTEXT       Are other institutions involved in this research? (If yes, please identify): Yes  FORMCHECKBOX  No  FORMCHECKBOX  Has Another IRB reviewed and approved this protocol? (If yes, please identify): Yes  FORMCHECKBOX  No  FORMCHECKBOX  FOR EVALUATION PURPOSES, PLEASE CHECK ANY OF THE FOLLOWING THAT APPLY TO YOUR PROTOCOL.  FORMCHECKBOX Questionnaires or Survey(s) to be Administered FORMCHECKBOX Filming, Video or Audio Recording of Subjects FORMCHECKBOX Review of Data Banks, Archives or Medical Records FORMCHECKBOX Oral History FORMCHECKBOX Subjects Major Language is not English FORMCHECKBOX WSC Students as Subjects FORMCHECKBOX Subjects to be Studied at WSU FORMCHECKBOX Subjects to be Studied at Non-WSU Location(s) FORMCHECKBOX Exclusion of Women or Children Subjects (must explanation reason for exclusion) FORMCHECKBOX Employees as Subjects (WSU or otherwise)APPLICATIONS WHICH TYPICALLY REQUIRE FULL COMMITTEE REVIEW ARE INDICATED BELOW. If you check one or more of the below-listed categories, please submit an original plus 15 copies of this application. FORMCHECKBOX Participants with Disabilities FORMCHECKBOX Protocol is of a Sensitive or Controversial Nature FORMCHECKBOX Children or Minor Subjects (under 18 yrs. Old) Assent Form Reqd FORMCHECKBOX Exposes Subject to Possibility of Physical or Mental Injury/Harm FORMCHECKBOX Prisoners, Parolees or Incarcerated Subjects FORMCHECKBOX Alcohol, Smoking or Drug Related Participation FORMCHECKBOX Suicidal Questionnaires and/or Evaluations FORMCHECKBOX Involves Attachment of Any Apparatus to the Subjects FORMCHECKBOX Pregnant Subjects FORMCHECKBOX Physical Exercise Studies FORMCHECKBOX Fetal, Placental or Surgical Pathology Tissue(s)  FORMCHECKBOX Involves Collection of Blood Samples (fingerpricks/venipuncture) FORMCHECKBOX Involves Deception or Manipulation of Subjects Behavior or Response FORMCHECKBOX Therapist/Client Relationship FOR WSU IRB USE ONLY: dATE RECEIVED: irb APPLICATION NO.: data collection Please check category wherein research will be conducted in one or more of the following methods, only: FORMCHECKBOX Normal educational practices in commonly accepted educational settings FORMCHECKBOX Educational tests (cognitive, diagnostic, aptitude, achievement) wherein subjects responses are not manipulated FORMCHECKBOX Collection or study of existing data, documents, records or specimens  FORMCHECKBOX Survey, Interview or Observational Procedures (if checked please answer the following): YESNOData will be collected so that responses cannot be identified by persons other than the researcher (either directly or indirectly) FORMCHECKBOX  FORMCHECKBOX Subjects responses if known outside of research could increase risk of civil/criminal liability or damage subjects financial standing or employability FORMCHECKBOX  FORMCHECKBOX Research involves collection of sensitive aspects of subjects own behavior, such as illegal conduct, drug use, sexual behavior or use of alcohol FORMCHECKBOX  FORMCHECKBOX minimal riskDoes Research Involve More than Minimal Risk to Subjects? If yes, please explain fully in Benefit & Risk section of this application FORMCHECKBOX  FORMCHECKBOX 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. [45 CFR 46.102(i) ??]description of projectPlease provide complete answers to the following questions as they relate to your use of human subject participants. Avoid the use of jargon, abbreviations or scientific terms, unless those items are defined in your procedures. If applicable, you should include copies of any tests, surveys or questionnaires along with your completed application. Use Additional Sheets for answering, if needed. Purpose & Significance: Explain the purpose of your research. Include any scientific need or rational as well as significance of knowledge.  FORMTEXT       Participant Population & Recruitment: Include the number of participants, gender and age(s). Explain rational for any participant exclusion. Describe how potential participants will be identified and recruited. (If applicable, submit copies of recruitment advertisements, flyers, newspaper ads, etc., along with completed application.)  FORMTEXT       Methods: This description should include instructions given to participants, activities in which subjects will be asked to participate or engage in, special incentives, and experimental procedures.  FORMTEXT       Benefit & Risk: Have the risks involved been minimized and are they reasonable in relation to the anticipated benefits of research? If more than minimal risk is involved, please explain what additional measures will be taken to ensure participant safety. Explain importance of knowledge that may reasonably be expected regarding risk.  FORMTEXT       Informed Consent or Assent( (Attach a copy of the consent and/or assent form(s) you will use to obtain informed consent from participants. Describe procedures for obtaining informed consent and answer the following: Who will be obtaining informed consent? When will subjects be asked to participate and sign the consent form (or given the opportunity to agree to consent)? If applicable, how will minors assent be obtained?  FORMTEXT       Anonymity( & Confidentiality: Describe how either anonymity or confidentiality of subjects will be maintained (Note: if a subject signs a consent form and/or identifiers are obtained by researcher, anonymity cannot be promised. Confidentiality should always be promised to the extent allowed by law.) For studies involving internet surveys, researcher should clarify how email addresses will be disassociated from submitted responses in order to maintain confidentiality.  FORMTEXT       Audio/Video Taping: If audio or video taping of subjects is included in your protocol please explain the disposition of the recordings and/or any other pictures or personal documentation collected during and after completion of your data collection. You should state how long these items will be kept, where stored, and a data destruction date, etc.  FORMTEXT       Compensation: If subjects will be compensated for their participation, provide detailed information about the amount an67> H U W Y     ( < > ? 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If non-monetary compensation (e.g., course credit, services) will be offered, explain how it will be provided. If no compensation will be provided, please state such.  FORMTEXT       Subject Matter: Is the research controversial? Is there a possibility your research will generate public concern? If so, please explain.  FORMTEXT       Debriefing: If applicable to your protocol, please explain your method for debriefing participants at the end of your data collection. If you do not intend to provide a debriefing please explain.  FORMTEXT        Please Identify the Review Category you believe is appropriate for this proposal: FORMCHECKBOX Exempt Review: Certain projects, such as those that involve only survey, questionnaire or interview procedures and anonymous participation, may be categorized as no risk and may be exempt from the Federal Policy for the Protection of Human Research Subjects. The IRB Chairperson will determine if the checklist application meets the exempt criteria. No research with participants under age 18 can be exempt. FORMCHECKBOX Expedited Review: Applications that involve no more than minimal risk to human subjects may be eligible for an expedited review by the Chairperson of the IRB.  FORMCHECKBOX Full Review: Applications that involve more than minimal risks or those in which the identity of participants is at risk require a full IRB review. By inserting my name below and submitting this form through email, I certify that I am knowledgeable and agree to comply with all regulations and policies governing research with human subjects. I acknowledge that I am responsible for requesting any proposed modifications to this protocol for review and approval by the WSU IRB prior to implementation. I further agree to report any adverse events immediately to the WSU IRB and to comply with all requests to report on the status of a study if so requested. (Faculty Advisors hereby also agree to have read and be responsible for guidance and assuring ethical standards during collection of data regarding this protocol). Principal Investigator (Faculty Researcher or Student): Date:Faculty Advisor (if applicable):Date:Co-Investigator (if applicable):Date:Co-Investigator (if applicable):Date:Co-Investigator (if applicable):Date:     Revised 4/6/16 ( Assent is an additional requirement whenever minors are asked to participant as research subjects (i.e., in addition to gaining parental consent, a researcher is required to gain assent from participants who are under the age of 18 years old.) Please see the WSU IRB webpage on the IRB portal channel for additional information regarding this requirement. ( A cover letter consent is typically used for  $IfgdA>wkdvO$$IfTV4(i( t0(6H44 Vaf4p Tln`abcqrstčzoh]jShA>U hhA>hhA>PJ^JjRhA>UjhA>U.j:Qh!/hA>5CJOJQJUaJ hA>5h}hA>5 h$shA> h}hA>hA>h!/hA>5CJOJQJaJ-jhA>5CJOJQJUaJmHnHu(jh!/hA>5CJOJQJUaJ$ $IfgdA>wkdP$$IfTV4(i( t0(6H44 Vaf4p Tjz $IfgdA>gdA>wkdQ$$IfTV40(i( t0(6H44 Vaf4p Tjla $IfgdA>tkdWR$$Ifl*+  t 0644 lap abt~~~ $IfgdA>xkd[S$$Ifl0.*n) t0644 lat%&'(Gg@AFGIJLMOPRSU]cefghnq}꽹깩h=CJaJh6hA>CJaJhnAhA>CJaJ j*hnAhA>0JCJaJhgkjhgkU hA>hih= h$shA>jThA>UjhA>UhA> hhA>hhA>PJ^J4(6~~~ $IfgdA>xkdTT$$Ifl0.*n) t0644 laghzxri $IfgdA>$If$a$gdA>gdA>xkdMU$$Ifl0.*n) t0644 la|| $IfgdA>zkdU$$IflP0(#0*(# t0644 lal|| $IfgdA>zkdVV$$IflO0(#0*(# t0644 lal|| $IfgdA>zkdV$$Ifl@0(#0*(# t0644 lal AG|| $IfgdA>zkdbW$$IflO0(#0*(# t0644 lalGHIKLNOQRTUdef~~~~~~~~v~~$a$gdA>gdA>zkdW$$IflO0(#0*(# t0644 lal }SsWwhgk h`hA>h=hA>U j*h6hA>0JCJaJh6hA>CJaJhA>CJaJfgdA>$a$gdA>$&dPa$gdA>$a$gdA>survey research wherein researcher in lieu of having potential participants sign a consent form will use a cover letter which states by completing the attached survey you are agreeing to participate in this research study. NOTE: DO NOT START DATA COLLECTION UNTIL YOU HAVE RECEIVED APPROVAL AND/OR STAMPED/APPROVED CONSENT FORMS (FOR USE IN YOUR STUDY) FROM THE WSU IRB. IF REVISIONS OR OTHER INFORMATION ARE NEEDED IN ORDER TO APPROVE YOUR PROTOCOL, YOU WILL BE ADVISED AND GIVEN AN OPPORTUNITY TO SUBMIT ANY REQUESTED ITEMS FOR FURTHER REVIEW TOWARDS APPROVAL. 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