ࡱ> Y 4bjbj[[ 469 \9 \_p| | hhh|||8\ |g@ " .(//4/aU{c,j$]r̷Uh?nTaU?n?n̷/4/%!a|a|a|?nR/h4/a|?na|a|J\F"/pnzB70gT^Gq hƪ ?n?na|?n?n?n?n?n̷̷a|?n?n?ng?n?n?n?n?n?n?n?n?n?n?n?n?n| > :  INCLUDEPICTURE "cid:image002.png@01D290D0.BFF35BC0" \* MERGEFORMATINET Institutional Review Board 1000 ASU Drive #210 Lanier Hall 114 Lorman, MS 39096-7500 Tel: 601-877-3964 Fax: 601-877-2327 E-mail:  HYPERLINK "mailto:IRB@alcorn.edu" IRB@alcorn.edu Application for Review of Research Involving Human Subjects All forms must be completed, signed by the RPI, and submitted by FAX, Email, or single-sided hard copy. Research Training):  FORMCHECKBOX  Yes  FORMCHECKBOX  No If Yes, please attach a copy of verification. 1. RESPONSIBLE PRINCIPAL INVESTIGATOR (RPI) The individual who has lead responsibility for conducting the research. The RPI may be a ASU employee or external individual. Whenever the responsible principal investigator is not a ASU faculty or staff member, the research must be supervised by a non-visiting ASU faculty or staff member, who will be designated as the Responsible Research Supervisor (RRS). Last Name:  FORMTEXT      First Name:  FORMTEXT       Academic Degree(s):  FORMTEXT      Dept. or Unit:  FORMTEXT      Office Address:  FORMTEXT      Mail Stop:  FORMTEXT      Street Address:  FORMTEXT      City:  FORMTEXT      State:  FORMTEXT      Zip Code:  FORMTEXT      Phone:  FORMTEXT      Fax:  FORMTEXT      E-mail:  FORMTEXT      ASU Status:  FORMCHECKBOX  Faculty  FORMCHECKBOX  Academic professional/Staff  FORMCHECKBOX  Student  1A. Responsible Research Supervisor (RRS) A member of the ASU faculty or staff (i.e., an employee of ASU) who has supervisory responsibility for the protection of the subjects and the conduct of the human subjects research described in the research protocol submitted for review under the ASU policy and procedures for human research protection. ASU students and graduate assistants cannot serve as RRS. Last Name:  FORMTEXT      First Name:  FORMTEXT       Academic Degree(s):  FORMTEXT      Dept. or Unit:  FORMTEXT      Office Address:  FORMTEXT      Mail Stop:  FORMTEXT      Phone:  FORMTEXT      Fax:  FORMTEXT      E-mail:  FORMTEXT      ASU Status:  FORMCHECKBOX  Faculty  FORMCHECKBOX  Academic professional/Staff  FORMCHECKBOX  Other _________________________ 1B. List all other ASU Co-Researchers  FORMTEXT        FORMTEXT        FORMTEXT        FORMTEXT       2. PROJECT TITLE  FORMTEXT       2A. Project Type:  FORMCHECKBOX  Master s project/thesis  FORMCHECKBOX  Faculty research  FORMCHECKBOX  Sponsored research  FORMCHECKBOX  Student research  FORMCHECKBOX  Doctorate research/thesis  FORMCHECKBOX  Other: please specify  FORMTEXT       2B. Joint Project  FORMCHECKBOX  Yes  FORMCHECKBOX  No Name of Lead Investigator/Organization:  FORMTEXT      Name of Partner Institution/Organization:  FORMTEXT      Partner Investigator Last Name:  FORMTEXT      First Name:  FORMTEXT       Academic Degree(s):  FORMTEXT      Dept. or Unit:  FORMTEXT      Office Address:  FORMTEXT      Mail Stop:  FORMTEXT      Street Address:  FORMTEXT      City:  FORMTEXT      State:  FORMTEXT      Zip Code:  FORMTEXT      Phone:  FORMTEXT      Fax:  FORMTEXT      E-mail:  FORMTEXT       3. FUNDING Indicate whether this research is funded by, or application has been made for, a grant, contract, or gift. 3A. STATUS  FORMCHECKBOX Research is not funded and is not pending a funding decision (Proceed to Part 4).  FORMCHECKBOX Research is funded (funding decision has been made).  FORMCHECKBOX Funding decision is pending. Funding proposal submission date:  FORMTEXT       3B. SOURCE(S) If the research is funded or pending a funding decision, mark and name all sources: Type of FundingMark all that applyName of Source FORMCHECKBOX ASU Department, College, or Campus (includes research board and campus fellowship training grants) FORMTEXT       FORMCHECKBOX Federal (from federal agencies, offices, departments, centers) FORMTEXT       FORMCHECKBOX Commercial Sponsorship (from corporations, partnerships, proprietorships) FORMTEXT       FORMCHECKBOX State of Mississippi Department or Agency (from any state office or entity) FORMTEXT       FORMCHECKBOX Gift or Foundation (public or private foundations, not-for-profit corporations, private gifts) FORMTEXT       FORMCHECKBOX Local Government Agencies (Cities, counties, municipalities) FORMTEXT       FORMCHECKBOX Mark if funding is passable through State sources FORMTEXT       FORMCHECKBOX Mark if funding is passable through Federal sources FORMTEXT        Mark here if the funding is through a Training Grant:  FORMCHECKBOX  3C. PROPOSAL Attach a complete copy of the funding proposal or contract.  FORMCHECKBOX Attached Sponsor-assigned grant number, if known:  FORMTEXT       Title of funding proposal or contract, if different from project title in part 2:  FORMTEXT       4. SUMMARIZE THE RESEARCH. In LAY LANGUAGE, summarize the objectives and significance of the research. All boxes are expandable so please use as much detail as possible.  FORMTEXT       5. Data Collection (mark all that apply)  FORMCHECKBOX  From existing data, documents, or records that are publicly available.  FORMCHECKBOX  From existing data, documents, or records that are confidential. Access to the documents or records is restricted and can occur by permission only.  FORMCHECKBOX  From existing biological, diagnostic, or pathological specimens that are confidential. Access to the specimens is restricted and can occur by permission only.  FORMCHECKBOX  By directly or indirectly interacting with subjects individually or in groups.  FORMCHECKBOX  From the observation of public behavior.  FORMCHECKBOX  Other (please explain)  FORMTEXT       5A. TYPE OF RESEARCH (mark all that apply) (Data collected from schools, institutions, organizations, etc., research must have written approval, on letterhead, from those organizations.) A.  FORMCHECKBOX Research conducted in a school setting that focuses on the following normal educational practices:  FORMCHECKBOX  Instructional strategies, techniques, or curricula for regular education  FORMCHECKBOX  Instructional strategies, techniques, or curricula for special education  FORMCHECKBOX  Classroom management methods for regular education  FORMCHECKBOX  Classroom management methods for special education B.  FORMCHECKBOX Research that involves the use of educational tests (diagnostic, aptitude, achievement), surveys, interviews, and/or observation of public behavior. C.  FORMCHECKBOX Research that involves the collection or study of existing data, documents, pathological specimens, and/or diagnostic specimens. D.  FORMCHECKBOX Research that involves the collection of biological samples by finger stick, heel stick, ear stick, or venipuncture. E.  FORMCHECKBOX Research that involves the collection of data by non-invasive means using one or more of the following procedures:  FORMCHECKBOX  voice, video, digital, or image recordings  FORMCHECKBOX  weighing or testing sensory acuity  FORMCHECKBOX  moderate exercise  FORMCHECKBOX  muscular strength testing  FORMCHECKBOX  physical sensors applied to the surface of the body or at a distance, and the procedure does not involve input of significant amounts of energy into the subject or an invasion of the subjects privacy  FORMCHECKBOX  flexibility testing  FORMCHECKBOX  magnetic resonance imaging (MRI)  FORMCHECKBOX  electrocardiography (ECG)  FORMCHECKBOX  electroencephalography (EEG)  FORMCHECKBOX  finger nail or hair clipping  FORMCHECKBOX  mouth or skin swab F.  FORMCHECKBOX  Research that is conducted by or subject to the approval of a department or agency head and is designed to study, evaluate, or otherwise examine a public benefit or service program, its procedures for obtaining benefits of services, possible changes in or alternatives to the program or its procedures, or possible changes in methods or levels of payments for benefits or services provided. G.  FORMCHECKBOX Taste and food quality evaluation and consumer acceptance studies in which wholesale foods without additives are consumed, and the food consumed contains food ingredients at or below the level known to be safe and for a use known to be safe. 5B. ANTICIPATED NUMBERS How many subjects, including controls, will you study in order to get the data that you need? If you plan to study disproportionate numbers of a given sex, race, or minority group, provide scientific rationale in 11. Please list and describe each performance cite separately. Performance SiteTotal1. FORMTEXT       FORMTEXT      2. FORMTEXT       FORMTEXT      3. FORMTEXT       FORMTEXT      TOTALS FORMTEXT      List anticipated numbers for additional performance sites on an attachment and mark here:  FORMCHECKBOX  5C. AGE RANGE Mark all that apply. Researchers planning to include children in research projects involving more than minimal risk must provide written documentation of the benefits that are likely to accrue to a child participating in the project. This should include information gathered on adults, if it exists, or an explanation about why it does not exist.  FORMCHECKBOX  07 years  FORMCHECKBOX  817 years  FORMCHECKBOX  1864 years  FORMCHECKBOX 65+ years  FORMCHECKBOX  If applicable, written documentation of benefits for including children in more than minimal risk research is attached. 5D. Research Will Focus on Specific Subject Groups Eligibility for participation in this research will be restricted based on the following criteria:  FORMCHECKBOX Gender or sex  FORMCHECKBOX  Race/Ethnicity  FORMCHECKBOX  Religion  FORMCHECKBOX Socioeconomic status  FORMCHECKBOX  Sexual orientation  FORMCHECKBOX  Age  FORMCHECKBOX English as a first language  FORMCHECKBOX Other (please describe)  FORMTEXT       5E. Adults (persons 18 years of age and older)  FORMCHECKBOX  ASU students  FORMCHECKBOX  Adults in the community (not ASU students)  FORMCHECKBOX  Pregnant women  FORMCHECKBOX  Adults in treatment  FORMCHECKBOX  ASU faculty and staff  FORMCHECKBOX  Adults having legal representatives (guardians)  FORMCHECKBOX  Adults with limited civil freedom (prisoners, parolees, probationers)  FORMCHECKBOX  Adults with psychological, cognitive, neurological, or intellectual impairment  FORMCHECKBOX  Adults with a life-threatening illness  FORMCHECKBOX  Adults with known history of trauma or victimization  FORMCHECKBOX  Elected or appointed public officials or candidates for public office 5F. Minors (children and adolescents under 18 years of age)  FORMCHECKBOX  ASU students  FORMCHECKBOX  Non-ASU minors  FORMCHECKBOX  Juvenile detainees  FORMCHECKBOX  Minors with known history of trauma or victimization  FORMCHECKBOX  Minors with known physical or psychological conditions 5G. Financial Interests: Indicate below if any investigators or any members of their immediate families have any relationships, commitments, or activities with the sponsor of this research that might present or appear to present a conflict of interest with regard to the outcome of the research. (If a financial conflict of interest exists, please submit the ASU approved conflict management plan. If you have questions about conflict of interest contact the Office of the Vice Chancellor for Academic Affairs and Provost at 217.206.6614.)  FORMCHECKBOX  Ownership, equity or stock options Has been disclosed to the ASU campus OR FORMCHECKBOX  has not been disclosed to the ASU campus  FORMCHECKBOX  Personal compensation such as royalties, consulting fees etc. has been disclosed to the ASU campus OR  FORMCHECKBOX  has not been disclosed to the ASU campus  FORMCHECKBOX  Intellectual property such as patents, trademarks, copyright, licensing, etc. has been disclosed to the ASU campus OR FORMCHECKBOX  has not been disclosed to the ASU campus  FORMCHECKBOX  Other conflict of interest: Has been disclosed to the ASU campus OR  FORMCHECKBOX  has not been disclosed to the ASU campus  FORMCHECKBOX  No conflicts exist 6. Recruitment 6A-1 RECRUITING PROCEDURES Specifically describe the systematic procedures for finding and recruiting subjects or requesting pre-existing data or materials. 1) State whether any of the researchers are associated with the subjects (e.g., subjects are students, employees, patients). 2) Name any specific agencies or institutions that will provide access to subjects or subject data. 3) Who will contact the prospective subjects? 4) Who gives approval if subjects are chosen from records? 5) Describe solicitation through the use of advertising (e.g., posters, flyers, announcements, newspaper, radio, television, Internet), face-to-face interaction, direct mail or phone contact, classrooms, subject pools, health care registries, patient referrals, and institutional  gatekeepers, as applicable.  FORMTEXT       6 A-2 Attach final copies of recruiting materials including the final copy of printed advertisements and the final version of any audio/taped advertisements and mark here: Attached  FORMCHECKBOX  Not applicable  FORMCHECKBOX  6 A-3 Attach written approval from agency, organization, or facility giving permission to conduct research at their location. Approval must include reference to a full understanding of the nature of the research and degree of their participation.  FORMCHECKBOX  Attached  FORMCHECKBOX  Not applicable  FORMCHECKBOX  Institutional Research 6B. WITHHELD INFORMATION Do you propose to withhold information from subjects prior to or during their participation?  FORMCHECKBOX  Yes  FORMCHECKBOX  No If yes, describe what will be withheld, justify the withholding (address risks, provide rationale), describe the debriefing plan, and attach a labeled copy of a written debriefing form, to be provided to subjects.  FORMCHECKBOX  Debriefing attached  FORMTEXT       7. RESEARCH PROCEDURES: 7A. Subjects will be asked to: (Mark all that apply)  FORMCHECKBOX  complete an online survey or questionnaire  FORMCHECKBOX  complete a paper survey or questionnaire  FORMCHECKBOX  complete a face-to-face interview  FORMCHECKBOX  with  FORMCHECKBOX  without audiotaping/videotaping  FORMCHECKBOX  complete a telephone interview  FORMCHECKBOX  perform research tasks such as viewing pictures or listening to a presentation  FORMCHECKBOX  provide biological samples (e.g., hair or nail clippings, saliva, etc.)  FORMCHECKBOX  other (please explain)  FORMTEXT        FORMCHECKBOX  does not apply -- data will be collected from existing records or documents only.  FORMCHECKBOX  does not apply -- data will be collected through behavioral observation only. 7B. Data will include: (Mark all that apply)  FORMCHECKBOX  private information about each subject (i.e., age; income; health status; psychological, educational, or physical test scores; grades; biological specimens; audio, video, or photographic records; etc.).  FORMCHECKBOX  the subjects personal opinions, beliefs, perceptions, views, values, experiences, and/or behaviors.  FORMCHECKBOX  the subjects professional opinions or expertise. 7C. The data collected will be: (Mark only one)  FORMCHECKBOX  coded for research purposes but the research data include codes or demographic identifiers that would permit the researcher to identify individuals either directly or indirectly, through links to individual subjects. In other words, the subject could be identified either directly or indirectly through demographic data or a master code list linking names and research code numbers.  FORMCHECKBOX  recorded in a way that does not allow the subject to be identified, either directly or indirectly by anyone (including the researcher), through coding, demographic information, or other identifiers linked to the subject cases. 7D. Data will be: (Mark only one)  FORMCHECKBOX  Anonymous. The researcher will not know who gave what answers. No identifying information will be collected. No links between subject names and research code numbers exist.  FORMCHECKBOX  Confidential. Research coding will allow the researcher to match subject identifiers with the data; however, the researcher will store the data securely and will not disclose any individually identifiable information collected.  FORMCHECKBOX  Confidential, unless the subject provides explicit written permission, on the consent form, indicating that his or her identifying information can be included in the research.  FORMCHECKBOX  Not confidential. Potential participants will be informed, on the consent form, that confidentiality will not be maintained. 7E. Using LAYPERSONS LANGUAGE, specifically describe what the participants (treatment groups and controls) will do and where the research activities will take place. Give approximate dates and durations for specific activities, including the total number of treatments, visits, or meetings required and the total time commitment. (for schools-based research where class time is used, describe in detail the activities planned for nonparticipants and explain where (e.g., in a classroom, in a private area) both participants and nonparticipants will be located during the research activities. Include a concise description of procedures, locations, time commitments, and alternate activities on the relevant consent and assent forms.)  FORMCHECKBOX  Attach final copies (survey, consents, protocols, power points, transcripts of oral presentations, etc.)  FORMTEXT       8. INFORMED CONSENT: University policy requires the execution of a comprehensive, written document that is signed by the subject (or the subjects authorized representative) as the principal method for obtaining consent from subjects. The language in the document must be understandable to the subject or the subjects legally authorized representative. (Attach informed consent and checklist) Children must assent (or, voluntarily agree) to participation and a parent must separately consent on behalf of their child (i.e., two different forms are generally required). Children under age 8 may assent either orally or passively, depending on their level of maturity. Children 817 years old should sign a written form unless the ASU IRB approves a different process. 8A. TYPE OF CONSENT Mark all that apply and attach one copy of each relevant form, letter, or script on university letterhead. Include translations, if consent will be obtained in a foreign language. Use headings, headers, or footers to uniquely identify each document and associate it with the subject group for which it will be used.  FORMCHECKBOX  Informed consent (assent) with an online document.  FORMCHECKBOX  Written informed consent (assent) with a document signed by  FORMCHECKBOX  adult subjects  FORMCHECKBOX  parent(s) or legal guardian(s)  FORMCHECKBOX  adolescents aged 817 years  FORMCHECKBOX  Waiver or alteration of informed consent (attach request for waiver form.)  FORMCHECKBOX  adult subjects  FORMCHECKBOX  parent(s) or legal guardian(s)  FORMCHECKBOX  adolescents aged 817 years  FORMCHECKBOX  Waiver of documentation (signature) of informed consent (attach request for waiver form.)  FORMCHECKBOX  adult subjects  FORMCHECKBOX  parent(s) or legal guardian(s)  FORMCHECKBOX  adolescents aged 817 years 8B. USE OF PROXY Will others (e.g., next of kin, legal guardians, powers of attorney) act on behalf of adult subjects in giving consent to participate in this research?  FORMCHECKBOX  Yes  FORMCHECKBOX  No If yes, describe  FORMTEXT       8C. USE OF PROXY OUTSIDE Mississippi If a proxy is used in research conducted outside Mississippi and/or the United States, provide justification (e.g., statement of an attorney or copy of applicable law) that the proxy is authorized under the laws of the jurisdiction in which the research will be conducted to consent to the procedures involved in this protocol.  FORMTEXT       8D. CONSENT PROCESS Describe when and where voluntary consent will be obtained, how often, by whom, and from whom. If cognitively impaired subjects (including children under age 8) will be involved, explain how the subjects understanding will be assessed and how often; include the questions that will be asked or actions that will be taken to assess understanding. Describe any waiting period between informing the prospective subject and obtaining the consent. Describe steps taken to minimize the possibility of coercion or undue influence. Indicate the language used by those obtaining consent. Indicate the language understood by the prospective subject or the legally authorized representative. If the research involves pregnant women, fetuses, or neonates, indicate whether consent will be obtained from the pregnant woman, mother, father, or all. 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FORMTEXT       9. RISKS 9A. DESCRIPTION Specifically describes all known risks to the subjects for the activities proposed and describes the steps that will be taken to minimize the risks. Include any risks to the subjects physical well-being, privacy, dignity, self-respect, psyche, emotions, reputation, employability, and criminal and legal status. Risks must be described on consent forms.  FORMTEXT       9B. RISK ASSESSMENTS Determining risk related to research is not always an easy task. Risks can be physical, psychological, social, economic, legal, or unknown. The probability (likelihood) as well as the magnitude (i.e., severity, duration, and reversibility) of potential harm must be considered. When evaluating research risk, it is also important to focus on the immediate or reasonably foreseeable risks of the research, as separate from potential risks or benefits associated with the consequences of applying the knowledge that might be gained from the research. The potential benefits of a study do not alter the risk classification. The risk/benefit assessment only refers to the acceptability of the risk, not the level of the risk. A commonly accepted definition of minimal risk is a level of risk no greater than that typically encountered in the daily lives of healthy individuals in the general population. Thus, the researcher should consider (a) the likelihood of potential harm; (b) the magnitude of potential harm; (c) whether the likelihood and magnitude of potential harm are greater than those encountered in the ordinary daily life of a healthy person; (d) what research procedures are in place to minimize the probability and/or magnitude of harm to subjects; and (e) the extent to which those research procedures are adequate to diminish the risk of harm. For example, a breach of confidentiality is a serious risk, but protections such as restricted access (locked files, stand-alone computers, password protections, and certificates of confidentiality) reduce the absolute risk significantly and may thereby make the overall risk to the subject minimal. Please consider the immediate or reasonably foreseeable risks of the research rather than the risks associated with the long-term outcome or consequences of applying the knowledge gained from the research.  FORMTEXT       9C. RISK LEVEL:  FORMCHECKBOX  No more than minimal risk (the probability and magnitude of harm or discomfort anticipated for participation in the proposed 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).  FORMCHECKBOX  More than minimal risk 9D. Data Monitoring Plan: Must describe the provisions for monitoring the data to ensure the safety of subjects (List who will periodically have access to the data, and monitor harms and benefits experienced by subjects? How often will monitoring occur? Where will the data be stored (locked cabinets, password protected files etc)? If appropriate, what criteria will be used to stop the research based on monitoring of the results?)  FORMTEXT       10. BENEFITS Describe the expected benefits of the research to the subjects.  FORMTEXT       11. BENEFITS Describe the expected benefits of the research to society.  FORMTEXT      If additional risk/benefit information is attached, mark here:  FORMCHECKBOX  12. INVESTIGATOR ASSURANCES: The signature of the responsible principle investigator is required (scanned or faxed signatures are acceptable). Other investigators are also responsible for these assurances and are encouraged to sign. I certify that the information provided in this application, and in all attachments, is complete and correct. I understand that I have ultimate responsibility for the protection of the rights and welfare of human subjects, the conduct of this study, and the ethical performance of this project. I agree to comply with all ASU policies and procedures, the terms of its Federal Wide Assurance, and all applicable federal, state, and local laws regarding the protection of human subjects in research. I certify that The project will be performed by qualified personnel according to the ASU IRB-approved protocol. The equipment, facilities, and procedures to be used in this research meet recognized standards for safety. No change will be made to the human subjects protocol or consent form(s) until proposed changes approved by the ASU IRB. Legally effective informed consent or assent will be obtained from human subjects as required. Unanticipated problems, adverse events, and new information that may affect the riskbenefit assessment for this research will be reported to the ASU IRB Office (601.877.3964) and to my Departmental Dean. Student and guest investigators on this project are knowledgeable about the regulations and policies governing this research, including any confidentiality and safety requirements. I agree to meet with the investigator(s), if different from myself, on a regular basis to monitor study progress. If I will be unavailable, as when on sabbatical or other leave, including vacation, I will arrange for an alternate faculty sponsor to assume responsibility during my absence. I will advise the ASU IRB by letter of such arrangements. 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