??ࡱ?>?? ??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????#` ??wybjbjm?m? ????"?$???????pppp???????84??\??P^?(???---ފ????????????$-?h??????`?@-``?pp??ً>>>`?p8???ފ>`ފ>>??>?D ?d?????v>???0?>I?X?I?>I??>?k-??^>L[---???^---?````???? x????x???pppppp???? IRB GUIDANCE FOR STUDENT RESEARCH AND CLASS PROJECTS Adopted in part, with permission, from The University of North Carolina - Chapel HillFederal regulations and University policies require prior Institutional Review Board (IRB) approval of research involving human subjects, as well as re-approval at least annually. This applies whether the research is conducted by faculty or students, by individuals or by a group. Please note that IRBs do not have the option of granting ?retroactive? approval of research projects or extensions on re-approval deadlines. Failure to obtain proper approval in advance may jeopardize your data, prevent you from publishing the results, and place you and the University in violation of federal regulations. At the same time, many class projects are conducted solely for educational purposes and not as research, and do not require IRB approval. This guidance document will help you determine whether or not you need to obtain approval from the IRB before conducting a given activity. You should err on the side of submitting or consulting with IRB or Department for Human Research Protections (DHRP) staff if there is any doubt that you need approval. All IRB forms and additional guidance are available on the  HYPERLINK "http://www.utoledo.edu/research/RC/HumanSubs_Menu.html" UT Department for Human Research Protections website. STUDENT RESEARCH Student research activities include, but are not limited to, projects that result in undergraduate honors theses, master?s theses, or doctoral dissertations. IRB approval is required if  HYPERLINK "http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm" \l "46.102" human subjects are involved, either directly or through use of identifiable data about them, and the project involves a systematic investigation individuals with an intent to develop generalizable new or expanded knowledge about living individuals. A systematic investigation is one that involves a predetermined method for studying a specific topic, answering a specific question(s), testing a specific hypothesis(es), or developing a theory. Generally, if there is an intention to publish the results in a peer-reviewed journal or to present results at a conference, then IRB review is required.Student researchers may submit applications as a student researcher or study personnel; however, a faculty member must serve as principal investigator or faculty advisor and signatory on all student research. Alternatively, a student researcher, with prior IRB approval, may be included on an existing IRB approved faculty project, if the student activity is (or will be, after an IRB approved modification) subsumed under that existing study. This latter option precludes the need for a separate IRB application from the student. Below are some common scenarios, with likely processing requirements: RESEARCH that involves direct human interaction or a manipulation of their environment (e.g., in person, or via mail, email, web survey, or telephone), or data from human subjects for which the researchers will have access to identifiers. ?! IRB approval required ?! Submit IRB application form with P.I. or faculty advisor signature; or amend existing approved study to add student to research personnel. Student researcher, co-investigators (if a group) and faculty advisor are required to complete  HYPERLINK "http://www.utoledo.edu/research/RC/HumanSubs/training.html" research ethics education and submit certificates of completion with the application, if not already on file.RESEARCH that is limited to secondary analysis of data, records or specimens that are either publicly available, de-identified or otherwise impossible to be linked to personal identities. ?! If source data has identifiers that will not be disclosed to the researcher, then a data use agreement between the researcher and the data custodian may be required to verify that the researcher will not have access to identifying codes. After receipt of the data use agreement, the IRB will issue a memo stating that no further IRB action is required. ?! If the source data either has no identifiers, or the data is publicly available, then the project is not human subject research and no IRB action is required.RESEARCH activities using departmental subject pools (e.g., Psychology, Business, Political Science) even when the activity is conducted for educational purposes as a class requirement. ?! ?IRB approval required if the intent is to develop new or expanded knowledge ?! ?submit an IRB application form for each activity by an individual or small group Student researcher, co-investigators (if a group) and faculty advisor must have current  HYPERLINK "http://www.utoledo.edu/research/RC/HumanSubs/training.html" research ethics education. CLASS PROJECTSClass projects with the limited objective of teaching proficiency in performing certain tasks or using specific tools or methods do not require IRB approval. Instructors and departments should provide guidance about ways to handle topics such as privacy, confidentiality and professional ethics when class projects are part of the course syllabus. IRB chairs and staff can share expertise related to managing risks of deductive disclosure, coercion-free recruiting, informed consent, and special considerations for projects that include potentially vulnerable individuals. Examples of common scenarios: CLASS PROJECTS involving secondary data analyses that are assigned and conducted as educational exercises, using data that is either publicly available, de-identified or otherwise impossible to be linked to personal identities. ?! No IRB action required (neither approval nor determination of human research status) because there are no identifiers and no interaction with people.CLASS PROJECTS involving secondary data analyses that are assigned and conducted as educational exercises, and that use data sets that include private information and codes that link to identifiers, but the students do not have access to the identifiers or the code key. Note - activity must be limited to class project use only. ?! No IRB action required (neither approval nor determination of human research status) Class instructor and department are responsible for providing the necessary training in respecting the confidentiality of the data. CLASS PROJECTS or PRACTICA that involve direct interaction (e.g., in person, via mail, email, web surveys, or telephone), but where the purpose is training, an educational exercise or professional development, and is not for research purposes. The project or practicum is not ?research? even if students ask people questions as part of learning how to conduct interviews or surveys, take histories, administer assessments, or perform  in-house evaluations as requested by the practicum site. ?! No IRB action required (neither approval nor determination of human researc<CK?????????ʸ????t?cN,>#he ?B*CJOJQJ^JaJph#h?PCB*CJOJQJ^JaJph)h?N?h?PCB*CJOJQJ^JaJph)h?PCh?PCB*CJOJQJ^JaJph#h0<B*CJOJQJ^JaJph#h ?B*CJOJQJ^JaJph#hW?B*CJOJQJ^JaJph#h?t?B*CJOJQJ^JaJph)h?N?hL?B*CJOJQJ^JaJph#hX?B*CJOJQJ^JaJph,hZS?hX?5?B*CJOJQJ^JaJph: ; ? ? ? % , 0 D ^ ` ? ? ? ? ? ?  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Class instructor and department are responsible for providing the necessary training in respecting the privacy of the individuals and the confidentiality of any resulting information, along with training in the relevant professional ethics. The Instructor should provide information about the assignment for the students to distribute to people who participate in these class projects. The information should list the instructor as the appropriate contact person should questions arise. CLASS PROJECTS or PRACTICA that involve direct interaction or an intervention or secondary analyses of private identifiable data and are undertaken as both an educational experience and as research (e.g., results of these activities will be presented publicly or otherwise disseminated, or the data will be stored and used by the students or others as research data). ?! IRB approval required ?! When there are several students in a class doing similar projects, a single IRB application may be submitted by the course instructor as PI, listing all students who will be involved. The similarities and differences must be clearly explained on the application and in the protocol. If projects vary greatly, then submit individual IRB applications with the instructor as PI or faculty investigator. The instructor and all student researchers must complete  HYPERLINK "http://www.utoledo.edu/research/RC/HumanSubs/training.html" research ethics education and submit certificates of completion along with the IRB application, if certificates are not already on file with the IRB. Department for Human Research Protections ?g?g i i?l?mmmmm$????j&`#$/??Ifgde?kd?$$If?l????0????'H?6`????j???0???"(??????????4? la?yt?8r?g?g?g?gh0h_hjjj0j2j?jJk?k l4l5l?l?l?l?l?l?l?l?l?l?l?l?l.m??????ʼ?ۼ??ʮ??ʠʠʠʒʄ?rdhyO*CJOJQJ^JaJ#jhyO*CJOJQJU^JaJhm?WCJOJQJ^JaJh?b?CJOJQJ^JaJhh$CJOJQJ^JaJh&a(CJOJQJ^JaJh? ?CJOJQJ^JaJ h?F;heCJOJQJ^JaJ&h?F;he5?CJOJQJ\?^JaJ h? ?5?CJOJQJ\?^JaJ.m/m0m@mImJm?m?m?m?m?m?m?m?m?m?m?m?m?m?mnxx??¯ա???q`XTXTXTXTIG?hn?CJaJUh?8rh?t?CJaJh?a?jh?a?U h?F;h?aCJOJQJ^JaJ h?F;h?!+CJOJQJ^JaJ h?F;heCJOJQJ^JaJhm?WCJOJQJ^JaJh?b?CJOJQJ^JaJ$hyO*h?b?0JCJOJQJ^JaJ$hyO*he0JCJOJQJ^JaJ#jhyO*CJOJQJU^JaJ/?j? hyO*h:;?CJOJQJU^JaJ?m?m?m?m?m?m?m?m?m?m?mOxPx}}}}}}}}}rh ??!`'gd? ^ ? ??!?gd? ^?kd? $$If?l??x?0????'H?6`????j???0???"(??????????4? la?yt\w? Page  PAGE 2 of  NUMPAGES 2 August 27, 2008The University of ToledoDepartment for Human Research ProtectionsInstitutional Review Board OfficesCCE Building ? 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