ࡱ> dfc_ Sbjbjڿڿ .f-b-bK....J4.60~llllG.u [6]6]6]6]6]6]6$ 9;p6GG6ll6kkkll[6k[6kk46l -qW5G6606o52<F2<062<60ak|wl66I"62<B : Ҵý Review Board for Research with Human Subjects ALL PROPOSALS FOR RESEARCH WITH HUMAN SUBJECTS MUST GO THROUGH THE INSTITUTIONAL REVIEW BOARD (IRB) FOR RESEARCH WITH HUMAN SUBJECTS. There are several categories of review for proposals involving research with human participants. 1. Exempt: Research which is exempt from review. 2. Expedited Review: Research which represents no more risk to participants than normal activity; these proposals may be given an expedited Review by the IRB chair and another member. 3. Full Review: Research which does involve some risk to the participant which must therefore be given a full review by the entire IRB Board. The determination of Class of Review (Exempt, Expedited or Full) is made by the IRB, and not by the investigator. In addition to the categories above, there are 2 additional Classifications of Review 4. Renewal: Previously approved studies can be renewed by the IRB if no substantial changes in methodology are proposed. 5. Minors: all studies that will involve the participation of minors ( < 18) require the use of a special form. This form will explain the rubric for determining which type of review is appropriate for your proposal. A check list is included to facilitate that initial determination. Finally, the forms for creating an IRB proposal are appended. Ҵý Review Board for Research with Human Subjects All research involving human participants at Ҵý must first be reviewed by the IRB. The purpose of the IRB is to insure the rights of participants in human research are protected. In order to achieve that goal, all investigators conducting research with human subjects will submit a proposal to the IRB on the appropriate form for review; only after the proposal is reviewed and approved will the actual research be conducted. The IRB will review proposals for research with human participants to insure that such research is conducted in a way that is in accord with federal guidelines for the protection of human participants and represents best practice at institutions like Ҵý. According to the guidelines of the Department of Health and Human Services (HHS Title 45, Part 46.101 to 46.409) research involving human participants can be divided into three categories: exempt, expedited review and full review. Exempt:. Exempt research is defined below but can be summarized as follows: The research involves the use of common educational assessment tests. Personal information that could be used to identify the participant is not recorded. Participation in the study carries no appreciable risks. Participants are at least 18 years oaf age and are not mentally ill. Participants are not coerced to participate in any way Examples of exempt research are: normal classroom assessment measures using standardized educational tests Behavioral data collected through observation of public behavior such as unobtrusively counting the number of people entering and leaving the library as a function of time of day Data obtained through public records if identification of the individuals involved is not possible. The determination that a proposal is exempt is made by the IRB and not the principal investigator. Non-Exempt Research: Non-exempt research can be divided into 2 categories: expedited review and full review. The determination as to whether a proposal is appropriate for expedited review or full review is made by the IRB and not by the principal investigator. All proposals that are judged to be non-exempt should include provisions for subjects giving informed consent as well as provisions for the investigator to provide debriefing to all participants. Expedited Review: Proposals selected for expedited review are proposals that in the opinion of the IRB, do not include procedures that place participants at greater risk than does everyday activities. A full description of the criteria for expedited review is provided below. Examples of research that would likely be selected for expedited review are: Studies that present no greater risk to participants than does every day activity Studies that involve anonymous responses Studies that do not involve disclosure of personal information such as sexual behavior or drug and alcohol use Studies that do not involve collection of bodily fluids Investigators who believe that their proposals are appropriate for expedited review should so indicate on the IRB submission form after filling out the checklist for expedited review. Proposals selected for expedited review are reviewed by the IRB head and one other committee member. In the case that the proposal is submitted by the IRB head, the IRB head will recuse themselves and two IRB committee members will make the determination. Proposals that are not exempt from review and do not meet the criteria for expedited review must be reviewed by the full committee. Examples of research that require full IRB committee review are: Any proposal for research involving participants younger then 18 Any proposal involving prisoners, patients receiving inpatient or outpatient mental health care Any proposal involving the collection of or exposure to bodily fluids such as blood, saliva, or semen. Any proposal involving deception. Any proposal in which disclosure of a participants responses could leave them liable for criminal prosecution Any proposal investigating private issues such as sexual behavior Any proposal investigating clinical disorders such as depression, anorexia, etc. Any proposal where the participants are video taped or audio taped in a way that would permit their identity to be known? Categories of Research that may be considered Exempt by the Institutional Review Board Exemption Categories The following exemption categories are from Title 45, Part 46 of the Code of Federal Regulations for the Protection of Human Subjects ( HYPERLINK "http://www.irb.uiuc.edu/?q=regulation-policies/common-rule.html" 45 CFR 46 ). Title 45, Code of Federal Regulations 46.101(b)(1) exempts research conducted in established or commonly accepted educational settings, involving normal educational practices, such as research on regular and special education instructional strategies, or research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. Title 45, Code of Federal Regulations 46.101(b)(2) exempts research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of  HYPERLINK "http://www.irb.uiuc.edu/?q=investigator-handbook/glossary.html" \l "public" public behavior, unless information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation. Exemption 2 does not apply to the following types of research involving  HYPERLINK "http://www.irb.uiuc.edu/?q=investigator-handbook/glossary.html" \l "child" children: surveys, interviews, and observations of public behavior when the investigator is a participant in the activities being observed. Title 45, Code of Federal Regulations 46.101(b)(3) exempts research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if human subjects are elected or appointed public officials or candidates for public office; or federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. Title 45, Code of Federal Regulations 46.101(b)(4) exempts research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. Title 45, Code of Federal Regulations 46.101(b)(5) exempts research and demonstration projects that are conducted by or subject to the approval of department or agency heads, and that are designed to study, 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 payment for benefits or services under those programs. Exemption 5 cannot be made if prior review is specifically required by statute, or if the Secretary of HHS determines that a research or demonstration project presents a danger to the physical, mental, or emotional well-being of a participant or subject of the research or demonstration project. The standard requirements for informed consent may be waived under Exemption 5 if the research could not practicably be carried out without the waiver, and certain other HHS requirements are met and documented (see  HYPERLINK "http://www.irb.uiuc.edu/?q=regulation-policies/common-rule.html" \l "45cfr46.116" 45 CFR 46.116(c)). Title 45, Code of Federal Regulations 46.101(b)(6) exempts taste and food quality evaluation and consumer acceptance studies, if wholesome foods without additives are consumed; or if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe by the Food and Drug Administration ( HYPERLINK "http://www.fda.gov" \t "_blank" FDA) or approved by the Environmental Protection Agency ( HYPERLINK "http://www.epa.gov" \t "_blank" EPA) or the Food Safety and Inspection Service of the US Department of Agriculture ( HYPERLINK "http://www.usda.gov" \t "_blank" USDA). Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) through an Expedited Review Procedure1 Applicability (A) 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 authorized by  HYPERLINK "http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm" \l "46.110" 45CFR46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects. (B) The categories in this list apply regardless of the age of subjects, except as noted. (C) The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects= financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal. (D) The expedited review procedure may not be used for classified research involving human subjects. (E) IRBs are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review--expedited or convened--utilized by the IRB. (F) Categories one (1) through seven (7) pertain to both initial and continuing IRB review. Research Categories (1) Clinical studies of drugs and medical devices only when condition (a) or (b) is met. (a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.) (b) Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling. (2) 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, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or (b) from other adults and children2, considering the age, weight, and health of the subjects, 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 per kg in an 8 week period and collection may not occur more frequently than 2 times per week. (3) 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 time of exfoliation or if routine patient care indicates a need for extraction; (c)permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by 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) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process 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. (4) 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. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.) 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, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic 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. (5) Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects.  HYPERLINK "http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm" \l "46.101" 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.) (6) Collection of data from voice, video, digital, or image recordings made for research purposes. (7) 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. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects.  HYPERLINK "http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm" \l "46.101" 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.) (8) Continuing review of research previously approved by the convened IRB as follows: (a) where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or (b) where no subjects have been enrolled and no additional risks have been identified; or (c) where the remaining research activities are limited to data analysis. (9) Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified. _______________________ 1 An expedited review procedure consists of a review of research involving human subjects by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB in accordance with the requirements set forth in  HYPERLINK "http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm" \l "46.110" 45 CFR 46.110. 2 Children are defined in the HHS regulations as "persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted."  HYPERLINK "http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm" \l "46.402" 45 CFR 46.402(a).  HYPERLINK "http://www.hhs.gov/ohrp/humansubjects/guidance/63fr60364.htm" Source: 63 FR 60364-60367, November 9, 1998. Categories of Research That Must Be Reviewed by the Institutional Review Board (IRB) through a Full Review Procedure1 Proposals involving: alcohol, nicotine or drugs of any kind. Proposals involving juveniles, the elderly, criminals, mental patients or individuals being treated for any disease. Individuals who are not able to give informed consent. Proposals involving shock or deception. Proposals that place the participant at greater risk than does behavior that is normal and customary in life. Proposals that expect the participant to divulge information of a very personal nature, defined as information that most individuals would not free divulge to others. Proposals that require participants to divulge information that if made public could lead to criminal prosecution. . 4 ` p  $  u | DJMQEF!!V"W"]"^"i"o"##2$3$$$$$&& (2(((,,,,9-:-K-L---<.p.....!/"/%/ h6] h0JjhU h5\hGh5CJaJh5CJaJ h5hTh5hIKh>*hIKh5hDAB* + \ ]      p q ] ^ J K _ [gd$a$gd[\CD,fNefQ{"# & Fgd & FgdgdE>LMNOP] %!&! [$\$^gd & Fdd[$\$gd & Fdd[$\$gdgd$a$gd & F gdgd&!q"##%?&&M'())1*z**,O- & Fdd[$\$gd & Fdd[$\$gd & Fdd[$\$gd & Fdd[$\$gd & Fdd[$\$gdgd & Fdd[$\$gd & Fdd[$\$gdO--.000M0000f335567+7789+:;<<@gd$a$gdgd & Fdd[$\$gd & Fdd[$\$gd%/&/\/]/////// 000001050L0M0x0y0000000111112447*7(;);>>]C^ClFmFFFFFdIeIIIIItMvMzN{NNNNNNNOO,P-P=P h6] hH*hOJQJh6>*]hCJH*aJhGh5CJ\aJh5CJ\aJ h0JhjhUE@B6EGuGJkJWKKK\MtMN@PPPQ2Q3QpQQRFRR\SS & Fgdgd$a$gdgd=P>P@PAPPPPPPPPPPPPPPPQQ&Q'Q0Q1QSSεάhy3hCJH*aJhGh5CJ\aJhu5CJ\aJh5CJ\aJhCJaJh0JOJQJ^J h0JhjhU,1h/ =!"#$% s2&6FVfv2(&6FVfv&6FVfv&6FVfv&6FVfv&6FVfv&6FVfv8XV~ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@_HmH nH sH tH H`H Normal CJPJ_HaJmH nHsH tHDA D Default Paragraph FontRiR  Table Normal4 l4a (k (No List 4U@4  Hyperlink >*phfB^@B  Normal (Web)dd[$\$PK![Content_Types].xmlN0EH-J@%ǎǢ|ș$زULTB l,3;rØJB+$G]7O٭Vc:E3v@P~Ds |w< K)f%/=PS*02[&!O-@S+,-./1EV]2$9%K%&!'%'\'''' (()))l>>>dAAAzFFFG,H=H@HHHKXXXXXXXXXXXXX8@0(  B S  ?exemptioncategoriesKK>|>|>|>|>|>|>|>|>|>| >| >| >| >| >|  GGR/16>.AFK      QYY/19>1AGK = *urn:schemas-microsoft-com:office:smarttags PlaceType=*urn:schemas-microsoft-com:office:smarttags PlaceName9*urn:schemas-microsoft-com:office:smarttagsplace?*urn:schemas-microsoft-com:office:smarttags stockticker    LV00=2H2556!6n6u6B7M7&8'8^<e<==vBwBK6D&4IJ14<HL^CP # J L ^ h j  ?`l)`EK z""""&(**>*+----.|/////23234944899:5===>>AA[C`CCCIIK33333333333333333333333333333333333333333333333333333LLQ{HHI3IKKMHHK 4O/@y[%[Qk6p;0+BR*6k @h7 5B9>J*!$CZ{ h^`OJQJo(hHh^`OJQJ^Jo(hHohpp^p`OJQJo(hHh@ @ ^@ `OJQJo(hHh^`OJQJ^Jo(hHoh^`OJQJo(hHh^`OJQJo(hHh^`OJQJ^Jo(hHohPP^P`OJQJo(hH^`.^`.pp^p`.@ @ ^@ `.^`.^`.^`.^`.PP^P`.h^`OJQJo(hHh^`OJQJ^Jo(hHohpp^p`OJQJo(hHh@ @ ^@ `OJQJo(hHh^`OJQJ^Jo(hHoh^`OJQJo(hHh^`OJQJo(hHh^`OJQJ^Jo(hHohPP^P`OJQJo(hHh^`OJQJo(hHh^`OJQJ^Jo(hHohpp^p`OJQJo(hHh@ @ ^@ `OJQJo(hHh^`OJQJ^Jo(hHoh^`OJQJo(hHh^`OJQJo(hHh^`OJQJ^Jo(hHohPP^P`OJQJo(hH^`.^`.pp^p`.@ @ ^@ `.^`.^`.^`.^`.PP^P`.^`.^`.pp^p`.@ @ ^@ `.^`.^`.^`.^`.PP^P`.^`.^`.pp^p`.@ @ ^@ `.^`.^`.^`.^`.PP^P`.^`.^`.pp^p`.@ @ ^@ `.^`.^`.^`.^`.PP^P`.h^`OJQJo(hHh^`OJQJ^Jo(hHohpp^p`OJQJo(hHh@ @ ^@ `OJQJo(hHh^`OJQJ^Jo(hHoh^`OJQJo(hHh^`OJQJo(hHh^`OJQJ^Jo(hHohPP^P`OJQJo(hH >J 5B*@h7[%Z4Op;[Qk                                     y3/?uEKK@LLLLKH@UnknownG.[x Times New Roman5Symbol3. .[x ArialsWP TypographicSymbolsTimes New RomanG5  hMS Mincho-3 fg?= .Cx Courier New;WingdingsA$BCambria Math"qh2h'2h'P @ &P @ &!24KK3qHP ?2!xx Washington CollegeGeorge SpilichWAC0         Oh+'0|  8 D P\dltҴýGeorge SpilichNormalWAC3Microsoft Office Word@G@-@O - P @ ՜.+,D՜.+,P  hp  Ҵý&K Ҵý Title 8@ _PID_HLINKSA\NV$=http://www.hhs.gov/ohrp/humansubjects/guidance/63fr60364.htm!;http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm46.402;http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm46.110;http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm46.101;http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm46.101;http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm46.110SThttp://www.usda.gov/a>http://www.epa.gov/u= http://www.fda.gov/]F @http://www.irb.uiuc.edu/?q=regulation-policies/common-rule.html 45cfr46.116&(?http://www.irb.uiuc.edu/?q=investigator-handbook/glossary.htmlchildWV?http://www.irb.uiuc.edu/?q=investigator-handbook/glossary.htmlpublic>@http://www.irb.uiuc.edu/?q=regulation-policies/common-rule.html  !"#$%&'()*+,-./012356789:;<=>?@ABCDEFGHIJKLMNOPQRTUVWXYZ\]^_`abeRoot Entry F-g1Table4b<WordDocument.fSummaryInformation(SDocumentSummaryInformation8[CompObjr  F Microsoft Word 97-2003 Document MSWordDocWord.Document.89q