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(YҷЁE14h3B83 00h -J@^C bCq6 x0>HY P40,|,<̐Gp9$@bd<--*ykF(fu΀ gRu@##:رbL ڐM: &#@A 6KB#OQ1q}CqV؆IPG|5hFjIQ IH(IטFbXjP$A@KDEz$E$Ax_ԵV HmJ!4P@LT :*$@-@AN, .C '.! @_d$md @ ҂2E< )h/0ASB Ȗ ڤ H6 xxe8AS&o͐` $$ $bbD @jAK{eyxyD55iQI 1I F!(3PE yxy9eyNm4`0 U0PP 3h70O| r .^I$(ukAZ 5(- 9F@0$PrXE @10K+*p-yYRP8}`QnK21/h<hI3(Ź!(3,N@]aP@ i Nbb4 ޯE& jwǟsR "nya!]_"II* lbL Zl Ω Ql=FZ-ՁXXOh" LC ZC:> YWg,CDЩ`8}hA!@Cn@" #I0g't9hP;)m_^ f-n͂R,Zl(: T,H2)&bZC>D r)Z>&Ap0[>d0R @yXGNBt1[jZ:=;  ŠHAqsrqȁڏOb 4h)A&o|xde8!A/P 4% @ y@kA'uBe3+k`77\Yldk [Ex͋z:)*@pxy.P:ut:h%x #,ѭ/@LEt*`cA ::ap$@<" mi^I$F@A> 60@RpU+% @h3+.ЩMG' k"A3Љ`8΁@ 2KY!g-׀qPE mb! ,^'nyYi *63h#1D7T/`+O20-#8b`D(y@35nAg0\ spX>͢9Y̠1JAXeTIQBhup,:"H.@CMd5/n!lDc4L- `Y n Yh4D7z!r 堶 xx4ld=/ϲ3x < ^<"* @cd @sxi=hI./t=(iAM @ xaq68!h97 h=7h1x~|1@BlF5RxxC,f&OmH< @ C`GBBcpBn]qL#F '@ŃP,hy!눹ap tmn^H 8 ~A1AD 6&3|, @ ghq5 z^x4@ *xae dx58!]# ہ  @ ˰Px%/|%̐L(@[2,v4Cm3A hB v LڏJ,xGn9X] gJKF >P% Γ@ b>>AwO08yy!Q/<@㓖T @ BBB|B`@l?4d,(ؒ]I@ BP|`Pw@q u|R ?OOb3ā|^>;@u RЩ&2$ I#g`g@R(A;0(@+<1 [d H;]h1@` C7.H 46W`.: 6 BЁ&1V惐p0` A!б w@Z6CX`wAC|c@1]-$9R.S?ԥ$Ɉ28:[ gƳ8h4@LH*`' 1bv8xA>d)* L$c`@wɏ?Ե2QpCd8 4jH} 6h$Z AǢ3(W C< 1+; ǁ6.q `Tm )~>xB ,C| @1#mu$hwR<a!(pC^^^>X|@ BA.8C>hN g28@vCㅶ 1 +D )[l33@ `A^ Z@ZಃXt=3@13u@oXq̏p rL P 2=G!$\q@ BP*X9+QPAQ. r;8!9pC+~De +܇zh/T #!fm @ 7u;pCHFTP!6B؆zn2-cfbqe 6-ʞ@g-VZkC npu @X X@cH~Fe!- @r08 Q&5EmS$B4Pa*H[Tc"7ya=-Hq0@ U`.,Ƚ<%`g3ػ A·8#udaYҴ @ |PgC jAX;4qB h?3@l' j NYǃe[,+.+R !h0m;{Zap; ,M)L,,߰ІV&!8@A 4Ә (ya!Xi+@1tsPhmH/0V @)L-DxyAX;@1[$ TNP$ cF/@ ͂g1;X$JFH"@녔"B4>%  kC#Z@ PF '$eG]H E(@pAΆg )o.PfXv'T^!f6n$K!Άv`@ Q t^!pvFu.<䇜 bĿ| "섖22^})@?CKRe05AjiX[O:HI|ޘu IENDB`.(   vhttp://www.nihtraining.com/ohsrsite/guidelines/45cfr46.htmlvhttp://www.nihtraining.com/ohsrsite/guidelines/45cfr46.htmlZhttp://www.hhs.gov/ohrp/irb/irb_guidebook.htmZhttp://www.hhs.gov/ohrp/irb/irb_guidebook.htm/ 00DTimes New Romanttxu 0DArialNew Romanttxu 0 DArial Narrowanttxu 0"0DWingdingsowanttxu 0 A.  @n?" dd@  @@`` `+"    "   !,b$%hgF5hO 0e0e A@A5%8c8c     ?1d0u0@Ty2 NP'p<'p@A)BCD|E?@8uʚ;~/ʚ;g4=d=d 0ppp@ <4!d!d@k 0tTu<4dddd@k 0tTu R0___PPT10 ___PPT9(l? %r!Understanding the Institutional Review Board  When Do I Need to Apply? IIA1 Salem State College Opening Day 200422A Objectives A&Discuss the role of the Institutional Review Board (IRB). Identify the necessary components for a proposed project to meet the requirements for an IRB application. Discuss and demonstrate the steps researchers should take to receive approval prior to initiating research endeavors on campus.P:;CkcCInstitutional Review BoardAThe IRB is an administrative body charged with the responsibility to assure compliance and provide documentation of such compliance with the Uniform Federal Policy for the Protection of Human Subjects (UFPPHS) http://www.hhs.gov/ohrp/ <AEAA Salem State College IRBAThe purpose of the IRB at Salem State College is to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institutionAConducting Research On CampusAIf it has been determined that the proposed projects meet the definition of research and human subjects then researchers will submit an application for research to the IRBbLaaaaDaA Defining ResearchA8Research  & systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalized knowledge. 1@  AAI Defining Human SubjectsA~Human subjects  & living individual(s) about whom an investigator conducting research obtains Data through intervention or interaction with the individual, Identifiable private information 1^ObAOA`AI IRB Review ProcessAAssuring subject participation is voluntary Identifying and managing potential risks to subject(s) and researcher(s) Assuring a balance exists between potential benefits of the research to the subject(s) and/or society and the risk assumed by the subject(s)ZA#IRB Review Process Length$ACExempt and Expedited applications are processed as quickly as possible, usually within 2 weeks Full Committee reviews or applications, which the IRB chairperson believes requires a full committee review, may take longer,_}A"Research Classification Categories##AkExempt Review Review of past records and surveys and questionnaires where there is anonymous participation and no risk to human subjects Expedited Review Research involving no more than minimal RISK to human subjects Full Committee Review Required when there is more than minimal RISK to participants or those in which the identity of participants is at riskVZ|ZZZ?ZZZxZC|CC C  C (CCCCCC)CCKC Assessing Risk$AC*Risk  & the probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. 1@AAI&Assessing RiskAbRanges from none-to-significant Minimal risk  & probability and magnitude of harm and discomfort anticipated in the proposed research are not greater, and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. 1d  A AAIA Informed ConsentAResearchers must inform subjects of the potential risk in the Informed Consent Form and then attempt to minimize or take the appropriate precautions to limit the risk0>AATA Informed ConsentAA copy of the consent form must be offered to subjects Consent of subjects under 18 years of age, or persons not competent to give informed consent, must be obtained from parent(s) or guardian(s),7A Disclosure Form A5Describes the research procedures Contains the same information as the consent form, but they need only be read or given to participants Used for research involving surveys, questionnaires, or interview procedures where there is total anonymity and there are no-to-minimal risks involved in participating N#ZZgZZZ6a Student Research AStudents conducting research should have a faculty sponsor who determines whether the research requires approval based upon the use of the definitions of research, human subjects and the risk to these subjectsA%  References ADepartment of Health and Human Services, Office for Human Research Protection (2004). Available at: http://www.hhs.gov/ohrp/ Office of Human Subjects Research (2001). Title 45 CFR Part 46 Protection Of Human Subjects. [Online] Available at: http://www.nihtraining.com/ohsrsite/guidelines/45cfr46.html. Retrieved September 1, 2004. Department of Health and Human Services, Office of Human Subjects Research (2001). IRB guidebook. [On-line] Available at: http://www.hhs.gov/ohrp/irb/irb_guidebook.htm. 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S  6\X `P   X*   6 W `   Z* H  0޽h ? ̙3380___PPT10.tm 0   $(  r  S L Hp  r   S  H @p  H  0޽h ? ̙33y___PPT10Y+D=' v = @B +m  0 `$(  r  S @ D   r  S  D @  H  0޽h ? ̙33y___PPT10Y+D=' v = @B +m  0 p $(   r  S 4 D   r  S   D @  H  0޽h ? f3"V+Nfy___PPT10Y+D=' v = @B +y  0 (0(  (x ( c $ D   x ( c $$7 D @  H ( 0޽h ? f3"V+Nfy___PPT10Y+D=' v = @B +m  0 L$(  Lr L S   D   r L S XƐ D @  H L 0޽h ? zTщ@U[|3y___PPT10Y+D=' v = @B +m  0 ,$(  ,r , S 4͐ D   r , S Dϐ D @  H , 0޽h ? f3"V+Nfy___PPT10Y+D=' v = @B +  0 8:(  8r 8 S ; D    8 S `Ґ D @  "p`PpH 8 0޽h ? f3"V+Nfy___PPT10Y+D=' v = @B +m  0 X$(  Xr X S 0ݐ D   r X S ݐ D @  H X 0޽h ? zTщ@U[|3y___PPT10Y+D=' v = @B +m   0  $(  r  S  D   r  S  D @  H  0޽h ? zTщ@U[|3y___PPT10Y+D=' v = @B +  0 @T:(  Tr T S  D    T S   D @  "P@08XH T 0޽h ? zTщ@U[|3y___PPT10Y+D=' v = @B +m  0 `d$(  dr d S Pa D   r d S ^ D   H d 0޽h ? zTщ@U[|3y___PPT10Y+D=' v = @B +m  0 $(  r  S z D   r  S h{ D @  H  0޽h ? zTщ@U[|3y___PPT10Y+D=' v = @B +m  0 l$(  lr l S   D   r l S   D @   H l 0޽h ? zTщ@U[|3y___PPT10Y+D=' v = @B +m   0 t$(  tr t S   D   r t S   D @   H t 0޽h ? zTщ@U[|3y___PPT10Y+D=' v = @B +m   0 |$(  |r | S d&  D   r | S ('  D @   H | 0޽h ? zTщ@U[|3y___PPT10Y+D=' v = @B +m   0 $(  r  S 3  D   r  S p4  D @   H  0޽h ? zTщ@U[|3y___PPT10Y+D=' v = @B +#  0 JB(  r  S h6  D   (  S W>d?f P 6?QuestionsImpact PH  0޽h ? zTщ@U[|3y___PPT10Y+D=' v = @B +  0  4F(  4x 4 c $?  D    4 c $D  D @   "p`PpH 4 0޽h ? f3"V+Nfy___PPT10Y+D=' v = @B +: 0 @(  X  C       S l  @b  JB___PPT9$ :The purpose of this workshop is to discuss the role of the Institutional Review Board, what is a human subject and why we protect them, and the steps researchers should be take to receive approval prior to initiating any research endeavors on campus.$- H  0޽h ? ̙33 0 $2(  $X $ C      $ S K   @b  JB___PPT9$ lUniform Federal Policy for the Protection of Human Subjects and how does it affect my research activities at Salem State College? The Uniform Federal Policy for the Protection of Human Subjects, (Title 45 Part 46 of the Code of Federal Regulations) is a federal document promulgated by the Department of Health and Human Services (DHHS) through the Office for Human Research Protection (OHRP) outlining the basic ethical principles that should underline research involving human subjects and provides recommendations for conducting such ethical research. Any empirical or educational investigations involving human beings and/or vertebrate animals conducted at Salem State College and/or by the members of its faculty, staff and student body under the sponsorship of the College have a responsibility for the protection of the rights and welfare of human and animal subjects. Z--< F  ;  H $ 0޽h ? ̙33. 0 ~(  X  C       S 0l   @p  XP___PPT92* Do we have an IRB committee at Salem State College? Yes, we do have an IRB at Salem State College. The IRB committee at Salem State College is a non-contract committee comprised of faculty and administrators charged with fulfilling the guidelines established by the OHRP and the institution regarding the rights and welfare of human subjects taking part in research conducted at, or sponsored by, the institution, regardless of the source of funding. @4--4  H  0޽h ? ̙337 0 0(  0X 0 C      0 S ~   @   YActivities meeting this definition are research and may be subject to a review by the IRBZZH 0 0޽h ? ̙33i 0 )!P(  PX P C     ! P S    @|  d\___PPT9>6 OIf I am conducing a research project on campus or using campus equipment do I need to go through a review process? Yes, it is the responsibility of the researcher(s) as well as the IRB committee to determine if the proposed activity meets the definitions of research and human subjects as defined by the Uniform Federal Policy for the Protection of Human Subjects. The IRB will then determine the extent of the review of the proposed activity. ts-L-s = O   H P 0޽h ? ̙33  0 RJ\(  \X \ C     J \ S    @T  <4___PPT9 `The review of research applications includes: assuring subject participation is voluntary and that subjects are free to withdraw at any time, identifying and managing potential risks to subjects and researcher, and assuring a balance exists between potential benefits of the research to the subject and/or society and the risk assumed by the subjects. $a-`AH \ 0޽h ? ̙33 0 P`(  `X ` C      ` S ,   @|  d\___PPT9>6 Are there different classifications of research? How do I know which category my research activities fall under? Research activities involving human subjects are classified into 3 categories: Exempt Review, Exempt Review includes activities involving reviewing of past records and surveys and questionnaires where there is anonymous participation and no risk to human subjects. While these activities 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; Expedited Review, Expedited Review includes activities involving no more than minimal risk to human subjects may be eligible for an expedited review by the Chairperson of the IRB; Full Committee Review, Full Committee Review occurs when there is more than minimal risk to participants or those in which the identity of participants is at risk will require a full IRB review. q-P-2-q P  H ` 0޽h ? ̙33~  0 >6ph(  hX h C     6 h S β   @  ~v___PPT9XP JX What is RISK, this seems to affect the different classifications of research? Risk is defined Uniform Federal Policy for the Protection of Human Subjects  the probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. The risk to subjects may range for none-to-significant. Minimal risk which determines the difference between an Expedited Review and Full committee review is the  probability and magnitude of harm and discomfort anticipated in the proposed research are not greater, and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examination or tests. For example, the risk of taking a blood pressure or flexibility training from a healthy individual for research is not greater than the risk of doing such activities as part of routine physical exam or physical training program. In some research the determination of risk can be tricky, since risk may involve the loss of confidentiality concerning personal information. Questions such as:  Have you ever smoked marijuana? Or  Have you ever cheated on a test? , may seem benign, but the identity of a respondent who gives an affirmative answers does put her/him at risk. In situations when a minimal risk is identified, it is the researcher s responsibility to inform the participants of the potential risk in the Informed Consent Form and then attempt to minimize or take the appropriate precautions to limit this risk. For example, providing access to a mental health professional when there is the potential risk of relapse of a psychological disorder as a result of the research. O--=--  C ;6=     H h 0޽h ? ̙33  0 ^Vp(  pX p C     V p S    @b  JB___PPT9$ >In situations when a minimal risk is identified, it is the researcher s responsibility to inform the participants of the potential risk in the Informed Consent Form and then attempt to minimize or take the appropriate precautions to limit this risk. For example, providing access to a mental health professional when there is the potential risk of relapse of a psychological disorder as a result of the research. D-   H p 0޽h ? ̙33B  0 x(  xX x C      x S ղ   @   Investigators should keep copies of consent forms in a locked file cabinet for three years after the completion of the project. H x 0޽h ? ̙33  0 d\(  X  C     \  S `   @b  JB___PPT9$ 8When the research involves only survey, questionnaire or interview procedures where the participants will remain totally anonymous (no names given) and there are minimal risks involved in participation, a Disclosure Form describing research procedures given to a participant may substitute for the consent form. A disclosure form is NOT sufficient if participants are tape recorded, even if risks are minimal. Disclosure forms should contain the same information as the consent forms, but they need only be read or given to participants. No signatures are required. P9-  r   H  0޽h ? ̙33 0 T(  X  C       S |1   @n  VN___PPT90( What if I am collecting information for a class assignment, do I need to go through the IRB? All students conducting research should have a faculty sponsor. It is the responsibility of the faculty sponsor to make a judgment whether the research requires an IRB based upon the use of human subjects and the risk to these subjects. If there are plans for publication or presentation of the work, approval for the study should be made prior to collecting any data. Information relative to the exempt and expedited process can be found on the webpage and on the Exempt Review Checklist. H]--] H  0޽h ? ̙337 0 0(  X  C       S >   @T  <4___PPT9 EThe committee meets once a month to review applications and set policy during the academic year (Sept 1 to June 1). For a Full Committee review please submit your application material 2 weeks prior to the meeting date. These dates vary and can be found on the IRB webpage.-H  0޽h ? ̙33r d,jlovqvxߔؤ.J t{k"wUʌg?"P}k^&Oh+'0DU hp( <H h t HUNDERSTANDING THE INSTUTIONAL REVIEW BOARD: WHEN DO I NEED TO APPLY 4265PC:\Program Files\Microsoft Office\Templates\Presentation Designs\Factory.pot Bill Murphy45Microsoft PowerPoint@Ȑ@5ذ@@uGSg  )'    """)))UUUMMMBBB999|PP3f333f3333f3ffffff3f̙3ff333f333333333f33333333f33f3ff3f3f3f3333f33̙33333f333333f3333f3ffffff3f33ff3f3f3f3fff3ffffffffff3ffff̙fff3fffff3fff333f3f3ff3ff33f̙̙3̙ff̙̙̙3f̙3f333f3333f3ffffff3f̙3f3f3f333f3333f3ffffff3f̙3f3ffffffffff!___www4'A x(xKʦ 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   <On-screen Show-g  Times New RomanArial Arial Narrow WingdingsFactoryIUnderstanding the Institutional Review Board When Do I Need to Apply? ObjectivesInstitutional Review BoardSalem State College IRBConducting Research On CampusDefining ResearchDefining Human SubjectsIRB Review ProcessIRB Review Process Length#Research Classification CategoriesAssessing RiskAssessing RiskInformed ConsentInformed ConsentDisclosure Form Student Research Slide 17 References  Fonts UsedDesign Template Slide Titles 8@ _PID_HLINKSA@ <http://www.nihtraining.com/ohsrsite/guidelines/45cfr46.html.http://www.hhs.gov/ohrp/irb/irb_guidebook.htm#_ 0Bill MurphyBill Murphy  !"#$%&')*+,-./0123456789:;<=>?@ABCDEFGHIJKLMNOPQRSTUVWXYZ[\]^_`abcdefghijklmnopqrstuvwxyz{|}~Root EntrydO)PicturesOCurrent UserSummaryInformation(tUPowerPoint Document(("DocumentSummaryInformation8