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PK![Content_Types].xmlj0Eжr(΢Iw},-j4 wP-t#bΙ{UTU^hd}㨫)*1P' ^W0)T9<l#$yi};~@(Hu* Dנz/0ǰ $ X3aZ,D0j~3߶b~i>3\`?/[G\!-Rk.sԻ..a濭?PK!֧6 _rels/.relsj0 }Q%v/C/}(h"O = C?hv=Ʌ%[xp{۵_Pѣ<1H0ORBdJE4b$q_6LR7`0̞O,En7Lib/SeеPK!kytheme/theme/themeManager.xml M @}w7c(EbˮCAǠҟ7՛K Y, e.|,H,lxɴIsQ}#Ր ֵ+!,^$j=GW)E+& 8PK!tH`2theme/theme/theme1.xmlYOo5#?MFT6mθloҽ( 7J\ʧ Axgv,It#egzA!/DҐh;K #xJ\*& A>Je++2a,/07" ^E2&lQ$Jqdo4$hITI=2פI F"v@+WWF`1Fi 2n !_潽ݫ92&|Z-odtD >^)=9 Zwzގ'YZ 6[ހbFI ]1gVө_,.,_ٴnyL#7i%lOcY ypf \}HU܏qvIGe\¡ WLaW2H7Cᜌv"s,552kfVfULT >,skB'+ \Hn…[4B\$c<"eՍX1g} j&$ݕ% iSncR79YAkg` [xL2f\Jذ?5lA9W%: X64T,՜U0E)`#5hC0cR}גu3mg_Rʧ~<:BC6ܯCQ "͔_Xqۦa8/:ELps̛#V)Q U02hB|m\CbhLhAP]v| rmY:# B,;X=߻,ɂ(G\Y䐰kzoP nI^ dy #Րks|l2R~6 MaZ~cכ*'m֕"+MιڊUҸZ^,k (GEozC~O l /i8AL5mjQ 0,>͙ŋ4vnavl'SA8hć]2%M0pg$hn PK! ѐ'theme/theme/_rels/themeManager.xml.relsM 0wooӺ&݈Э5 6?$Q ,.aic21h:qm@RN;d`o7gK(M&$R(.1r'JЊT8V"AȻHu}|$b{P8g/]QAsم(#L[PK-![Content_Types].xmlPK-!֧6 +_rels/.relsPK-!kytheme/theme/themeManager.xmlPK-!tH`2theme/theme/theme1.xmlPK-! ѐ'e theme/theme/_rels/themeManager.xml.relsPK]` : Y 4(  4 4 H@'?Rectangle 7` `  n* C   r 4  x`'0e0e?Rectangle 3D T  2 Responsible Conduct in Human Research (Fall 2009),3 'C C  3 @`r 4  xp(0e0e?Rectangle 6,<   J Header image designed by Michelle Jordan, UMBC Creative Services, 2009 .K  F6 K 4 zA??harpotagPicture 9harpotagp fBff33___PPT10u..2`at+D=' = @B +Z 8(  8 8 fr(?6Slide Number Placeholder 5``  l* C    8  xs(0e0e ?Rectangle 2P `    K In brief     8  xt(0e0e ?Rectangle 3 `  FEthics/Regulations What is research Involvement of the IRB Types of review and the consent process The  Bottom linev v v @` fBff33___PPT10i.sH+D=' = @B + Z 0<(  < < fu(?6Slide Number Placeholder 5``  l* C   < <  x w(0e0e ?Rectangle 2P `    p. Doing the right thing   ` <  x@x(0e0e ?Rectangle 3 `   Real integrity is doing the right thing, knowing that nobody s going to know whether you did it or not - Oprah Winfrey 1 Various codes for the proper and responsible conduct of human research have been incorporated into researchers interact with people and how universities conduct business. 1 http://www.wow4u.com/oprahwinfrey/index.html { Z Z Z2 Z Zy   -  Z @` fBff33___PPT10i.3+D=' = @B +Z P@(  @ @ f'?6Slide Number Placeholder 5``  l* C   < @  xy(0e0e ?Rectangle 2P `    p,To do the right thing, know about the ethics- -( - @  x|(0e0e ?Rectangle 3 `  G 45CFR46 - Protection of Human Subjects - ensures minimal standards for the ethical treatment of research subjects based on past history Medical research Social and Behavioral Research Foundations of ethics in human research Freedom from harm Privacy Voluntary participation Protection from risks and safeguard from harm  P0 P* P3 P P. P P+` 0 )3  .02= > p @` @ A??ohrp_headerPicture 5ohrp_header X fBff33___PPT10i. CI+D=' = @B +Z  pD(  D D f@~(?6Slide Number Placeholder 5``  l* C   * D  x`(0e0e ?Rectangle 2P `    ^Understand what research is:  n D  x(0e0e ?Rectangle 3 `  Research: Systematic investigation that contributes to generalizable knowledge In other words, an investigator will be "engaged in research", has proposed an intention to explore a particular topic, while interacting with a living person and either publish (e.g., in a journal) or present at a conference. Human Subjects: Living individuals about whom an investigator conducting research obtains data through intervention or interaction with the individual or identifiable private information pO Z Z Z Z E   ` fBff33___PPT10i.Ɗpj+D=' = @B +~Z Hi(  H H f@(?6Slide Number Placeholder 5``  l* C   4 H  x(0e0e ?Rectangle 2P `    h$Purpose of human research compliance% %( % H  x`(0e0e ?Rectangle 3 `  TRequired by the federal government as well as the University of Maryland Ethical review of research Ensure participants rights are protected and that they are safeguarded from risk and harm Compliance with federal guidelines and principles Department of Health and Human Services University of Maryland System U.S. Department of Education`I  c Iv 2c Uh @` H A??jkpwaze0[1]Picture 6jkpwaze0[1] h  H vA??md-flagPicture 7md-flagP p  H A??ed_gl_headerPicture 8ed_gl_headerP s fBff33___PPT10i.t@3+D=' = @B +Z L(  L L f (?6Slide Number Placeholder 5``  l* C    L  x@(0e0e ?Rectangle 2P `    IThe IRB  " L  x`(0e0e ?Rectangle 3 `  VMembers include: Scientists and non scientists from various disciplines on campus as well as graduate and undergraduate student members Individuals not affiliated with the Campus who represent the concerns of the Community Provides assurance to the federal government that UMBC will comply with the rules and regulations and provides oversight for the university's human research use program z Z Zc ZT Z Zw W  @` fBff33___PPT10i. ;+D=' = @B +Z P{(  P P f(?6Slide Number Placeholder 5``  l* C   % P  x(0e0e ?Rectangle 2P `    YSafeguards from harms (  P  x(0e0e ?Rectangle 3 `  /cEmotional or psychological harm Social harm Physical harm Financial harm Legal harm Moral harmd      d  ` fBff33___PPT10i.2@+D=' = @B +Z T(  T T f (?6Slide Number Placeholder 5``  l* C   # T  x(0e0e ?Rectangle 2P `    WProtection from risks  { T  x(0e0e ?Rectangle 3 `  The greatest risk is often a breach of confidentiality This risk could lead to: social stigma, loss of employment legal prosecution embarrassment damaged family relationships emotional risks (relive or reveal violence ), which may lead to physical danger j8    7    ` fBff33___PPT10i.CNp{I$+D=' = @B +?Z  JBX*(  X X f(?6Slide Number Placeholder 5``  l* C   / X  x(0e0e ?Rectangle 2P `    c!Enhancing voluntary participation" " " X  x(0e0e ?Rectangle 3 `  (Involves the consent process It is a  Process or a  Conversation that most of the time uses a  Document Research statement Purpose Procedures Confidentiality Risks Benefits Freedom to withdraw statement Contact info for the investigator and the IRB Signature and date line h ZN Z Z ZN   ` fBff33___PPT10i.NJo8+D=' = @B + Z  0\(  \ \ f(?6Slide Number Placeholder 5``  l* C   ! \  x(0e0e ?Rectangle 2P `    UTypes of Approval $ z \  x(0e0e ?Rectangle 3 ` ^V___PPT980 H0Exempt Federal regulations specify that certain types of research pose no or very low risks to participants, a minimal review from the IRB is required. Expedited Activity must not involve no more than minimal risk to subjects. The regulatory definition of "minimal risk" is 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 and falls within list of expedited procedures Full Board Full board review is performed by the whole committee and reviews studies that are more than minimal risk, involve vulnerable populations, or involve special circumstances. Sensitive topics include: sex, drugs, alcohol use, suicide.  qP P  qP P  qP P P   1 @` fBff33___PPT10i.rC+D=' = @B +*Z  5-P`(  ` ` f`(?6Slide Number Placeholder 5``  l* C   " `  x(0e0e ?Rectangle 2   VTypes of research: $  `  x(0e0e ?Rectangle 3    Low or less than minimal risk Educational research - improving educational practice in educational settings (no clinical and counseling research) Educational tests - use of educational tests (cognitive, diagnostic, aptitude, achievement) where subjects cannot be identified, directly or through identifiers linked to the subjects. Surveys, questionnaires, interviews, or observation not involving "sensitive" topics, such as criminal or sexual behavior, alcohol or drug use on the part of the participants unless anonymity is guaranteed and informed consent cannot be reasonably obtained (i.e. anonymous observations). Preexisting data/samples that are publicly available and the data is deidentified and uncoded and stripped of identifiers. If on the IRB s list of pre-approved data holders , no need for IRB review Minimal Risk Survey or interview procedures where responses are recorded in such a manner that subjects can be identified, and if known outside the research, could reasonably place the subject at risk of criminal or civil liability Research deals with sensitive aspects of the subject's own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol, unless data is recorded in such a fashion that identities are kept secure and protection mechanisms put in place Deception Research which include minors (under the age of 18) as participants May not require IRB review Activities that are not hypothesis driven Data collected for educational or teaching purposes and is not disseminated outside the institution. Literature review to support research purpose or research question Surveys issued or completed by University personnel for the intent and purposes of improving services and programs of the University  P P P(  Pc P   )  _   "B @` ` A??"review imagePicture 7review image.jpgp fBff33___PPT10i.PD$+D=' = @B +7Z  B:pd"(  d d f?6Slide Number Placeholder 5``  l* C   : d  x0e0e ?Rectangle 2P `    n*What does an IRB expect of an application?+ +( + d  x{0e0e ?Rectangle 3 `b >6___PPT9 {iConsideration of how the substantive issues & methods fit with ethical guidelines & IRB requirements Clarity in statement of problem, Research Questions & Methods of data collection Consistency in content of all documents Completeness of all materials C+C+C+C=Successful Protocol Courtesy of University of Louisville Human Subjects Protection Program Office  qP% PP P P XI  0,P j @` fBff33___PPT10i.p9+D=' = @B + Z    h (  h h f?6Slide Number Placeholder 5``  l* C   ( h  x@0e0e ?Rectangle 2 `   \What happens after review?   h  x0e0e ?Rectangle 3` `   FBAnnual Continuation and Approval Expedited board approved human subject protocols at UMBC are approved for a total of five years. A protocol is initially approved for a period of up to 12 months. Four (4) continuations or renewals may be requested, each for a period of up to 12 additional months. Protocol Modifications Any proposed change to an already approved human subject research protocol, measures, or informed consent document during the period of IRB approval must be submitted in writing to the IRB immediately for review and approval Closing a Protocol Protocol closure may occur when data collection is completed, when basic data analyses are completed and when all contact with participants has ended. Reporting Adverse Events Unanticipated problems involving risks to subjects or others Protocol Deviations and Violations Protocol deviations and/or instances of noncompliance with IRB regulations --------------------------------------------------------------------------------------------------------------------------------------- Protocol Monitoring (PAPM) Post approval protocol monitoring (PAPM) to protect research participants, to educate researchers about human subject protection issues and to improve the quality of research by detecting errors and/or omissions that might occur when performing research activities. 2B  PB  x  ># V W*AY$6Z\%H^7 @` fBff33___PPT10i.Q+D=' = @B +SZ ^Vl>(  l l f?6Slide Number Placeholder 5``  l* C   < l  x 0e0e ?Rectangle 2P `    p,What is the bottom line for an investigator?- -( - l  x@0e0e ?Rectangle 3 `  Be trained and fully aware Following IRB conditions and requirements Reporting progress of research Be aware of your own ethics   @` fBff33___PPT10i.nB~+D=' = @B +Z p(  p p f?6Slide Number Placeholder 5``  l* C   * p  x0e0e ?Rectangle 2P `    ^Expectations from the IRB? ( x p  x0e0e ?Rectangle 3 `  LWhen in doubt, ask questions; seek help Remember: consideration, clarity, consistency, completeness Don t initiate research before obtaining IRB approval. Renew ongoing proposals each year in a timely fashion. Stay within the approved scope of the project. Submit modifications to the IRB and wait for approval before initiating the change to the research. Report Adverse Events. IRBs are more than enforcers/regulators  Z  @` fBff33___PPT10i. '+D=' = @B +Z t(  t t f`?6Slide Number Placeholder 5``  l* C    t  x0e0e ?Rectangle 2P `    < (  t  x0e0e ?Rectangle 3 `   5523 Research Park Drive Suite 310 Baltimore, MD 21228 HARPO@umbc.edu www.umbc.edu/ressearch/HARPO 410-455-3868 (FAX) Tim Sparklin: 410-455-2737 Mary Lilly: 410-455-3958 j 9 {  9B72<Od<JfLh @` t zA??harpotagPicture 9harpotag@ fBff33___PPT10i.ݷP+D=' = @B + C;|#(  | | flXlX?Rectangle 7u   n* C  L |  r0e0ex?Rectangle 2*    |  ~@lXlXx?Rectangle 3 0   N    3380___PPT10.9P:B C; #(    flXlX?Rectangle 7u   n* C  L   r0e0ex?Rectangle 2*      ~lXlXx?Rectangle 3 0   N    3380___PPT10.9B  @m(     0e0ex?4Slide Image Placeholder 1*   $   `lXlXx?(Notes Placeholder 2 0   N   3  )lXlX?6Slide Number Placeholder 3u   n* C  L 3380___PPT10.8+N  5-`(    f)lXlX?Rectangle 7u   n* C  L   r0e0ex?Rectangle 2*       ~`)lXlXx?Rectangle 3 0r  ZR___PPT94,   Why worry of ethics? The purpose of ethics or ethical principles in research involving humans is the protection of the welfare and the rights of participants Three human rights must be safeguarded by researchers: freedom from harm, privacy, and voluntary participation. Participants have the right not to be harmed by participating in research. Thus, they have the right not to be exposed to physical, emotional, or psychological dangers without very strong justification, and even then only after agreeing to participate with fully informed consent. Human participants have the right to privacy, i.e., to determine how information obtained from them is used, whether it is publicly shared, etc. They therefore have a right to confidentiality and a right to full disclosure (i.e., informed consent) regarding the study they participate in. Human subjects have the right to freely choose to participate or not participate in studies, to know what it is they are volunteering to participate in, and even to withdraw their participation in a study after it has begun. Again, they should be informed of such rights. PROTECTION FROM RISKS Minor transient harms occur in normal every-day life (transportation delays; inclement weather; embarrassment; fatigue; etc.). Such high-probability, low-magnitude harms are within the definition of "low-risk" research. Researchers may have to state what the probability of transient harm occurring is; whether the harm is likely to be lasting in any way; and what steps will be taken to ameliorate the harm. Typical examples of harm in social and behavioral science research: Emotional or psychological harm, for example when a research interaction causes upset, or worry about breach of confidentiality, or questions about emotional or traumatic events stirs up depression, worry or anxiety. Social harm due to stigma or other negative social outcomes of breach of confidentiality. Physical harm if revelations about others get back to those persons, particularly when researchers study domestic violence, gang activity, political activity in a conflict zone, drug or alcohol use/abuse, or other phenomena concerning violence-prone individuals. Financial harm if revelations result in loss of employment or insurance coverage. Legal harm when illegal activities are disclosed. Moral harm when participation in research strengthens subjects' inclinations to behave unethically.  P PQ " P# PQ! P E ) _  3380___PPT10.NJ߸# q(    f)lXlX?Rectangle 7u   n* C  L   r0e0ex?Rectangle 2*   b   ~)lXlXx?Rectangle 3 0   What is research with human participants? The project must first fall under the definition of research with human subjects. A research project means taking part in an activity that is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Systematic investigation refers to an organized, scientific way of collecting information from people or participants, using a series of questions or observations. Contributing to generalizable knowledge comes from research activities that are designed to contribute to the general body of knowledge. "Research" is defined in the Code of Federal Regulations as "a systematic investigation that contributes to generalizable knowledge" In other words, an investigator will be "engaged in research", has proposed an intention to explore a particular topic, while interacting with a living person and either publish (e.g., in a journal) or present at a conference.x*  )R, j   3380___PPT10.NJ#ɶ| (    f (lXlX?Rectangle 7u   n* C  L   r0e0ex?Rectangle 2*      ~ )lXlXx?Rectangle 3 0   Why is the IRB involved? Members of an IRB represent the background, expertise and scope of social and behavioral science required by federal regulations. The main mission of the IRB is to see to the appropriate protection of human participants in behavioral research, according to the regulations established by the Department of Health and Human Services (DHHS) - Office of Human Research Protections (OHRP). Who - Members of the UMBC IRB represent the background, expertise and scope of social and behavioral science required by DHHS. In addition, the UMBC IRB have a person not affiliated with UMBC, but participates as a full voting member Why review - The main mission of the IRB is to see to the appropriate protection of human participants in behavioral research, according to the regulations established by the Department of Health and Human Services (DHHS) - Office of Human Research Protections (OHRP) ,     3380___PPT10.9 C ! m(     0e0ex?4Slide Image Placeholder 1*   $    )lXlXx?(Notes Placeholder 2 0   N   3  @)lXlX?6Slide Number Placeholder 3u   n* C  L 3380___PPT10.8+NQ  (    f*lXlX?Rectangle 7u   n* C  L   r0e0ex?Rectangle 2*      ~*lXlXx?Rectangle 3 0   Minor transient harms occur in normal every-day life (transportation delays; inclement weather; embarrassment; fatigue; etc.). Such high-probability, low-magnitude harms are within the definition of "low-risk" research. Researchers may have to state what the probability of transient harm occurring is; whether the harm is likely to be lasting in any way; and what steps will be taken to ameliorate the harm. Typical examples of harm in social and behavioral science research: Emotional or psychological harm, for example when a research interaction causes upset, or worry about breach of confidentiality, or questions about emotional or traumatic events stirs up depression, worry or anxiety. Social harm due to stigma or other negative social outcomes of breach of confidentiality. Physical harm if revelations about others get back to those persons, particularly when researchers study domestic violence, gang activity, political activity in a conflict zone, drug or alcohol use/abuse, or other phenomena concerning violence-prone individuals. Financial harm if revelations result in loss of employment or insurance coverage. Legal harm when illegal activities are disclosed. Moral harm when participation in research strengthens subjects' inclinations to behave unethically.   ! P E ) ^   3380___PPT10.9 K  m(     0e0ex?4Slide Image Placeholder 1*   $   *lXlXx?(Notes Placeholder 2 0   N   3  *lXlX?6Slide Number Placeholder 3u   n* C  L 3380___PPT10.8+NR$  (    f *lXlX?Rectangle 7u   n* C  L   r0e0ex?Rectangle 2*       ~*lXlXx?Rectangle 3 0    Consent Consent - no investigator may involve a human being as a subject in research unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. The written presentation of information in the consent form is used to document the basis for consent and for the subject's future reference. Remember that obtaining participant consent is a process. The consent form is merely the documentation of informed consent and does not, in and of itself,constitute informed consent. The fact that a subject signed a consent form does not mean that he/she understood what was being agreed to or truly gave their voluntary consent. Consent must be given without coercion or undue influence. Consent - no investigator may involve a human being as a subject in research unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. The written presentation of information in the consent form is used to document the basis for consent and for the subject's future reference. Remember that obtaining participant consent is a process. The consent form is merely the documentation of informed consent and does not, in and of itself,constitute informed consent. The fact that a subject signed a consent form does not mean that he/she understood what was being agreed to or truly gave their voluntary consent. Consent must be given without coercion or undue influence. Provisions for confidentiality must be specified as well as a description of procedures for protecting privacy, including specific information regarding how data will be stored to ensure security and confidentiality. If data are to be in the form of audio/video tape recordings or photographs, procedures protecting confidentiality should be described. Be sure to describe to participants the steps used to preserve confidentiality. In the course of certain projects, confidentiality may not be absolute or perfect. This must be expressed to participants. An anonymousstudy means there is NO WAY ANYONE can tell if a person was a participant in the study and they cannot be identified by the information they give, (including the investigator). Even if data is coded, it can be de-coded and become identifiable. A confidential study means that while their identity potentially could be determined from the information they give, steps will be taken to insure that they will not be identified. Be sure to describe to participants the steps used to preserve confidentiality. A study cannot be both confidential and anonymous. If confidentiality/anonymity cannot be ensured, clearly state this under the "risk" section of the consent form.  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   2On-screen Show (4:3)unbcv  Times New RomanArial Wingdings Quadrant 1_Quadrant 2_Quadrant 3_Quadrant 4_Quadrant 5_Quadrant 6_Quadrant 7_Quadrant 8_Quadrant 9_Quadrant 10_Quadrant 11_QuadrantK Header image designed by Michelle Jordan, UMBC Creative Services, 2009 In brief Doing the right thing-To do the right thing, know about the ethicsUnderstand what research is:%Purpose of human research complianceThe IRBSafeguards from harmsProtection from risks"Enhancing voluntary participationTypes of ApprovalTypes of research:+What does an IRB expect of an application?What happens after review?-What is the bottom line for an investigator?Expectations from the IRB? Slide 17  Fonts UsedTheme  Slide Titles 8@ _PID_HLINKSA (10%20Real-Life%20Mad%20Scientists...pdfSocial_Behave%20research.pdf9http://www.umbc.edu/HARPO/listofdataholders 07_15_09.doc<http://www.umbc.edu/research/HARPO/IRB/IRBpostapproval.html continuation<http://www.umbc.edu/research/HARPO/IRB/IRBpostapproval.htmlmodifications<http://www.umbc.edu/research/HARPO/IRB/IRBpostapproval.htmlclosure<http://www.umbc.edu/research/HARPO/IRB/IRBpostapproval.htmladverse<http://www.umbc.edu/research/HARPO/IRB/IRBpostapproval.html deviations<http://www.umbc.edu/research/HARPO/IRB/IRBpostapproval.htmlpapmmailto:HARPO@umbc.edu$http://www.umbc.edu/ressearch/HARPO(10%20Real-Life%20Mad%20Scientists...pdfSocial_Behave%20research.pdf9http://www.umbc.edu/HARPO/listofdataholders 07_15_09.doc<http://www.umbc.edu/research/HARPO/IRB/IRBpostapproval.html continuation<http://www.umbc.edu/research/HARPO/IRB/IRBpostapproval.htmlmodifications<http://www.umbc.edu/research/HARPO/IRB/IRBpostapproval.htmlclosure<http://www.umbc.edu/research/HARPO/IRB/IRBpostapproval.htmladverse<http://www.umbc.edu/research/HARPO/IRB/IRBpostapproval.html deviations<http://www.umbc.edu/research/HARPO/IRB/IRBpostapproval.htmlpapmmailto:HARPO@umbc.edu$http://www.umbc.edu/ressearch/HARPO _&sparklinsparklin  !"#$%&'()*+,-./0123456789:;<=>?@ABCDEFGHIJKLMNOPQRSTUVWXYZ[\]^_`abcdefghijklmnopqrstuvwxyz{|}~      !"#$%&'()*+,-./0123456789:;<=>?@ABCDEFGHIJKLMNOPQRSTUVWXYZ[\]^_`abcdefghijklmnopqrstuvwxyz{|}~      !"#$%&'()*+,-./0123456789:;<=>?@ABCDEFGHIJKLMNOPQRSTUVWXYZ[\]^_`abcdefghijklmnopqrstuvwxyz{|}~      !"#$%&'()*+,-./0123456789:;=>?@ABCDEFGHIJKLMNOPQRSTUVWXYZ[\]^_`abcdefghijklmnopqrstuvwxyz{|}~Root EntrydO)PicturesOCurrent UserSummaryInformation(<PowerPoint Document(&DocumentSummaryInformation8