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Doing the right thing   f <  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. Be aware of aspect of being a responsible researcher, know how to conduct research appropriately and understand one s role in the research process 1 http://www.wow4u.com/oprahwinfrey/index.html |{ Zp Z Zy   -   @` fBff33___PPT10i.3+D=' = @B +Z P@(  @ @  p%0e0e ?Title 1P ` j  F>___PPT9  8Underlying principles of responsible conduct of research988Q @  &0e0e ?,Content Placeholder 2 `~ ZR___PPT94, { discourage research misconduct and questionable research practices ensure integrity of research and scholarly activities@ z qy{ @`{ @ f'?6Slide Number Placeholder 3``WF>___PPT9   *, C C   fBff33___PPT10i.W@>+D=' = @B +Z pD(  D D f` ?6Slide Number Placeholder 5``  l* C   < D  x)0e0e ?Rectangle 2P `    p,To do the right thing, know about the ethics- -( - D  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 @` D A??ohrp_headerPicture 5ohrp_header X fBff33___PPT10i. CI+D=' = @B +Z  H(  H H f@.?6Slide Number Placeholder 5``  l* C   * H  x`/0e0e ?Rectangle 2P `    ^Understand what research is:  n H  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 Li(  L L f@b?6Slide Number Placeholder 5``  l* C   4 L  x`c0e0e ?Rectangle 2P `    h$Purpose of human research compliance% %( % L  x d0e0e ?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 @` L A??jkpwaze0[1]Picture 6jkpwaze0[1] h  L vA??md-flagPicture 7md-flagP p  L A??ed_gl_headerPicture 8ed_gl_headerP s fBff33___PPT10i.t@3+D=' = @B +Z P(  P P f ?6Slide Number Placeholder 5``  l* C    P  xi0e0e ?Rectangle 2P `    IThe IRB   P  x j0e0e ?Rectangle 3 `  KMembers 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 p Z qZc ZT Z Z  @` fBff33___PPT10i. ;+D=' = @B +Z T(  T T fj?6Slide Number Placeholder 5``  l* C   0 T  x`l0e0e ?Rectangle 2P `    d Oversight ensures that there are! !( !p T  x@n0e0e ?Rectangle 3 `  rSafeguards from harm Emotional or psychological harm Social harm Financial harm Legal harm Protections from Risks greatest risk is often a breach of confidentiality Opportunities for voluntary participation the  consent process  the process that involves a conversation that most of the time uses a document J  3 * g Z  3*f     :  ` fBff33___PPT10i.2@+D=' = @B +dZ  ogXO(  X X f`i?6Slide Number Placeholder 5``  l* C   " X  x0e0e ?Rectangle 2   VTypes of research: $  X  xn0e0e ?Rectangle 3   DLow or less than minimal risk (pose no or very low risks ) 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 2  )  _   "$7 @` X A??"review imagePicture 7review image.jpgp fBff33___PPT10i.PD$+D=' = @B +7Z  B:0\"(  \ \ f?6Slide Number Placeholder 5``  l* C   : \  x@0e0e ?Rectangle 2P `    n*What does an IRB expect of an application?+ +( + \  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 +2 Z  =5P`(  ` `  p 0e0e ?Title 1P ` j  F>___PPT9  pProtection of Human Subjects. `  @0e0e ?,Content Placeholder 2 `v RJ___PPT9,$ Must comply with relevant Federal regulations as well as institutional guidelines and policies Responsibility for obtaining appropriate approval before conducting research involving human subject Need for approval based on if the work qualifies as research, it involves human subjects, and if it is exempt from IRB (human research compliance) review Syracuse University, Research Ethics and Academic Integrity video vignettes, 2002, http://gradschpdprograms.syr.edu/resources/videos.php T`` >bW  5    ) @`{ ` f?6Slide Number Placeholder 3``WF>___PPT9   *, C C   ` RA??Picture 4 p  + fBff33___PPT10i.W`+D=' = @B +SZ  ^Vpd>(  d d f?6Slide Number Placeholder 5``  l* C   < d  x0e0e ?Rectangle 2P `    p,What is the bottom line for an investigator?- -( - d  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  h(  h h f?6Slide Number Placeholder 5``  l* C   * h  x0e0e ?Rectangle 2P `    ^Expectations from the IRB? ( x h  x@0e0e ?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 l(  l l f ?6Slide Number Placeholder 5``  l* C    l  x@0e0e ?Rectangle 2P `    < (  l  x`0e0e ?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<O1<J3Lh @` l zA??harpotagPicture 9harpotag@ fBff33___PPT10i.ݷP+D=' = @B + C;t#(  t t f lXlX?Rectangle 7u   n* C  L t  r0e0ep?Rectangle 2*    t  ~"lXlXp?Rectangle 3 0   N    3380___PPT10.9P:B C; x#(  x x f` lXlX?Rectangle 7u   n* C  L x  r0e0ep?Rectangle 2*    x  ~`&lXlXp?Rectangle 3 0   N    3380___PPT10.9B  @|m(  | |  0e0ep?4Slide Image Placeholder 1*   $ |  'lXlXp?(Notes Placeholder 2 0   N   3 | )lXlX?6Slide Number Placeholder 3u   n* C  L 3380___PPT10.8+N-  `(     0e0ep?4Slide Image Placeholder 1*   D   *lXlXp?(Notes Placeholder 2 0R  :2___PPT9  2    lXlX?6Slide Number Placeholder 3u WF>___PPT9   *, C C L 3380___PPT10.W0  5-(    f`VlXlX?Rectangle 7u   n* C  L   r0e0ep?Rectangle 2*       ~TlXlXp?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`PlXlX?Rectangle 7u   n* C  L   r0e0ep?Rectangle 2*   b   ~QlXlXp?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 TlXlX?Rectangle 7u   n* C  L   r0e0ep?Rectangle 2*      ~WlXlXp?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(     0e0ep?4Slide Image Placeholder 1*   $   `YlXlXp?(Notes Placeholder 2 0   N   3  \lXlX?6Slide Number Placeholder 3u   n* C  L 3380___PPT10.8+NQ  (    fplXlX?Rectangle 7u   n* C  L   r0e0ep?Rectangle 2*      ~]lXlXp?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(     0e0ep?4Slide Image Placeholder 1*   $   `_lXlXp?(Notes Placeholder 2 0   N   3  @rlXlX?6Slide Number Placeholder 3u   n* C  L 3380___PPT10.8+N * @m(     0e0ep?4Slide Image Placeholder 1*   $    tlXlXp?(Notes Placeholder 2 0   N   3  ulXlX?6Slide Number Placeholder 3u   n* C  L 3380___PPT10.8+N.  `(     0e0ep?4Slide Image Placeholder 1*   D    lXlXp?(Notes Placeholder 2 0R  :2___PPT9  2    xlXlX?6Slide Number Placeholder 3u WF>___PPT9   *, C C L 3380___PPT10.W@ % m(     0e0ep?4Slide Image Placeholder 1*   $   zlXlXp?(Notes Placeholder 2 0   N   3  |lXlX?6Slide Number Placeholder 3u   n* C  L 3380___PPT10.8+N ) m(     0e0ep?4Slide Image Placeholder 1*   $   }lXlXp?(Notes Placeholder 2 0   N   3  lXlX?6Slide Number Placeholder 3u   n* C  L 3380___PPT10.8+N C;#(    f lXlX?Rectangle 7u   n* C  L   r0e0ep?Rectangle 2*      ~@lXlXp?Rectangle 3 0   N    3380___PPT10.90CUrZ| `N NV,_i;,o*0u6?^FyNU^dl7v %ҩO %,Ah-Oh+'0 hp  $ 0 <HP8Human and Animal Research Protections Office (HARPO)Timothy Sparklin Quadrant sparklin76Microsoft Office PowerPoint@@`a@073@2WGg  pp  pA 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   &On-screen Show (4:3)unbc8N 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 thing9Underlying principles of responsible conduct of research-To do the right thing, know about the ethicsUnderstand what research is:%Purpose of human research complianceThe IRB!Oversight ensures that there areTypes of research:+What does an IRB expect of an application?Protection of Human Subjects-What is the bottom line for an investigator?Expectations from the IRB? Slide 15  Fonts UsedTheme  Slide Titles 8@ _PID_HLINKSAtT6http://gradschpdprograms.syr.edu/resources/videos.php(10%20Real-Life%20Mad%20Scientists...pdfSocial_Behave%20research.pdf9http://www.umbc.edu/HARPO/listofdataholders 07_15_09.doc6http://gradschpdprograms.syr.edu/resources/videos.phpmailto:HARPO@umbc.edu$http://www.umbc.edu/ressearch/HARPO(10%20Real-Life%20Mad%20Scientists...pdfSocial_Behave%20research.pdf9http://www.umbc.edu/HARPO/listofdataholders 07_15_09.doc6http://gradschpdprograms.syr.edu/resources/videos.php6http://gradschpdprograms.syr.edu/resources/videos.phpmailto:HARPO@umbc.edu$http://www.umbc.edu/ressearch/HARPO _sparklinsparklin  !"#$%&'()*+,-./0123456789:;<=>?@ABCDEFGHIJKLMNOPQRSTUVWXYZ[\]^_`abcdefghijklmnopqrstuvwxyz{|}~      !"#$%&'()*+,-./0123456789:;<=>?@ABCDEFGHIJKLMNOPQRSTUVWXYZ[\]^_`abcdefghijklmnopqrstuvwxyz{|}~      !"#$%&'()*+,-./0123456789:;<=>?@ABCDEFGHIJKLMNOPQRSTUVWXYZ[\]^_`abcdefghijklmnopqrstuvwxyz{|}~      !"#$%&')*+,-./0123456789:;<=>?@ABCDEFGHIJKLMNOPQRSTUVWXYZ[\]^_`abcdefghijklmnopqrstuvwxyz{|}~Root EntrydO)PicturesRCurrent UserSummaryInformation((PowerPoint Document(DocumentSummaryInformation8