ࡱ> vw(    :http://www.ethicsproject.com/:http://www.ethicsproject.com// 0LDTimes New RomanttxU 0@ .  @n?" dd@  @@`` XP>11    #  - "   0AA@ʚ;ʚ;g4rdrdTU 0pp@ <4!d!d@w 0tTU<4dddd@w 0tTU <4BdBd@x 0t80___PPT10 pp? %q=Deep Listening: The Ethnography of the Ethical Review ProcessMaureen H. Fitzgerald The University of Sydney Fitzgerald, M. H. (2004, 9-12 November). Deep listening: The ethnography of the ethical review process. Paper presented at the 7th World Congress of Bioethics: Deep Listening: Bridging Divides in Local and Global Ethics, (p. 94). Sydney. bf\%Project upon which the Paper is BasedAn Analysis of Research Ethics and The Ethical Review Process as Culture and Cultural Process ARC Discovery Grant DP0343014 http://www.ethicsproject.com @^ " " .{  0|23 Ethnography,Epitomise some of the most contentious issues in the research ethical review process Ethnographers tend to have the most difficulty getting through the process Review falls at the wrong point in the process Committees have difficulties understanding it Does not fit with the models they normally used/./T"M/./  T  Ethnography\Epitomises the concept of deep listening in an attempt to achieve  thick description It is about interpretation It is about context For anthropologists context is everything&** #% Ethnography1Multimethodology par excellence For example, this project uses Participant observation, observation, formal and informal interviews, everyday conversations, case studies, participation in everyday life, reviews of relevant documents, and analyses of the literature Everything is data for the ethnographer ^ )   ' & Formal Interviews/Discussions *By number of people n=186, researchers (experienced, students), committee chairs, admin officers, members, policy makers, some more than one interview/discussion Australia=59, Canada=51, New Zealand=16, UK=14, USA=45 Face-to-face, telephone, email Length H" 20 minutes to more than 4 hours Number of countries = 5 Number of cities/metropolitan areas (N=35) Australia=6, Canada=8, New Zealand=4, UK=8, USA=9ZZ7ZZ2Z7& " c2  Other DataInformal interviews with researchers, committee members, etc Everyday talk (informal interviews) with everyday people Taxi cab and shuttle van drivers Friends, family, and acquaintances Strangers encountered in everyday life Case studies 6vkvk(  Other Kinds of DataThe published literature from a variety of fields Application forms and related documents Personal experiences Consultations with community members in preparation for projects Discussion as part of research projects Projects I have been involved with Student projects Colleagues projects@oiHoiH(Y    Committee ObservationsContacts nH"40 (total not known as intermediaries were often involved) 28 observed (12 Australia, 2 Canada, 3 New Zealand, 4 UK, 7 USA) 7 refusals (Australia 4, Canada 1, UK 2) 5 approved but missed for logistical reasons or meeting cancelled 1 approved but not observed. "  $$ EthnographyOIt is process and product Its intention is to communicate with others to learn about and understand phenomena and then present this understanding in a manner that will help others understand In this case The process of trying to understand the ethical review process to help others understand it through publications and presentations B""( 5 01 A Case Study( The Ethics Project %&In the beginningThere are many tales to tell This is a tale about the ethical review process It is just one example Highlights common issues and experiences Will only present part of the process and an abbreviated chronology6M@DM@D  Reviews for This ProjectTOne formal full committee application/review One exempt review Five additional reviews of the original application (up to 3 years after initial submission) Reviews through multiple email questions Many acceptances based on the information sheet and some information on me Negotiations with committees took from a few minutes to three monthsUZU The First Review Process7 Oct 2001  Initial submission 6 Dec 2001  Response from Committee 20 Dec 2001  Response to response 13 Feb 2002  The ambiguous letter Feb-July  Sought advice on meaning of letter and what to do, continued to approach committees overseas, prepared for study leave 8 Aug 2002  Met with Chair of Committee 22 Aug 2002  Received unambiguous letter of approval$lZh7Questions/Comments from Ethics Committee 7 October 20011. The Committee noted the response to Q3.4 regarding the issue of confidentiality. The Committee was of the opinion that although the researcher was not interested in the actual applications but in the deliberations of the Committee, these deliberations are conducted on the understanding that they are confidential. Further, whether the researcher is interested in the actual applications or not, access is provided to documents which would otherwise be considered confidential. There is a compromise in the confidentiality of both the Committee members and applicants. The committee will reconsider this protocol when this important issue is addressed. (Confidentiality) 2. In addition, the Committee requested an indication of the number of professional colleagues, experts, key informers [sic] and HEC's [sic] the researcher will interview/discuss/observe (Q5.1(a)). (Numbers) 3. The response to Q6.4(c) should specify that data would be stored at a secure University site. (Storage) (Is this an oxymoron?)8Z""&&""" &"]"" &"&B I 34%Response to Response 20 December 2001Two pages including references Included references to the National Statement and my professional code of ethics (with web address) Included offer to provide additional supporting documentation or answer other questions Included an invitation to the committee to participate, but also gave them an  out so they would not have to reject the application in toto if they opted outNzZ:cThe First Review Process7 Oct 2001  Initial submission 6 Dec 2001  Response from Committee 20 Dec 2001  Response to response 13 Feb 2002  The ambiguous letter Feb-July  Sought advice on meaning of letter and what to do, continued to approach committees overseas, prepared for study leave 8 Aug 2002  Met with Chair of Committee 22 Aug 2002  Received unambiguous letter of approval.lZh#4Core of Response from the Committee 13 February 2002The Committee discussed your response regarding the issue of confidentiality at length. Although you state that you are interested in the review process rather than the content of applications the Committee considers these issues inherently inseparable. Further, the Committee feels that it would be inappropriate for you to observe the deliberations on confidential ethics applications submitted by your fellow University of Sydney colleagues, particularly without their specific consent for you to do so. (Confidentiality/Consent) Based on the above considerations the Committee is unable to approve your protocol to observe this HREC. (Refusal) Should you wish to proceed with this study at other institutions please apply to their HREC directly. (Confusing  No approval for any part of study? Must go through application process for all committees?) zYZ"&j" &f"i&"W  The QuandaryFIt was not clear if I had general approval to engage in the other data collection exercises  the letter only mentioned observations of committees I had exempt review status from a committee in the US Other committees would allow observation if I had approval from my institution s committee$$ AMy study leave had been approved, but I felt I could not begin the research without clear, unambiguous approval By the time I received the unambiguous approval my study leave had already begun The ARC Grant was pending with indications that it was likely to be awarded and I would need ethics approval to get the funding BB&'The First Review Process7 Oct 2001  Initial submission 6 Dec 2001  Response from Committee 20 Dec 2001  Response to response 13 Feb 2002  The ambiguous letter Feb-July  Sought advice on meaning of letter and what to do, continued to approach committees overseas, prepared for study leave 8 Aug 2002  Met with Chair of Committee 22 Aug 2002  Received unambiguous letter of approval.lZ_457Reason I did not initially go directly to the CommitteeNegative experiences in the past Did not want to get the committee  off side  or at least not any more than it was already  for fear of long range repercussions In this research I have similar data from others in such situations&DD8Dealing with the Quandary Using an Ethnographic ApproachuShowed letter (the data) to colleagues (key informants) and ask for their interpretation All agreed that it was at best ambiguous, many thought it meant I would have to go through the ethics review process with all potential committee Some asked: what are they afraid of (a question that was to be asked again later when I talked about committees not allowing observations)*YY I had the opportunity to meet a highly respected scholar in the area and put off further action until I could meet with him and discuss the situation and get his advice. He thought I needed to go to a higher authority, but who? At this time the only available route to an appeal was to this committee or to the University. If an appeals process had been available would it have been the best thing to do?Z In the meantime I continued to negotiate with committees overseas I then approached a chair of a committee I was using as an advisor and asked his advice. He said I needed to approach the chair to ask what I needed to do to get approval. '(The First Review Process7 Oct 2001  Initial submission 6 Dec 2001  Response from Committee 20 Dec 2001  Response to response 13 Feb 2002  The ambiguous letter Feb-July  Sought advice on meaning of letter and what to do, continued to approach committees overseas, prepared for study leave 8 Aug 2002  Met with Chair of Committee 22 Aug 2002  Received unambiguous letter of approval$lZ _56Approaching the ChairContacted office  no response Emailed Chair directly He said make an appointment Contacted office  no response until 1 hours before meetingMeeting with the ChairHe did not have my file when I arrived So he read my copy of the letter  This is a terrible letter. I can see why you are confused. Offered a sincere apology and said I had only received part of the letter Said project had been approved months earlier Stated he would get a new letter out to me that day Received the letter two weeks later0WZH="$H=  0V 0V<It isn t over until it is overFor many committees the approved information letter with some background information on me was sufficient Others had lists of questions, most dealing with  confidentiality Still others wanted to review the original application and all correspondence from the committee (did not include the latter because of the nature of the one letter)SS9:Reviews for This ProjectOne formal full committee application/review One exempt review Five additional reviews of the original application (up to 3 years after initial submission) Reviews through multiple email questions Many acceptances based on the information sheet and some information on me"#QuestionHas anyone else ever had potential participants in a project ask to see the original ethics approval application form before deciding whether or not to participate? If you have, I would like to hear about it?-/5Using Ethnography to Develop and Answer Key QuestionsApplying ethnography to the ethical review process  its parts and the process as a whole Using a case example as a method for doing thisWhat are they worried about?A very important question We are not the ethics police This was not presented as, nor was it intended to be, an evaluation of the committee s decisions, just the process of decision making; and attempt to look inside the black box What is it about the cultural context or the review process that leads to events, like the refusal of an observation?<7v7v!"One Issue ConfidentialityThe word confidentiality is not use in the information sheet. So, given the information in the letter, did they assume it did not apply? What is more important a description of realistic intent or using expected words, even if they cannot be guaranteed? Does the focus on confidentiality highlight critical issues in the review process or something about the cultural context in which it occurs? (e.g. lack of trust) BZuZZu !The last paragraph?Observations of the ethical review process by ethics committees will focus on the deliberations and the topics discussed, not specific applications. No identifying information on any applicants or information that will allow the identification of specific applications or projects will be recorded or used in any way.  @Z> > :Why were the words confidentiality and anonymity not used?`Can t guarantee them Legally The legal guidelines make this clear Previous cases cited in the literature (e.g. McNabb, Ogden, Punch) Given some of potential participants (i.e., high profile people) they could not be guaranteed Studying up (Nader) Would be unethical to promise more than can be guaranteedZZhZ^ZZ:Zh^  :< This Raises Some QuestionsWhat does confidentiality mean? Was there a confounding of confidentiality with anonymity by the committee or me? Did the last paragraph of the information sheet not apply to both confidentiality and anonymity?*-Disconfirmed ExpectanciesDid the fact that words like confidentially were not explicitly used create a sense of disconfirmed expectancies for committees? Was it lack of understanding or confounding of key terms? Was that the source of the problem? Or are there deeper issues at play Moral panic (not doing their job) (Cohen) Fear of the anthropologist as a folk devil or evaluator Lack of understanding of the nature of ethnographyFZZ"l67The Case and Other Data Suggest!Relationship issues Between researchers and committees Within committees (?) Structural issues Open vs Closed Committees (Fitzgerald & Yule 2004) Accountability and transparency Review process issues Did this require full committee review Multiple committee reviews Need to take this longZ:ZZSZZYZ: Y  e78Process SuggestsCultural issues Values Focus on confidentiality, anonymity, and privacy Trust/Distrust (of researchers and structures of authority) Honesty Integrity Audit cultures (Strathern) Paper trails m m     89Process SuggestsCultural issues continued Communication issues Often impersonal (formal letters or emails) Decontextualised Writing skills Acquisition and construction of knowledge etc, etcZL3L)   {) )*Some Things to Think AboutWhat do experiences like this tell us about the review process and the societies in which they occur What do they tell us about roles and relationships and how they unfold in particular contexts (e.g. within the committee, between me/researchers and committees)++More Things to Think About;What do they tell us about the cultural concerns of modern societies The review process as an enactment of sociocultural concerns and ideals What do they tell us about the cultural ideas about the nature of knowledge, its acquisition and it social construction (e.g. ideas about ethnography and other methodologies)<EZHZZEH..Even More Things to Think On}What do they tell us about the cultural context in which the review process takes place (e.g. lack of trust, privacy, transparency, accountability, decision making within groups) What do they tell us about the nature of communication within a particular cultural context Verbal vs written (personal vs impersonal) communication Lack of context information for comments and requests.ZoZo,Q,,Some Final Things to Think OnFinally So what are the real concerns of ethics committees when they become the object of research Are there different standards for them compared to those they purport to protect Do the current structures and processes lead to more ethical research more ethical review processes@44/0FinallyCan an understanding of ethnography as a process lead researchers and committees to engage in  deep listening and can this lead to better applications and an enhancement of the review of ethics applicationsAcknowledgementsMy sincere appreciation to all the people who have contributed to this project This Project was funded in part by an ARC Discovery Grant (DP0343014) and study leave supported by the Faculty of Health Sciences, the University of Sydney(  W  W12   0` ` ̙33` 333MMM` ff3333f` f` f` 3>?" dd@,|?" dd@   " @ ` n?" dd@   @@``PR    @ ` ` p>> 6. 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Fitzgerald@C:\Program Files\Microsoft Office\Templates\maureen\My Blue.potMaureen Fitzgerald42Microsoft PowerPoint@ Q@`@]=Z G :g    y3f--$xx--'&&-/_--$44--0`--$44--1b--$44--2e--$44--3g--$ 4 4--5k--$  4 4  --7o--$  4 4  --9s--$  4 4  --4>4==--0a--$>?4?4>>--/_--$?@4@4??---&&&--&&- && &~$= @ @?>=;96$1'/)-,,.*/)0(1'1'1'0'/(-)**(+'+&+%*$)$(#&###!###" " "!!    $&(,0 4 7 ; = ? @ @& &&-~$= @ @?>=;96$1'/)-,,.*/)0(1'1'1'0'/(-)**(+'+&+%*$)$(#&###!###" " "!!    $&(,0 4 7 ; = ? @ @-&&&&&-&&&TNPP-/_--$44--0`--$44--1b--$44--2e--$44--3g--$ 4 4--5k--$  4 4  --7o--$  4 4  --9s--$  4 4  --4>4==--0a--$>?4?4>>--/_--$?@4@4??--- '&&TNPP'3f--%? @ @?>=;95$1'/)-++-*/)0(0'0'0'0'.(,)**(+'+&+%*$)$(#&#$#!##""" " "!!     #&(,0 4 7 ; = > ? @ @--'@Times New Roman-. %2 )'Deep Listening: The .. %2 (&Deep Listening: The ."SystemȌ-@Times New Roman-. 02 5Ethnography of the Ethical .. 02 4Ethnography of the Ethical .-@Times New Roman-. 2 A1Review Process.. 2 @0Review Process.-@Times New Roman-. '2 V/Maureen H. Fitzgerald.. '2 U.Maureen H. Fitzgerald.-@Times New Roman-. +2 ^5The University of Sydney.. +2 ]4The University of Sydney.-@Times New Roman-. .2 cFitzgerald, M. H. (2004, 9.-@Times New Roman-.  2 cH-2.-@Times New Roman-. :2 cI"12 November). Deep listening: The .-@Times New Roman-. E2 h)ethnography of the ethical review process.-@Times New Roman-.  2 h`.2.-@Times New Roman-. *2 hbPaper presented at the y.-@Times New Roman-. g2 m@7th World Congress of Bioethics: Deep Listening: Bridging Divide.-@Times New Roman-.  2 ms .-@Times New Roman-. .2 r-in Local and Global Ethics.-@Times New Roman-. "2 rX, (p. 94). Sydney..-՜.+,D՜.+,L    On-screen ShowUniversity of Sydney'&0 2Times New RomanMy Blue>Deep Listening: The Ethnography of the Ethical Review Process&Project upon which the Paper is Based Ethnography Ethnography EthnographyFormal Interviews/Discussions Other DataOther Kinds of DataCommittee Observations Ethnography A Case StudyIn the beginningReviews for This ProjectThe First Review Process8Questions/Comments from Ethics Committee 7 October 2001&Response to Response 20 December 2001The First Review Process5Core of Response from the Committee 13 February 2002 The Quandary Slide 20The First Review Process8Reason I did not initially go directly to the Committee9Dealing with the Quandary Using an Ethnographic Approach Slide 24 Slide 25The First Review ProcessApproaching the ChairMeeting with the ChairIt isnt over until it is overReviews for This Project Question6Using Ethnography to Develop and Answer Key QuestionsWhat are they worried about?One Issue ConfidentialityThe last paragraph;Why were the words confidentiality and anonymity not used?This Raises Some QuestionsDisconfirmed Expectancies The Case and Other Data SuggestProcess SuggestsProcess SuggestsSome Things to Think AboutMore Things to Think AboutEven More Things to Think OnSome Final Things to Think OnFinallyAcknowledgements Slide 48  Fonts UsedDesign Template Slide Titles0 8@ _PID_HLINKSAthttp://www.ethicsproject.com/Root EntrydO)zf]"d@Current User,SummaryInformation(;PowerPoint Document('&_&CybrCybrk  !"#$%&'()*+,-./0123456789:;<=>?@ABCDEFGHIJKLMNOPQRSTUVWXYZ[\]^_`abcdefghijklmnopqrstuvwxyz{|}~Root EntrydO)Current UserSummaryInformation(;PowerPoint Document('&DocumentSummaryInformation8