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Ethics in Research on Human Participants: Why Do We Need Institutional Review Boards? H. Canan Sümer Department of Psychology May 03, 2012.

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1 Ethics in Research on Human Participants: Why Do We Need Institutional Review Boards? H. Canan Sümer Department of Psychology May 03, 2012

2 Scope of the Ethical Dilemmas Involved in Research with Human Participants  Lab experiments (individual or group based) E.g.: Watson’s (1920), Milgram’s (1963) & Zimbardo’s (1971) studies, and deception studies.  Field experiments/studies: E.g.: Altruism and bystander effect studies; prejudice formation studies on grade school children  Survey, interview, and case studies Adults Children Infants Special groups 2

3 Watson (1920)  Place: Johns Hopkins University  Purpose: Examination of the development of fear response through classical conditioning  Subject: An 8-month old baby named “Little Albert” “Watson felt that following the principles of classical conditioning he could condition a child to fear a distinctive stimulus which normally would not be feared by a child.” 3

4 Watson (1920)  Phases of the Experiment: Assessing the baby’s initial response to a number of different objects (live lab rat, rabbit, monkey, dog, fur, etc.). In general, positive reactions to these stimuli. Little Albert showed no fear toward any of these objects. Recording the baby’s reaction to a loud noise (produced by striking a hammer against a steel bar). It was FEAR. Repeated pairings of rat and loud noise (7 times). Presentation of the rat alone starts producing a fear response similar to the loud noise. Observation that the fear response developed for rat was generalized to other objects such as rabbit, dog, monkey, and even the experimenter’s hair.  Results: Using classical conditioning one can develop or significantly shape behavior (and Watson got fired but not because of this controversial experiment!) 4

5 5

6 APRIL 2000 (Johns Hopkins Magazine) Pioneers of Scholarship It's All in the Upbringing By Joanne Cavanaugh SimpsonJoanne Cavanaugh Simpson   Little Albert B., a healthy, stolid 9-month-old baby*, was shown a live rat, a rabbit, a dog, and a monkey. He showed no fear.  But he cried when a researcher struck a hammer against a steel bar. Hopkins pyschology professor John B. Watson and his assistant, Rosalie Rayner, then made a clanging sound each time the boy touched the rat.  After seven such pairings, Albert B. cried and avoided the animal-- even when there was no loud noise. In fact, days later, he showed fear when he saw the rat, the rabbit, the dog, and a sealskin coat. He also had a "negative" response to a bearded Santa Claus mask and the hair on Watson's head.  As the months went on, young Albert didn't cry consistently at the sight of the white rat. So the researchers let the animal crawl against the child's chest. Watson and Rayner reported: "He first began to fret and then covered his eyes with both hands." Source: * Not in bold in the original document. 6

7 Source: 7

8 Milgram (1963)  Place: Yale University  Purpose: Examination of the processes involved in obedience and conformity behaviors  Participants: Adult men from different occupations, reached through newspaper ads ($4 for an hour – would be $20 today)  Roles: Teacher and student (a confederate) 8

9 Announcement of Milgram’s Experiment ( Source: ) Descript ion Advertisement for the recruiting of the Milgram experiment subjects. The GIF from this page [[1]] was losslessy compressed to PNG (it was in public domain).Milgram experiment[1] Dateoriginally uploaded in July 2009 (log)log Source File:Milgram_Experiment_ad vertising.gif AuthorPoolisfun (talk)talk Permissi on (Reusin g this file)Reusin g this file Public domainPu blic domainfal sefalse This media file is in the public domain in the United States. This applies to U.S. works where the copyright has expired, often because its first publication occurred prior to January 1, 1923. See this page for further explanation. public domainUnited Statespublicationthis page CatalàCatalà | Česky | Deutsch | English | Español | Eesti | فارسی | Suomi | Français | Gaeilge | Galego | עברית | Magyar | Igbo | Italiano | 日本 語 | Македонски | മലയാളം | Malti | Plattdüütsch | Nederlands | Polski | Português | Português do Brasil | Română | Русский | ไทย | Vèneto | 中文 | ‪ 中文 ( 简 体 ) ‬ | ‪ 中文 ( 繁體 ) ‬ | +/−ČeskyDeutsch EnglishEspañolEesti فارسیSuomiFrançais GaeilgeGalego עברית MagyarIgboItaliano 日本 語Македонски മലയാളം MaltiPlattdüütsch NederlandsPolski PortuguêsPortuguês do BrasilRomânăРусский ไทยVèneto 中文 ‪ 中文 ( 简 体 ) ‬ ‪ 中文 ( 繁體 ) ‬+/− This image might not be in the public domain outside of the United States; this especially applies in the countries and areas that do not apply the rule of the shorter term for US works, such as Canada, Mainland China (not Hong Kong or Macao), Germany, Mexico, and Switzerland. The creator and year of publication are essential information and must be provided. See Wikipedia:Public domain and Wikipedia:Copyrights for more details.rule of the shorter term Wikipedia:Public domain Wikipedia:Copyrights Date/TimeThumbnail Dimension s UserComment current 23:32, 1 August 2009 633 × 989 (16 KB) Richardfab i {{Informa tion |Descripti on=Advert isement for the recruiting of the Milgram experimen t subjects. The GIF from this page http://en. wikipedia. org/wiki/Fi le:Milgram _Experime nt_adverti sing.gif was losslessy compresse d to PNG (it was in public domain). Milgram experimen t http://en. wikipedia. org/wiki/Fi le:Milgram _Experime nt_adverti sing.gif 9

10 Milgram (1963)  Task: Teaching a list of word-pairs (e.g., rabbit- pillow) to the student who is in the next room.  The participant in the role of the teacher would then test the student’s learning by reading the first word of each pair and asking for the second one.  The learner would press a button to indicate his response. If the answer was incorrect, the teacher would administer a shock to the learner (starting with 45 volts), with 15-volt increments for each wrong answer. If correct, the teacher would read the next word. 10

11 Source: 11

12 Milgram (1963, 1965)  Manipulation: In reality there were no shocks! Yet, all participants in the teacher role thought that they were actually giving shock. Pre-recorded sounds were presented after each shock level.  Results: 27 out of 40 participants (65%) went up to 450 volts despite all the screaming and begging coming from the next room. No participants seriously questioned the experimenter before 300 volts. When they indicated they wanted to quit they were instructed to go on by the experimenter. And a large majority followed the instructions. Video recordings of this study indicate that participants showed signs of extreme stress as they heard the screams of pain coming from the learner but they did continue. 12

13 Implications: 1. «Ordinary people, simply doing their jobs, and without any particular hostility on their part, can become agents in a terrible destructive process.» 2. «Relatively few people have the resources needed to resist authority. » 13

14 Zimbardo (1971)  Place: Stanford University  Purpose: To examine the influence of the context/situation on behavior and to study roles, rules and group identity processes.  Participants: Twenty-four male college students, recruited through newspaper ads, were randomly assigned to roles of prisoners and guards (paid $15 daily – would be $~60 today).  Procedure: Those who would play the role of prisoners were individually arrested in their homes and brought to the prison where they were placed into their cells by the guards. 14

15 Zimbardo (1971) Source: 15

16 Zimbardo (1971)  Procedure: The experiment took place in a mock prison situated in the basement of the Stanford University psychology building. From the very first day the roles were internalized: The guards became sadistic and the prisoners became depressed and showed signs of extreme stress. The participants adapted to their respective roles beyond the experimenter's expectations. Even the visitors became part of this game. At the end of the fifth day, five prisoner participants dropped out because of extreme distress. The experimenter called off the experiment after only six days, much before the planned termination date. 16

17  These three studies raised questions about the research ethics of scientific experimentation because of the extreme emotional stress and/or the psychological harm to the participants. 17

18 Ethical Violations in Lab and Field Experiments  Involuntary nature of participation  Including infants/minors/nonadults (“aklı baliğ”/“reşit” olmayan kişiler) without the approval of their parents or custodians  Deceiving participants; completely or partially concealing the purpose of the study; misinforming participants about the purpose of the study  Exposing participants to physically and/or psychologically distressing conditions  Not letting the participants know that they can leave at any time during the experiment  Failure to debrief participants when needed 18

19 Ethical Violations in Surveys, Interviews and Case Studies:  Involuntary nature of participation  Including infants/minors/nonadults without the approval/ consent of their parents or custodians  Deceiving participants; completely or partially concealing the purpose of the study; misinforming participants about the purpose of the study  Obtaining personal information without the knowledge/consent of the participants  Using data for purposes other than the one shared with participants  Revealing the identity of participants to other parties without their approval/consent  Asking questions that invade the privacy of the participants  Failure to debrief participants when needed 19

20 Institutional Review Boards – IRBs – in Preventing Ethical Violations in Research with Human Participants  IRBs (Human Subjects Committees), are institutional monitoring entities securing compliance with universal ethical principles in research with human participants.  In most Western countries IRBs are established within universities to ensure that research involving human participants is carried out abiding by ethical principles. 20

21 Institutional Review Boards – IRBs – in Preventing Ethical Violations in Research with Human Participants  In most countries and universities the IRB process is taken very seriously and sensitively. Researchers are required to take on-line training programs on research ethics before they are allowed to apply for an IRB review  Review process is very meticulous and there are laws and legislation relevant to human participation in research. (Note. As an example see 21

22 DEĞERLENDİRMEDEN MUAF / YARI MUAF OLAN PROJELER Araştırmanın kategorisi belirlenir. Kurul Üyeleri İnceler ve onay yazısını gönderir. Kurul Üyeleri inceler ve onaylar. Başvuru tamam. Sekreterliğin yorumlarıyla birlikte incelenmek üzere kurul başkanlığa ve iki üyeye gönderilir. Komite üyeleri araştırmacıdan revizyon ya da ek bilgi ister. Araştırmacıyla irtibat kurulup revizyon istekleri iletilir. Araştırmacı revize edilmiş materyalleri sunar. Revize edilen başvuru Sekreterlik tarafından incelenir. TÜM KURUL DEĞERLENDİRMESİNE TABİ OLAN PROJELER Revize edilen materyaller komite üyelerinin isteklerine uygun değildir. Araştırmacı başvurusunu ilgili birime sunar. Başvuru kaydedilir ve İA Etik Kurulu Sekreterliğine gönderilir. Eksik başvuru Araştırmacıdan ek bilgi istenir Araştırmacı başvurusunu tamamlamak için ek bilgi sunar. Araştırmacı tarafından revize edilen materyaller kurul üyelerinin isteklerine uygun bulunur. Onay yazısı araştırmacı ve proje yöneticisine gönderilir. Başvuru bir sonraki “Tam Kurul “toplantısı için gündeme alınır. Kurul üyeleri araştırmacıdan revizyon ya da ek bilgi ister. Araştırmacı istenen revize edilmiş materyalleri sunar. Revize edilen başvurular Sekreterlik tarafından incelenir. Araştırmacı tarafından revize edilen materyaller kurul üyelerinin isteklerine uygun bulunur. Revize edilen materyaller komite üyelerinin isteklerine uygun değildir. Revizyon isteklerini iletmek üzere araştırmacıyla tekrar irtibat kurulur. Source: Florida State University Office of Research 22

23 METU Human Subjects Review Board (“ODTÜ İnsan Araştırmaları Etik Kurulu”) ( Established in 2006 Main Mission  To assure that research involving human participants (by faculty members or students) is conducted in compliance with the universal principles of research ethics with due respect to the psychological and physical well-being of the participants.  To raise awareness of the researchers about the rights of the participants from whom they collect data through seminars, conferences, publications, and other developmental activities.  To ensure that studies requiring data collection from human participants are conducted in compliance with “METU Ethical Principles in Research with Human Participants.” 23

24 Why do We Need a Human Subjects Committee or Institutional Review Board?  In social sciences (e.g., psychology, sociology, management) and some physical sciences (e.g., biology, genetics) “data” are collected from human participants, either directly or indirectly.  Data collection is carried out through verbal reports (e.g., interviews and surveys) performance indicators (e.g., recordings of problem solving activities, simulation performance, and reaction time) physiological/neurological measurements/assessments (e.g., functional magnetic resonance imaging-FMRI studies) observation.  Researchers have responsibility for protecting the rights of human participants who provide data. Their main responsibility is to make sure that there are no threats to psychological and physical well- being of their participants. 24

25 Basic Rights of Human Participants under the Protection of the IRB TO KNOW  Who the researcher(s) is(are)  The scope and purpose of the study to which they are about to participate  The potential benefits and risks involved  The extent of their participation (expected duration, nature of contribution, participation expected, etc.)  Participation is completely voluntary  The right to stop participating in the study at any time desired without any sanctions or negative consequences  How the confidentiality of his/her responses will be protected; how and for what purpose the data will be used, and who will have access to data/information provided  How and when he/she can direct further questions concerning the study 25

26 Responsibilities of the Researchers Overseen by the IRB  To design their study in such a way that participants are not exposed to risks or disturbances beyond the minimal risks/disturbances associated with daily life.  To inform their participants about the purpose and scope of their study before the onset of data collection explaining how the data will be used and how confidentiality of their responses will be handled.  To make sure that participation is voluntary and inform participants about this.  To obtain the informed consent (“Bilgilendirilmiş Onay Formu”) of their participants in writing.  To take the necessary precautions so that the data will only be used for the intended purposes. 26

27 Responsibilities of the Researchers Overseen by the IRB  To obtain written approval of parents or custodians of participants in special categories (infants, children, mentally challenged and other minors) (“Ebeyn Onay Formu”)  To fully debrief participants (both verbally and written) following data collection especially when the purpose of the study could not be completely revealed to them, using a Debriefing Form (“Katılım Sonrası Bilgilendirme Formu”). Explaining the reasons of not revealing the purpose of the study completely and answering any question participants might have concerning the study.  To take the responsibility of the participants who were adversely (emotionally and/or physically ) affected by unforeseen/uncontrollable factors in the processes of data collection, analysis, storage, and reporting. 27

28 The Process of Human Subjects Review in METU Step I: Application to the Applied Ethics and Research Center (AERC) Application Form*IA_BasvuruFormu_R.docIA_BasvuruFormu_R.doc Project Information Form*IA_ProjeBilgiFormu_R.docIA_ProjeBilgiFormu_R.doc Informed Consent Form Parental Consent Form (if needed)IA_EbeveynOnayFormu_Ornek_R.docIA_EbeveynOnayFormu_Ornek_R.doc Debriefing Form (if needed) Examples of the tools, measures, questionnaire, protocols to be used in the study. Application Check ListIA_Basvuru_KontrolListesi_R.docIA_Basvuru_KontrolListesi_R.doc *Forms can be obtained from 28

29 The Process of Human Subjects Review in METU Step II – Control and Assignment of the Application to Reviewers  The AERC’s secretariat controls the application and if complete, the application is sent to independent reviewers of the university. 29

30 The Process of Human Subjects Committe Review in METU Step III: Review  The reviewers examine the Application Form, Project Information Form, Informed Consent Form, Debriefing Form (if required), and the tools/scales/measures to be used in the study to make sure that the study is designed in compliance with universal research ethics involving human participants.  Decisions made: Accept Revise and resubmit Reject 30

31 The Process of Human Subjects Review in METU Step III: Review Revise and Resubmit Decision Examples:  Incomplete information (e.g., purpose of the study not being clearly stated)  Potentially disturbing questions, procedures, or methods that could easily be modified without intruding the integrity of the study  Critical information being omitted in the Informed Consent and/or Debriefing Form and/or Parental Consent Form  Incomplete or biased information in the instructions  Reject Decision Examples:  A foreseeable risk/damage to the participants  Inclusion of questions /instruction discriminatory in nature 31

32 The Process of Human Subjects Review in METU Step IV: Informing the Applicant/Researcher about the Result of the Review Process 32

33 METU Human Subjects Review Committee Activities (2007-2011) 20072008200920102011 Total # of Applications171179212231248 Applications (METU)159152208226223 Applications (Outside)1274525 Total # of Reviewers25118913 Mean Review Duration (Days)10.983.902.387.465.29 33

34 Human Subjects Review in Undergraduate Student Research in METU  Some courses in our university require students collect data from human participants as part of a class project.  These are usually small scale projects requiring collecting data using surveys, interviews or in a lab situation within the university.  Some departments in our university established their own human subjects review process for undergraduate studies in collaboration with the University’s Human Subjects Committee.  The application form for undergraduate studies is a simplified one. IAEK_Undergraduate Application Form.Revised.docIAEK_Undergraduate Application Form.Revised.doc  In the Department of Psychology in 2010 45 student projects went through the review process. 34

35 Informed Consent Form – Example ÇALIŞMA ÖNCESİ KATILIMCI BİLGİ FORMU Bu araştırmanın amacı, yaşama olan yaklaşım ve tutumlarınız ile genel duygu durumunuza ilişkin bilgi toplamaktır. Sizden kimlik belirtici hiçbir bilgi istenmemektedir. Cevaplarınız tamamıyla gizli tutulacak ve sadece araştırmacılar tarafından değerlendirilecektir. Anketi doldurmadan önce size çalışma hakkında bilgi verilecek ve daha sonra da çalışmaya gönüllü katılımınızı teyit etmek için bu formu imzalamanız istenecektir. Anket sonunda ise çalışmaya yönelik sorularınız cevaplanacaktır. Anket, genel olarak kişisel rahatsızlık verecek soruları içermemektedir. Ancak katılım sırasında sorulardan ya da herhangi bir başka nedenden ötürü kendinizi rahatsız hissederseniz cevaplama işini yarıda bırakmakta serbestsiniz. Böyle bir durumda anketi uygulayan kişiye, anketi tamamlamadığınızı söylemeniz yeterli olacaktır. Anket sonunda, bu çalışmayla ilgili sorularınız cevaplanacaktır. Bu çalışmaya katıldığınız için şimdiden teşekkür ederiz. Şimdi lütfen, aşağıdaki formu doldurup imzalayarak uygulayıcıya geri veriniz. Bu çalışmaya tamamen gönüllü olarak katılıyorum ve istediğim zaman yarıda kesip bırakabileceğimi biliyorum. Verdiğim bilgilerin bilimsel amaçlı olarak kullanılmasını kabul ediyorum. Tarihİmza 35

36 Debriefing Form – Example KATILIM SONRASI BİLGİ FORMU Bu çalışmada veriler, “Üniversite öğrencileri arasında madde kullanımını ve yordayıcı kişilik faktörleri” başlıklı bir araştırma projesi için toplanmaktadır. Araştırmanın temel amacı, genel olarak katılımcılar arasında (özellikle üniversite öğrencileri) madde kullanımının sıklık derecesini belirlemektir. Ayrıca, katılımcıların, çeşitli yaşam alanları ve kendileri hakkındaki duygu, düşünce ve tutumları ile genel duygu durumlarının madde kullanımı ile olan ilişkisine bakılacaktır. Bu amaçla, madde kullanımının sıklığını belirlemeye yarayan bir ölçeğin yanısıra “Rosenberg Özsaygı Ölçeği”, “Yaşam Doyumu Ölçeği”, “Heyecan Arama ve Risk Alma Ölçeği”, “Pozitif/Negatif Afektivite Ölçeği” ve “Kısa Semptom Envanteri” veri toplama araçları içine eklenmiştir. Ayrıca, katılımcılardan bir demografik bilgi anketini doldurmaları istenmiştir. Madde kullanım sıklığı ile yukarıda belirtilen tutum, davranış ve kişilik özellikleri arasında kullanılan maddenin türüne ve kullanım miktarına göre değişen bir ilişki beklenmektedir. Bu çalışmanın verilerinin Haziran 2005 tarihinin sonuna kadar elde edilmesi amaçlanmaktadır. Elde edilen bilgiler sadece bilimsel amaçlarla kullanılacaktır. Çalışmanın sonuçlarını öğrenmek ya da bu araştırma hakkında daha fazla bilgi almak için Psikoloji Bölümü öğretim üyelerinden Doç. Dr. Canan Sümer veya Doç. Dr. Belgin Ayvaşık ile iletişim kurabilirsiniz. Prof. Dr. Canan Sümer: Beşeri Bilimler Binası, Psikoloji Bölümü, Oda No. 225, Tel: 3132 Prof. Dr. Belgin Ayvaşık: Beşeri Bilimler Binası, Psikoloji Bölümü, Oda No. 138, Tel: 5112 36

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