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Powerpoint research assignment - The Continual Cycle of...

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Unformatted text preview: The Continual Cycle of Science The Research question about the real world Theory Research hypothesis Interpretation Statistical analyses Data gathering Research Methods in Psychology Research ■ The goals of psychology are to describe, explain, predict, change, prevent, increase, decrease, modify, shape, extinguish, cause, and control behavior. ■ These goals are accomplished by using the scientific method, which is systematic and empirical . . . [that is] . . . based on observable empirical and measurable events. and Extracted from Prentice-Hall Ch. 1 PP Slide Show for Davis & Palladino Text, Psychology, 4th Extracted Edition. Dr. Vessels’ Additions are shown in brackets. Dr. Case Studies & Naturalistic Observation A case study is an in-depth analysis of a single case person or event. Although the findings of a case study may apply only to the person who was studied, they may provide direction for further study using other methods. methods. To study behavior in real-life settings, To psychologists often use naturalistic observation. naturalistic This technique also may suggest research projects using more controlled approaches. In using naturalistic observation, the onlooker must be unobtrusive and avoid influencing the behavior being studied. Extracted from Prentice-Hall Ch. 1 PP Slide Show for Davis & Palladino Text, Psychology, 4th Edition. Vessels’ additions are shown in brackets. Vessels’ Correlational Research Correlational ● Correlational studies do not inform us about cause; [rather, they reveal relationships and help us form reasonable hypotheses (informed predictions) about whether or not one event or variable causes another]. ● Correlational research tells whether the values of two variables are related. variables Extracted from Prentice-Hall Ch. 1 PP Slide Show for Davis & Palladino Text, Psychology, 4th Edition. Dr. Vessels’ additions are shown in brackets. Extracted Dr. Making Inferences about Causality Making Hypothesis: Children who watch Hypothesis: violence on television tend to be more aggressive toward their peers and siblings. siblings. Question: Can we infer a causal Question: relationship between these two variables? variables? Watching Violence on TV + Violent Behavior Inferences about Causality Inferences Answer: not necessarily Explanation: Although causality implies correlation, correlation does not necessarily imply causality. necessarily Elaboration: There are at least three Elaboration: at other ways to explain the correlation between TV viewing and aggressive behavior. behavior. Three Plausible Alternative Inferences about Causality Inferences (1) Acting aggressively makes you want (1) to watch more violent TV to Watching Violent on TV + Violent Behavior The 2nd Plausible Alternative Inference about Causality Inference (2) Acting violent makes you want to (2) watch more TV and watching TV makes you act more violently makes Watching Violent on TV + + Violent Behavior The 3rd Plausible Alternative The Inference about Causality Inference (3) A “third variable” influences both variables, causing them to be correlated variables, Watching Violence on TV Violent Behavior + Living in a Violent Family + How do we choose from these possibilities? these One way to do so is to conduct an One experiment. experiment. In an experiment, at least one In variable is manipulated (i.e. manipulated systematically varied) by a researcher in order to study its effects on another variable. variable. Experimental Research Experimental Basic features: (a) At least one variable is manipulated (a) or varied by the experimenter: independent variable (IV) independent (IV) (b) Another variable that is expected to (b) be changed by the manipulation is called the dependent variable (DV) dependent (DV) (c) Random assignment to two groups (c) Random Watching + Violent DV Violent on TV Behavior IV Experimental Research Because it can . . . [support] cause-andBecause effect statements, . . . the experimental effect method is the most powerful . . . method By manipulating an independent variable (the possible cause), the researcher . . . ), [can determine with reasonable certainty] . . . . whether [or not] it influences the dependent variable (the effect). dependent ). Extracted from Prentice-Hall Ch. 1 PP Slide Show for Davis & Palladino Text, Psychology, 4th Edition. Dr. Vessels’ additions are shown in brackets. Dr. Possible Specifics of Experimental Study IV The Independent Variable is watching violence on TV Levels: (a) view an episode of the Sopranos (b) view an episode of the Sopranos in which the violent scenes have been edited DV The Dependent Variable is aggressive behavior Operational definition: The number of times the child punches his or her peers on the playground Single Group or Within-Subject Designs Versus Multiple Group or Between-Subject Designs ● ● The former offers at least some control through pre-post testing. The latter offers control through random assignment of subjects, which makes the groups equivalent. Pre-post testing can still be used, which essentially incorporates a within-subject aspect that strengthens the study. When random assignment is not possible and intact groups must be used, control is only achieved through pre-post testing in both groups and using the same statistical test as with the random groups design with pre-post testing (ANCOVA), but with needed adjustments based on the reliability of measures used. ● Threats to Internal Validity or Cause-Effect Inferences There are many threats to internal validity in single group or withinsubject studies as seen below, and these are not removed with pretesting. There is only one threat to internal validity when using multiple-group or between-subject designs: the groups not being comparable before the study. This threat is called selection bias. A selection threat is anything other than the program that results in posttest differences between groups. Primary Source: Trochim, William M.K. (2005). Single Group Threats. Retrieved fromhttp://www.socialresearchmethods.net/kb/intsing.htm There Are Two Major Types of Experimental Research Experimental (1) True experimental research design – Search for cause-and-effect Search relationships in a “manipulated environment” environment” Random assignment to groups Independent variable manipulated Independent – – Two Major Types of Experimental Research Continued Research (2) Quasi-experimental research design – Search for cause-and-effect Search relationships in a “manipulated environment” environment” – No random assignment to groups – Independent variable manipulated Are subjects assigned randomly to experimental and control groups? YES Randomized or True Experiment NO Is there a comparison group? Are there pre-post measures? YES Quasi-Experiment NO Non-Experiment Source: Trochim, William M.K. (2005). Types of Designs. Retrieved from http://www.socialresearchmethods.net/kb/destypes.htm Two-Group Posttest-Only Randomized Experiment ● This is the simplest experimental design. ● The experimental group gets the treatment or program or independent variable (X) and the control group doesn't. ● Notice that a pretest is not required for this design because we assume that the two groups are equivalent to begin with. R R X O O Source: Trochim, William M.K. (2005). Two-Group Experimental Designs. Retrieved from http://www.socialresearchmethods.net/kb/expsimp.htm The Analysis of Covariance Design (ANCOVA or ANACOVA) is simply a pretest-posttest randomized experimental design. The pre-program measure or pretest is called a "covariate" because we "covary" it with the outcome variable in order to remove variability or “noise.” The ANCOVA design is a "noise reduction" experimental design. It "adjusts" for the effects of one variable on another. You can use any continuous variable as a covariate. The pretest is usually best because it is the most highly correlated with the posttest. When you "remove' it, you remove extraneous variability from the posttest. ROXO RO O Source: Trochim, William M.K. (2005). Covariance Designs. Retrieved fromhttp://www.socialresearchmethods.net/kb/expcov.htm Categorizing Other Experimental Designs We can divide all other experimental designs into two categories: signal enhancers and noise reducers. Enhancing the “signal” (effects) or reducing the “noise” (variability) improves the research. The signal-enhancing experimental designs are called factorial designs. Here the focus is on aspects of the program or treatment and how they are separated in the study plan. In a typical factorial design there are many different variations of the treatment or independent variable. There are two types of noise-reducing experimental designs: covariance designs and blocking. These designs use information about the makeup of the sample or about preprogram variables to remove some of the noise in your study. Primary Source: Trochim, William M.K. (2005). Classifying Experimental Designs. Retrieved from http://www.socialresearchmethods.net/kb/expclass.htm The signal-enhancing experimental designs are called factorial designs. Here the focus is on aspects of the program or treatment and how they are set up in the study. In a typical factorial design there are many different variations of the treatment or independent variable. Source: Trochim, William M.K. (2005). Factorial Designs. Retrieved fromhttp://www.socialresearchmethods.net/kb/expfact.htm Quasi-Experimental Research Designs The Non-Equivalent Groups Design (NEGD) is frequently used in social research. It is structured like a pretest-posttest randomized experiment but lacks random assignment. Intact treatment and comparison groups are used instead. There are other quasi-experimental designs besides the NEGD. The NEGD is especially vulnerable to internal validity threats. Prior differences between the groups may affect the outcome of the study. This can lead to the conclusion that a program did not have an effect when in fact it did, or that it did have an effect when in fact it didn't. NOXO NO O Source: Trochim, William M.K. (2005). Quasi-Experimental Designs. Retrieved fromhttp://www.socialresearchmethods.net/kb/quasiexp.htm Ethics A branch of philosophy in which we study and evaluate arguments about right and wrong actions. Research ethics A branch of philosophy in which we study and evaluate arguments about right and wrong actions in the search for generalizable knowledge, scientific theories and principles, and technological advancement. Research Ethics Topics 1. Data acquisition, management, sharing, and ownership 2. Mentor / trainee responsibilities 3. Publication practices and responsible authorship 4. Peer review 5. Collaborative science 6. Research involving human subjects 7. Research involving animal subjects 8. Research misconduct 9. Conflict of interest and commitment - NIH Core Instructional Areas The Ethics of Human Research Is About: • Doing valid research (using accepted scientific methods) • Appropriate sampling (to get valid results) • Respecting people and their communities • Protecting research participants • Benefiting individuals and society • Creating a basis for socially beneficial policies • Disseminating findings effectively • Facilitating the application of findings Well Known Major Cases Involving Unethical Research in the U.S. Involving Tuskegee Syphilis Study 1932-1972 U.S. Radiation Experiments 1940s Willowbrook Study, NY 1956-1972 Milgram Study, 1961 Jewish Chronic Disease Hospital, 1963 U.S. Army LSD studies/National Airport, U.S. 1963-4 1963-4 Stanford Prison Study, 1971 Nazi War Crimes - WWII Victims of Dr. Josef Mengele's Victims of Dr. Josef Mengele's medical experiments at Auschwitz­Birkenau. Poland, 1944. Nazi physician Carl Clauberg performed medical experiments on prisoners in Block 10 of the Auschwitz camp. Poland, between 1941 and 1944 Mid 20th Century Scandals Scandals Willowbrook State School, Staten Island, NY, 1950s Willowbrook State School, Staten Island, NY, 1950s • Children at this institution for the retarded were fed extracts of stools from individuals infected with the hepatitis virus. • Justification by Willowbrook’s Research Director, Dr. Saul Krugman, was that children in the crowded facility would likely contract hepatitis anyway. • Parental “permission” was obtained through misleading them about lengthy admission process for non­participating children. Jewish Chronic Disease Hospital Cancer Experiments ­ 1960s • Twenty two chronically ill, debilitated, non­cancer patients injected with live human cancer cells • They were not told about the cancer cells because doctors (researchers) "did not wish to stir up any unnecessary anxieties in the patients" who had "phobia and ignorance" about cancer. • Research funded by U.S.P.H.S. and American Cancer Society. • Two years later, the American Cancer Society elected the principal investigator to be their Vice­President. Stanford Prisoner Study Stanford 1971 http://www.prisonexp.org/ PHS Syphilis Study Study Disclosed 1972 1932, Public Health Service study, in collaboration with the Tuskegee Institute in Macon County, Alabama, undertook a study of untreated syphilis in hopes of justifying treatment programs for blacks. 600 black men (399 with syphilis, 201 without) were told they had "bad blood," a local term used to describe syphilis, anemia, and fatigue. Penicillin, treatment of choice, was discovered in 1940s but was withheld. In exchange for taking part in the study, the men received free medical exams, free meals, and burial insurance. Although originally projected to last 6 months, the study actually went on for 40 years. PHS Syphilis Study PHS To entice their continued participation, PHS doctors sent them a letter titled, “Last Chance for Special Free Treatment.” The men submitted to painful and dangerous spinal taps. The fact that autopsies would eventually be required was also concealed. The Surgeon General of the United States participated in enticing the men to remain in the experiment, sending them certificates of appreciation after 25 years in the study. By end of study in 1970s, 28 men were dead of syphilis, 100 were dead of related complications, 40 of their wives were infected, and 19 of their children were born with congenital syphilis. BC Martinson, MS Anderson, & R de Vries. (2005). Nature, 435: 737-38 BC Nature Scientists Behaving Badly Scientists • NIH funded survey • 3,247 early/mid career • (~47% rr) Engaged in Top 10 Behaviors • Early = 28% • Mid = 38% • Overall = 33% plus expect an underreporting bias. Significant Events Significant PHS Syphilis Study, formerly “Tuskegee Study” Nuremberg Code 1947 U.S. Scandals U.S. Henry Beecher: "Ethics and Clinical Research" Henry Public Health Service Policy Adopting IRBs Declaration of Helsinki Declaration Stanford Prisoner Study (1971) Stanford Prisoner Study (1971) PHS “Tuskegee Study” Revealed (1972) PHS National Research Act & 45 CFR 46 National Belmont Report (1979) Belmont 1930 1940 1950 1960 1970 1980 Common Rule 1991 Significant Events Significant President Clinton apologizes to PHS Syphilis study survivors Jesse Gelsinger dies at U Penn OPRR shuts down LA VA Medical, Duke, U Ill, UC, U Penn Nicole Wan dies at Rochester 1996 OPRR shuts down VCU, UAB, U Okla OPRR reorganized as OHRP, moved to Cabinet level and Director replaced, June 2000 Ellen Roche dies at Johns Hopkins; OHRP suspends JH federally funded research Secretary's Advisory Committee on Human Research Protections replaces National Human Research Protections Advisory Committee 1990 1996 1997 1999 2000 2001 2002 Ethical Framework Ethical P Principles C Consequences I Interests FFP? FFP? Fabrication is making up results and recording or reporting the fabricated results. reporting Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record. represented Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit and without specific approval, including those obtained through confidential review of others' research proposals and manuscripts. others' Belmont Report, 1979 Belmont National Commission for the Protection National of Human Subjects of Biomedical and Behavioral Research Behavioral This report is the basis of all federal This regulations regarding the protection of human subjects in research human http://www.hhs.gov/ohrp/humansubjects/guidance/belm ont.htm Historical Review – Ethical Codes Belmont Report Belmont 9/30/1978 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research submitted its report entitled “The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research.” The Report, named after the Belmont Conference Center at the Smithsonian Institution where the discussions were held, sets forth the basic ethical principles underlying the acceptable conduct of research involving human subjects. Belmont Report, 1979 Belmont Articulates 3 Basic Ethical Principles: s Respect For Persons – Autonomy of the Individual Individual Beneficence – Risk Minimization Justice – Burdens and Benefits of Research are Equitably Distributed are s s Historical Review – Ethical Codes Belmont Report Belmont Respect for persons – informed consent which contains the three elements: information, comprehension and voluntariness Beneficence – risk/benefits assessment: study is carefully designed so that the benefits are maximized and any potential harm is minimized (benefit is not monetary!) Justice – requires all subjects be treated fairly: selection of research subjects must be the result fair selection procedures and fair selection outcomes The Belmont Report The Respect for Persons – Recognition of personal dignity and Recognition autonomy autonomy – Special protection of those with Special diminished autonomy diminished – Informed Consent Information Comprehension Voluntariness The Belmont Report The Beneficence – Obligation to protect persons from harm – Maximize anticipated benefit, minimize Maximize possible harm possible – Risk/benefit ratio Risk – probability, magnitude Benefit – subject, society The Belmont Report The Justice – Fair distribution of research benefits and Fair burdens burdens – Inclusion/exclusion on scientific basis Inclusion/exclusion rather than convenience, availability rather – Two levels of justice Social Individual ** More information about the Belmont Report can be found in the ** UI Investigator’s Guide Chapter 2. UI Federal Regulations Federal DHHS – Title 45 CFR Part 46 FDA – Title 21 CFR Part 50, Protection of Title Human Subjects Human – Title 21 CFR Part 56, Institutional Title Review Boards Review Federal Regulations for the Protection of Subjects from Research Risks (Based on Belmont Report) (Based 45 CFR Part 46 1981 45 CFR 46 45 Subpart A -- Basic Protections Subpart B -- Pregnant Women, Subpart Neonates and Fetuses Subpart C -- Prisoners Subpart Subpart D -- Children Oversight Oversight Federal law requires the Department of Health and Human Services (DHHS) to issue regulations for the protection of human subjects in research projects [codified at Title 45, Part 46 of the Code of Federal Regulations, Protection of Human Subjects] The Office of Human Research Protections (OHRP) is the unit within DHHS that implements the regulations for the protection of human subjects Fundamental Provisions of 45 CFR Part 46, Subpart A • • • Assurance of Compliance IRB requirements Legally effective informed consent Assurance of Compliance (1) Each institution engaged in research covered by 45 CFR part 46 and which is conducted or supported by HHS shall provide assurance satisfactory to the HHS Secretary that it will comply with the requirements set forth in 45 CFR part 46 [45 CFR 46.103(a)]. Assurance of Compliance (2) • • • • Statement of principles governing institution in the discharge of its responsibilities for protecting the rights and welfare of human subjects Designation of one or more IRBs List of IRB members Written IRB procedures [45 CFR 46.103(b)] What is an IRB? What Independent panel conducts review of Independent proposed research, to protect the rights and welfare of participants welfare – – – At least 5 members, both genders Diversity and appropriate expertise Varied professions Scientists Non-scientists – – – – At least one unaffiliated member Sensitive to community attitudes Knowledge of vulnerable populations Ad hoc consultants IRB Requirements • • • • • • Membership Functions and operations Review of research (initial and continuing) Expedited review procedures Criteria for IRB approval Records [45 CFR 46.107-111] IRB Review and Approval (46.111) IRB This section of the regulations provides the This criteria for IRB approval of research. It includes requirements, such as: requirements, - risks to subjects are minimized, - risks are in relation to anticipated benefits, - selection of subjects is equitable, - iinformed consent will be sought from each nformed subject, and will be appropriately documented, subject, 45 CFR 46 – IRB Composition 45 At least 5 members Quorum = more than half Varying backgrounds One member nonscientific (required One for quorum) for One member not affiliated No individual conflict of interest 45 CFR 46 – IRB Duties 45 Review and approve, require Review modifications (for approval), or disapprove research research Require informed consent and Require documentation as required by regulations documentation Notify investigator in writing Continuing review at intervals appropriate Continuing to degree of risk (at least annually) to 45 CFR 46 – IRB Approval Criteria 45 Risks to subjects minimized Risks to subjects reasonable in relation to – anticipated direct benefit – knowledge to be gained Selection of subjects equitable Informed consent sought and documented Appropriate provisions for monitoring safety Provisions to protect privacy & confidentiality Additional safeguards for vulnerable populations UI Investigator’s Guide Chapter 6, Section F Types of IRB Review Types 1) Determination if human Determination subjects research subjects 2) Exempt 3) Expedited Review 4) Full Committee Review 4) Full IRB Review and Approval (46.111) IRB This section of the regulations provides the This criteria for IRB approval of research. It includes requirements, such as: includes risks to subjects are minimized, risks are in relation to anticipated benefits, selection of subjects is equitable, iinformed consent will be sought from each nformed subject, and will be appropriately documented, subject, This section of the regulations provides the This criteria for IRB approval of research. It criteria includes requirements, such as: the research plan makes adequate provision the for monitoring of data, for adequate provisions for privacy/confidentiality adequate of subjects, of when subjects are likely to be vulnerable – when adequate safeguards have been included adequate IRB Review and Approval (46.111) IRB (cont’d) 45 CFR 46 – Vulnerable Populations Populations Subpart D – Children – No greater than minimal risk – one signature may No be sufficient be – Greater than minimal risk, prospect of direct benefit Greater – one signature may be sufficient one – Greater than minimal risk, no prospect of direct Greater benefit, likely to yield knowledge about condition/disorder – two signatures condition/disorder – None of above, but opportunity to understand, None prevent, alleviate serious problem affecting health/ prevent, welfare of children – two signatures UI Investigator’s Guide, Chapter 8, Section C Methods of Assuring Confidentiality • • • • • • • • • • Gather data anonymously Strip off identifiers Certificates of confidentiality Data brokering Encryption of data stored online “Ethical proofreading” of qualitative descriptions Statistical methods Inter-file linkage Error inoculation Top coding BPS Ethical Principles for Conducting Research with Human Participants 1 Research Respect and consideration for participants: ● (Informed) Consent ● provision of information about, e.g. ● competence of potential participants ● freedom to give voluntary consent •objectives of study (ensure promises realistic) •what is required of participants ● Deception ● Debriefing ● to be avoided if possible ● to complete participant understanding BPS Professional Code of Conduct (2000) British Psychological Society British Competence – maintain and develop, recognise and work within maintain limits limits Consent – obtain valid and informed consent of participants Confidentiality Confidentiality – maintain adequate records but preserve maintain confidentiality of information confidentiality Personal Conduct Personal – behave professionally, not damaging clients or behave undermining public confidence undermining Researcher Safety and Well-Being Researcher Physical safety (re accident, illness, Physical violence) violence) – – – – Lone and night working Travel Dangerous working conditions Organisational procedures Psychological well-being – Exposure to distressing information – Harassment, intimidation, etc. Reputation – Unsuitable or illegal situations BPS Ethical Principles for Conducting Research with Human Participants 2 Research ● Withdrawal from the investigation ● Confidentiality ● Protection of participants ● Observational research ● Giving advice ● Colleagues ● from physical/psychological harm in procedures ● from exacerbating pre­existing conditions ● during procedure or subsequently Data Protection Data Obtaining data – Legitimate interest (limited to requirements) – Consent (informed as to storage, use, etc.) Processing and storing – Manual or electronic – Security Disclosing – Awareness, security, permission Deleting or archiving – Period, reason, security Informed Consent Informed Participants should not be: – Physically harmed – Psychologically harmed – Forced to participate, or be unreasonably Forced compelled to participate compelled Levels of Risk to Participants Levels No risk – anonymous educational testing, observing public behavior, studying publicly available documents, etc. available Minimal risk – taking recordings using physical sensors, having healthy volunteers doing moderate exercise, doing research on such topics as perception, cognition, etc. such More than minimal risk – research involving deception and debriefing, collecting confidential responses regarding potentially embarrassing behaviors, etc. embarrassing Courses for Instructors Courses Kenneth Pimple, Poynter Center, Indiana Kenneth University University Teaching Research Ethics http://poynter.indiana.edu/tre 4 days ORI ORI http://ori.hhs.gov RCR Education Products – General Subject Authorship and – Areas Authorship – Human Subjects Publication Publication – – Animal Subjects Peer Review – Collaboration – Data Management – Mentoring – Conflicts of Interest – Research Misconduct Points for Discussion Websites Publications Publications “The journal publishes original empirical, methodological, empirical, policy policy and theoretical papers, cases studies, conference reports and book reviews that address book issues issues of integrity and accountability in research.” Accountability in Research http://www.tandf.co.uk/journals/titles/089 Publications Publications Journal of Empirical Research on Human Research Ethics http://www.csueastbay.edu/JERHRE The Journal “publishes empirical research and reviews of empirical literature on human research ethics…In addition, JERHRE seeks to create collaboration among institutions and researchers concerned about the responsible conduct of research.” Courses Courses RCREC Internet Course http://rcrec.org/resources Responsible Conduct of Research Internet Instruction – – – – – – – – Animal Subjects Human Subjects Data Management Conflicts of Interest Authorship Publication and Peer Review Collaboration and Mentoring Research Misconduct Courses Courses Columbia Internet Tutorials http://ccnmtl.columbia.edu/projects/rcr Web-based RCR Tutorials – Data Management – Conflicts of Interest – Authorship and Peer Review – Collaboration – Mentoring – Research Misconduct Courses Courses CITI: Collaborative Institutional Training Collaborative Initiative Initiative http://www.citiprogram.org RCR Course to be released soon Guidance Guidance The Belmont Report http://ohsr.od.nih.gov/guidelines.php3 The Nuremberg Code http://ohrp.osophs.dhhs.gov/irb/irb_appendices.htm#j5 NIH online training Human Participant Protections Education for Research Teams http://cme.nci.nih.gov/ Office for Human Research Protections (OHRP) http://ohrp.osophs.dhhs.gov/ OHRP Website OHRP http://www.hhs.gov/ohrp/ Check website for guidance on many Check different ethical and regulatory considerations. considerations. Guidance Guidance Institutional Review Board Guidebook http://ohrp.osophs.dhhs.gov/irb/irb_guidebook.htm National Institutes of Health (NIH) Guidelines for the Conduct of Research Involving Human Subjects at NIH http://ohsr.od.nih.gov/guidelines.php3 National Science Foundation (NSF) Behavioral and Cognitive Sciences http://www.nsf.gov/search97cgi/vtopic National Science Foundation (NSF) The Common Rule http://www.nsf.gov/search97cgi/vtopic ...
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