Chapter 11:  Standards in Research and Publication

Chapter 11:  Standards in Research and Publication

8. RESEARCH AND PUBLICATION

8.01 Institutional Approval

When institutional approval is required, psychologists provide accurate information about their research proposals and obtain approval prior to conducting the research.  They conduct the research in accordance with the approved research protocol.

• This standard has four basic requirements
  • Psychologists must know if and from whom institutional approval is required.
  • If receiving federal funding, required to establish institutional review boards (IRBs) to protect the rights and safety of research participants
  • Follow federal, state, and local laws requiring the review and regulation of research involving animal subjects
  • Many social welfare agencies, health care facilities, school, correctional facilities, businesses, and other public and private organizations have their own internal review requirements for research
• Federal guidelines list activities that are exempt from institutional review, the exempt status of any specific project must be approved by an institution’s IRB.
• Applications for institutional review must be accurate and approval obtained before the research is conducted.
  • Any changes in the participant informed consent language or procedures, compensation, confidentiality protections, or methods that increase human or animal participant risk or safety should be resubmitted for institutional approval
• Implications of HIPAA state investigators conducting program evaluation or archival research involving PHI should be aware that institutions, health plans, or providers who have obtained the information must have a waiver from either an IRB or a “privacy board”.

 

8.02 Informed Consent to Research

(a) When obtaining informed consent as required in Standard 3.10, Informed Consent, psychologists inform participants about (1) the purpose of the research, expected duration, and procedure; (2) their right to decline to participate and to withdraw from research once participation has begun; (3) the foreseeable consequences of declining or withdrawing; (4) reasonably foreseeable factors that may be expected to influence their willingness to participate such as potential risks, discomfort, or adverse effects; (5) any prospective research benefits; (6) limits of confidentiality; (7) incentives fro participation; and (8) whom to contact fro questions about research and research participants’ rights.  They provide opportunity for the prospective participants to ask questions and receive answers.  

• Ensuring Consent is Informed, Rational, and Voluntary
  • Must obtain and document written or oral consent, which included providing information in a language and at a language level understood by prospective participants.
  • Describing the nature of participation
    • Prospective participants must be given information and the opportunity to ask questions about the purpose, duration, procedures, foreseeable risks, potential benefits, and compensation.
  • The voluntary nature of participation
    • Consent procedures must directly inform participants they will not be penalized for declining participation.
    • The conditions under which individuals will qualify for full compensation for participation or continuation of experimental interventions if they withdraw from the study must be fully described.
  • Confidentiality
    • Informed consent procedures must provide a clear explanation of the extent and limits of confidentiality including (1) whether investigators must comply with reporting requirements such as mandated child abuse reporting, elder abuse, or duty-to-warn laws; (2) the investigator’s confidentiality and disclosure policy for responses indicating a participant or another person is in immediate danger; (3) if the method of data collection itself may limit the extent of confidentiality protections as may be the case when research is conducted via Internet; or (4) if the investigator has applied for and received DHHS Certificate of Confidentiality that protects research records from most types of subpoenas.
    • If conducting research in the schools or studies involving children or adults with questionable consent should be familiar with evolving federal and state laws governing guardian’s rights of access to health- or school-related records
  • Persons legally incapable of giving informed consent, follow the same requirement from Standard 3.01b:
    • Provide appropriate explanations and obtain assent for research participation from personal legally incapable of informed consent, such as children or adults with severely impaired cognitive capacities.
    • Obtain appropriate permission from a legally authorized person, if such substitute consent is permitted or required by law.
    • Psychologists who do not obtain the active permission of guardians violate this standard except when the research meets the conditions for Standard 8.05
  • Implications of HIPAA
    • All providers who are covered entities under HIPAA should comply with regulations
    • In order for a covered entity to create, use, or disclose PHI for research purposes, must receive a signed authorization from the prospective participant and can be combined with informed consent
      • A valid authorization must contain the following:
        • A description of the information to be used or disclosed
        • Specific identification of the person who will be involved in the request
        • A description of each purpose of the requested used or disclosure
        • An expiration date
        • Signature and date of signature
        • A statement regarding the individual’s right to revoke authorization
        • Exceptions to the right of revocations
        • The consequences to the individual of a refusal to sign the authorization
        • The participant must receive a copy of the authorization
      • Parental Consent in School Based Research
        • The Protection of Pupil Rights Amendment (PPRA) seeks to ensure that certain instructional materials used in connection with a federally funded survey, analysis, or evaluations of students are available for inspection by parents. The types of materials that are applied are
          • Political affiliation
          • Mental and psychological problems potentially embarrassing to the student and his or her family
          • Sexual behaviors and attitudes
          • Illegal, antisocial, self-incriminating, and demeaning behaviors
          • Critical appraisals of other individuals with whom respondents have close family relationships
          • Legally recognized privileged or analogous relationships
          • Income
        • Conducting research in schools should keep up-to-date on the implantation of the Hutchinson Amendment to the Reauthorization of the Elementary and Secondary Education Act (ESEA)
      • CASE
        • A psychologists was conduction a study on language skills involving adults with mild levels of mental retardation and developmental disabilities (MR/DD) living in community group residences. Some of the prospective participants had a parent or sibling who was their legal guardian.  Other prospective participants had maintained the legal right to consent to decisions affecting their live, but such decisions were often made in collaboration with residence staff and family.  The psychologist obtained signed permission from all legal guardians followed by the signed assent of individuals who wished to participate.  The psychologist obtained signed consent from all adults with MR/DD who had the legal right to consent.  However, information forms were also sent in advance to the family members with whom these individuals relied on for decision making.  In all situations, the psychologist did not attempt to obtain consent from a prospective participant until after a resident staff member had confirmed that the individual wanted to be approached.
      • VIOLATION
        • A psychologist decided to conduct a survey study on martial conflict over the Internet. She posted an explanation of the study on a university Web site.  Those who wished to participate were asked to download the questionnaire into their personal computers and to e-mail their responses back to the psychologist.  The explanation on the Web site claimed that participant responses were anonymous and thus there were no risks to confidentiality.  However, the psychologist’s university did not have the technology necessary to de-identify respondent e-mail address, so in fact there was a chance that an e-mail address might be recognized by the psychologist, a research assistant, or others.  In addition, the Web site explanation did not want participants to password protect the completed filed saved on their personal computer.

 

8.02 Informed Consent to Research

(b) Psychologists conducting intervention research involving the use of experimental treatments clarify to participants at the outset of the research (1) the experimental nature of the treatment; (2) the services that will or will not be available to the control group(s) if appropriate; (3) the means by which assignment to treatment and control groups will be made; (4) available treatment alternatives if an individual does not which to participate in the research or wishes to withdraw once a study has begun; and (5) compensation for or monetary costs of participating including, if appropriate, whether reimbursement from the participant or a third-party payor will be sought. 

• This new standard governs research on behavioral, psychosocial, biomedical, psychopharmacological, or other interventions involving individuals, families, groups, or communities
• Addressing the “therapeutic” misconception
  • Informed consent procedures address the general misconception that “experimental” treatment means “better” treatment with known direct benefits for participants
  • The primary goal of intervention research is to provide generalizable information on whether a particular type of intervention is successful
  • Must take reasonable steps to communicate to prospective participants that the purpose of conducting treatment research is to determine whether or not a treatment works of how it works in comparison to another treatment
  • This standard does not prevent psychologists from describing direct benefits that may be derived from participation such as:
    • Access to new treatment not yet available for general use
    • Benefits of the experimental treatment if it proves effective during or following the conclusion of the study
    • Comprehensive psychological assessment and monitoring
    • Treatment referrals
    • Upon participant-signed authorization, forwarding a summary of the participants response to the treatments conditions to a qualified mental health professional `
  • Explanation about control groups and methods of assignment to treatment conditions should be adequately describe by the nature, potential risks, and probable benefits
    • When appropriate, the nature of random assignment should be explained in understandable language
    • If using sing- or double-blind procedures should describe the extent to which participants and members of the treatment and research teams will know the group to which the participant has been assigned
  • Have to assure research participation is voluntary. Procedures must assure clients currently receiving services that dissent will not disrupt their ongoing treatment and inform individuals new to the treatment facility of available alternative services
  • Costs and compensation:
    • The cost of treatments provided in intervention research may be provided at no cost to the participant through federal or private funding
    • Understanding the financial costs and the extent to which third-party payors will be aware of diagnoses and services received is essential for informed decision making
    • Prospective participants are given sufficient information about the nature of such financial arrangements to make an informed decision about participation
  • Have to comply to HIPAA regulations

 

 

8.03 Informed Consent for Recording Voices and Images in Research

Psychologists obtain informed consent from research participants prior to recording their vices or images for data collection unless (1) the research consists solely of naturalistic observations in public places, and it is not anticipated that the recording will be used in a manner that could cause personal identification or harm, or (2) the research design includes deception, and consent for the use of the recording is obtained during debriefing.

• Must obtain informed consent to electronically record research participation before beginning data collection
• Auditory and visual records pose a greater risk of personal identification over time
• Restricting data access to the research team best protects personal identification
• If recording will be used for training purposes or presentation at professional meetings, consent must be obtained specifically for these purpose unless image scrambling, voice distortion, or other identity-masking techniques can ensure adequate disguise
• The phrase “prior to recording their voices or images for data collection” allows investigators to record the consent procedure itself for documentation or other legitimate purposes as long as participant permission is obtained in advance and recording ceases if the individual refuse participation.
• Investigators may record the voices and images of persons without their consent if
  • Observations occur in a public setting in which one would have no reasonable expect of privacy
  • Procedures do not disturb or manipulate the natural surroundings
  • Protections are in place to guard against personal identification and harm, especially when the behaviors observed place participants at legal or social risk, for ex- drug dealing.

 

8.04 Client/Patient, Student, and Subordinate Research Participants

(a) When psychologists conduct research with clients/patients, students, or subordinates as participants, psychologists take to protect the prospective participants from adverse consequences of declining or withdrawing from participation. 

• Clients/pts., students, employees, prisoners, or other institutionalized persons may not feel free to decline or withdraw participation in a study conducted by a psychologist serving as their treatment provider, professor, supervisor, employer or member of the institutional staff.

 

(b) When research participation is a course requirement or an opportunity for extra credit, the prospective participant is given the choice of equitable alternative activities. 

• In many colleges and universities, psychology instructors require or give extra course credit for undergraduate student participation in research.
• This standard addresses these concerns by requiring that psychologists offer students pedagogical alternatives equivalent in time and effort to research participation.
• CASE
  • A graduate student member of the APA received permission to collect data for her doctoral dissertation at her internship site. The methodology included individual interviews with patients at the veterans hospital where she interned.  The graduate student restricted her recruitment to hospital patients who were not in the section in which she worked.  In addition, she hired and trained a research assistant to recruit and obtain informed consent.
• VIOLATION
  • A psychology department instituted a 2-hour research participation requirement for all students enrolled in introductory psychology classes. Students who did not wish to participate in the research had set up a meeting to explain their objection to the instructor and write a 15-page paper on a research topic approved by the professor.  In anonymous course evaluations, many students said they had participated in the required research because they were afraid they would get a bad grade in the course if the professor knew they did not want to participate in the subject pool or they believed it would take more than 2 hours to complete a 15-page paper.

 

8.05 Dispensing with Informed Consent for Research

Psychologist may dispense with informed consent only (1) where research would not reasonably be assumed to create distress or harm and involves (a) the study of normal educational practices, curricula, or classroom management methods conducted in educational settings; (b) only anonymous questionnaires, naturalistic observations, or archival research for which disclosure of responses would not place participants at risk of criminal or civil liability or damage their financial standing, employability, or reputation, and confidentiality is protected; or (c) the study of factors related to job or organization effectiveness conducted in organizational settings for which there is no risk to participants’ employability, and confidentiality is protected or (2) where otherwise permitted by law or federal or institutional regulations.  

• Standard restricts dispensing with informed consent for research to three well-defined conditions:
• When working in an institution with an IRB, investigators designing research that meets the criteria of Standard 8.05 must still obtain appropriate institutional approval for such waivers.
• Research conducted in school
  • Studies of normal educational practices that do not require informed consent include comparisons of different instructional methods and classroom management techniques, or evaluation of educational placement.
  • Should be familiar with FERPA and other federal regulations that may require parental access to their child’s school records.
  • Permission to dispense with informed consent for research in educational settings does not apply to studies designed to describe or test hypotheses regarding the relationship between student personality traits or mental health disorders and school performance.
  • Some school based programs, such as drug prevention programs, may not be considered a normal educational practice and would not meet Standard 8.05 criteria for waiver of parental permission or child assent.
  • VIOLATION
    • A developmental psychologist received from a local school district to design and test a conflict resolution program for fifth and sixth graders. The school permitted her to offer the program during the regularly scheduled health classes.  Half of the classes served as controls.  The success of the program was evaluated by comparing baseline and postprogram responses of children to questions about their conflicts with peers, siblings, and parents.  The psychologist told the school superintendent that according to the APA Ethics Code, parental permission would not be required for this type of research.
  • Anonymous, Naturalistic, or Archival Research
    • Informed consent is not required for investigations using anonymous questionnaires, naturalistic observations, or archival research when (1) confidentiality is protected; (2) disclosure or responses would not place participants at legal, financial, or social risk; and (3) the research methods would not reasonably be expected to cause distress or harm.
    • Unless anonymity can be assured, psychologists should avoid dispensing with informed consent when personal information collected would create participant distress.
    • Anonymity is confused with confidentiality. Most people only use subject numbers on questionnaires to protect confidentiality.
    • Anonymity occurs when neither the investigator nor the public can identify who participated in the study.
    • Questionnaires are not anonymous when linked to other data or collected longitudinally.
    • Should consider whether the uniqueness of a population studied increases the probability that anonymous, naturalistic, or archival procedures may not be sufficient to safeguard identification.
    • Studies of individual response in chat rooms and on listservs may be considered naturalistic observation if the users have no reasonable expectations of privacy and the investigator.
  • Studies of Job or Organization Effectiveness
    • Recognizes the right and responsibility of organizations to draw on the research expertise of psychologists to investigate factors related to job or organization effectiveness as long as (1) research participation does not pose a direct risk to an individual’s current employment status, (2) confidentiality is adequately protected, and (3) the research procedures themselves would not be expected to create distress or harm.
    • The phrase “not reasonably be assumed to create distress or harm” highlights that it would be ethically inappropriate to dispense with informed consent for organizational effectiveness using measures of psychopathology or biological data
    • Can dispense with informed consent reasons not included in part 1 of standard where consent waiver is permitted by law or federal or institutional regulations
  • HIPAA Requirements
    • PHI may by used for research purposes without client authorization if the covered entity receives written documentation that waiver of patient authorization has been approved by an IRB in conformance with federal guidelines
      • Covered entities may waive the requirement for client authorization for the use and disclosure of their PHU for research under certain conditions
        • Information is de-identified
        • The researcher is reviewing the PHI for the sole purpose of preparing a research protocol, the information is necessary for the research purposes, and the PHI is not removed from the covered entity’s premises
        • Research is on decedent’s information
        • Disclosure is restricted to a limited data set
        • The investigator signs a business associate contract
      • CASE
        • An anonymous survey on attitudes toward caretaking of ill elderly household members included (1) a brief questionnaire asking for general demographic information such as gender, age, and ethnicity of household members and (2) health-related information such as whether there was an ill elderly person living in the household, which family member did or would take care of an elder family member if her or she was ill, how the respondent rated the adequacy of their health insurance plan for elder care, and several questions tapping who the respondent thought should be most responsible for elder care, for example, spouses, adult children, private nursing homes, or government-run hospitals. The survey was mailed to 10,000 randomly selected households in a large metropolitan area where respondents could not reasonably be expected to be identified by their answers or zip code.  No names were on the survey, and the mailed packet included a self-addressed stamped envelope.

 

Fisher, C. B. (ed). (2002). The forum. Ethics & Behavior, 12(3), 279-293. This article is available on-line through the library.

 

Case Vignette: Informed Consent and Fluctuating Decisional Capacity. Alice, a 25-year-old woman with schizophrenia, hates the physical side effects of the medication that is successfully controlling her thought disorder. She consents to enroll in a medical research study designed to test how long persons with schizophrenia can remain free of psychiatric problems after stopping medication. Two weeks into the study, her parents begin to worry that some of Alice’s “bizarre” behavior may be returning. When they ask Alice to withdraw from the study, she refuses. Her parents approach the hospital conducting the study to challenge the legitimacy of Alice’s consent to remain in a study that places her mental health at risk.

• Fisher, C. B. Respecting and Protecting Mentally Impaired Persons in Medical Research
  • Dilemma: How do we balance our moral obligation to respect the dignity and autonomy of persons with mental disorders to make their own decisions with the obligation to ensure that ill-informed or incompetent choices do not jeopardize their welfare or leave them open to exploitation?
  • Base answer on individual’s ability to not only understand the nature of the experiment but to rationally calculate whether the possibility of deriving benefit from the research outweighs the risks. . . Who decides what is or is not a “rational” criterion for a risk-benefit calculation?
    • EX: We offer a homeless veteran $50 a week to participate in a study exposing them to a harmful substance?  Is the person’s decision that $50 outweighs my health rational?
  • Can you put yourself in Alice’s shoes? Consider the following:
    • Suppose you do not have a mental impairment but suffer from debilitating migraine headaches that have prevented you from going to work and participating in most everyday activities. You have the chance to participate in a study on an experimental medicine that may reduce the frequency of your migraine episodes. The side effects of the medicine are minimal, but it needs to be administered through an injection once a day for several months. You are very squeamish about needles and refuse to be in the study.
    • Your spouse and children cannot believe that you would refuse to be in a study that could help you get your life back, and they begin to question whether you are cognitively competent to make this decision. Would they be ethically justified in taking away your right to refuse to participate in this study? Would they be morally obligated to override your judgment if they thought the experimental treatment might make you well? Should the answers to these questions be different if you had a diagnosed mental disorder?
  • Rosenfeld, B. Competence to Consent to Research: Where Psychology, Ethics, and the Law Intersect
    • Informed consent requires that any decision regarding medical treatments must be knowing, voluntary, and competent.
    • Knowing
      • Burden on tx. physicians- must provide a reasonable amount of information regarding the known risks and benefits of a recommended treatment, as well as the risks and benefits of treatment alternatives.
    • Voluntariness, pertains to context. Individuals must be free to make their own decisions without undue coercion from others.
    • The issue of competence is perhaps the most important. Although the burden of competence falls on the decision maker, it is incumbent on clinicians and researchers to make sure this condition is met.
      • The law typically assumes that every adult is competent to make decisions for themselves unless proven otherwise, but in several populations, the burden of demonstrating competence may shift as a practical matter, if not legally (e.g., with mental illness, mental retardation, or with severe medical illness).
    • Regarding Alice’s Case
      • First, we must assume that Alice, the 25-year-old woman with schizophrenia, provided valid informed consent at the time she agreed to participate in the study.
      • Second, given the nature of this study, we can probably assume that specific criteria were in place to determine when a subject’s symptoms were sufficiently severe as to warrant discontinuing the study (i.e., resuming medication).
        • Assuming these two conditions are met, Alice’s parent’s have no legal authority to challenge the study protocol, and an analysis of her current mental state is not necessary.
      • Competence to consent is typically only at issue at the outset of a study—it is not necessarily an ongoing requirement. ? I challenge this- informed consent is an ongoing process and consideration.
    • McKenzie, D. M. What Theological Understandings Contribute to Protecting Mentally Impaired Persons in Medical Treatment and Research
      • Autonomy- “an individual capable of deliberation about personal goals and acting under the direction of such deliberation”, beneficence- obligation to do good- do no harm and maximizing benefits, justice- enable people to participate in society to the degree to which they are able- so not everyone is necessarily treated equally
      • It is not clear to me that the first case is strictly a matter of informed consent and assessing whether or not Alice is capable of giving consent. I think we need to question the intent of a study “designed to test how long persons with schizophrenia can remain free of psychiatric problems after stopping the medication.” What is the point of this study and whose interests is it serving? Would we stop giving insulin to diabetics to see how long it would take them to go into insulin shock? The mother of one of my students is a schizophrenic who is currently in prison for the attempted murder of her daughter. This woman failed to take her medication regularly. I mentioned this case to my student, and she was utterly appalled that such a study would be conducted.
      • We need to attend to the common good, which is not the utilitarian conception of the greatest good for the greatest number, but the sum total of conditions necessary for the well-being of individuals to flourish.

 

Case Vignette: Informed Consent and Impaired Decisional Capacity. John, a 40-year-old man with mental retardation, has been starting fights in the community residence in which he lives. Standard treatments for aggressive disorders have not helped John, and he may have to be institutionalized if the residence supervisors cannot control his behavior. John is eligible for research at a nearby hospital testing a new drug for aggressive behavior. Fearful of being treated by doctors he does not know, he refuses to participate. His supervisor thinks that despite John’s concerns he should be enrolled in the study because it may be his last chance to stay in the residence where feels happy and safe.

• Fisher, C. B. Respecting and Protecting Mentally Impaired Persons in Medical Research
  • Given unique characteristics of each prospective research participant (John- impaired reasoning and limited opportunities to make autonomous decisions), ensuring a fair consent outcome may require the use of guardian permission or assisted decision-making procedures.
  • In John’s case- resident supervisor could have taken steps to find out if research team could allay John’s fears about new doctors, perhaps by arranging doctor visits to the residence or have John visit the hospital.
  • Discuss with John his concerns about the possibility that the might have to leave the residence, and help him consider pros and cons of decision.
  • Then respect John’s decision- ultimate decision of weighing risks and benefits is John’s.
  • What are consequences of over-riding John’s decision making authority?
    • Make him lose authority in other areas of his life: legal capacity to consent
    • Make him question his own ability to make decisions.
  • Rosenfeld, B. Competence to Consent to Research: Where Psychology, Ethics, and the Law Intersect
    • Presumably, because he has been offered this treatment directly (rather than approaching a judge or guardian), John’s mental retardation is not so severe as to render him obviously incompetent.
    • Thus, the first step in this scenario is to assess John’s decision-making capacity, an assessment typically done by a clinical psychologist or a consultation—liaison psychiatrist.
  • McKenzie, D. M. What Theological Understandings Contribute to Protecting Mentally Impaired Persons in Medical Treatment and Research
    • The second case may indicate the dangerous tendency that we have to medicalize all human complaints.
    • In this case, the supervisor indicates that John feels happy and safe in his community residence, but then, why this sudden inability to control his anger? Is it possible that there is something wrong in the structure of the group home rather than something that needs to be treated with a “new drug for aggressive behavior?” The supervisor indicates, too, that John is afraid to be treated by doctors whom he does not know. Who wouldn’t be!
    • We need to analyze the ways in which society constructs illness, and we need to take the time, for which no medical treatments for aggressive behavior can be a substitute, to get to know John and identify the source of his anxiety and fear. Medicine is no substitute to the call for others to bear burdens. The supervisor lacks the legal authority to enroll John in hospital testing, but he need not abandon his own ability to empower John through compassionate service. “Standard treatments for aggressive disorders” must begin with the engaged concern of others.

 

Case Vignette: Informed Consent and Diminishing Decisional Capacity. Nina, a 76-year-old woman in the beginning stages of Alzheimer’s disease, wishes to sign an advanced directive consenting to participate in a medical treatment study for patients with advanced Alzheimer’s. Her participation in the study will begin when she reaches the stage at which her cognitive capacities will be seriously impaired. Her adult children question Nina’s authority to make decisions for a time in the future when her consent capacity will be deficient.

• Fisher, C. B. Respecting and Protecting Mentally Impaired Persons in Medical Research
  • Nina’s case illustrates a problem inherent in issuing and following advance directives—neither the individual nor those who will serve as her legal guardian can know with certainty how she will think and feel in a diminished state.
  • The process of obtaining ethically acceptable advanced directives should include a series of information-sharing sessions among Nina, her children, and the medical scientists, during which the following would be discussed:
    • The scientists provide Nina and her family with information about the anticipated course, nature of, and potential risks and benefits of research participation.
    • Nina provides the scientists and her children with information to help them understand her value system, the way she evaluates physical or emotional pain, her views on the altruistic value of research participation, and other personal perspectives that would allow her children to make future decisions from her perspective.
    • Nina’s children share their moral philosophies on consent-relevant dimensions so that they and Nina can decide whether or not the advance directives can be carried out in a manner that honors both their value orientations.

 

Standard 8: part 2

8.06 Offering Inducements for Research Participation

(a) Psychologists make reasonable efforts to avoid offering excessive or inappropriate financial or other inducements for research participation when such inducements are likely to coerce participation.

• Selecting noncoercive compensation for research participation helps ensure that participation is voluntary and research burdens are not borne unequally by economically disadvantaged populations
• Compensation for effort, time, and inconvenience is permitted as long as individuals are not encouraged to lie or conceal information that would disqualify them from the research
• Institutions adopt various standards on compensation such as having a standard compensation rate or having defined noncoercive financial inducements
• This standard is connected to Principle D in which fairness and justice entitle all persons to equal compensation for equal levels of participation
• Consulting with individuals in the population being recruited can help how the IRB determines the extent of compensation

(b) When offering professional services as an inducement for research participation, psychologists clarify the nature of the services, as well as the risks, obligations, and limitations. 

• Providing psychological services as compensation for research participation is ethical when participants are fully aware of (a) the nature and risks of services, (b) the personal and financial obligations and time commitment involved, and (c) limitations of the type and in the length of services provided

 

8.07 Deception in Research

(a) Psychologists do not conduct a study involving deception unless they have determined that the use of deceptive techniques is justified by the study’s significant prospective scientific, educational, or applied value and that effective nondeceptive alternative procedures are not feasible.

• Deceptive techniques intentionally withhold information or misinform participants about the purpose of the study, the experimental procedures or equipment, of the roles of research team members
• Deception research can have the advantage of keeping participants naïve about the purpose and procedures of a study, thereby increasing methodological realism and spontaneous response to experimental manipulation
• Studies are ethically justified only if psychologists demonstrate that
  • (1) prospective benefits to science or society significantly outweigh violating participants’ right to determine whether they want to be involved in the type of experimental procedures for which they are recruited
  • (2) nondeceptive alternative procedures do not offer sufficient scientific controls to test the hypothesis under investigation
• Failure to use scientifically valid nondeceptive alternative methods simply because of inconvenience or financial cost under some circumstances may be a violation of this standard

(b) Psychologists do not deceive prospective participants about research that is reasonably expected to cause physical pain or serve emotional distress.

• Prohibits withholding or misleading prospective participants about procedures causing physical pain or severe emotional distress

(c) Psychologists explain any deception that is integral feature of the design and conduct of an experiment to participants as early as feasible, preferably at the conclusion of their participation, but no later than at the conclusion of the data collection, and permit participants to withdraw their data. 

• Individuals must be informed about a study’s deceptive aspects as soon as possible, this procedure is often called
• There may be situations in which explaining the deception can compromise the methodological validity of the research, therefore, dehoaxing may be delayed until data collection is completed
• Take reasonable steps to alleviate psychological harm resulting from dehoaxing and may withhold information about deceptive procedures to protect the participant from harm
• A new requirement in this standard is that psychologist must permit participants to withdraw their data after learning about the deception
• Giving individuals an opportunity to withdraw data should be interpreted as implying their “deferred” consent to the deception—informed consent can only be prospectively obtained

 

 

• VIOLATION
  • A psychologist at a university in New York decided to study ways in which three types of warning systems would positively or negatively affect crowd behavior in response to a perceived terrorist attack a year following the September 11, 2001, attack on the United States. During one period of the day, the psychologist had confederates enter nine different classrooms and use of one of the three types of wandering systems to instruct students in evacuation procedures for a “suspected bomb that might be planted in the building by a terrorist group.”  Many students stared crying or screaming, come called their parents on cell phones to say goodbye, and two students fainted during the exercise.

 

8.08 Debriefing

(a) Psychologists provide a prompt opportunity for participants to obtain appropriate information about the nature, results, and conclusions of the research, and they take reasonable steps to correct any misconceptions that participants may have of which the psychologists are aware.

• Informed consent procedures often do not include the hypothesis or other information about the research that would not be expected to affect the willingness to participate but might bias participant responding
• Debriefing procedures provide participants the opportunity to be informed about such undisclosed information and to ask questions about the research
• Requires psychologists to take reasonable steps to correct any misconceptions about the research of which they are aware
• Should make a summary of the results of the research available to participants
• Can make summaries available through mailings to participants, newsletters to the site at which the research occurred, Web site postings, or other mechanisms that do not incur unreasonable expense

(b) If scientific or humane values justify delaying or withholding this information, psychologists take reasonable measures to reduce the risk of harm.

• May be humane justification for withholding information about the nature, results, and conclusions of research
• Child participants may not have the recursive thinking skills to understand the rationale behind the research, in such cases the study should be explained to the children’s guardian

(c) When psychologists become aware that research procedures have harmed a participant, they take reasonable steps to minimize the harm. 

• Try to alleviate psychological distress or harm arising from research participation of which they are aware
• May not be able to anticipate participant stress reactions in response to debriefing. May have to alleviate distress by explaining participant responses within the context of normative behavior
• May anticipate post-experimental stress if debriefing includes information concerning personal health vulnerabilities and should be prepared to provide referrals for appropriate counseling services
• CASES
  • Investigators working with inpatient boys diagnosed with conduct disorder designed an analog task that could distinguish between the children’s use of instrumental and hostile aggression. The task was a computer game in which the boys played against an unseen “buy” (in actuality formatted responses programmed by the investigators) in an adjacent room.  According to the rules of the game, opponents could block each other’s computer game (instrumental aggression) or send a noxious, but not harmful, noise through the computer headsets (hostile aggression).  The investigators believed that these deceptive conditions were safer for the participants than alternative methodologies that manipulated or observed aggression in actual competitive situations.  Parents thought the research was important but voiced concern that if the boys were told about the deception, they would lose trust in the staff at the facility.  The investigators agreed.  To minimize any distress that might emerge during the computer game, the boys were told they had won.
  • In a study to examine psychosocial factors contributing to the spread of the HIV/AIDS virus among intravenous drug users (IDU’s), participants (a) answered questions about their drug use, needle sharing, sexual history, and sexual practices; (b) responded to standardized psychological assessments; and (c) had their blood tested for the HIV virus, hepatitis C, and other sexually transmitted diseases. The results of these blood tests were provided to participants during debriefing.  The investigators developed two types of debriefing procedures.  Aware that telling IDUs that they had tested negative for sexually transmitted diseases might lead them to falsely assume they were “AIDS safe”. Debriefing for these participants included counseling on continued risk of infection and risk reduction practices.  Debriefing for participants who test positive included counseling on availability of current treatments for these disorders, risk reduction practices, and referrals to appropriate health care provides.

 

8.09 Human Care and Use of Animals in Research

(a) Psychologists acquire, care for, use, and dispose of animals in compliance with current federal, state, and local laws and regulations, and with professional standards.

• The use of animals in research enables the control and manipulation of environmental, biological, and genetic factors leading to scientific discoveries producing tangible benefits for humans and animals not possible otherwise.
• Have a moral obligation to protect the animal subjects’ welfare
• The federal government through the Health Research Extension Act of 1985 regulates the humane care and protection of animals used in research
• The National Institutes of Health (NIH) through the Office of Laboratory Animal Welfare administers programs and provides guidance to institutions that must comply with policies
• All institutions covered by the act have an Institutional Animal Care and Use Committer (IACUC) to approve and monitor ethical dilemmas in animal research
• Animal research practices must be in compliance with the Guidelines for Ethical Conduct in the Care and Use of Animals
• Various organizations have comprehensive rules for the conduct of animal research
• APA requires members working outside the United States to follow applicable laws and regulations of the country in which the research is conducted

(b) Psychologists trained in research methods and experienced in the care of laboratory animals supervise all procedures involving animals and are responsible for ensuring appropriate consideration of their comfort, health, and humane treatment.

• Should have appropriate training and supervise all personnel involved with animal subjects
• Competencies include education, training, or experience with relevant animal research models
• Conducting animal field research should have sufficient knowledge of the ecosystems they will observe to minimize harm

(c) Psychologists ensure that all individuals under their supervision who are using animals have received instruction in research methods and in the care, maintenance, and handling of the species being used, to the extent appropriate to their role. 

• Ensure all personnel involved in housing, care, experimental methods, or disposal of animal research subjects are competent to fulfill these duties
• Should mare sure that individuals to whom animal care is delegated are sufficiently knowledgeable about the species and the duties they must perform through prior education, training by the psychologist, or close supervision

(d) Psychologists make reasonable efforts to minimize the discomfort, infection, illness, and pain of animal subjects.

• Species-appropriate housing, sanitary conditions, feeding, regular veterinary check-ups, and development and monitoring of safety conditions during active experimentation should be implemented to protect the health and welfare of animal research subjects
• Should be alert and competent to detect signs of illness or injury
• When alternative experimental procedures are available, should select the one that will produce the minimum amount of animal discomfort

(e) Psychologists use a procedure subjecting animals to pain, stress, or privation only when an alternative procedure is unavailable and the goal is justified by its prospective scientific, educational, or applied value.

• Exposing animals to experimentally induced pain or suffering is not ethical unless psychologist can demonstrate that the knowledge produced from experimentation has the clear potential to substantially contribute to science

(f) Psychologists perform surgical procedures under appropriate anesthesia and follow techniques to avoid infection and minimize pain during and after surgery.

• Research requiring surgery must be conducted by appropriately trained psychologists or other competent personnel using methods that minimize risks of infection and pain
• Unless there is legitimate scientific or medical reason to do so otherwise, animals must be anesthetized throughout surgical procedure

(g) When it is appropriate that an animal’s life be terminated, psychologists proceed rapidly, with an effort to minimize pain and in accordance with accepted procedures.  

• May have to terminate animal’s life when procedures create chronic pain or discomfort that cannot be alleviated through medication or other remedies
• Sometimes animals are unsuitable for future research and returning it to the wild or having a home outside the laboratory is not safe of possible
• Sometimes autopsies are necessary to validate the efficacy of surgical procedures or understand physiological processes
• When termination is necessary, must use procedures that are humane, immediate, and appropriate for the species.
• According to APA ethical guidelines, termination should be in accordance with procedures of the latest version of the American Veterinary Medical Association Panel on Euthanasia
• CASE
  • A psychologist studying cognition in pigeons presented various landmarks and observed the pigeons’ use if these cues. During initial testing, the psychologist unexpectedly found that some arrangements caused confusion resulting in minor injuries when several pigeons flew into the landmark.  The psychologist modified these arrangements to protect the animal’s safety.
  • Researchers designed a study with rhesus monkeys to test the reinforcing effects of three commonly abused drugs. To enable the animals to reinforce their behavior with the drugs, a catheter was implanted in a juglar vein.  The procedure was conducted under an effective anesthesia and aseptic conditions.  Monkeys were treated postoperatively with antibiotics for 10 days and with an analgesic for 3 days.  Testing was no begun until it was determined that the monkey was in good postoperative health.  The investigators also determined that using a within-subjects design could minimize the number of monkeys needed to adequately test the reinforcing properties of the drugs.  After the experiment, the catheters were removed under the sane careful anesthesia and aseptic conditions and each monkey was given appropriate postoperative care.
• VIOLATION
  • An introductory psychology laboratory instructor decided to demonstrate to the class how the phenomenon of learned helplessness is experimentally tested. The demonstration included placing laboratory rats in a cage with an electrified grid and preventing them from escaping when a painful shock was distributed through the grid.
  • A psychologist who conducted research on aggressive behavior in male rats hired a research assistant to clean each animal’s housing. Rather than provide direct supervision, the psychologist told the assistant to begin work and to feel free to ask the psychologists any questions that arose.  To facilitate cleaning, the assistant decided to take three of the animals out of their separate housings and place them in a larger empty glass enclosure.  The animals immediately began to fight with each other, incurring several injuries.

 

8.10 Reporting Research Results

(a) Psychologists do not fabricate data. 

• Do not falsify, make up, alter, or distort the responses of human participants or animal subjects or the results of data analysis
• Not just limited to published reports, but also applies to the fabrication of the data in journal entries or international manipulation of the data collection process

(b) If psychologists discover significant errors in their published data, they take reasonable steps to correct such errors in a correction, retraction, erratum, or other appropriate publication means. 

• The research design, measurement tools, and analytic strategies selected by an investigator may lead to erroneous conclusions
• Erroneous conclusions about natural phenomena based on methodologically sound research designs are a natural part of the scientific process and are not unethical
• A cornerstone of scientific progress is the process of self-correction
• Purpose of this standard is to safeguard the self-correction process by requiring that psychologists take steps to correct errors in published reports that compromise the readers ability to replicate the research design
• CASE
  • Following the publication of an article, a psychologist realized that the F values and probability levels in one of the tables had been wrongly transcribed. The psychologist wrote to the editor of the journal requesting that an addendum be published briefly describing the error and informing readers they can obtain the corrected table from the author.  The psychologist also placed an addendum page onto all reprints distributed to other investigators.
• VIOLATION
  • After conducting planned statistical analyses of the data, a psychologist realized that if the data from just 4 of the 30 participants were eliminated, the statistical analyses would yield significance. The characteristics of these 4 participants met all the original inclusion criteria for the study and there was not deviation in the administration of testing procedures for these individuals.  Reasoning that there must be some undetected characteristic responsible for these participants’ outlier responses, the psychologist decided to eliminate their data from the analysis.  Because there were not criteria other than their responses on which to exclude them, the psychologist decided not to report their elimination in a manuscript submitted for publication.

 

8.11 Plagiarism

Psychologists do not represent portions of another’s work or stat as their own, even if the other work or data source is cited occasionally

• Plagiarism is the representation of another person’s ideas or words without appropriate credit
• Common misconception is that plagiarism is limited to word-for-word replication or paraphrasing
• Violation of this standard also occurs when a psychologist knowingly presents throughout a publication or formal report another’s ideas

 

8.12 Publication Credit

(a) Psychologists take responsibility and credit, including authorship credit, only for work they have actually performed or to which they have substantially contributed.

• Prohibits psychologists from taking credit for research they did not directly perform or for which they did not make a substantial intellectual contribution
• Substantial intellectual contributions include formulating the hypothesis, developing the experimental design, selecting the analytic procedures, interpreting the data, writing the first draft of the article, or providing important intellectual revisions to the manuscript
• Any psychologist listed as an author must take responsibility for the content of the publication

(b) Principal authorship and other publication credits accurately reflect the relative scientific or professional contributions of the individuals involved, regardless of their relative status.  Mere possession of an institutional position, such as department chair, does not justify authorship credit.  Minor contributions to the research or to the writing for publications are acknowledged appropriately, such as in footnotes or in an introductory statement. 

• Principal authorship must reflect the extent to which each individual contributed to the origination of the research problem, the research designing, interpretation of results, and drafting of the manuscript
• Standard is used to protect students and junior faculty or research associates from exploitation by professors, supervisors, of senior administrators
• Standard requires that minor contributions not constituting authorship be acknowledged
• Minor contributions include supportive functions such as designing or building the apparatus, suggesting or advising about statistical analysis, collecting or entering the data, modifying or structuring a computer program, and recruiting participants or obtaining animals

(c) Except under exceptional circumstances, a student is listed as principal author on any multiple-authored article that is substantially based on the student’s doctoral dissertation.  Faculty advisors discuss publication credit with students as early as feasible and throughout the research and publication process as appropriate. 

• Recognizes that doctoral work is expected to represent an independent and original contribution
• Doctoral students should receive principal authorship on publications substantially based on their dissertation
• Rare exception might occur when a student’s doctoral dissertation is published in monograph form as part of a collection of studies by other researches that cumulatively substantiates or supports or refutes a hypothesis
• Student’s conducting master’s and undergraduate honors research often work within an apprenticeship model
• Current standard has eliminated “thesis” from this requirement
• When honors or master’s level students make the primary contributions to a project, their right to be listed as first author is protected

 

 

8.13 Duplicate Publication of Data

Psychologists do not publish, as original data, data that have been previously published.  This does not preclude republishing data when they are accompanied by proper acknowledgement.

• When present the same data in different publications without proper acknowledgement, jeopardize the evolution of scientific knowledge by giving the erroneous impression that replication of results has occurred
• Publishing original data in more than one source without proper attribution misrepresents the amount of experimental work the author has actually conducted
• Does not prohibit publishing the same data in different journals or on Web sites for the purpose of reaching different audiences
• Publishing multiple or piecemeal reports of different aspects of a single research project may be unethical

 

8.14 Sharing Research Data for Verification

(a) After research results are published, psychologists do not withhold the data in which their conclusions are based from other competent professional who seek to verify the substantive claims through reanalysis and who intend to use such data only for that purpose, provided that the confidentiality of the participants can be protected and unless legal rights concerning proprietary data preclude their release.  This does not preclude psychologists from requiring that such individuals or groups be responsible for costs associated with the provision of such information.

• Self-correcting nature requires investigators to share research data for the purpose of replication and reanalysis.
• Protects the integrity of science through independent validation of data coding, analysis, and interpretation
• Should follow guidelines for data retention (Standard 6.01 Documentation of Professional and Scientific Work and Maintenance of Records)
• Term “competent professionals” limits the obligation to provide data to individuals competent in the research methods and data analytic techniques
• Not required to share data with individuals for purposes of developing and testing new theories or other goals beyond reanalysis and verification
• Recognizes there may be legitimate, ethical, legal, and financial barriers

(b) Psychologists who request data from other psychologists to verify the substantive claims through reanalysis may use shared data only for the declared purpose.  Requesting psychologists obtain prior written agreement for all other uses of the data.

• Protects the intellectual property rights of the owner of the data by prohibiting the requesting psychologist from piggybacking on the work of another
• Data cannot be used to test related or peripheral hypotheses
• VIOLATION
  • On the basis of a written request, a psychologist received data from another psychologist to verify through inspection of the data and reanalysis the interpretation of findings stated in a recent publication. After receiving the data, the psychologist realized that there were several additional hypotheses that could be tested with the data set.  The psychologist quickly developed an analytic plan and got together a team of graduate students to implement the plan in time to submit the analysis of new hypotheses for presentation at an upcoming professional meeting.

 

8.15 Reviewers

Psychologists who review material submitted for presentation, publication, grant, or research proposal review respect the confidentiality of and the proprietary rights in such information of those who submitted it. 

• Prohibited from using privileged and proprietary information obtained through confidential review of research materials
• Protects the intellectual property rights of individuals who describe their theories, research designs, and data in unpublished materials from use by others who obtain this information during the peer review process
• VIOLATION
  • A research psychologist on an NIH special emphasis panel was primary reviewer on an RO1 grant application addressing a conceptual problem the psychologist had been tackling in her own lab. The psychologist wrote a critical review of the proposal and argued strongly for a score in the unfundable range.  Several months later, the principal investigator of the RO1 application was distressed to learn that the psychologist had begun a series of studies almost identical to those in the rejected proposal.

 

As we go through these cases- what ethical standards apply?  What is the unethical behavior?  Any strong feelings about these studies?  What would is be like to be a participant in these studies?

 

Deception in Research

 

1.http://www.stanford.edu/dept/DoR/hs/History/his06.html History: The Jewish Chronic Disease Hospital Study
In 1963, studies were undertaken at New York City’s Jewish Chronic Disease Hospital to develop information on the nature of the human transplant rejection process. These studies involved the injection of live cancer cells into patients who were hospitalized with various chronic debilitating diseases.
Previous studies had indicated that healthy persons reject cancer cell implants promptly. Patients with widespread cancer also reject homografts, however, rejection is delayed substantially when compared with healthy subjects. Researchers said that consent had been given orally, but was not documented. They felt that documentation was unnecessary because it was customary to undertake much more dangerous medical procedures without the use of consent forms. Further, patients were not told that they would receive cancer cells because, in the view of the investigators, this would frighten the patients unnecessarily. Investigators defended this view on the basis that they had good cause to predict that the cancer cells were going to be rejected.

 

 

2. http://www.stanford.edu/dept/DoR/hs/History/his07.html

History: The Willowbrook Study
From 1963 through 1966, studies were carried out at the Willowbrook State School, a New York State institution for “mentally defective persons.”
These studies were designed to gain an understanding of the natural history of infectious hepatitis and subsequently to test the effects of gamma globulin in preventing or ameliorating the disease. The subjects, all children, were deliberately infected with the hepatitis virus; early subjects were fed extracts of stools from infected individuals and later subjects received injections of more purified virus preparations. Investigators defended the deliberate injection of these children by pointing out that the vast majority of them acquired the infection anyway while at Willowbrook, and perhaps it would be better for them to be infected under carefully controlled research conditions. During the course of these studies, Willowbrook closed its doors to new inmates, claiming overcrowded conditions. However, the hepatitis program, because it occupied its own space at the institution, was able to continue to admit new patients. Thus, in some cases, parents found that they were unable to admit their child to Willowbrook unless they agreed to his or her participation in the studies. This case caused a public outcry because of the perception that parents and their children were given little choice about whether or not to participate in research.

 

3. Milligram’s Studies of Obedience

• Milgram’s Obedience Experiments (Milgram (1965, 1974))
  • What happens when the demands of authority clash with the demands of conscience?
  • Scene staged by Milgram: two men come to Yale University’s psychology laboratory to participate in a study of learning and memory. A stern experimenter in a gray technician’s coat explains that this is a pioneering study of the effect of punishment on learning.
  • As a teacher you are required to punish errors by delivering shocks of increasing intensity.
  • A 47-year-old accountant who is the experimenter’s confederate, pretends that his slip says “learner” and is ushered into an adjacent room.
  • Teacher and experimenter then return to the main room. The teacher takes his place before a “shock generator” from 15 to 450 volts in 15-volt increments. The switches are labeled “slight Shock”, “Very Strong Shock”, “Danger: Severe Shock”. The 435- and 450 volt- appears “XXX”.
  • If the participant complies with the experimenter the learner grunts at 75, 90 and 105. At 120 volts the learner shouts that the shocks are painful. At 150 volts he cries out, “experimenter, get me out of here! I won’t be in the experiment anymore! I refuse to go on!” By 270 volts his protests have become screams of agony, and he continues to insist to be let out.
  • At 300 and 315 volts, he screams his refusal to answer. After 330 volts he falls silent. The experimenter stated that the non-responses should be treated as wrong responses.
  • Four verbal prods:
    • Prod 1: Please continue (or Please go on)
    • Prod 2: The experiment requires that you continue
    • Prod 3: It is absolutely essential that you continue
    • Prod 4: You have no other choice; you must go on.
  • People guesses that they would disobey by about 135 volts; none expected to go beyond 300 volts. When asked how far they thought other people would go- no one expected someone to go to XXX on the shock panel.
  • The experiment with 40 men- 26 of them (65%) progressed to 450 volts. All who reached 450 complied with a command to continue the procedure until, after two further trials, the experimenter called a halt.
  • Having expected a low rate of obedience, Milgram was disturbed. Milgram next made the learner’s protests even more compelling.
  • The teacher heard the learner mention “his slight heart condition” and the experimenter reassuring “although the shocks may be painful, they cause no permanent tissue damage”.
  • Of 40 new men in this experiment, 25 (63%) fully complied with the experimenter’s demands.
  • The Ethics of Milgram’s Experiments
    • Critics argue that he stressed them against their will. Many of the “teachers” did experience agony. They sweated, trembled, stuttered, bit their lips, groaned, or even broke into uncontrollable nervous laughter.
    • One participant’s wife told him, “You can call yourself Eichmann”
    • CBS television depicted the results and the controversy in a two-hour. When surveyed afterward, 84% said they were glad to have participated; only 1 percent regretted volunteering.
    • The ethical controversy was “terribly overblown”.

 

Research Fraud– if you do a search on an internet search engine- it really surprised me how many recent cases of research fraud have been reported!

1.Researcher Admits Fraud in Grant Data

In the worst case of scientific fakery to come to light in two decades, a top obesity researcher who long worked at the University of Vermont admitted yesterday that he fabricated data in 17 applications for federal grants to make his work seem more promising, helping him win nearly $3 million in government funding.

Eric T. Poehlman, a leading specialist on metabolic changes during aging, acknowledged that he altered and made up research results from 1992 to 2002, including findings published in medical journals that overstated the effect of menopause on women’s health.

Under a plea agreement with federal prosecutors, Poehlman, 49, will be barred for life from receiving federal funding, pay back $180,000, and plead guilty to a criminal charge of fraud that could bring jail time. He agreed to ask scientific journals to retract and correct 10 articles they published by him.

Dr. Eric T. Poehlman, a former tenured research professor at the University of Vermont (UVM) College of Medicine in Burlington, Vermont, has agreed to a comprehensive criminal, civil, and administrative settlement related to his scientific misconduct in falsifying and fabricating research data in numerous federal grant applications and in academic articles from 1992 to 2002. A number of these applications were supported by NIH and NIH was cited as the sponsor within many of the resulting publications.

The National Institutes of Health (NIH) funds meritorious biomedical research with the full expectation that its funded researchers will meet the highest standards of research integrity. NIH considers the scientific misconduct admitted by Dr. Poehlman deplorable and an affront to the American people and the vast community of scientists who conduct their research in an honorable and ethical manner.

Dr. Poehlman has agreed to retract or correct 10 scientific articles which he authored, published from 1992 -2002, because of falsified or fabricated data. The retractions and corrections are a necessary and appropriate way to inform the scientific community of information that may influence their research. Many of these articles appeared in prominent, peer-reviewed medical journals and have been cited in subsequent research and grant applications by Dr. Poehlman and others. The work spanned areas of science including metabolism and aging, energy expenditures during the menopausal transition, and energy balance and body fat distribution. Currently, there are no funded grants supporting the work of Dr. Poehlman and, under the terms of the agreement, he will not be eligible for future NIH funding. The public announcement of the misconduct finding and the list of scientific articles to be retracted are available at: http://www.ori.dhhs.gov/misconduct/cases/poehlman.shtml. NIH encourages the scientific community to review this information and consider its impact on related research.

Poehlman has been under investigation by UVM since 2000, when lab technician Walter F. DeNino noticed a discrepancy in results after Poehlman had taken them home to work on during the weekend.  During the investigation, Poehlman destroyed electronic documents, presented false documents and had other colleagues produce other false documents in an effort to cover up his misdeeds.  When the UVM discovered evidence of fraud, they handed the case to the Office of the United States Attorney.

Poehlman changed and made up research in applications and papers on the effect of menopause on women’s metabolism, the impact of aging on older men and women, the impact of hormone replacement therapy on obesity in post-menopausal women, the study of metabolism in Alzheimer’s patients and the effect of endurance training on metabolism.

In a paper on published in the Annals of Internal Medicine in 1995, Poehlman said he had tested 35 healthy women and retested the same women six years later in the “The Longitudinal Menopause Study: 1994-2000” when he actually falsified and fabricated test results for 32 of the women.

 

2 Transsexual Women Say Professor Didn’t Tell Them They Were Research Subjects (must be subscribed to the Chronicle of Higher Education to access)
http://chronicle.com/daily/2003/07/2003071703n.htm
Two transexual women who are featured in a book by J. Michael Bailey, chairman of the psychology department at Northwestern University, filed complaints with the university and claim that Bailey did not obtain their “consent as participants.” The book, “The Man Who Would Be Queen: The Science of Gender-Bending and Transsexualism” contains numerous interviews with and several stories about transsexual women, but these women say they were never aware that they were Bailey’s research subjects. This July 17, 2003 article from the Chronicle of Higher Education discusses reactions to Bailey’s book by subjects who were interviewed for it, Bailey’s reaction to the charges, and concerns voiced by scholars about institutional review board regulations regarding social science research.

Additional details about this case can be found in the following from the Chicago Tribune.

• Author is Ripped for Transsexual Research (7/29/03)
  http://www.chicagotribune.com/features/health/chi-0307290175jul29,1,4677060.story
• Transsexuals File Complaints Over Book (7/30/03)
  http://www.chicagotribune.com/features/women/chi-0307300049jul30,1,3972228.story

NOTE: An update on this case can be found in an article titled, “Northwestern U. Psychologist Is Accused of Having Sex with Research Subject.” This article can be found in the December 12, 2003 edition of the Chronicle of Higher Education at http://chronicle.com/prm/daily/2003/12/2003121204n.htm.

UPDATE (12/1/04): Northwestern University has completed its investigation into this case against J. Michael Bailey but has indicated that the findings will not be released. No word at this time as to whether or not this psychology professor will be reprimanded, and Bailey has not been available for comment. An update on this case can be found in “Northwestern U. Concludes Investigation of Sex Researcher but Keeps Results Secret,” which appears in the December 1, 2004 issue of the Chronicle of Higher Education.

Northwestern U. Psychologist Is Accused of Having Sex With Research Subject

By ROBIN WILSON

A transsexual woman who is described in a book by J. Michael Bailey, chairman of the psychology department at Northwestern University, says the professor had sex with her while she was a subject of his research. The woman also says that Mr. Bailey, as a psychologist, supplied her with a letter she needed from a professional supporting her desire for sex-change surgery.

Mr. Bailey has declined to comment on the accusations.

His book, The Man Who Would Be Queen: The Science of Gender-Bending and Transsexualism, was published this year by the National Academies Press (The Chronicle, June 20). The transsexual woman filed an anonymous complaint against Mr. Bailey with Northwestern in July.

 

 

 

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