Research ethics: review boards, consent and deception

Transcript

RyanA graduate student is setting up her first study. Participants will be told it's about proofreading. Really, it's about how people react when a confederate, a member of the research team, makes a rude remark halfway through.

SoheeSo there's a cover story, a planted actor, and a whole set of ethical questions packed into one lab session.

RyanWelcome to EPPP Prep, the podcast. I'm Ryan.

SoheeI'm Sohee. Today: research ethics. Review boards, informed consent and when it can be dispensed with, deception and debriefing, and who gets their name first on the paper.

RyanLet's start with why these rules exist. The OpenStax psychology textbook tells the story of the Tuskegee Syphilis Study. Beginning in 1932, the U.S. Public Health Service recruited rural Black men from Tuskegee, Alabama, for a study of syphilis.

SoheeThe men who tested positive were never told they had the disease. By 1947, penicillin was recognized as an effective treatment, and none was given to them. Many unknowingly spread the infection to their wives and children, and died without treatment.

RyanThe study ended in 1972, when the national press discovered it. The textbook says the outrage led directly to the National Research Act of 1974, and to the strict guidelines for human research we follow today.

SoheeWhich brings us to the institutional review board, or IRB. Under the federal regulations for protecting human research subjects, each IRB has at least five members, with varying backgrounds.

RyanAt least one member whose primary concerns are scientific, at least one whose primary concerns are nonscientific, and at least one who isn't otherwise affiliated with the institution and isn't in the immediate family of someone who is.

SoheeAnd what counts as research? The regulation defines it as a systematic investigation designed to develop or contribute to generalizable knowledge.

RyanTo approve a study, the IRB must find, among other things, that risks to subjects are minimized, that risks are reasonable in relation to anticipated benefits and the importance of the expected knowledge, and that selection of subjects is equitable.

SoheePlus, informed consent will be sought, to the extent the regulation requires, and appropriately documented, unless documentation is appropriately waived. You'll also hear the phrase minimal risk. It means the probability and magnitude of harm or discomfort aren't greater than what's ordinarily encountered in daily life, or during routine physical or psychological examinations or tests.

RyanThe Ethics Code connects to all of this through Standard 8.01. When institutional approval is required, psychologists give accurate information about their proposals, obtain approval before conducting the research, and conduct it in accordance with the approved protocol.

SoheeSo approval comes first, and the study you run is the study that was approved.

RyanNow consent. Standard 8.02 lists what participants are told. The purpose, expected duration and procedures. Their right to decline, and to withdraw once they've started. The foreseeable consequences of declining or withdrawing. Factors like potential risks, discomfort or adverse effects. Prospective benefits. Limits of confidentiality. Incentives. And whom to contact with questions.

SoheeAnd they get an opportunity to ask questions and receive answers. The federal regulation adds two touches worth knowing. Consent must begin with a concise, focused presentation of the key information. And it can't include exculpatory language, wording that has participants waive their legal rights or releases researchers from liability for negligence.

RyanFor intervention research with experimental treatments, Standard 8.02b adds more. The experimental nature of the treatment. What services the control group will or won't receive. How assignment to groups is made. Alternatives if someone doesn't want to take part or withdraws. And compensation or costs of participating.

SoheeWhat about students in an intro course, where participation earns credit? Standard 8.04. When research participation is a course requirement or a chance for extra credit, the student is given the choice of equitable alternative activities.

RyanAnd when psychologists study their own clients, students or subordinates, they take steps to protect them from adverse consequences of declining or withdrawing. Standard 8.06 has the same spirit: avoid excessive or inappropriate inducements when they're likely to coerce participation.

SoheeChildren. The federal regulation defines children as people who haven't reached the legal age for consent to the procedures involved, under the law of the jurisdiction where the research takes place. So there's no single national age.

RyanFor children, the IRB looks for provisions to seek the child's assent, when the children are capable of it, and the permission of parents or a guardian. Assent means the child's affirmative agreement. And the regulation is explicit: mere failure to object shouldn't be read as assent.

SoheeNow, can a researcher ever skip consent entirely? Standard 8.05 says yes, in narrow cases. Either the research would not reasonably be assumed to create distress or harm and fits one of three listed types, or law or regulations otherwise permit it.

RyanStudies of normal educational practices, curricula or classroom management in educational settings. Or only anonymous questionnaires, naturalistic observations or archival research, where disclosing responses wouldn't expose people to criminal or civil liability or damage their finances, employability or reputation, and confidentiality is protected.

SoheeOr studies of job or organization effectiveness in organizational settings, with no risk to employability and confidentiality protected. That's the third type. The separate route is where law or federal or institutional regulations otherwise permit it.

RyanThe trap answers here: consent has no exceptions. Or it can be skipped only if participants are debriefed later. Or it can be shortened to a verbal agreement but never dropped. None of those is what 8.05 says.

SoheeBack to our graduate student and her cover story. Standard 8.07. Part a: deception is used only if it's justified by the study's significant prospective scientific, educational or applied value, and effective nondeceptive alternatives aren't feasible.

RyanPart b: psychologists don't deceive prospective participants about research that's reasonably expected to cause physical pain or severe emotional distress.

SoheeAnd part c is the timing rule the exam loves. Explain the deception as early as is feasible, preferably at the conclusion of each person's participation, but no later than the conclusion of data collection. And permit participants to withdraw their data.

RyanPause and think. The student worries that early participants will tip off friends in the subject pool. So she plans to explain the deception after the paper is published. Is that allowed?

SoheeNo. That worry can push the explanation to the end of data collection, but no later. Publication is too late. And every participant gets the chance to withdraw their data, even though they agreed to take part.

RyanDebriefing, Standard 8.08, is broader. Psychologists provide a prompt opportunity for participants to get information about the nature, results and conclusions of the research, and take reasonable steps to correct misconceptions they know about. If a procedure harmed a participant, they take reasonable steps to minimize the harm.

SoheeA quick word on animals. Standard 8.09 says procedures that subject animals to pain, stress or privation are used only when an alternative is unavailable and the goal is justified by its prospective value. And OpenStax notes that animal proposals are reviewed by an Institutional Animal Care and Use Committee, which also inspects animal facilities twice a year.

RyanNow the publication side. Standard 8.10: psychologists don't fabricate data. And if they discover significant errors in their published data, they take reasonable steps to correct them, through a correction, retraction, erratum, or other appropriate means.

Sohee8.11, plagiarism: don't present portions of another's work or data as your own, even if you cite the source occasionally. 8.13: don't publish previously published data as original data. And 8.14: after publication, don't withhold your data from competent professionals who want to verify your claims through reanalysis, provided participants' confidentiality can be protected.

RyanAnd 8.15, for reviewers: respect the confidentiality and proprietary rights of material submitted for review.

SoheeThen authorship, Standard 8.12. Psychologists take credit, including authorship credit, only for work they actually performed or substantially contributed to. Principal authorship reflects relative scientific or professional contribution, regardless of status. And merely holding a position, like department chair, doesn't justify authorship credit.

RyanMinor contributions are acknowledged in other ways, such as a footnote or an introductory statement.

SoheeAnd the dissertation rule. Except under exceptional circumstances, a student is listed as principal author on any multiple-authored article substantially based on the student's doctoral dissertation. Advisors discuss publication credit with students as early as feasible, and throughout the process.

RyanPause and think, number two. An advisor funded the lab, supervised the project, and has a well-known name. The article is substantially based on her former student's dissertation. Who's the principal author?

SoheeThe former student, unless there are exceptional circumstances. Not the advisor because of rank or funding. Not alphabetical order. And it doesn't depend on the advisor agreeing to step aside.

RyanLet's recap. An IRB has at least five members, including a scientist, a nonscientist, and someone unaffiliated with the institution. Approval comes before the research, and the research follows the approved protocol.

SoheeConsent covers purpose, procedures, the right to decline and withdraw, risks, benefits, confidentiality limits, incentives and contacts. Students get equitable alternatives. Children give assent; parents or guardians give permission.

RyanConsent may be dispensed with only for research not reasonably assumed to cause distress or harm, of the listed types, or where law or regulations permit.

SoheeDeception needs significant value and no feasible alternative, is never about research expected to cause physical pain or severe distress, and is explained no later than the end of data collection, with the right to withdraw data.

RyanAnd credit follows contribution, not status. A dissertation-based article lists the student first.

SoheeResearch ethics can feel like a long list. But every item traces back to the Tuskegee lesson: the people in a study are owed the truth and real choices. Hold onto that, and the details have somewhere to land.

RyanYou're doing careful, honest work by studying this. Keep going. Thanks for listening to EPPP Prep.

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