D2.Psy.4.9-12: Ethical Guidelines for Human and Animal Research Participants

Overview

Lesson Procedure

70-75 minutes of class time across 5 phases.

1. Warm-Up5-10 minutes
2. Direct Instruction25 minutes
3. Guided Practice15 minutes
4. Independent Practice15 minutes
5. Closure10 minutes

1. Warm-Up5-10 minutes

   Warm-Up Prompt

   "A researcher wants to know whether a sudden loud noise makes people forget what they just read. List everything the researcher owes the people who take part. Would your list change if the participants were 10-year-olds? If they were hamsters?"

   Collect answers in three columns (adults, children, animals). Students usually name telling people what will happen, letting them say no, keeping their information private and not hurting anyone. Tell them that all of these are written down in two kinds of guidelines: the American Psychological Association's Ethics Code, which psychologists follow, and federal rules, which institutions must follow. Today students apply both to study plans written on paper, and judge two famous early studies against them. Nobody runs a study.

2. Direct Instruction25 minutes

   The guidelines in D2.Psy.4.9-12 (SVHS summary; read the sources for exact wording)

   Guideline	Who issues it	Who and what it covers	Key requirements
   APA Ethics Code: Ethical Principles of Psychologists and Code of Conduct (2002, amended effective June 1, 2010, and January 1, 2017)	American Psychological Association, the professional association of psychologists	Psychologists' work, including research with people and animals (Section 8: Research and Publication)	Institutional approval when required (Standard 8.01); informed consent, including the right to decline and to withdraw (8.02); deception only when justified, with no workable alternative, never about research expected to cause pain or severe emotional distress, and explained as early as feasible (8.07); debriefing, and reasonable steps to minimize any harm the research caused (8.08); humane care and use of animals (8.09)
   Protection of human subjects, 45 CFR part 46	U.S. Department of Health and Human Services	Research with people that the policy covers	Review by an institutional review board (IRB) using approval criteria (46.111, Source 1); required elements of informed consent (46.116, Source 2); for children, the children's assent and a parent's or guardian's permission (46.408, Source 2)
   Animal Welfare regulations, 9 CFR chapter I, subchapter A	U.S. Department of Agriculture	Warm-blooded animals used in research, as defined in 9 CFR 1.1 (Source 4), which excludes birds, rats of the genus Rattus and mice of the genus Mus bred for research	Review by an Institutional Animal Care and Use Committee (IACUC) that checks pain and distress, alternatives, duplication, living conditions and veterinary care (2.31, Source 4)

   The APA Ethics Code is copyrighted, so this page names its standards and summarizes them in its own words; teachers can read the full code on the APA website. Its five general principles are Beneficence and Nonmaleficence, Fidelity and Responsibility, Integrity, Justice, and Respect for People's Rights and Dignity. The federal rules are public, and Sources 1 and 2 quote them. Read Source 1 aloud, clause by clause.

   (a) In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied:

   (1) Risks to subjects are minimized:

   (i) By using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk, and

   [...]

   (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (e.g., the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.

   (3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted. The IRB should be particularly cognizant of the special problems of research that involves a category of subjects who are vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons.

   (4) Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by, § 46.116.

   [...]

   (6) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.

   (7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

   (b) Basic elements of informed consent. Except as provided in paragraph (d), (e), or (f) of this section, in seeking informed consent the following information shall be provided to each subject or the legally authorized representative:

   (1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures that are experimental;

   (2) A description of any reasonably foreseeable risks or discomforts to the subject;

   (3) A description of any benefits to the subject or to others that may reasonably be expected from the research;

   [...]

   (5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;

   [...]

   (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled; and

   [...]

   (a) In addition to the determinations required under other applicable sections of this subpart, the IRB shall determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent. In determining whether children are capable of assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved. [...]

   (b) In addition to the determinations required under other applicable sections of this subpart, the IRB shall determine, in accordance with and to the extent that consent is required by § 46.116 of the pre-2018 Requirements or the 2018 Requirements, as applicable, that adequate provisions are made for soliciting the permission of each child's parents or guardian. [...]

   • Applying the IRB criteria: Source 1, clauses (1) and (2)

     An invented study asks adult volunteers to memorize 20 words in 2 minutes and then write as many as they can. What risks does it carry, and how do clauses (1) and (2) apply?

     Result: Risks are small: mild frustration or boredom. Clause (1)(i) asks for procedures "that do not unnecessarily expose subjects to risk": a short session with a break and a clear right to stop keeps risk low. Clause (2) asks whether risks are "reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge": minimal risk and useful knowledge about memory pass that test.

   • Checking a consent statement: Source 2, section 46.116(b)

     An invented consent paragraph says: "This is a research study about memory. You will learn a word list and write what you recall; it takes 15 minutes. You may feel mildly frustrated. You may not benefit directly, but the results may help teachers. Your answers are stored by number, not name. Taking part is your choice, and you may stop at any time with no penalty." Which required elements does it cover?

     Result: Element (1): research, purpose, duration and procedures. Element (2): "foreseeable risks or discomforts" (mild frustration). Element (3): benefits "to the subject or to others" (none direct; possible help to teachers). Element (5): confidentiality (stored by number). Element (8): participation "is voluntary" and the subject "may discontinue participation at any time without penalty." All five printed elements are covered.

   • Deception and debriefing: APA Standards 8.07 and 8.08

     An invented memory study does not tell volunteers in advance that there will be a surprise recall test at the end, because knowing would change how they read. Is this deception allowed, and what must follow?

     Result: It can be justified: the surprise is needed for a valid answer, a nondeceptive version would not work, and it causes no pain or severe distress. Afterward the researchers explain the surprise as early as feasible, at the end of the session, let volunteers withdraw their data, and debrief them about the study's purpose.

   • Children: Source 2, section 46.408

     A paper plan proposes a study of how 12-year-olds choose between two book covers. What does section 46.408 add to the adult rules?

     Result: Two things. The IRB must see "adequate provisions are made for soliciting the assent of the children," the child's own agreement in words a child understands, and also for "soliciting the permission of each child's parents or guardian." A parent's yes does not replace the child's own choice: in a study like this one, a child who says no is not enrolled. (The IRB may set assent aside only in narrow cases, such as children too young to be consulted or a treatment with an important direct benefit available only in the research.)

   • Animals: Source 4 and APA Standard 8.09

     An invented plan observes how hamsters explore a new cage arrangement. Which requirements about care apply before and during the study?

     Result: Source 4 clause (vi): living conditions "appropriate for their species" and care "directed by the attending veterinarian or other scientist trained and experienced"; clause (vii): medical care "provided as necessary by a qualified veterinarian." APA Standard 8.09 adds that trained, experienced psychologists supervise all procedures with animals and that everyone they supervise is instructed in the care and handling of the species.

3. Guided Practice15 minutes

   Read Source 3, NIH's guiding principles, then use them with Sources 1 and 2 to review Proposal A in Source 7 as a class. The board's job is to adhere to the guidelines: approve, require changes, or disapprove, with reasons tied to a source.

   1NIH Clinical Center researchers published seven main principles to guide the conduct of ethical research:

   [...]

   2Scientific validity. A study should be designed in a way that will get an understandable answer to the important research question. This includes considering whether the question asked is answerable, whether the research methods are valid and feasible, and whether the study is designed with accepted principles, clear methods, and reliable practices. Invalid research is unethical because it is a waste of resources and exposes people to risk for no purpose

   3Fair subject selection. The primary basis for recruiting participants should be the scientific goals of the study — not vulnerability, privilege, or other unrelated factors. Participants who accept the risks of research should be in a position to enjoy its benefits. Specific groups of participants (for example, women or children) should not be excluded from the research opportunities without a good scientific reason or a particular susceptibility to risk.

   [...]

   4Independent review. To minimize potential conflicts of interest and make sure a study is ethically acceptable before it starts, an independent review panel should review the proposal and ask important questions, including: Are those conducting the trial sufficiently free of bias? Is the study doing all it can to protect research participants? Has the trial been ethically designed and is the risk–benefit ratio favorable? The panel also monitors a study while it is ongoing.

   5Informed consent. Potential participants should make their own decision about whether they want to participate or continue participating in research. This is done through a process of informed consent in which individuals (1) are accurately informed of the purpose, methods, risks, benefits, and alternatives to the research, (2) understand this information and how it relates to their own clinical situation or interests, and (3) make a voluntary decision about whether to participate.

   6Respect for potential and enrolled participants. Individuals should be treated with respect from the time they are approached for possible participation — even if they refuse enrollment in a study — throughout their participation and after their participation ends. This includes:

   7respecting their privacy and keeping their private information confidential

   8respecting their right to change their mind, to decide that the research does not match their interests, and to withdraw without a penalty

   [...]

   9informing them about what was learned from the research

   1Invented proposals, written for this page. Three student teams submit plans to a class review board. None of these studies will be run; the board reviews the plans on paper.

   2Proposal A, "Music and Memory": The team wants to test whether background music changes how many words people recall. Volunteers aged 18 and older from a community college would learn a 20-word list with or without music and write down the words they remember. The team will explain the task, say that volunteers may stop at any time, and store answers under a number instead of a name.

   3Proposal B, "Surprise Stress Test": The team wants to see how 14-year-olds react to stress. Without telling them in advance, the team would announce a fake surprise test in a class, watch the students' reactions, and reveal the truth a week later. The team says asking for permission first "would ruin the surprise."

   4Proposal C, "Maze Learning in Hamsters": The team wants to learn whether hamsters find food in a maze faster after practice. It plans to keep 30 hamsters without food for two days so they are motivated, and has not yet asked a veterinarian about care or considered whether fewer animals would answer the question.

   Modeled review of Proposal A (Source 7, paragraph 2).

   • Consent: the team plans to explain the task and the right to stop (Source 2, elements (1) and (8)). Required change: state the time it takes, the small risk of frustration (element (2)) and the lack of direct benefit (element (3)) in the consent statement.
   • Privacy: answers stored "under a number instead of a name" meets Source 1, clause (7).
   • Selection: adult volunteers from a community college fit the question, and Source 3, paragraph 3 asks that recruiting follow "the scientific goals of the study." Note the limit for the findings, not the ethics: one college is a narrow sample.
   • Review and respect: an independent panel reviews it first (Source 3, paragraph 4), and volunteers should be told what was learned afterward (Source 3, paragraph 9).

   Decision: approve with the consent changes. Proposals B and C are left for Activity 1.

4. Independent Practice15 minutes

   Students read Source 4, the federal animal-care review rules and the definition of "animal" they use, and two historical studies: Watson and Rayner's 1920 study of one infant (Source 5) and Thorndike's puzzle-box method with hungry animals (Source 6). Both are presented as history and as cases to judge, not as models. For each study, students list what was done, which current guideline it would conflict with, and what a modern version would have to change. The quiz uses these sources.

   (1) In order to approve proposed activities or proposed significant changes in ongoing activities, the IACUC shall conduct a review of those components of the activities related to the care and use of animals and determine that the proposed activities are in accordance with this subchapter unless acceptable justification for a departure is presented in writing; Provided, however, That field studies as defined in part 1 of this subchapter are exempt from this requirement. Further, the IACUC shall determine that the proposed activities or significant changes in ongoing activities meet the following requirements:

   (i) Procedures involving animals will avoid or minimize discomfort, distress, and pain to the animals;

   (ii) The principal investigator has considered alternatives to procedures that may cause more than momentary or slight pain or distress to the animals, and has provided a written narrative description of the methods and sources, e. g., the Animal Welfare Information Center, used to determine that alternatives were not available;

   (iii) The principal investigator has provided written assurance that the activities do not unnecessarily duplicate previous experiments;

   [...]

   (vi) The animals' living conditions will be appropriate for their species in accordance with part 3 of this subchapter, and contribute to their health and comfort. The housing, feeding, and nonmedical care of the animals will be directed by the attending veterinarian or other scientist trained and experienced in the proper care, handling, and use of the species being maintained or studied;

   (vii) Medical care for animals will be available and provided as necessary by a qualified veterinarian;

   [...]

   Animal means any live or dead dog, cat, nonhuman primate, guinea pig, hamster, rabbit, or any other warmblooded animal, which is being used, or is intended for use for research, teaching, testing, experimentation, or exhibition purposes, or as a pet. This term excludes birds, rats of the genus Rattus, and mice of the genus Mus, bred for use in research; horses not used for research purposes; and other farm animals, such as, but not limited to, livestock or poultry used or intended for use as food or fiber, or livestock or poultry used or intended for use for improving animal nutrition, breeding, management, or production efficiency, or for improving the quality of food or fiber. This term also excludes falconry. [...]

   1Experimental work has been done so far on only one child, Albert B. This infant was reared almost from birth in a hospital environment; his mother was a wet nurse in the Harriet Lane Home for Invalid Children. Albert's life was normal: he was healthy from birth and one of the best developed youngsters ever brought to the hospital, weighing twenty-one pounds at nine months of age. He was on the whole stolid and unemotional. His stability was one of the principal reasons for using him as a subject in this test. We felt that we could do him relatively little harm by carrying out such experiments as those outlined below.

   [...]

   2At first there was considerable hesitation upon our part in making the attempt to set up fear reactions experimentally. A certain responsibility attaches to such a procedure. We decided finally to make the attempt, comforting ourselves by the reflection that such attachments would arise anyway as soon as the child left the sheltered environment of the nursery for the rough and tumble of the home. We did not begin this work until Albert was eleven months, three days of age. Before attempting to set up a conditioned response we, as before, put him through all of the regular emotional tests. Not the slightest sign of a fear response was obtained in any situation.

   [...]

   31. White rat suddenly taken from the basket and presented to Albert. He began to reach for rat with left hand. Just as his hand touched the animal the bar was struck immediately behind his head. The infant jumped violently and fell forward, burying his face in the mattress. He did not cry, however.

   42. Just as the right hand touched the rat the bar was again struck. Again the infant jumped violently, fell forward and began to whimper.

   5In order not to disturb the child too seriously no further tests were given for one week.

   [...]

   6IV. "Detachment" or removal of conditioned emotional responses. Unfortunately Albert was taken from the hospital the day the above tests were made. Hence the opportunity of building up an experimental technique by means of which we could remove the conditioned emotional responses was denied us. Our own view, expressed above, which is possibly not very well grounded, is that these responses in the home environment are likely to persist indefinitely, unless an accidental method for removing them is hit upon. [...]

   1[...] After considerable preliminary observation of animals' behavior under various conditions, I chose for my general method one which, simple as it is, possesses several other marked advantages besides those which accompany experiment of any sort. It was merely to put animals when hungry in inclosures from which they could escape by some simple act, such as pulling at a loop of cord, pressing a lever, or stepping on a platform. (A detailed description of these boxes and pens will be given later.) The animal was put in the inclosure, food was left outside in sight, and his actions observed. Besides recording his general behavior, special notice was taken of how he succeeded in doing the necessary act (in case he did succeed), and a record was kept of the time that he was in the box before performing the successful pull, or clawing, or bite. This was repeated until the animal had formed a perfect association between the sense-impression of the interior of that box and the impulse leading to the successful movement. When the association was thus perfect, the time taken to escape was, of course, practically constant and very short.

   2If, on the other hand, after a certain time the animal did not succeed, he was taken out, but not fed. If, after a sufficient number of trials, he failed to get out, the case was recorded as one of complete failure. Enough different sorts of methods of escape were tried to make it fairly sure that association in general, not association of a particular sort of impulse, was being studied. Enough animals were taken with each box or pen to make it sure that the results were not due to individual peculiarities. None of the animals used had any previous acquaintance with any of the mechanical contrivances by which the doors were opened. So far as possible the animals were kept in a uniform state of hunger, which was practically utter hunger. [...]

5. Closure10 minutes

   Discussion: consider the impact. Ask: What do these guidelines protect, and what do they cost? Push for both sides: protections for participants and for public trust, against the time and paperwork of review and the studies that can no longer be done. Students should support each claim with a source.

   Exit ticket: "Name one guideline from today and explain how it would have changed one of the two historical studies."

   Teacher notes. (1) Watson and Rayner's study (Source 5) deliberately produced fear in an infant, records no permission from a parent, and ended without removing the fear responses. It conflicts with current requirements in Sources 1 and 2 and with the APA Ethics Code. It is taught as a historical case; do not re-enact, simulate or role-play it, and do not reproduce the procedure with anyone. (2) Thorndike's animals were kept in "practically utter hunger" (Source 6), which an IACUC would review against Source 4 today. (3) The APA Ethics Code is summarized, not quoted; check the current version on the APA website before teaching details. (4) Source 7's proposals are invented, and none will be carried out.

Differentiation Strategies

Assessment Guidance

1. Question 1 of 20 · Multiple Choice

   A psychologist who is a member of the American Psychological Association plans a study with volunteers at a private company. No federal agency funds or supports it. Which guideline applies to her as an APA member?

   AThe APA Ethics Code, including its research standards BThe Animal Welfare regulations in 9 CFR CNo guideline, because the study is privately funded DOnly the rules her company chooses to write for itself

2. Question 2 of 20 · Multiple Choice

   According to Source 1, clause (6), what may a research plan need to include "When appropriate"?

   AA payment schedule for every participant BA list of the journals that will publish the results CA way to monitor the data to keep subjects safe DA promise that the study's hypothesis will be confirmed

3. Question 3 of 20 · Multiple Choice

   Source 1, clause (3) asks the IRB to take special care with subjects "vulnerable to coercion or undue influence." Which group does the clause name?

   ACollege athletes BRetired teachers CPrisoners DOnline shoppers

4. Question 4 of 20 · Multiple Choice

   According to Source 1, clause (2), which of these should the IRB not count among the research risks it weighs?

   ADiscomfort that participants may feel during the study's procedures BRisks that come from the research procedures themselves CThe importance of the knowledge the study is expected to produce DPossible effects of the research on public policy later on

5. Question 5 of 20 · Multiple Choice

   Under Source 2, element (1), what must a consent statement include besides the purpose, duration and procedures?

   AThe names of the other people who have agreed to take part BIdentification of any procedures that are experimental CA guarantee that the study will produce useful results DThe amount the researchers are paid for their work

6. Question 6 of 20 · Multiple Choice

   According to Source 2, section 46.408(a), what must the IRB take into account in deciding whether children are capable of assenting?

   AThe children's ages, maturity and psychological state BThe children's grades and recent test scores at school CWhether the parents have already given permission DHow much the study will cost to run with children

7. Question 7 of 20 · Multiple Choice

   Source 3, paragraph 2 says invalid research is unethical. What reason does it give?

   AIt makes the researchers look careless in the eyes of other scientists BIt produces results that the public finds hard to understand CIt wastes resources and exposes people to risk for no purpose DIt takes longer to publish than research that is valid

8. Question 8 of 20 · Multiple Choice

   Under Source 3, paragraph 3, when may a study leave out a group of participants such as women or children?

   AWhenever including them would make recruiting slower BWhenever the researchers already know people in that group CNever, because every study must include every group DWith a good scientific reason or a particular risk to them

9. Question 9 of 20 · Multiple Choice

   According to Source 4, clause (1), which kind of study is exempt from the IACUC's review of activities with animals?

   AStudies that use fewer than ten animals BField studies, as part 1 defines them CStudies that last less than one week DStudies paid for by a private company

10. Question 10 of 20 · Multiple Choice

    Source 4, clause (iii) requires written assurance that activities "do not unnecessarily duplicate previous experiments." What is the ethical reason for this rule?

    AAnimals should not be used to learn something that is already known BJournals refuse to publish studies that repeat earlier work CDuplicate studies always produce different results from the original DRepeating a study is never useful in science, with or without animals

11. Question 11 of 20 · Multiple Choice

    In Source 5, paragraph 2, the researchers went ahead after "comforting ourselves by the reflection that such attachments would arise anyway." Which current requirement replaces this kind of self-judgment?

    AA rule that only senior researchers may make such decisions BA requirement that the results be shared with the hospital CReview by an independent board before the study begins DA rule that the study must be repeated by the same team

12. Question 12 of 20 · Multiple Choice

    Source 5, paragraph 6 reports that Albert "was taken from the hospital the day the above tests were made," so the researchers never tried to remove the fear responses. Which APA standard most directly addresses this situation for a researcher today?

    AStandard 8.09, Humane Care and Use of Animals in Research BStandard 8.01, Institutional Approval CStandard 8.07, Deception in Research DStandard 8.08, Debriefing

13. Question 13 of 20 · Multiple Choice

    Source 6 says: "So far as possible the animals were kept in a uniform state of hunger, which was practically utter hunger." Which requirement in Source 4 is most directly at issue?

    AClause (iii), on not duplicating previous experiments BClause (i), on minimizing discomfort and distress CClause (vii), on medical care by a qualified veterinarian DThe field-study exemption in clause (1)

14. Question 14 of 20 · Multiple Choice

    Which of these is the kind of pressure that Source 1, clause (3) asks an IRB to watch for?

    AA teacher giving extra credit to students in her own study BA researcher posting a flyer at a public library CA volunteer reading a consent statement before deciding to join DA review board asking a team to shorten its survey

15. Question 15 of 20 · Short Answer

    Write a consent statement of 5-7 sentences for an invented paper study in which adult volunteers rate how funny 10 cartoons are. Include Source 2 elements (1), (2), (3), (5) and (8), and label each.

    Show model answer

16. Question 16 of 20 · Short Answer

    Consider the impact. Suppose the rules in Sources 1 and 4 had been in force when the studies in Sources 5 and 6 were done. Describe one specific change each rule would have required, and name one cost and one benefit of such rules for psychology as a science.

    Show model answer

17. Question 17 of 20 · Short Answer

    An invented study would tell volunteers that they had failed an intelligence test, when they had not, in order to observe how they react. Using the APA standards in the Direct Instruction table, explain whether this deception would be allowed, and propose a design that could study reactions to setbacks more ethically.

    Show model answer

18. Question 18 of 20 · Short Answer

    An invented plan asks whether guinea pigs can learn which of two doors leads to a treat. Using Source 4, list three things the IACUC must determine before approving the plan, and add one requirement from APA Standard 8.09 as summarized in this lesson.

    Show model answer

19. Question 19 of 20 · Short Answer

    Consider the impact of section 46.408 (Source 2) on research with teenagers. Give one benefit for participants, one cost or challenge for researchers, and explain whether the benefit justifies the cost.

    Show model answer

20. Question 20 of 20 · Short Answer

    Your class wants to survey students at your school about their study habits. Plan, on paper only, every step needed to follow the guidelines from first idea to final report. Cite at least three sources from this page.

    Show model answer

These standards connect to D2.Psy.4.9-12: prerequisites to review first, parallel standards at the same level, and next steps that build on it.

Standard text: National Council for the Social Studies (NCSS), The College, Career, and Civic Life (C3) Framework for Social Studies State Standards: Guidance for Enhancing the Rigor of K-12 Civics, Economics, Geography, and History (Silver Spring, MD: NCSS, 2013). NCSS was not involved in the production of this lesson and does not endorse it.