Deception in Human Research

1. Deception in Human Research

2. Learning Objectives • Define Deception and Incomplete Disclosure • Understand when Deception or Incomplete Disclosure are allowable in human research • Review APA recommendations

3. Deception/Incomplete Disclosure • Deception is intentionally misleading prospective participants about the research. • Incomplete Disclosureis not giving participants accurate or adequate information about some aspect of the research. • Both Deception and Incomplete Disclosure interfere with a participant’s ability to provide legally effective informed consent.

4. Use of Deception in Research • Often necessary to study human behavior. • In general, the IRB must consider: • Is the use of deception scientifically and ethically justified? • Would the information being withheld from the subjects influence their decision to participate in the research? • Is it permissible to alter and/or the exclude a required element of informed consent? • Is it appropriate to debrief participants?

5. Required Elements of Informed Consent • A statement that the study involves research. • An explanation of the purposes of the research. • A description of the procedures to be followed. • A description of any reasonably foreseeable risks or discomforts to the subject. • A description of any benefits to the subject or to others which may reasonably be expected from the research.

6. Required Elements of Informed Consent • A description of appropriate alternative procedures. • A statement describing the extent, if any, to which confidentiality of records will be maintained. • An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights. • A statement that participation is voluntary.

7. Example • An investigator wants to understand which background music is more distracting in a learning environment - Country versus Hip-Hop. The investigator intends to recruit college students and explain to participants that she is interested in examining learning and memory. • Participants will be required to learn sets of words and then be tested on recall and recognition of the words immediately after and 24 hours later. • The participants are not told about the “true” purpose of the research or certain elements of the study design. Therefore if the research is to be conducted, some of the required elements of consent must be altered.

8. Alteration of the Elements of Informed Consent DHHS 45 CFR 46.116(d) An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent, or waive the requirements to obtain informed consent provided the IRB finds and documents that: • the research involves no more than minimal risk to the subjects; • the waiver or alteration will not adversely affect the rights and welfare of the subjects; • the research could not practicably be carried out without the waiver or alteration; and • whenever appropriate, the subjects will be provided with additional pertinent information after participation.

9. APA Guidelines on Use of Deception in Research • Do not conduct a study involving deception unless it has been 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. • Do not deceive prospective participants about research that is reasonably expected to cause physical pain or severe emotional distress. • Explain any deception that is an integral feature of the design and conduct of an experiment to participants as early as is 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.

10. APA Guidelines on Use of Deception in Research Debriefing Participants • Provide a prompt opportunity for participants to obtain appropriate information about the nature, results, and conclusions of the research, and take reasonable steps to correct any misconceptions that participants may have. • If scientific or humane values justify delaying or withholding this information, take reasonable measures to reduce the risk of harm. • If investigators become aware that research procedures have harmed a participant, take reasonable steps to minimize the harm.

11. e-IRB Application and IRB Reviewer Checklist • When Deception is proposed… • Investigators are required to complete Appendix G • IRB Reviewers must complete Supplementary IRB Checklist – Waiver/Alteration of Informed Consent

12. Any questions?

13. Thanks for listening!