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Institutional Review Board

Guidance on Use of Deception and Incomplete Disclosure in Research

September 2026

A. Overview

Some research plans to deliberately withhold information about the purpose of the research, and/or procedures employed, or purposely mislead participants by providing false information about some aspect of the research—these methodologies are commonly referred to as deception or incomplete disclosure in research. Johns Hopkins University (“JHU”) recognizes that deception and incomplete disclosure can be valuable research methods, and studies involving the use of deception and incomplete disclosure have resulted in significant contributions to science. However, these methodologies place a duty on researchers to provide scientific justification for their use. Researchers must also provide the appropriate additional safeguards, beyond those normally in place, to protect the rights and welfare of study participants. The JHU Institutional Review Boards (“IRB” or “IRBs”) have the responsibility to ensure these methodologies do not negatively influence or affect participants. The purpose of this guidance is to assist the JHU IRBs when reviewing a research study requesting the use of deception or incomplete disclosure.

B. Definitions and Examples

1. Deception: When a researcher provides false information to research participants or intentionally misleads them about an aspect of the research study.

Scenarios include when researchers tell participants:

  • They perform poorly on a task, regardless of their actual performance.
  • About a research activity that is not a task they will actually be expected to complete or know about.
  • To expect pain from an activity, but no painful procedure will be administered.
  • That a task will be more difficult or take longer than it truly will.

Examples include:

  • Participants complete an IQ test, and are falsely told that they did very poorly in order to monitor their emotional reactions, regardless of their actual score on the test.
  • In order to induce stress, study researchers tell participants that they will give a speech that evaluators will observe on video, when the participants’ speeches will not actually be recorded or observed.
  • Participants who don’t know they are in a research study are observed to see how they behave when they find valuables (e.g., wallet, laptop) unattended in a public location.
  • An anxiety study, in which participants are told by researchers to expect mild pain and discomfort during the course of the study, but no painful procedures are administered.

2. Incomplete Disclosure: A type of deception that involves withholding information about the real purpose of the study, or the nature of the research.

Scenarios may include studies when researchers do not tell participants:

  • The specific purpose of the study and only provide general information about the purpose.
  • How performance on tasks will be assessed and only disclose that researchers will track how much time was spent on tasks.
  • That a timed task they are asked to complete cannot be completed to assess frustration.
  • That observation of group dynamics is the true purpose of the study and only informs participants that they will be asked to complete organized group activities.

Examples include:

  • Participants are asked to take a quiz for research, but they are not told that the research question involves how background noise affects their ability to concentrate.
  • Participants are asked to read a list of words or view a series of images but are not told that their memory will be tested.
  • Participants are asked to complete a puzzle or play a game, but they are not told the puzzle or game has missing pieces.
  • To further understanding of how representations of same sex couples depicted in commercials influence consumer behavior, participants are exposed to advertisements featuring same-sex couples and heterosexual couples while their heart rate, facial muscle movement, and sweat responses are recorded. Participants are informed that their reactions to the commercials are being studied, but they are not told that the researchers are examining if the sexual orientation of characters in commercials influences them.
  • A study where participants do not know that they are being randomized to different levels of financial incentives for completing tasks or behaviors (e.g. walking a certain distance or engaging in smoking cessation behavior) to test the threshold at which these incentives impact behavior.

C. When can an IRB approve deception or incomplete disclosure in research?

Under the Common Rule, an IRB may approve human subjects research that uses deception or incomplete disclosure methods and/or procedures if it meets the criteria for waiver, alteration of informed consent, or qualifies as exempt research.[1]

For all research studies, requests for use of deception or incomplete disclosure may be approved by a JHU IRB under 45 CFR § 46.116(f)(3) if it is clear (as determined and documented by the JHU IRB) that:

 

  • The research study is minimal risk;
  • There are no undisclosed risks to participants;
  • The use of deception or incomplete disclosure will not adversely affect the rights and welfare of the subjects;
  • The research study, or scientific aims of the research study, could not practicably be accomplished without the use of deception or incomplete disclosure;
  • There is an adequate plan for debriefing participants. If the PI requests an exception to the requirement for a debriefing, the study may be referred to the full board for review;
  • There is an adequate plan for dissemination of research results to participants; and
  • For exempt studies, there is prospective consent from the participant that deception/incomplete disclosure is a part of the research study. See below for more detail.

D. When is the use of deception or incomplete disclosure in research not approvable by a JHU IRB?

For all research studies, requests for use of deception or incomplete disclosure may not be approved by a JHU IRB if determined by the JHU IRB that:

  • The study is greater than minimal risk;
  • Any information about study-related risks is withheld;
  • Alternatives are available to accomplish the goals of the research that do not involve deception or incomplete disclosure;
  • The request is intended to unduly influence people to volunteer for a study they would not otherwise enroll into;  
  • The request places participants at financial, physical, legal, psychological, or social risk, that while minimal, is of unique concern in its character due to deception or incomplete disclosure; and/or
  • The alteration of consent for the purposes of deception or incomplete disclosure is for FDA-regulated research (Expedited Category #1 or Category #9, when applicable).

E. IRB Responsibilities and Considerations

When reviewing research that involves deception or incomplete disclosure, the JHU IRBs must evaluate the information provided by the researcher and consider potential risks and harms to participants, such as:

  • Participants may feel coerced to have acted against their will.
  • Participants might not have chosen to participate if fully informed.
  • If observed without consent, participants may feel invasion of privacy.
  • Damage to self-esteem—feeling ashamed, guilty, stressed, or embarrassed.
  • Participants are forced to have knowledge about themselves that they otherwise might not want to know.
  • Participants may feel loss of control, may be distrustful or suspicious.

F. Deception and Incomplete Disclosure Qualifying for Exempt Review

Research involving deception and incomplete disclosure may be exempt provided the research meets all the criteria required under 45 CFR § 46.104(d)(3). The 2018 Revised Common Rule allows for deception to be approved as exempt if: 1) the research falls into one of the established exemptions; and 2) participants prospectively agree to the use of deception. Given these requirements, deception research at JHU is unlikely to be exempt; nonetheless, the IRB retains discretion to evaluate each protocol individually and may grant an exemption when justified.

If a research study that includes deception or incomplete disclosure does not qualify for an exemption, the research study still may be approved under 45 CFR § 46.116(f)(3) (general waiver or alteration of consent), provided the research study meets all of the criteria for a waiver or alteration of informed consent under that regulation (See criteria for 45 CFR § 46.116(f)(3) above).

G. Debriefing

 

When an investigator uses deception or incomplete disclosure, the Common Rule requires that participants be debriefed at the end of the study, when appropriate. Participants should be given a simple, clear and informative explanation of the rationale for the design of the study and the methods used and should have the opportunity to ask questions. The JHU IRBs shall ensure that a researcher has included an appropriate debriefing process when considering whether to approve the use of deception or incomplete disclosure in a research study. The primary goals of a debriefing process are to:

 

  • inform participants of the true goals of the research study;
  • remove any effects of false information they were given;
  • educate participants about the research process, why deception is sometimes necessary, how false beliefs can sometimes persevere; and
  • make participants feel that they are an important part of the research process.

The JHU IRBs in collaboration with the researcher will determine whether participants should be debriefed either after unwittingly participating in the research or after knowingly participating in research that involved deception or incomplete disclosure. The researcher may decide, or the JHU IRB may require, that the debriefing include an option for participants to withdraw their data from the research study after they learn the true nature of the research, if it is of a particularly sensitive nature (e.g., the withheld aim of the study is that the researcher is measuring participants’ racism or biases).

The JHU IRBs shall require researchers to debrief participants as early as feasible. The IRBs shall consider if an immediate debriefing may compromise study results, and if so, should discuss options with researchers, such as: sending the debriefing information when the study is completed via mail, email or by phone; or participants can be given a URL where they can get debriefing information and a date upon which it will be available.

At a minimum, the debriefing script must include the following: study title, IRB protocol number, researcher’s name and contact information for follow-up questions, statement thanking participants for taking the time to participate in the study, explanation of what was being studied in lay terms (i.e., purpose, hypothesis, aim), explanation of how participants were deceived, explanation of why deception was necessary in order to carry out the research, explanation of how the results of the deception will be evaluated. Click here for a sample debriefing script, which is provided for illustrative purposes and may not be used without prior review and approval by the IRB.

The JHU IRBs may consider a request to waive the requirement for debriefing. If such a waiver is requested, sufficient justification for the waiver must be supplied by the researcher. The JHU IRBs may refer such a waiver to the convened IRB for review, if determined to be necessary to assess the appropriateness of the waiver request.

 

H. Researcher Responsibilities

 

In the event that a research study includes the use of deception or incomplete information, the researcher should provide the JHU IRBs with the following. The specific information required may differ per study and planned use of deception:

 

  • Documentation to support that the study design meets all of the criteria for a waiver or alteration of informed consent under the Common Rule (see, Section C.);
  • A description of the manner of deception or incomplete disclosure and how it will take place;
  • An explanation as to why the research study, or scientific aims of the research study, could not practicably be accomplished without the use of deception or incomplete disclosure;
  • A description of whether the deception or incomplete disclosure results in any increased risk to participants;
  • An indication of whether the deception or incomplete disclosure may affect a participant’s willingness to participate in the research study;
  • A description of the post-study debriefing. Where thought to be appropriate, the post study debriefing may include offering the participant the option to withdraw their data from the research study. In certain circumstances, a justification may be proposed to waive the debriefing requirement;
  • A copy of the debriefing script;
  • A description of the plan for disseminating research results to the participants;
  • A description of any previous use of deception or incomplete disclosure in similar research and a summary of any actual harms or reactions from participants (if known); and
  • A description of alternatives to deception or incomplete disclosure that were considered and an explanation as to why these alternatives were rejected.
  • Provision of the incentive that a subject did not receive such that after the debriefing all subjects receive the same incentive.

 

[1] 45 CFR § 46.116(f)(3) (General Waiver or Alteration of Consent) or 45 CFR § (§46.104(d)(3)(Exempt Research).