Deception in Research w/ Sample Debriefing Scripts

Owner: Vice President of Academic Affairs
Author: CSS IRB
Contact: irb@css.edu
Policy Number: 14
Effective Date: 10/8/2021

1. POLICY

It is the policy of The College of St. Scholastica to allow the use of deception or incomplete disclosure of information in research with human participants when the deception or incomplete disclosure is of scientific value and does not place the research participant in significant financial, physical, legal, psychological, or social risk. The Human Subject Regulations do not address research involving deception.

2. PURPOSE

The purpose of this policy is to describe the information required within IRB application materials, the process and procedures of review when projects involving human subjects will include deception or incomplete disclosure of information and investigator responsibilities when using deception or incomplete disclosure

3. DEFINITIONS

Authorized Deception means to inform participants prior to the study that a study will not be described accurately or that some procedures will be deceptive, providing them an opportunity to decide whether to participate on these terms.

Deception means to intentionally provide misleading or false information.

NOTE: Examples of studies that involve deception might include having participants complete a quiz and are falsely told that they did poorly, regardless of their performance, or having 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.

Incomplete Disclosure means to withhold information about the true purpose or nature of the research.

NOTE: Examples of studies that involve incomplete disclosure might include having participants take a quiz for research, but they are not told the research question involves how background noise affects their ability to concentrate, or having participants complete a survey to evaluate customer service when the true purpose of the study is to correlate psychological responses with patient care satisfaction.

4. IRB REVIEW and IRB APPLICATION REQUIREMENTS

Projects involving deception or incomplete disclosure requires approval of the convened IRB. The CSS IRB will determine the level of risk associated with the research and the population involved.

If the study design precludes subjects from knowing they are in a study, the IRB may grant a waiver of consent. Research involving deception or incomplete disclosure must meet all criteria for IRB approval (See, CSS IRB SOP #12 Criteria For IRB Approval Of Research and Checklist() and all criteria for approval of a waiver of consent or alteration of consent elements (See also, CSS IRB SOP #15 Waiver or Alteration of Consent (Waiver Request Form Reviewer Checklist).)

Studies that use deception and/or the withholding of information as part of their experimental design must meet all the requirements of 45 CFR §46.116(d), described below, and include a post-study debriefing (attached), unless an exception is granted by the IRB. In the event that a study includes the use of deception, the investigator must:

1. Provide a justification for the deception (i.e., why the study could not be conducted without deception);
2. Describe the manner of deception (e.g., the participants are not informed of the true intent of the study) and/or how the deception will take place (e.g., a confederate will simulate an accident);
3. Note whether the deception results in any increased risk to participants (e.g., confederates engage in a staged altercation which could result in emotional upset); and
4. Describe how any additional risks would be minimized (where appropriate).

5. CONSENT, AUTHORIZED DECEPTION, CONSENT DOCUMENTATION and DEBRIEFING

Research involving deception or incomplete disclosure of information, by design, does not include all elements of the consent process or removes the consent process altogether. In order to ensure the basic principle of respect for persons found in the Belmont Report, guide the ethical conduct of research using deception or incomplete disclosure research, as necessary, will or may include the following, as applicable:

1. Authorized Deception

Research using this process must inform participants during the consent process that the study will not be described accurately or that some procedures will be deceptive.

2. Consent and Debriefing Documentation

Research using authorized deception or incomplete disclosure of information must document re-consent and debriefing using either a signature, e-signature, or other form of documentation recording that the re-consent process occurred unless the research qualifies for waiver of consent documentation (See CSS IRB Policy #15 Waiver or Alteration of Consent).

3. Waiver of Consent or Alteration of Consent

Research involving deception or incomplete disclosure of information and does not qualify as exempt research must meet all criteria for IRB approval (See, CSS IRB SOP #12 Criteria For IRB Approval of Research and Checklist) and all criteria for approval of a waiver of consent or alteration of consent elements (See, CSS IRB SOP #15 Waiver or Alteration of Consent).

4. Debriefing Process and IRB Application Requirements

Research using deception or incomplete disclosure, must include a debriefing process at the end of the study, when appropriate. Debriefing may be inappropriate if debriefing regarding the deception may cause more harm than the deception itself. The following considerations must be included and described in the appropriate IRB application:

1. Participants should be debriefed as early as feasible. If an immediate debriefing may compromise study results, debriefing information can be sent 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. A master participant list of names and ID number is needed if participants request their data be withdrawn/deleted.
2. When appropriate, the research may include an option for participants to withdraw their data from the 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). If the participant does not withdraw their data, the participant must re-consent by signature and date at the bottom of the debriefing form.
3. If the research will not include a debriefing process, justification for not including this process must be described in the IRB application.

6. PARTICIPANT DEBRIEFING INFORMATION

If a debriefing process is appropriate for the research, the process may include the following information, as appropriate and serve the following purposes:

1. Inform participants of the true goals of the research study.
2. Remove any effects of false information they were given.
3. Educate participants about the research process, why deception is sometimes necessary, how false beliefs can sometimes persevere, and reiteration of the societal/scientific benefit of research.
4. Provide an opportunity for the participant to withdraw their data.
5. Provide the participant with a copy of the debriefing information form along with the participant’s signed and dated consent to their data and further understanding of the real intent of the research.

7. DHHS REGULATIONS - 45 CFR 46.104 EXEMPT RESEARCH

Deception is allowed in some exempt research (benign behavioral interventions) as long as certain conditions are met. (See also, CSS IRB SOP #10 Exempt Determination Review Process and Checklist.)

§46.104

3. (i) Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:
   1. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
   2. Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or
   3. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §ll.111(a)(7).

2. For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.
3. If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.

References

IRB EasyEd for IRB Members and Staff (2017 Apex Ethical, Volume 3 Number 6)

University of Nebraska - Lincoln: https://unl.app.box.com/s/akxrh4jtdi6zkn4xth2uw10nqkox09w6 UCLA: http://ora.research.ucla.edu/OHRPP/Documents/Consent/Debriefing_Script.doc University of Massachusetts – Amherst: https://www.umass.edu/research/form/debriefing-form- deception

SAMPLE DEBRIEFING SCRIPT / FORM

(Children)

[Insert title of the study.]

Thank you for your participation in our research study, [insert name of study].

I would like to discuss with you in more detail the study you just participated in and to explain exactly what we were trying to study.

Before I tell you about all the goals of this study, however, I want to explain why it is necessary in some kinds of studies to not tell people all about the purpose of the study before they begin. [alternate language for deception studies: “… to not tell people all about the procedures in which they will be asked to participate.”]

As you may know, scientific methods sometimes require that participants in research studies not be given complete information about the research until after the study is completed. Although we cannot always tell you everything before you begin your participation, we do want to tell you everything when the study is completed.

We don't always tell people everything at the beginning of a study because we do not want to influence your responses. If we tell people what the purpose of the study is and what we predict about how they will react, then their reactions would not be a good indication of how they would react in everyday situations.

[insert explanation of study purpose, describe the information about the study purpose or the study procedures that was withheld and explain the reason why the information was withheld, as applicable.]

If other people knew the true purpose of the study, it might affect how they behave/answer questions, so we are asking you not to share the information we just discussed.

Now that the study has been explained, do you agree to allow the investigator to use the data that we collected from your participation in this study?

YES                                                         NO                

I hope you enjoyed your experience and I hope you learned some things today. If you have any questions later please feel free to contact me. [provide sheet with contact names, addresses, telephone numbers, emails, for Principal Investigator, Faculty Sponsor, other co-investigators]

Do you have any other questions or comments about anything you did today or anything we've talked about?

Thank you again for your participation.

Child’s Name:                                                                                                             Date:                            

PI Name:                                                                                                                     Date:                            

SAMPLE PARENT / LAR DEBRIEFING SCRIPT / FORM

[Insert title of the study.]

Thank you for your child’s participation in our study! Your child’s participation is greatly appreciated.

Purpose of the Study:

Earlier in our permission form we informed you that the purpose of the study was [insert brief sentence about original stated purpose of study]. In actuality, our study is about [insert statements describing what the true purpose of the study is, the actual deceptive activities (this includes any fake articles or research stimuli that were utilized) and the results/findings you were/are looking for].

Unfortunately, in order to properly test our hypothesis, we could not provide your child with all these details prior to your child’s participation. This ensured that your child’s reactions in this study were spontaneous and not influenced by prior knowledge about the purpose of the study. [Insert statement reiterating any fabricated research activities or stimuli to ensure participants do not leave study believing false materials.] If we had told your child the actual purposes of our study, your child’s ability to [insert study activity] could have been affected. We regret the deception, but we hope you understand the reason for it.

Confidentiality:

Please note that although the purpose of this study has changed from the originally stated purpose, everything else on the permission form is correct. This includes the ways in which we will keep your child’s data confidential. [Insert sentence reiterating how data is secured and maintained].

Now that you know the true purpose of our study and are fully informed, you may decide that you do not want your child’s data used in this research. If you would like your child’s data removed from the study and permanently deleted, please check the appropriate line below.

If you wish your child to remain in this study and consent to the use of your child’s data, please check the appropriate line below [insert instructions on how participant can have study data deleted].

                               I do not agree with my child’s participation and want my child’s data destroyed.

                               I agree with my child’s participation and consent to the use of my child’s data. Final Report:

If you would like to receive a copy of the final report of this study (or a summary of the findings) when it is completed, please feel free to contact us.

Useful Contact Information:

If you have any questions or concerns regarding this study, its purpose or procedures, please feel free to contact the researcher(s), [insert name(s) and phone number(s)].

If you have other concerns about this study or would like to speak with someone not directly involved in the research study, you may contact:

Chair of the Department contact information                                                                                   

Faculty advisor contact information                                                                                                  

If you have any questions concerning your child’s rights as a research subject, you may contact,

College of St. Scholastica IRB Chairperson                                                                                            

The true purpose of this research has been explained to me. I have had the opportunity to ask questions. I agree with the true purpose of this research and the use of data collected from my child.

Name:                                                                                                             Date:                                       

Please keep a copy of this form for your future reference. Once again, thank you for your participation in this study!

SAMPLE DEBRIEFING SCRIPT / FORM

(Adult)

[Insert title of the study.]

Thank you for your participation in our study! Your participation is greatly appreciated. Purpose of the Study:

Earlier in our consent form we informed you that the purpose of the study was [insert brief sentence about original stated purpose of study]. In actuality, our study is about [insert statements describing what the true purpose of the study is, the actual deceptive activities (this includes any fake articles or research stimuli that were utilized) and the results/findings you were/are looking for].

Unfortunately, in order to properly test our hypothesis, we could not provide you with all these details prior to your participation. This ensures that your reactions in this study were spontaneous and not influenced by prior knowledge about the purpose of the study. [Insert statement reiterating any fabricated research activities or stimuli to ensure participants do not leave study believing false materials.] If we had told you the actual purposes of our study, your ability to [insert study activity] could have been affected. We regret the deception, but we hope you understand the reason for it.

Confidentiality:

Please note that although the purpose of this study has changed from the originally stated purpose, everything else on the consent form is correct. This includes the ways in which we will keep your data confidential. [Insert sentence reiterating how data is secured and maintained].

Now that you know the true purpose of our study and are fully informed, you may decide that you do not want your data used in this research. If you would like your data removed from the study and permanently deleted, please check the appropriate line below.

If you wish to remain in this study and consent to the use of your data, please check the appropriate line below [insert instructions on how participant can have study data deleted].

                               I do not wish to participate and want my data destroyed.

                               I wish to continue with my participation and consent to the use of my data. Final Report:

If you would like to receive a copy of the final report of this study (or a summary of the findings) when it is completed, please feel free to contact us.

Useful Contact Information:

If you have any questions or concerns regarding this study, its purpose or procedures, or if you have a research-related problem, please feel free to contact the researcher(s), [insert name(s) and phone number(s)].

If you have other concerns about this study or would like to speak with someone not directly involved in the research study, you may contact: