Required for student human subjects research and will oversee the conduct of student conducted research.

Students and their faculty advisor are responsible for human subjects protections. They can be the student’s dissertation or thesis chair; however, this is not always the case.

The sponsor will provide valuable recommendations about experimental designs aimed at reducing the risk to human subjects.

Audio or video recording usually increases the risk to research subjects as it provides an opportunity to identify them.

We encourage researchers to use audio and video recording only as necessary to conduct research. The consent forms for research involving the recording of audio or video must include the necessary confidentiality provisions:

1. The interviews or sessions will be audio or videotaped;
2. Media will be coded so that no personally identifying information is visible on them;
3. Media will be kept in a secure place (e.g., a locked file cabinet in the investigator's office or password protected device);
4. Media will be heard or viewed only for research purposes by the investigator and his or her associates; and
5. Media will be erased after they are transcribed or coded.
   1. If you wish to keep the recordings because of the requirements of your professional organization with respect to data or because you may wish to review them for additional analyses later, the statement about erasing them should be omitted and you should state that they will be retained for possible future analysis.
   2. If you wish to present the recordings at a convention or to use them for other educational purposes, you should get special permission to do so by adding, after the signature lines on the consent form, the following statement,
      • "We may wish to present some of the tapes from this study at scientific conventions or as demonstrations in classrooms. Please sign below if you are willing to allow us to do so with the tape of your performance." Add another signature line prefaced by, "I hereby give permission for the video (audio) tape made for this research study to be also used for educational purposes." 

This procedure makes it possible for a participant to agree to being taped for research purposes and to maintain the confidentiality of the information on that tape.

Definition(s) & Examples:

Deception: involves deliberately misleading subjects about research purposes or activities by intentionally providing inaccurate or false information and/or by withholding information, with the intention of misleading subjects about the research purpose or procedures. 

Active Deception: Intentionally providing inaccurate or false information to participants.

• Participants take a quiz and are falsely told a result regardless of performance.
• Participants are observed unaware that they're in a research study to see how they react to unattended valuables in a public location. 

Incomplete Disclosure: Information about the real purpose of the research is deliberately withheld or concealed form participants.

• Participants are told they're taking a customer service survey and are not told the research question involves how background noise affects their concentration.

Passive Deception:
Omits important information if providing full study details would affect participant behavior and their choice to participate.

• Researchers record participants without knowledge or consent.
• Participants think that they are evaluating fictional job applicants when the survey examines their tendency to discriminate.

Behavioral intervention: involves the performance of a cognitive, intellectual, educational, or behavioral task; or the manipulation of the subject’s physical, sensory, social, or emotional environment. 

Background:

Any research in which information is withheld until subjects have participated to some degree should be considered as a deception study.

This type of research methodology is sometimes used to:

• Improve study validity,
• Assure study integrity, or
• Allow data collection that would otherwise be unobtainable because of defensiveness, shame, etc.

Guidelines:

Regarding the design, review and conduct of studies involving deception:

• Only acceptable for studies that are no more than minimal risk.
• The use of deception should have no adverse effects on the well-being of subjects.
• The IRB has sufficient information to determine that the value of the research outweighs the risk of waiving some aspects of the requirement for full disclosure in the informed consent process.
• There is no reasonable alternative to scientifically and effectively address the research question without the use of deception.
• Subjects are not deceived about any aspect of the study that would alter their willingness to participate.
• As soon as it is appropriate, debriefing should be accomplished and the deception explained to subjects.
• Subjects should be informed prospectively of the use of deception and consent to its use.
• During debriefing inform subjects of their right to withdraw their data, if they wish, and how that will be accomplished.

P.I. Requirements:

• Explain the reason(s) for use of deception in the study design. Specifically, address why complete disclosure would compromise the scientific validity of the study.
• Describe the extent of the deception in detail and how it relates to the study aims and design.
• Justify and discuss how the proposed research, involving deception involves no more than minimal risk to subjects. Consider all levels of increased risk subjects could experience as a result of the deception.
• Justify and discuss why there are no feasible or scientifically valid alternative methods, which do not involve deception, to conduct the research.
• Describe the methods for prompt disclosure to debrief subjects. This should be accomplished as soon as possible after subjects complete research related activities.
• Describe how you will assure that subjects leave with a clear and accurate understanding of the deception and the reasons for using this methodology.
• Request a waiver or alteration of the elements of informed consent in your protocol.
• Protocols including deception or incomplete disclosure will demonstrate that the PI is aware of, will minimize, and have a plan in place to address possible negative impacts on participants.

Potential Risks:

There are several potential risks associated with use of deception and these should be considered when designing the study:

• Subjects may feel that they were coerced to act against their will. If so and if they had been completely informed, they may have chosen not to participate.
• Subjects may feel ashamed, guilty, stressed, or embarrassed because they now have knowledge about themselves that they otherwise would not have known or would not want to know.
• Subjects may feel a loss of control that will cause distrust and suspicion regarding human subjects research in general.
• The research may undermine the trust, or create mistrust, in research.

Debriefing Requirements:

Debriefing is an essential part of the informed consent process and is mandatory when the research study involves use of deception or incomplete disclosure. The debriefing provides participants with a full explanation of the hypothesis being tested, procedures to deceive participants and the reason(s) why it was necessary to deceive them. It should also include other relevant background information pertaining to the study. When required elements of informed consent are waived or altered by the IRB, in accordance with criteria provided in the regulations, participants must be debriefed at the end of the study. Debriefing can occur via email, in-person, virtually over Zoom, etc.
At a minimum, the debriefing statement should include the following:

• Label the document as “Debriefing Statement”
• Study title
• PI name and contact information for follow-up questions
• Student researcher’s name and contact information, if applicable, for follow-up questions
• Thank participants for taking the time to participate in the study
• Explain what was being studied (i.e., purpose, hypothesis, aim) in lay terms
• Explain how participants were deceived
• Explain why deception was necessary to carry out the research
• Explain how the results of the deception will be evaluated
• An opportunity for participants to withdraw consent after the true purpose of the study is revealed.
• Participants should be given at least 48 hours to make this decision and provide
• Contact information for the contact to withdraw from the study.

Generally, participants will be debriefed immediately following their participation in the study. However, a delay between finishing research tasks and debriefing might be necessary at times. For example, if early participants might reveal study details to subsequent participants, thereby impacting study validity, then a delayed debriefing might be warranted.
In such cases, the consent form must state that subjects will be debriefed later after the study is complete. In addition, the consenting section in the IRB protocol must provide the scientific rationale and/or justification as to why delayed debriefing is necessary.

The IRB must review and approve all advertisements that will be used to recruit subjects to a specific research study.

Generally, advertisements used to recruit research subjects should be limited to information that a potential subject would need to determine if they are eligible and interested in participating.

The ads should include information such as:

• the name and address of the research facility;
• the condition or disease that will be the focus of the research;
• the purpose of the research with reference to the fact that the study is investigational;
• a summary of criteria for eligibility to participate;
• the time and other commitments that will be required of the subject; and
• the location of the study and the office to contact for further information.

Ads may state that reimbursement for time, travel, etc. will be given.

The ads should not:

• contain explicit or implicit claims of safety and efficacy or equivalency or superiority to other approved treatments
• emphasize the amount of reimbursement that subjects will receive.
• promise a favorable outcome or benefits

When the advertisements conform to the above guidelines, they may be approved for any advertising format, e.g., posted flyers, newspaper advertisements, Internet advertisements, radio/television, slides shown prior to films at movie theaters.

To avoid multiple requests for review and approval, investigators should specify all anticipated advertising formats in their original request. A template is available on our Forms page.

Policy:

Texas Education Code, Chapter 51, Subchapters E-2 and E-3, is a Texas State Law that requires all employees (both faculty and staff) at a public or private post-secondary institution to promptly report to the Title IX Coordinator any knowledge of any incidents of sexual assault, sexual harassment, dating violence, or stalking "committed by or against a person who was a student enrolled at or an employee of the institution at the time of the incident".

Do I have a responsibility to report an incident I learn about during the conduct of a research project?

• date reported
• type of incident
• location of incident (if known)
• date/time of incident (if known)
• faculty/staff member reporting

Does being designated as a confidential employee for SB 212 change my status as a mandated reporter?

No. You are still required to report incidents you witness or receive information about to the Title IX Coordinator. Your confidential employee designation only applies to information received through the course and scope of the research project.

Should I say anything about reporting requirements for SB 212 in my informed consent process?

Yes. Include the following statement in your informed consent document if, in your opinion, it is likely the research may reveal reportable incidents (e.g., sexual assault, sexual harassment, dating violence, and/or stalking):

Texas Education Code, Chapter 51, Subchapters E-2 and E-3, requires reporting incidents of sexual assault, sexual harassment, dating violence, or stalking committed by or against a person who was a student enrolled at or an employee of UTEP at the time of the incident. However, the researchers working on this study have been designated as confidential employees. This means that if we learn about any incidents of sexual assault, sexual harassment, dating violence, or stalking, we are only required to report the type of incident reported and the date we learn about the incident. We will not report any information that could identify you.

Policy:

Texas law requires the reporting of suspected child abuse or neglect. If there is a reasonable chance that information may be elicited concerning child or elder abuse or neglect, or potentially dangerous future behavior to others as part of the research protocol, the following disclosure must be made:

Under certain situations, we may break confidentiality. Texas law requires that the disclosure of child or elder abuse, neglect, or potentially dangerous future behavior to yourself or others, be reported to the proper authorities. If during the study we learn about this information, we will report it to the appropriate authorities including the police and/or the Texas Department of Family and Protective Services, and/or an emergency medical facility.

Policy:

Before involving a human subject in research, an investigator shall obtain the legally effective informed consent of the subject or the subject's legally authorized representative. 

An investigator shall seek informed consent only under circumstances that provide the prospective subject or the legally authorized representative sufficient opportunity to discuss and consider whether to participate and that minimize the possibility of coercion or undue influence. 

The information that is given to the subject or the legally authorized representative shall be in language understandable to the subject or the legally authorized representative. 

The prospective subject or the legally authorized representative must be provided with the information that a reasonable person would want to have to make an informed decision about whether to participate, and an opportunity to discuss that information. 

Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension. 

Informed consent must present information in sufficient detail relating to the research and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject's or legally authorized representative's understanding of the reasons why one might or might not want to participate. 

No informed consent may include any exculpatory language through which the subject or the legally authorized representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence. 

Required Elements of Consent

• A statement that the study involves research.
• An explanation of the purpose of the research.
• A description of the procedures to be followed and identification of any procedures that are experimental.
• The expected duration of the participant's participation.
• A description of any reasonably foreseeable risks or discomforts to the participant. If there are no such risks or discomforts, the consent form should so state.
• A description of any benefits to the participant or to others which may be reasonably expected from the research. If there are no such benefits, the consent form should so state.
• A statement describing the extent to which confidentiality of records identifying the participant will be maintained.
• A statement that participation is voluntary, that refusal to participate involves no penalty or loss of benefits to which the participant is otherwise entitled, and that the participant may discontinue participation at any time without penalty or loss of benefits.
• One of the following statements must be included in the consent process for limited review, expedited review, or full board review that involves the collection of identifiable private information or identifiable biospecimens:
  • A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility.
  • A statement that the subject's information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.
• A statement of who is responsible for the research including the name and phone number of the Principal Investigator and IRB contact information.

Additional Elements of Consent

• For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
• A description of any procedures that are experimental and a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant.
• A statement that the treatment or procedure may involve risks to the participant (or to an embryo or fetus if the participant is pregnant) which are currently unforeseeable.
• Anticipated circumstances under which the participation may be terminated by the investigator without regard to the participant's consent
• Any additional costs to the participant that may result from participation in the research.
• The consequences of a participant's decision to withdraw from the research and procedures for orderly termination of participation by the participant
• A statement that significant new findings developed during the research, which may relate to the participant's willingness to continue participation, will be provided to the participant.
• The approximate number of participants involved in the study.
• A statement that the subject's biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit.
• A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions.
• For research involving biospecimens, whether the research will or might include whole genome sequencing.

Policy:

Use these questions to determine the difference between a clinical study and a clinical trial:

1. Does the study involve human participants?
2. Are the participants prospectively assigned to an intervention?
3. Is the study designed to evaluate the effect of the intervention on the participants?
4. Is the effect being evaluated a health-related biomedical or behavioral outcome?

If yes, your study meets the NIH definition of a clinical trial, even if…

• You are studying healthy participants
• Your study does not have a comparison group (e.g., placebo or control)
• Your study is only designed to assess the pharmacokinetics, safety, and/or maximum tolerated dose of an investigational drug
• Your study is utilizing a behavioral intervention
• Only one aim or sub-aim of your study meets the clinical trial definition

Studies intended solely to refine measures are not considered clinical trials.

Studies that involve secondary research with biological specimens or health information are not clinical trials.

All applicable clinical trials must be registered on clinicaltrials.gov. The following language is required in the informed consent for clinical trials:

A description of this study will be available on http://www.ClinicalTrials.gov as required by U.S. law. This web site will not include information that can identify you. At most, the web site will include a summary of the results. You can search this web site at any time.