Welcome To The Human Research Protection Program
Texas Tech University is committed to protecting the rights and welfare of individuals participating in research. Texas Tech's Institutional Review Board (IRB) is charged with reviewing all human subjects research in accordance with federal regulations (45 CFR 46), state laws, and local and University policies (TTU OP 74.09).
The Human Research Protection Program (HRPP) serves as a liaison to the IRB and point of contact for participants and researchers.
Getting Started
TTU requires human subject training to educate and update researchers about ethical principles and regulatory requirements for their work with human research participants. This requirement, went into effect on January 1, 2023, reflects Texas Tech University's commitment to the protection of the rights and welfare of human research participants and to the researchers who strive to conduct excellent and impactful research.
Responsible conduct of research involving human research participants requires not only compliance with regulations and guidelines developed to support ethical research practices, but also thoughtful consideration of multiple factors that define an acceptable study. These include critical evaluations of our best understanding of previous research, of risks and potential benefits, of alternative methods, and so on. The decision to conduct a study with human participants carries both ethical and regulatory responsibilities to protect the welfare and interests of those participants, to design the study to minimize risks to participants, and to engage in ongoing training for researchers working to protect the interests and welfare of research participants.
All research study personnel who engage with participants will need to complete human subject training prior to IRB approval of a research protocol and prior to conducting any human research-related activities. Human research-related activities include recruitment of participants, consenting of participants, data collection (anonymous or identifiable), gaining access to identifiable data, and/or conducting analysis of identifiable data. These training requirements will apply to all Principal Investigators, Co-Investigators, and research staff/students. This includes both individuals within the TTU system and external collaborators.
TTU research personnel must complete one of the following trainings every 3 years: CITI - TTU Human Subject Research - Required Basic or TTU Human Subject Training
Vulnerable populations require special considerations and additional safeguards to protect the rights and welfare of these participants. Individuals in these groups may be considered potentially vulnerable because they may not be able to make informed decisions for themselves, they may be in situations in which they can easily be manipulated, or they may be a convenient and readily available study population.
Vulnerable populations may include but not limited to:
- Children
- Expedited proposals that involve children require two reviewers and will possibly require a longer review time frame. An assent form will be required along with the parental consent form. Research involving schools may require school administrative approval and knowledge of FERPA regulations.
- Prisoners
- Research involving prisoners are submitted as full board proposals. The research team will be required to attend a full board meeting on the last Tuesday of the month.
- Individuals with Impaired Decision-Making Capacity
- Adult or child participants who are unable to fully understand the informed consent process due to a traumatic brain injury, developmental disorders, intellectual disabilities, and serious mental illness are other common and devastating problem.
- Economically or Educationally Disadvantaged Persons
Recruitment refers to the overall process of attracting and selecting participants for research. This is the beginning of the informed consent process and is one of the most challenging parts of research. It can be conducted through newspapers, emails, posters, fliers, advertisements, verbal announcements, or by soliciting volunteers in public spaces.
Download the following templates and adapt according to your research. Appropriate documents need to be submitted with the IRB.
The purpose of a consent form is to inform research participants about the research and their rights as human participants. It takes two components to achieve this goal: the consent process and the consent form.
Download the following templates and adapt according to your research. Appropriate documents need to be submitted with the IRB.
Oral Script for the Informed Consent Process - Exempt, Expedited & Full Board
Informed Consent Template with Signature - Expedited Categories 2, 5, 6, 7 & Full Board
Informed Consent Template with Waiver of Written Consent - Expedited with a Waiver of Written Consent
Non Invasive and Invasive Procedures Consent Form Template - Expedited Categories 1, 3, 4 & Full Board
Exempt Informed Consent Template - Option 1 - Exempt
Exempt Informed Consent Template - Option 2 - Exempt
Online Survey Consent Template with Electronic Signature - Expedited & Full Board
Online Survey Consent Template with Waiver of Written Consent - Exempt, Expedited & Full Board with a Waiver of Written Consent
TTNI Policies and Consent Form
Key information is essential to the decision-making process and must be presented at the beginning of the consent document. Participants must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and be given an opportunity to discuss that information. The consent process, whether written or oral, must cover all required elements of consent.
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:
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- 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.
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- The following statement about participants’ rights: “Dr. (Principal Investigator) will answer any questions you have about the study. You can call (phone number) or email (email address). Questions can also be directed to the Human Research Protection Program (HRPP), Office of the Vice President for Research, Texas Tech University, Lubbock, Texas 79409, 806-742-2064.”
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Additional Elements of Consent
- For research involving more than minimal risk: An explanation concerning compensation for research-related injury as follows: "If this research project causes injury (physical, psychological, social, economic, legal, etc.), Texas Tech University or the Student Health Services, may not be able to treat your injury. You will have to pay for treatment from your own insurance. The University does not have insurance to cover such injuries. More information about these matters may be obtained from Dr. Alice Young, Associate Vice President, Research Integrity, Office of the Vice President for Research, (806) 742-3905, 355 Administration Building, Texas Tech University, Lubbock, Texas, 79409." If there is a specific plan for liability, it should be described in place of this statement.
- For research that involves any procedures or treatments that a participant might reasonably construe to be therapeutic: 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.
- A statement about the expiration date of the project's approval: "This consent form is not valid after (expiration date)." The expiration date is the anniversary of last day of the month preceding the approval. The letter informing the investigator of the approval of a proposal specifies the date of expiration.
Broad Consent
Required Elements of Broad Consent:
- A description of any reasonably foreseeable risks or discomforts to the subject.
- A description of any benefits to the subject or to others that may reasonably be expected from the research.
- A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
- 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.
- A general description of the types of research that may be conducted with the identifiable private information or identifiable biospecimens. This description must include sufficient information such that a reasonable person would expect that the broad consent would permit the types of research conducted;
- A description of the identifiable private information or identifiable biospecimens that might be used in research, whether sharing of identifiable private information or identifiable biospecimens might occur, and the types of institutions or researchers that might conduct research with the identifiable private information or identifiable biospecimens;
- A description of the period of time that the identifiable private information or identifiable biospecimens may be stored and maintained (which period of time could be indefinite), and a description of the period of time that the identifiable private information or identifiable biospecimens may be used for research purposes (which period of time could be indefinite);
- A statement that they will not be informed of the details of any specific research studies that might be conducted using the subject's identifiable private information or identifiable biospecimens, including the purposes of the research, and that they might have chosen not to consent to some of those specific research studies;
- A statement that such results may not be disclosed to the subject; and
- An explanation of whom to contact for answers to questions about the subject's rights and about storage and use of the subject's identifiable private information or identifiable biospecimens, and whom to contact in the event of a research-related harm.
- 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.
- For research involving biospecimens, whether the research will or might include whole genome sequencing.
Technical material and the purpose of the study must be explained in lay terms. Procedures should be explained from the point of view of what will happen to the participant during the study. A general rule of thumb is to write the consent form at a 7th grade reading level. Adjustments up or down from that standard can be made depending on the target population of participants. Consent forms need to be written in the second person.
The participant must sign and date the consent form. Exempt Categories 1-6 DO NOT require a signature. Handwritten or electronic signatures are both recognized forms of a signature. Researchers can request a waiver of written consent or a waiver or alteration of the elements of consent. One copy of the consent form must be given to the participant and one copy must be retained by the investigator. The investigator must keep consent forms for a period of three years after the closure of the IRB. Expiration dates on consent forms change when renewals are conducted and approved.
The consent process, whether written or oral, must cover all basic elements unless a waiver is formally requested.
A short form consent is used when the participant or legally authorized representative is verbally presented the elements of informed consent. This is most useful when a study is complex. The short form allows the individual obtaining the consent to engage in a continuous dialogue with the participant.
Download the following template and adapt according to your research. Appropriate documents need to be submitted with the IRB.
For IRB approval, two documents are required for short form consent.
- The oral summary of the elements of consent required by 45 CFR 46.116.
- Provide the document to the IRB in English and in the participant's preferred language.
- The short form consent that states the elements of informed consent have been orally presented to the participant or a legally authorized representative
- Provide the document to the IRB in English and in the participant's preferred language.
Participant or Legally Authorized Representative
- Sign and date short form consent
- Provided with the signed copy of the short form consent and oral summary
Witness
- Observe the oral presentation of informed consent
- Must understand both English and the participant's preferred language
- Must not be a part of the research team or involved in the research
- Sign and date the short form consent and oral summary
Individual Obtaining Consent
- Verbally presents the elements of informed consent
- Research team may use a translator to obtain consent
- A second individual is still required to serve as the witness
- Sign and date the oral summary
When minors (under the age of 18 in most states) are involved in research, the regulations require the assent of the minor and the consent of the parent(s) or legally authorized representative. There are four components in achieving this goal when research involves minors: the consent process and the consent form for parents; and the consent process and assent form for minors.
Download the following templates and adapt according to your research. Appropriate documents need to be submitted with the IRB.
Preschool-Kindergarten Assent Form Template - Expedited & Full Board
1st-8th Grade Assent Form Template - Expedited & Full Board
9th-12th Grade Assent Form Template - Expedited & Full Board
Parent Consent Form Template - Expedited & Full Board
While children may be legally incapable of giving informed consent, children should be asked whether or not they wish to participate in the research. The child should be given an explanation of the proposed research procedures in a language that is appropriate to the child's age, experience, maturity, and condition. This explanation should include a discussion of any discomforts and inconveniences the child may experience. If the child objects to the research, the study is stopped immediately.
An IRB may approve a consent procedure that omits some or alters some of the elements of informed consent.
For an IRB to waive or alter consent, the IRB must find:
- The research involves no more than minimal risk to the participants.
- The research could not practicably be carried out without the requested waiver or alteration.
- If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format.
- The waiver or alteration will not adversely affect the rights and welfare of the participants.
- Whenever appropriate, the participants or legally authorized representatives will be provided with additional pertinent information after participation.
An IRB may approve a research proposal in which a researcher will obtain information or biospecimens for the purpose of screening, recruiting, or determining the eligibility of prospective participants without the informed consent of the prospective participant or the participant's legally authorized representative, if either of the following conditions are met:
- The researcher will obtain information through oral or written communication with the prospective participant or legally authorized representative.
- The researcher will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.
Waiver of Written Consent
An IRB may waive the requirement for the researcher to obtain a signed informed consent form for some or all participants if it finds any of the following:
Signed Consent:
- That the only record linking the participant and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. Each participant (or legally authorized representative) will be asked whether the participant wants documentation linking the participant with the research, and the participant's wishes will govern.
- That the research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside of the research context.
- If the participants or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to participants and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.
In cases in which the documentation requirement is waived, the IRB may require the researcher to provide participants or legally authorized representatives with a written statement regarding the research.
The Institutional Review Board (IRB) should determine that the risks to subjects are reasonable in relation to anticipated benefits [21 CFR 56.111(a)(2)] and that the consent document contains an adequate description of the study procedures [21 CFR 50.25(a)(1)] as well as the risks [21 CFR 50.25(a)(2)] and benefits [21 CFR 50.25(a)(3)].
It is not uncommon for subjects to be paid for their participation in research, especially in the early phases of investigational drug, biologic or device development. Payment to research subjects for participation in studies is not considered a benefit, it is a recruitment incentive. Financial incentives are often used when health benefits to subjects are remote or non-existent. The amount and schedule of all payments should be presented to the IRB at the time of initial review. The IRB should review the amount of payment and the proposed method and timing of disbursement to assure that neither are coercive or present undue influence [21 CFR 50.20].
Any credit for payment should accrue as the study progresses and not be contingent upon the subject completing the entire study. Unless it creates undue inconvenience or a coercive practice, payment to subjects who withdraw from the study may be made at the time they would have completed the study (or completed a phase of the study) had they not withdrawn. For example, in a study lasting only a few days, an IRB may find it permissible to allow a single payment date at the end of the study, even to subjects who had withdrawn before that date.
While the entire payment should not be contingent upon completion of the entire study, payment of a small proportion as an incentive for completion of the study is acceptable to FDA, providing that such incentive is not coercive. The IRB should determine that the amount paid as a bonus for completion is reasonable and not so large as to unduly induce subjects to stay in the study when they would otherwise have withdrawn. All information concerning payment, including the amount and schedule of payment(s), should be set forth in the informed consent document.
Examples include:
- Cash
- Check
- Gift Card
- Drawing
- Course Credit
- Extra Credit
Research studies occasionally involve the deception of participants. The participants are provided with false or incomplete information about the research in order to obtain unbiased data with respect to the participants' attitudes and behavior.
- Deception occurs when a researcher intentionally gives research participants misleading or false information about some aspect of the research
- Deliberately misinforming participants
- Incomplete Disclosure occurs when a researcher intentionally withholds information from participants about the true purpose or nature of the research
- Omitting or withholding key information about the research
Deception may only be used:
- In Limited research if they participant is made aware in the informed consent process that the research involves deception.
- In Expedited and Full Board research.
- When the risk is no greater than minimal.
- When the research is not feasible without the deception.
- When debriefing is provided.
Deception affects the informed consent process because participants are not provided accurate information on the required elements of consent and therefore cannot make an informed decision to participate in the research. A request for a Waiver or Alteration of Informed Consent must be requested in the IRB application. Even though the IRB may agree to alter the required elements of consent, a consent process is still required, and the consent document must provide a truthful description of the study to the extent possible.
Information to include in the IRB:
- Justification of deception
- Process of debriefing
- When, how, and by whom participants will be debriefed
- Copy of debriefing statement
- Explain any risks and benefits associated with the deception
- Request a Waiver or Alteration of Informed Consent
- When a study uses deception, fully informed consent cannot be obtained from participants because they are not provided with enough information to make an informed decision.
Researchers may choose to debrief participants about their research after their participation has ended or the research is complete. The debriefing process is a requirement for studies that employ deception, sexual misconduct, self-harm, and substance abuse. However, it can also be used as an educational tool and to provide counseling resources.
The process to debrief participants must be explained in your IRB submission. Researchers are strongly encouraged to debrief participants as soon as possible after the research. Your submission must indicate who will debrief participants and the debriefing document.
General Debriefing
- Label the form as "Debriefing Statement"
- Study title
- Thank participants for taking the time to participate in the study
- A full explanation of the hypothesis being tested
- Relevant background information pertaining to the research
- PI name and contact information for follow-up questions
- If the study involves sensitive topics, it may be appropriate to give participants an opportunity to withdraw their consent to participate.
- If the Research Topic is Sexual Misconduct, Discrimination, Harassment or Violence include the following additional language:
- If you want to report sexual misconduct at Texas Tech University, you can contact the Office for Student Civil Rights & Sexual Misconduct. You can then meet with the office staff and they will open an investigation into this matter. If you would like me to file a report with the Office for Student Civil Rights & Sexual Misconduct on your behalf and help you get into contact with these resources, please let me know. (This language is not required for exempt research.)
- Resources available to the participants – The resource document provided can be adapted to fit the needs of the research participants and topics.
Deception Debriefing
- Procedures used to deceive participants
- Why it was necessary to deceive participants
- Participants should also be given the opportunity to withdraw completely any and all material collected.
- If the research study involved the use of audio or video recording a participant, the researcher must provide them an opportunity to withdraw their consent for the use of such recordings.
View resources
Researchers collect and receive data in various forms. Here are the key terms to think about when collecting, analyzing, and storing data to protect the participants privacy and confidentiality.
- Anonymous Data: Data was collected without identifiers and was never linked to an individual.
- Individual identifiers that might be collected in the course of data collection:
- Names
- All geographic subdivisions smaller than a State, including street address, city, county, precinct, zip code, and their equivalent geocodes, except for the initial three digits of a zip code if, according to the current publicly available data from the Bureau of the Census: (a) The geographic unit formed by combining all zip codes with the same three initial digits contains more than 20,000 people; (b)The initial three digits of a zip code for all such geographic units containing 20,000 or fewer people is changed to 000
- All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death; and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older
- Telephone numbers
- Fax numbers
- Electronic mail addresses
- Social security numbers
- Student ID numbers
- Medical record numbers
- Health plan beneficiary numbers
- Account numbers
- Certificate/license numbers
- Vehicle identifiers and serial numbers, including license plate numbers
- Device identifiers and serial numbers
- Web Universal Resource Locators (URLs)
- Internet Protocol (IP) address numbers
- Biometric identifiers, including finger and voice prints
- Full face photographic images and any comparable images
- Any other unique identifying number, characteristic, or code; and the covered entity does not have actual knowledge that the information could be used alone or in combination with other information to identify an individual who is a subject of the information
- Coded Data: Personal identifiers have been removed from the data and replaced with a participant code. The personal identifier(s) and participant code are in a separate document away from the data. This allows the researcher to trace the data back to the original source. If a link exists, data are considered indirectly identifiable and not anonymous, anonymized or de-identified.
- Indirectly Identifiable Data: Data does not include personal identifiers, but link identifiers to the data with a code. This data is still considered identifiable
- De-Identified Data: All personal identifiers are permanently removed from data. No code or key exists to link the individual back to the data.
- Confidentiality is when the researcher knows the identity of a research participant/entity but takes steps to protect the identity from being discovered by others.
Individual identifiers that might be collected in the course of data collection:
Title IX - Sexual Misconduct
Research activities must be compliant with applicable federal and state laws and university policies. The IRB and HRPP office expect all researchers to put the participant's well-being and safety first.
Title IX
All TTU employees and students are required to report to the TTU Office for Student Civil Rights & Sexual Misconduct if they receive information about sexual misconduct, discrimination, harassment or violence that meets one or more of the following criteria:
- Is alleged to have been perpetrated by a TTU student, staff, or faculty member, OR
- The alleged victim is a TTU student, staff, or faculty member, OR
- Has occurred on TTU property or during a TTU activity.
If The Research Topic Is Sexual Misconduct, Discrimination, Harassment or Violence
If there is a reasonable expectation that the target population will disclose information about sexual misconduct, discrimination, harassment or violence while participating in the research a plan for this circumstance must be included in the research protocol and informed consent. The research team does not report this information to the Office for Student Civil Rights & Sexual Misconduct, unless, the participant requests to the research team that the incident be reported to the Office for Student Civil Rights & Sexual Misconduct on the participant's behalf. Your IRB will state in the findings of the IRB approval letter if the research team is not required to report to the Office for Student Civil Rights & Sexual Misconduct. If the participant is in immediate threat, call 911.
Exempt research is anonymous and cannot be reported at the individual level. This does not require a change to the informed consent document. Additional language can be added to the debriefing script. When it is feasible, the IRB and HRPP office recommend that the data is collected anonymously, and researchers do not have access to identifiers.
Limited research cannot include sexual misconduct topics. If identifiers are needed for the research this must be reviewed through the expedited or full board process.
Expedited and full board research will require the additional language to the informed consent process and debriefing script.
Informed Consent Language
How are we protecting your privacy?
Your name will not be linked to any material in reports, publications or presentations. No one other than the researchers associated with this project will have access to the raw data. All related documentation will be stored in the researcher's locked office and on a password protected computer.
Additional Language:
As a researcher, I am not required to report to TTU authorities and/or law enforcement officials on the information that you may disclose in the course of this research related to sexual misconduct, violence, harassment, or discrimination, etc. You should be aware disclosures made during this research will not prompt a Title IX investigation into possible sexual misconduct.
If we believe that you or someone else are in imminent danger of serious physical harm, we may need to contact someone to make sure you're safe. This would only happen if we were not able to work with you directly to come up with a plan to keep you, or someone else, safe.
Debriefing Language
Must include a list of resources available to participants.
Additional Language:
If you want to report sexual misconduct at Texas Tech University, you can contact
the Office for Student Civil Rights & Sexual Misconduct. You can then meet with the
office staff and they will open an investigation into this matter. If you would like
me to file a report with the Office for Student Civil Rights & Sexual Misconduct on
your behalf and help you get into contact with these resources, please let me know.
If The Research Topic Is NOT Sexual Misconduct, Discrimination, Harassment Or Violence
If a research participant discloses Title IX: sexual misconduct information this would trigger mandatory reporting to the TTU Office for Student Civil Rights & Sexual Misconduct. In addition, this will constitute a reportable incident to the HRPP office since it is an unanticipated event. This is an unanticipated event because the research team did not expect the research participants to disclose sexual misconduct information. The Principal Investigator must complete an incident submission in Cayuse IRB within three days of learning of the issue and report the incident to the TTU Office for Student Civil Rights & Sexual Misconduct. If the participant is in immediate threat, call 911.
Abuse & Neglect
Research activities must be compliant with applicable federal and state laws and university policies. The IRB and HRPP office expect all researchers to put the participant's well-being and safety first.
Abuse and Neglect of a Child, Elderly Individual or Adults with Disabilities
All TTU employees and students are required to report alleged or suspected abuse and neglect of a child, elderly individual, or adults with disabilities or impaired decision-making skills.
If the Research Topic is about Abuse and Neglect of a Child, Elderly Individual, Adults with Disabilities or Impaired Decision-Making Skills
If there is a reasonable expectation that the target population will disclose information about abuse and neglect while participating in the research, a plan for this circumstance must be included in the research protocol and informed consent. The research team will report alleged or suspected abuse and neglect to the Texas Department of Family and Protective Services. If the participant is in immediate threat, call 911.
Informed Consent Language
How are we protecting your privacy?
Your name will not be linked to any material in reports, publications or presentations. No one other than the researchers associated with this project will have access to the raw data. All related documentation will be stored in the researcher's locked office and on a password protected computer.
Adult Consent Form: The researcher(s) will not maintain as confidential, information about known or reasonably suspected incidents of abuse or neglect of a child, dependent adult or elder, including, but not limited to, physical, sexual, emotional, and financial abuse or neglect. If any researcher has or is given such information, he or she may be required to report it to the authorities.
Child/Impaired Decision-Making Assent Form: We will not tell anyone what you tell us without your permission unless there is something that could be dangerous to you or someone else. If you tell us that someone is or has been hurting you, we may have to tell that to people who are responsible for protecting you so they can make sure you are safe.
Debriefing Language
Must include a list of resources available to participants.
If the Research Topic is NOT about Abuse and Neglect of a Child, Elderly Individual, Adults with Disabilities or Impaired Decision-Making Skills
If a research participant discloses information triggering the need for mandatory reporting to the Texas Department of Family and Protective Services, this will constitute a reportable event to the HRPP office since it is an unanticipated incident. The Principal Investigator must complete an incident submission in Cayuse IRB within three days of learning of the issue and report the incident to the Texas Department of Family and Protective Services. If the participant is in immediate threat, call 911.
Mental Health, Self-Harm, Criminal Behavior, & Substance Abuse
Research activities must be compliant with applicable federal and state laws and university policies. The IRB and HRPP office expect all researchers to put the participant's well-being and safety first.
Mental Health, Self-Harm, Criminal Behavior, and Substance Abuse
TTU employees and students are NOT required to report alleged or suspected self-harm, criminal behavior, or substance abuse.
When it is feasible, the IRB and HRPP office recommend that the data is collected anonymously, and researchers do not have access to identifiers.
If the Research Topic is about Mental Health, Self-Harm, Criminal Behavior, and Substance Abuse
If there is a reasonable expectation that the target population will disclose information about Mental Health, Self-Harm, Criminal Behavior, and Substance Abuse while participating in the research, the researcher needs to provide information in the protocol about plans for providing referral information, assessing participant safety, and/or contacting others outside the research team to ensure participants safety. Example language is provided below in the section describing how privacy is protected.
If the research team decides to report an alleged or suspected self-harm, criminal behavior, and substance abuse, this will constitute a reportable event to the HRPP office. The Principal Investigator must complete an incident submission in Cayuse IRB within three days of learning of the issue. If the participant is in immediate threat, call 911.
Observed or known concerns in the TTU community
Raiders Report
Informed Consent Language
How are we protecting your privacy?
Your name will not be linked to any material in reports, publications or presentations. No one other than the researchers associated with this project will have access to the raw data. All related documentation will be stored in the researcher's locked office and on a password protected computer.
Confidentiality rules prevent anyone from the research team sharing information about you with anyone outside of the research team without your permission. There are some very rare exceptions to this that you should know about. For example, if you tell us about a child or an elderly adult who is being abused, we are required to report that to the appropriate authorities. Also, if we believe that you or someone else are in imminent danger of serious physical harm, we may need to contact someone to make sure you're safe. This would only happen if we were not able to work with you directly to come up with a plan to keep you, or someone else, safe.
Debriefing Language
Must include a list of resources available to participants.
Office of Research & Innovation
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Address
Texas Tech University, 2500 Broadway, Box 41075 Lubbock, TX 79409 -
Phone
806.742.3905 -
Email
vpr.communications@ttu.edu