Texas Tech University

Consent Process

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.  

Consent Form Example

Information for exempt IRBs

TTNI Informed Consent Form

Genetics Informed 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:
      • 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.
      • 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.”

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

Broad consent for the Storage, Maintenance, and Secondary Research use of Identifiable Private Information or Biospecimens

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.
Additional Elements of Consent:
  • 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.