• 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.”

• 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 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.

• 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.

• 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.