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The IRB determines, for each protocol it reviews, which of the following elements and disclosures must be included in the informed consent process. Investigators can avoid delay in the review process by ensuring that all applicable items are included and reflect the latest institutional language.

Basic Elements

Each item listed must be included unless the IRB approves a waiver or alteration of informed consent.

• A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures that are experimental;
• A description of any reasonably foreseeable risks or discomforts to the participant;
• A description of any benefits to the participant or to others that may reasonably be expected from the research;​
• A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant;
• A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained;
• 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 it consists of, or where further information may be obtained;
  • The UAB statement must be included: “UAB has not provided for any payment if you are harmed as a result of taking part in this study. If such harm occurs, treatment will be provided. However, this treatment will not be provided free of charge.”
  • If the research is sponsored, include whether or not the sponsor(s) will provide compensation for and/or pay for treatment of research-related injuries
    • When the sponsor(s) will not provide compensation for or pay for treatment of research-related injuries, include the name of all sponsors in the UAB 
    • When the sponsor(s) will provide compensation for and/or pay for treatment of research-related injuries, include the specific language provided by the sponsor(s) regarding injury compensation. Note: The IRB must be provided with “sponsor verification” in the form of a letter signed by the sponsor(s) with the same wording given in the consent form, a model consent form included in the protocol and listed in the Table of Contents of the protocol with the same wording, or in the contract or agreement.​

• An explanation of whom to contact for answers to pertinent questions about the research and research participants’ rights, and whom to contact in the event of a research-related injury to the participant;A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled; and
• One of the following statements about any research 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; or
• A statement that the participant’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.
• For research involving UAB students or employees, the appropriate statement must be included (see Sample Informed Consent Document​).

Disclosures

In seeking informed consent, the following information will be disclosed to the participant unless waived by the IRB:

• Only IRB-approved advertisements and recruitment materials.
• If applicable, relevant animal data and their significance should be explained to potential participants.
• An explanation of measures to prevent pregnancy that should be taken while in the study, if applicable.
• A statement that notes the possibility that specific entities (e.g., UAB IRB, OHRP, FDA and foreign regulatory agencies, if appropriate) may inspect the research records.
• A statement that any reportable diseases/conditions detected during the research will be reported to the county or state health department:
  • Where HIV testing is conducted, individuals whose test results are associated with personal identifiers must be informed of their own test results and provided the opportunity to receive appropriate counseling before and after the testing;
  • Where other protocol testing for reportable diseases is conducted, individuals will be informed of the results and told where to obtain counseling and referred to their primary care physician or the state health department.
• Where drug screening is conducted, participants will be told that the results may exclude them from the study or if the information in the opinion of the investigator poses significant harm to the participant or risks to others that the results of the drug testing will be reportable to a third party.
• Where DNA/genetic testing is conducted as part of the study, this information should be clearly stated and the testing will be limited to the disease under study or for other disease with the participants' permission.
• When any other applicable federal, state, or local laws, require additional information to be disclosed to the proper authorities in cases such as:
  • child abuse and neglect;
  • elder abuse and neglect.

• When a participant is the first one to undergo a new procedure, this information should be clearly stated.
• For research involving collection of biological or tissue specimens in conjunction with a clinical protocol:
  • A statement on retention and future use of biological or tissue specimens within the body of the study consent documents rather than a separate informed consent document including the following choices:
    • Limiting use for specified diseases;
    • Allowing unlimited use;
    • Contacting participants prior to use;
    • Option not to allow use of specimens for future research.
  • A statement clearly noting that participants may refuse permission for future research use of their biological specimens without affecting their participation in the study or their care by the health provider.
  • A statement that participants may change their mind and refuse to permit their specimens to be used at some time in the future to the extent their specimens are identifiable.

Additional Elements

One or more of the following elements of information, when appropriate, shall also be provided to each participant or the legally authorized representative:

• A statement that the particular treatment or procedure may involve risks to the participant (or to the embryo or fetus, if the participant is or may become pregnant), that are currently unforeseeable. Examples of when the IRB requires this element are:
  
  • Phase I or II clinical investigations;​
  • Experimental procedures or treatments with limited available data on risks.​
• Anticipated circumstances under which the participant’s participation may be terminated by the investigator without regard to the participant’s or legally authorized representative’s consent. Examples of when the IRB requires this element are:
  
  • If the sponsor may stop the study;
  • If the investigator reserves discretion to remove the participant from the study;
  • If the investigator may remove the participant from the study should the investigator determine it is in the best interest of the participant; or
  • If the participant does not follow study instructions.
• Any additional costs to the participant that may result from participation in the research. Examples of when the IRB requires this element are:
  
  • If study procedures result in potential billing to the participant or third party payers;
  • If participants may have out-of-pocket costs from participation in the research (e.g., parking, meals, transportation); or​
  • If a possibility exists that a study drug become commercially available and no longer provided at no cost to the participant.
• The consequences of a participant’s decision to withdraw from the research and procedures for orderly termination of participation by the participant. Examples of when the IRB requires this element are:
  • If drug dose tapering is required and has risks to participants;
  • When a follow-up visit or testing is required for safety reasons.
• A statement that significant new findings developed during the course of the research that 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. The IRB generally requires this element with respect to the number of participants locally and, if applicable, nationally.
• A statement that the participant’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 results, including individual research results, will be disclosed to subjects, and if so, under what conditions.
• For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).

Broad Consent

Elements of broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens.

UAB is not adopting broad consent at this time.

Other Information in the Informed Consent

Other information that should be included as applicable can be found in the Sample Consent Form found on the Forms page​ of the UAB IRB website