Recruitment, Consent, & Authorization

IRB Review Criteria

The IRB uses several checklists and worksheets to ensure that your recruitment, consent, and authorization processes meet regulatory requirements.  You can find these in the eIRB Library.

Recruitment

Strategies, plans, and activities relating to notifying and/or contacting potential research participants with the intent of screening, obtaining informed consent, and/or enrolling them into a study.

Consent [45 CFR 46.116 and 117]

The process by which an individual learns about a study and its potential benefits and risks to determine if he/she wishes to participate. Typically, a research participant’s decision to participate in research is documented by a signature on a consent form. The informed consent process continues until the study is complete by maintaining open lines of communication between participants and the study team, and informing the participant of any new information that may impact the decision to continue participation.

  • A statement that the study involves research
  • An explanation of the purposes of the research
  • The expected duration of the subject's participation
  • A description of the procedures to be followed
  • Identification of any procedures which are experimental
  • A description of any reasonably foreseeable risks or discomforts to the subject
  • A description of any benefits to the subject or to others which 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 subject
  • A statement describing the extent, if any, to which confidentiality of records identifying the subject 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 they consist of, or where further information may be obtained
  • Research, Rights or Injury: An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject
  • 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

Additional Elements as Appropriate

  • A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant), which are currently unforeseeable
  • Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent
  • Any additional costs to the subject that may result from participation in the research
  • The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject
  • A statement that significant new findings developed during the course of the research, which may relate to the subject's willingness to continue participation, will be provided to the subject
  • The approximate number of subjects involved in the study
Waiver of Documentation of Consent [45 CFR 46.117(c)]

Potential participants are presented (either verbally or in writing) with the same information required in a written consent document, but documentation of the process (signing of the consent form) has been waived by the IRB.

Criteria:

(1) The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context; or

(2)The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern.

Electronic Consent

Generally, an electronic consent process is granted a waiver of documentation of consent by the IRB. However, it is possible for an electronic consent process to include a valid electronic signature. Contact the RSPO for more information about this option.

Waiver or Alteration of Consent [45 CFR 46.116(d)]

For some minimal risk research, the IRB can waive the requirement for obtaining informed consent or to approve a consent procedure that leaves out or alters some or all of the elements of informed consent otherwise required under the regulations.

Criteria:

(1) The research involves no more than minimal risk to the participants;

(2) The waiver or alteration will not adversely affect the rights and welfare of the participants;

(3) The research could not practicably be carried out without the waiver or alteration; and

(4) Whenever appropriate, the participants will be provided with additional pertinent information after participation.

Assent of Children [45 CFR 46.401 (subpart D)]

Although children do not have the legal capacity to “consent” to participate in research, they should be involved in the process to the extent they are able and should usually be asked to agree to participate. This is called “assent.” The process for obtaining assent from children is similar to consent of adults in that the basic elements of consent are required to be presented to the child in language that is applicable to their age. Parental permission is usually required for the child’s participation.  If parents will be subjects in the research, separate consent for their own participation must also be obtained. Please consult the RSPO team if you have questions about assent and parental permission processes.

There are times when parental permission is not required for children to participate in a research project. Please refer to the KPNW Guidance on Children and Consent for more information.

Waiver of Assent [45 CFR 46.408 and 46.116(d) and 21 CFR 50.55(d)]

In certain cases where assent of children and/or parental permission is not feasible or appropriate, the IRB can consider waiving the requirement.  See the review checklists in the eIRB Library for specific criteria.

Other Types of Waivers

The IRB can also waive consent requirements for certain types of research on emergency medicine practices or public benefit programs.  Contact the RSPO about these options.

HIPAA Authorization [45 CFR 46.160 and 164]

Also called Privacy Rule Authorization or PRA, written permission from an individual for use and/or disclosure of protected health information (PHI) that meets the requirements of the HIPAA Privacy Rule and any more stringent or additional requirements under state or other applicable laws.

Core Elements

  • Description of PHI to be used or disclosed (identifying the information in a specific and meaningful manner).
  • The name(s) or other specific identification of person(s) or class of persons authorized to make the requested use or disclosure.
  • The name(s) or other specific identification of the person(s) or class of persons who may use the PHI or to whom the covered entity may make the requested disclosure.
  • Description of each purpose of the requested use or disclosure. Researchers should note that this element must be research study specific, not for future unspecified research.
  • Authorization expiration date or event that relates to the individual or to the purpose of the use or disclosure (the terms "end of the research study" or "none" may be used for research, including for the creation and maintenance of a research database or repository).
  • Signature of the individual and date. If the Authorization is signed by an individual's personal representative, a description of the representative's authority to act for the individual.

Required Statements

  • The individual's right to revoke his/her Authorization in writing and either (1) the exceptions to the right to revoke and a description of how the individual may revoke Authorization or (2) reference to the corresponding section(s) of the covered entity's Notice of Privacy Practices.
  • Notice of the covered entity's ability or inability to condition treatment, payment, enrollment, or eligibility for benefits on the Authorization, including research-related treatment, and, if applicable, consequences of refusing to sign the Authorization.
  • The potential for the PHI to be re-disclosed by the recipient and no longer protected by the Privacy Rule. This statement does not require an analysis of risk for re-disclosure but may be a general statement that the Privacy Rule may no longer protect health information.

The IRB may approve a waiver or alteration of HIPAA authorization provided that the research meets the applicable regulatory criteria. These requirements overlap with but are not the same as those for waiver or alteration of consent and waiver of documentation of consent. [45 CFR 164.512(i)(2)(ii)]

Criteria:
  • The research could not practicably be conducted without the waiver or alteration;
  • The research could not practicably be conducted without access to and use of the PHI;
  • The use or disclosure of the PHI involves no more than minimal risk to the privacy of the subjects as a result of:
    • An adequate plan to protect the PHI from improper use and disclosure;
    • An adequate plan to destroy any identifiers contained in the PHI at the earliest opportunity consistent with the research; and
    • Adequate written assurances that the PHI will not be reused or re-disclosed to any other person or entity, except as required by law, for authorized oversight of the research study, or for other research for which the use or disclosure of PHI would be permitted.

The waiver/alteration may apply to the whole study, or it may apply to one portion of the study, such as recruitment by phone before subjects will be asked to sign an authorization to enroll in the study. Regardless, the PHI collected under the waiver must be the "minimum necessary" in order to accomplish the research purpose.