Description

Potential participants, or the parents of children who are 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. 

Situations When It Is Used

This process is often used in minimal risk research involving the administration of online or mailed surveys, telephone interviews, or when anonymous sensitive information is collected and you do not want any written documentation that links the participant to the research study.

Conditions For Approval

The IRB may waive the requirement for the investigator to obtain a signed consent form for some or all participants if it finds either:

1. That the only record linking the participant and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each participant will be asked whether or not he or she wants documentation linking him or her with the research.  The participant's wishes will govern.
   (NOTE: The FDA has not adopted this category so it cannot be used if the research is subject to the FDA regulations at 21 CFR 50.) 
2. That the research presents no more than minimal risk of harm to participants (i.e., the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests) and involves no procedures for which written consent is normally required outside of the research context. In cases in which the documentation requirement is waived, the IRB may require the investigator to provide participants with a written statement regarding the research.
   

HIPAA Requirements

If you plan to use or share protected health information (PHI) when conducting your research, you must conduct your study in accordance with the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA). 

This means that when applying for a waiver of documentation of consent, you will also have to request a waiver or alteration of HIPAA Authorization.  The IRB can grant the waiver of alteration if it determines the following criteria are met:

1. Use or disclosure involves no more than minimal risk to the privacy of individuals because of the presence of at least the following elements:
   1. An adequate plan to protect health information identifiers from improper use or disclosure,
   2. An adequate plan to destroy identifiers at the earliest opportunity absent a health or research justification or legal requirement to retain them, and
   3. Adequate written assurances that the PHI will not be used or disclosed to a third party except as required by law, for authorized oversight of the research study, or for other research uses and disclosures permitted by the Privacy Rule;
2. Research could not practicably be conducted without the waiver or alteration; and
3. Research could not practicably be conducted without access to and use of PHI.

Description

This waiver applies in the special circumstances when the IRB determines that it is not necessary to obtain the participants’ consent to conduct the research.

The IRB may approve research where investigators leave out or alter elements of informed consent, provided the research meets all applicable regulations.

HHS regulations allow the IRB to waive the requirement for obtaining informed consent or parental permission 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. 

The FDA does not allow a waiver or alteration of the requirements for obtaining informed consent except in special circumstances. 

Situations When It Is Used

The IRB often grants a waiver of consent for retrospective chart review studies. 

On rare occasions, prospective collection of data through intervention or interaction with participants may be granted a waiver of consent.  With compelling reason, a waiver of consent may be granted for studies where secondary participants may be involved and it would be either prohibitive or potentially dangerous to obtain a consent.  For example, parental permission for a child to participate may be waived if consenting the parent could be detrimental to the child.

As another example, some research designs require that participants be left unaware of the particular purpose of the research, because the participants’ responses might be biased if they know in advance what the investigators are seeking. Such research designs do not preclude offering potential participants some information about the research and giving them the opportunity to decide whether or not to participate.

Additional Provision For Children Who Are Participants

The IRB may waive the requirements for obtaining parental or guardian permission under the following provision:

1. The IRB determines that a research protocol is designed to study conditions in children or a participant population for which parental or guardian permission is not a reasonable requirement to protect the participants (for example, neglected or abused children), and the following 2 additional criteria are also met:
   1. an appropriate mechanism is in place to protect the children, and
   2. the waiver is not inconsistent with federal, state, or local law (45 CFR 46.408(c)). The choice of an appropriate substitute mechanism (for example, appointing a child advocate or an assent monitor) for protecting children participating in research would depend on the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and the child’s age, maturity, status, and condition (45 CFR 46.408(c)). Note that an IRB may waive the requirement for obtaining parental or guardian permission under 45 CFR 46.408(c) even if the research involves more than minimal risk to the child subjects.

HHS Scenarios For Possible Waiver

For ADULTS and CHILDREN, a waiver or alteration of the requirements for obtaining informed consent can occur under any of the following three provisions set forth by HHS:

1. Research in general: an IRB may waive or alter the requirement of informed consent under 45 CFR 46.116(d), provided that the IRB finds and documents that all of the following four conditions are met:
   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.
2. Public benefit or service programs: an IRB may approve a consent procedure that alters some or all of the elements of informed consent, or waive the requirement to obtain informed consent under HHS regulations at 45 CFR 46.116(c), provided that the IRB finds and documents that both of the following conditions are met:
   1. the research could not practicably be carried out without the waiver or alteration; and
   2. the research or demonstration project is to be conducted by or participant to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine:
   3. public benefit or service programs;
   4. procedures for obtaining benefits or services under those programs;
   5. possible changes in or alternatives to those programs or procedures; or
   6. possible changes in methods or levels of payment for benefits or services under those programs.
3. Research in emergency settings: an IRB may also waive the requirement for obtaining informed consent if it finds and documents that the research meets the requirements of the HHS Secretarial waiver under45 CFR 46.101(i) that permits a waiver of the general requirements for obtaining informed consent in a limited class of research in emergency settings.

FDA Scenario for Waiver

The FDA only permits an IRB to approve a clinical investigation without participants' informed consent for Emergency Research.

HIPAA

If you plan to use or share protected health information (PHI) when conducting your research, you must conduct your study in accordance with the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA).

This means that when applying for a waiver of documentation of consent, you will also have to request a waiver or alteration of HIPAA Authorization.  The IRB can grant the waiver of alteration if it deems the following criteria are met:

1. An adequate plan to destroy identifiers at the earliest opportunity absent a health or research justification or legal requirement to retain them, and
   1. An adequate plan to protect health information identifiers from improper use or disclosure,
   2. An adequate plan to destroy identifiers at the earliest opportunity absent a health or research justification or legal requirement to retain them, and
   3. Adequate written assurances that the PHI will not be used or disclosed to a third party except as required by law, for authorized oversight of the research study, or for other research uses and disclosures permitted by the Privacy Rule;
2. Research could not practicably be conducted without the waiver or alteration; and
3. Research could not practicably be conducted without access to and use of PHI.

Obtaining and documenting informed consent of subjects who do not speak English

Department of Health and Human Services regulations for the protection of human subjects require that informed consent information be presented "in language understandable to the subject" and, in most situations, that informed consent be documented in writing (45 CFR §46.116 and §46.117).

Where informed consent is documented in accordance with §46.117(b)(1), the written consent document should embody, in language understandable to the subject, all the elements necessary for legally effective informed consent. Subjects who do not speak English should be presented with a consent document written in a language understandable to them. OPRR strongly encourages the use of this procedure whenever possible.

Alternatively, §46.117(b)(2) permits oral presentation of informed consent information in conjunction with a short form written consent document (stating that the elements of consent have been presented orally) and a written summary of what is presented orally. A witness to the oral presentation is required, and the subject must be given copies of the short form document and the summary.

When this procedure is used with subjects who do not speak English, (i) the oral presentation and the short form written document (see sample attached) should be in a language understandable to the subject; (ii) the IRB-approved English language informed consent document may serve as the summary; and (iii) the witness should be fluent in both English and the language of the subject.

At the time of consent, (i) the short form document should be signed by the subject (or the subject's legally authorized representative); (ii) the summary (i.e., the English language informed consent document) should be signed by the person obtaining consent as authorized under the protocol; and (iii) the short form document and the summary should be signed by the witness. When the person obtaining consent is assisted by a translator, the translator may serve as the witness.

The IRB must receive all foreign language versions of the short form document as a condition of approval under the provisions of §46.117(b)(2). Expedited review of these versions is acceptable if the protocol, the full English language informed consent document, and the English version of the short form document have already been approved by the convened IRB.

It is the responsibility of the IRB to determine which of the procedures at §46.117(b) is appropriate for documenting informed consent in protocols that it reviews.

• Short Form English (PDF)
• Short Form Arabic (PDF)
• Short Form Croatian (PDF)
• Short Form French (PDF)
• Short Form Hmong (PDF)
• Short Form Khmer (PDF)
• Short Form Lao (PDF)
• Short Form Oromo (PDF)
• Short Form Russian (PDF)
• Short Form Somali (PDF)
• Short Form Spanish (PDF)
• Short Form Vietnamese (PDF)

(1) Before involving a human subject in research covered by this policy, an investigator shall obtain the legally effective informed consent of the subject or the subject's legally authorized representative.

(2) An investigator shall seek informed consent only under circumstances that provide the prospective subject or the legally authorized representative sufficient opportunity to discuss and consider whether or not to participate and that minimize the possibility of coercion or undue influence.

(3) The information that is given to the subject or the legally authorized representative shall be in language understandable to the subject or the legally authorized representative.

(4) The prospective subject or the legally authorized representative 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 an opportunity to discuss that information.

(5) Except for broad consent (UMKC did NOT adopt the use of broad consent) obtained in accordance with paragraph (d) of this section:

(i) Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.

(ii) Informed consent as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject's or legally authorized representative's understanding of the reasons why one might or might not want to participate.

(6) No informed consent may include any exculpatory language through which the subject or the legally authorized representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.

In seeking informed consent the following information shall be provided to each subject or the legally authorized representative:

(1) 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;

(2) A description of any reasonably foreseeable risks or discomforts to the subject;

(3) A description of any benefits to the subject or to others that may reasonably be expected from the research;

(4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;

(5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;

(6) 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;

(7) 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;

(8) 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; and

(9) One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:

(i) 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

(ii) 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.

Additional elements of informed consent. Except as provided in paragraph (d), (e), or (f) of this section, one or more of the following elements of information, when appropriate, shall also be provided to each subject or the legally authorized representative:

(1) 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) that are currently unforeseeable;

(2) Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's or the legally authorized representative's consent;

(3) Any additional costs to the subject that may result from participation in the research;

(4) The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;

(5) A statement that significant new findings developed during the course of the research that may relate to the subject's willingness to continue participation will be provided to the subject;

(6) The approximate number of subjects involved in the study;

(7) 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;

(8) A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions; and

(9) 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).

General Information:

The person consenting participants to the research may be the principal investigator or an individual authorized by the principal investigator and approved by the IRB to obtain consent for the specific protocol, such as a co-investigator, or team member. Regardless of who is obtaining consent, the Principal Investigator is responsible to ensure the correct procedures are carried out.

The consent process and procedure for obtaining consent may occur with:

• an adult capable of providing consent;
• the legally authorized representative when the participant is an adult unable to give consent;
• one or both biologic or adoptive parents when the participant is a child; or in the absence of a parent, a person other than a parent authorized under applicable law to consent on behalf of the child to participate in the research.

If the participant is an adult unable to consent, the IRB must have specifically approved the protocol to allow the enrollment of adults unable to consent. If permission is obtained from a legally authorized representative this person must be in the class or persons approved by institutional policy or the IRB.

If the participant is a child, the IRB must have specifically approved the protocol to allow the enrollment of children. Permission is obtained from both parents unless: one parent is deceased, unknown, incompetent, not reasonably available; only one parent has legal responsibility for the care and custody of the child; or he IRB has specifically approved the protocol to allow the permission of one parent regardless of the status of a second parent.

If the participant/representative understands more than one language, whenever possible, conduct the consent process in the preferred language of the participant/representative.

If the participant/representative cannot speak English the IRB must have specifically approved the protocol to allow the enrollment of participants able to speak in a language the participant understands.

All discussions for consent should be conducted in a private and quiet setting.

If at any point a participant/representative indicates that he or she does not want to take part in the research study, the process stops.

The Consent Process:

1. If the consent process will be documented in writing with the long form of consent documentation:
   1. Verify that you are using the most current IRB-approved version of the study specific consent form and that the consent form is in language understandable to the participant/representative.
   2. Provide a copy of the consent form to the participant/representative. Whenever appropriate provide the consent form to the participant/representative in advance of the consent discussion.
   3. If the participant/representative cannot read, a verbal consent may be appropriate or you may need to have an impartial witness present during the consent discussion. If the study involves greater than minimal risk, there must be a witness to attest that the information in the consent form and any other information provided was accurately explained to, and apparently understood by, the participant/representative. The witness may be a family member or friend and may not be a person involved in the design, conduct, or reporting of the research study. The witness is there to verify that consent was freely given.
   4. If the participant/representative cannot speak English, obtain the services of an interpreter fluent in both English and the language understood by the participant/representative. The interpreter may be a member of the research team, a family member, or friend of the participant/representative.
   5. Read the consent document (or have an interpreter read the translated consent document) with the participant/representative. Explain the details in such a way that the participant/representative understands what it would be like to take part in the research study.
   6. When obtaining consent is completed, you must offer a signed copy to the participant / representative. The participant /representative is not obligated to take the document but it must be offered. 

2. If the consent process will be documented in writing with the short form of consent documentation:

   Note: The short form consent is typically used only when the potential participant does not speak English and there is not enough time to translate the approved written English consent form into a language understandable to him or her.

   1. Verify that you are using the most current IRB-approved version of the study specific short consent form and summary that the short consent form is in language understandable to the participant/representative.
   2. Provide copies to the participant/representative. Whenever appropriate provide the short consent form and summary to the participant/representative in advance of the consent discussion.
   3. Obtain the services of an interpreter fluent in both English and the language understood by the participant/representative. The interpreter may be a member of the research team, family member, or friend of the participant/representative.
   4. Obtain the services of an impartial witness who is fluent in both English and the language spoken by the participant/representative to be present during the entire consent discussion to attest that the information in the short consent form, summary, and any other information provided was accurately explained to, and apparently understood by, the participant/representative. The witness and the interpreter may be the same person. The witness may be a family member or friend. The witness may not be a person involved in the design, conduct, or reporting of the research study as the witness is there to verify that consent was freely given.
   5. Have the interpreter translate the summary (not the short consent form) to the participant/representative.
   6. Through the interpreter, explain the details in such a way that the participant/representative understand what it would be like to take part in the research study. When necessary provide a different or simpler explanation to make the information understandable.
   7. Have the participant/representative read the short consent form or have the interpreter read the short consent form to the participant/representative.
   8. When obtaining consent is completed, you must offer a written copy to the participant / representative. The participant /representative is not obligated to take the document but it must be offered.

3. If the requirement for written documentation of the consent process has been waived by the IRB:

   1. It is your obligation to follow the same process of obtaining consent as described above. You will use a consent document following the consent template with the only difference being the participant is not asked to sign the document.
   2. It is your obligation to provide a copy of the script to the participant/representative.
   3. If the participant/representative cannot speak English, obtain the services of an interpreter fluent in both English and the language understood by the participant/representative. The interpreter may be a member of the research team, a family member, or friend of the participant/representative.
   4. Read the script (or have an interpreter translated the script) with the participant/representative.
   5. Explain the details in such a way that the participant/representative understands what it would be like to take part in the research study.
   6. Invite and answer the participant/representative’s questions and give the participant/representative time to discuss taking part in the research study with family members, friends and other care providers as appropriate.
   7. Invite and encourage the participant/representative to take the written information home to consider the information and discuss the decision with family members and others before making a decision.
   8. Ask the participant/representative questions to determine if the participant/representative understands the information provided. 

4. If the participant/representative agrees to take part in the research study:

   1. If the participant is a child:

      1. Whenever possible explain the research using language that is age appropriate and/or cognitively consistent with the child’s ability to understanding.
      2. Request the assent (affirmative agreement) of the child unless the capability of the child is so limited that the child cannot reasonably be consulted or the IRB determined that assent was not a requirement. It is recommended that when appropriate, children under age 7 should be verbally assented and 7+ assented in writing.
      3. Once a child indicates that he or she does not want to take part in the research study, this process stops.

   2. If the participant is an adult unable to consent:

      1. Whenever possible explain the research to the extent compatible with the adult’s understanding.
      2. Request the assent (affirmative agreement) of the adult unless the capability of the adult is so limited that the adult cannot reasonably be consulted or the IRB determined that assent was not a requirement.
      3. Once an adult unable to consent indicates that he or she does not want to take part in the research study, this process stops.