Informed Consent Requirements

Informed consent is an ongoing process, not simply a form that is signed. The purpose of informed consent is to ensure that prospective participants receive the information they need to understand the research and make a voluntary, informed decision about whether to participate.

The consent process begins when a prospective participant is first approached about the research and continues throughout the participant's involvement in the study. Researchers should provide information in language and a format that is understandable and appropriate for the intended participant population. Participants should have sufficient opportunity to ask questions, consider whether to participate, and make a voluntary decision without coercion or undue influence.

Participants have the right to:

• Receive sufficient information to make an informed decision about participation;
• Ask questions and receive understandable answers;
• Decide whether or not to participate;
• Decline participation without penalty or loss of benefits to which they are otherwise entitled; and
• Withdraw from the research at any time, subject to any limitations that have been clearly explained during the consent process.

Federal requirements for informed consent are established in 45 CFR 46.116, and requirements for documentation of consent are established in 45 CFR 46.117.

When Is Informed Consent Required?

Before involving a human participant in research covered by the federal regulations, investigators generally must obtain legally effective informed consent from the participant or the participant's legally authorized representative (LAR), unless the IRB has approved an alteration or waiver of informed consent in accordance with applicable regulations.

Informed consent requirements apply when research involves interaction or intervention with individuals and, as applicable, when identifiable private information or identifiable biospecimens are used for research. The specific consent requirements depend on the nature of the research and the applicable regulations.

The consent process must:

• Provide information in language understandable to the participant or LAR;
• Give the participant or LAR sufficient opportunity to consider whether to participate;
• Minimize the possibility of coercion or undue influence;
• Provide the information a reasonable person would want in order to make an informed decision; and
• Begin with a concise presentation of the key information most likely to help the prospective participant understand why they may or may not want to participate.

The informed consent process and documentation must accurately reflect the IRB-approved research protocol. The Principal Investigator (PI) is responsible for ensuring that the approved consent process is followed.

Required Consent Information

Depending on the research, the informed consent process must address applicable elements such as:

• The fact that the activity involves research;
• The purpose of the research;
• The expected duration of participation;
• Research procedures and identification of experimental procedures;
• Reasonably foreseeable risks or discomforts;
• Potential benefits;
• Appropriate alternatives, when applicable;
• Confidentiality and privacy protections;
• Compensation or treatment for research-related injury, when applicable;
• Contact information for questions about the research and participants' rights;
• A statement that participation is voluntary and that participants may discontinue participation without penalty or loss of benefits to which they are otherwise entitled; and
• Additional information required by the regulations when applicable to the study.

Consent documents may not contain exculpatory language that causes participants or their legally authorized representatives to waive or appear to waive legal rights or release the investigator, sponsor, institution, or their agents from liability for negligence.

Use of the SVSU Informed Consent Template

Researchers conducting human-subjects research at SVSU are expected to use the SVSU Informed Consent Template when preparing consent materials, unless an alternative format has been approved by the IRB.

The template is designed to incorporate the required elements of informed consent and provide a consistent framework for communicating study information to participants.

Researchers should:

• Modify the template as appropriate for the specific study;
• Remove sections that are not applicable, as directed within the template;
• Retain all required elements relevant to the study;
• Ensure that the information accurately describes the research procedures, risks, potential benefits, confidentiality protections, and participant rights; and
• Ensure that the consent document is consistent with the procedures described in the IRB application.

Use of the SVSU template helps facilitate IRB review and supports a clear and consistent consent process. Use of the template does not replace the investigator's responsibility to ensure that the consent process is appropriate for the specific study and participant population.

Informed Consent, Waiver of Documentation, and Waiver of Informed Consent

These three concepts are related but not interchangeable. Investigators should understand the distinction because each has different implications for participant protections and requires IRB review when applicable.

1. Informed Consent

Informed consent means that the participant or legally authorized representative receives the required information about the research, has an opportunity to ask questions and consider participation, and voluntarily agrees to participate.

In most research requiring consent, consent is documented using an IRB-approved written consent form signed by the participant or LAR. A copy of the signed document must be provided to the person signing it. Electronic signatures may be used when approved and appropriate.

Example: A participant reviews the IRB-approved consent form, discusses the study with the researcher, has an opportunity to ask questions, signs the consent form, and receives a copy.

2. Waiver of Documentation of Informed Consent

A waiver of documentation of informed consent means that the IRB waives the requirement for the participant to provide a signature or other written documentation of consent. It does not, by itself, waive the requirement to obtain informed consent.

The participant must still receive the information required by the approved consent process and voluntarily agree to participate.

Under 45 CFR 46.117, an IRB may waive the requirement for a signed consent form when, for example:

1. The only record linking the participant to the research would be the consent document and the principal risk would be potential harm from a breach of confidentiality; or
2. The research presents no more than minimal risk and involves procedures for which written consent is not normally required outside of the research context.

The IRB may require that participants receive a written statement containing information about the research even when a signature is not required.

Example: Participants receive an IRB-approved information sheet before completing a minimal-risk anonymous survey. The IRB has waived the requirement for a signature, but participants still receive the information necessary to make an informed decision about participation.

Important: A waiver of documentation does not mean that the researcher can simply skip the consent process. The participant must still be informed and must agree to participate unless the IRB has separately approved an alteration or waiver of informed consent.

3. Waiver or Alteration of Informed Consent

A waiver or alteration of informed consent is different from a waiver of documentation.

An IRB may, under limited circumstances, approve a procedure that waives the requirement to obtain informed consent or alters some or all of the required elements of informed consent.

Under 45 CFR 46.116, the IRB must determine and document that the applicable regulatory criteria have been satisfied. For a general waiver or alteration, these include that:

• The research involves no more than minimal risk to participants;
• The research could not practicably be carried out without the requested waiver or alteration;
• When identifiable private information or identifiable biospecimens are involved, the research could not practicably be carried out without using them in an identifiable format;
• The waiver or alteration will not adversely affect the rights and welfare of participants; and
• When appropriate, participants or their legally authorized representatives will be provided with additional pertinent information after participation.

A waiver or alteration of informed consent is not automatic and should not be assumed to be appropriate simply because obtaining consent may be difficult or inconvenient.

Example: A retrospective research study uses existing identifiable medical records and meets the regulatory criteria for an IRB-approved waiver of informed consent.

Quick Comparison

Requesting a Waiver or Alteration

Investigators requesting either:

• a waiver of documentation of informed consent, or…
• a waiver or alteration of informed consent…

must clearly identify the request in the IRB application and provide a justification addressing the applicable regulatory criteria.

The IRB will determine whether the request meets the requirements for approval.

Researchers should not assume that a waiver will be granted. If a waiver or alteration is not approved, the study must use the IRB-approved consent process before research activities requiring consent begin.

Informed Consent Procedures Must Be Described in the IRB Application

The IRB application must clearly describe how informed consent will be obtained and documented, including:

• Who will obtain consent;
• When and where consent will occur;
• How the study will be explained to participants;
• How questions will be addressed;
• How the researcher will assess participant understanding when appropriate;
• How consent will be documented;
• How a copy of the consent information will be provided to participants; and
• Any requested waiver or alteration of informed consent or documentation.

The consent procedures described in the IRB application must be consistent with the submitted consent materials and the approved research protocol.

Research Involving Children

Research involving children requires additional protections. When applicable, the IRB must determine that adequate provisions are made for obtaining parental or guardian permission and for soliciting the assent of children who are capable of providing assent.

In determining whether a child is capable of providing assent, the IRB considers factors such as the child's age, maturity, and psychological state. The IRB may determine that assent is not required under circumstances permitted by the regulations.

Parental or guardian permission must be documented in accordance with applicable informed consent documentation requirements. When the IRB determines that child assent is required, the IRB also determines whether and how assent must be documented.

In certain circumstances, the IRB may determine that parental or guardian permission is not a reasonable requirement for protecting the children involved. In such cases, the IRB may approve an alternative mechanism for protecting the children when permitted by applicable federal, state, and local law.

Researchers conducting studies involving children should address parental permission, child assent, and documentation procedures specifically in the IRB application.

Research Involving Health Information

Research involving protected health information may also be subject to the requirements of the Health Insurance Portability and Accountability Act (HIPAA) and its Privacy Rule.

When applicable, investigators must ensure that the consent process and study documents contain the required HIPAA authorization or other appropriate documentation. HIPAA requirements are separate from, but may apply in addition to, the informed consent requirements of the IRB.

Researchers should identify any applicable HIPAA requirements in the IRB application.

Key Takeaways

Informed consent is a process—not simply a signature. Remember the distinction:

• Informed Consent: The participant receives the required information, has an opportunity to ask questions and consider participation, and voluntarily agrees to participate.
• Waiver of Documentation: The participant still goes through the consent process, but the IRB waives the requirement for a signature or other documentation of consent.
• Waiver or Alteration of Informed Consent: The IRB approves the omission or alteration of some or all consent requirements under specific regulatory circumstances.

When submitting an IRB application, investigators should clearly describe how informed consent will occur, how it will be documented, and whether any waiver or alteration is being requested.

Informed Consent documents can be found here, or on the IRBNet Website under Forms and Templates.

Questions About Informed Consent

If you are unsure whether training is required, which CITI course you should complete, whether your training is current, or how to document your training for an IRB submission, please contact:

Dr. Marcia Ditmyer

SVSU IRB Chair

irbchair@svsu.edu