Informed Consent Process & Documentation Questions/Answers

The Investigator develops an informed consent process appropriate to the research and population emphasizing comprehension and voluntary participation. Investigators understand the difference between consent process (which is ongoing) and consent documentation. 

The ORI Informed Consent website serves as a one-stop website with informed consent resources ranging from creation to documentation and everything in between. Linked pages include guidance on various processes, situations, and subject populations.  Also, includes links to externally launched external consent trainings.

Questions

Describe your informed consent process?

What is the difference between Informed Consent, and the process of obtaining Assent and Parental Permission?

What is Informed Consent Key Information?

Does the Key Information need to be a full page if the entire consent is not much longer than a page?

Under what conditions can informed consent be altered or waived for minimal risk research?

Under what circumstances can documentation of informed consent be waived?

Answers

Describe your Informed Consent Process?

• The informed consent process involves the “who”, “what”, “when’, “where”, and “how” that result in a valid, effective informed consent.  Investigators indicate in the IRB application, which study personnel will obtain consent and describe the proposed process in the research description.

• In developing a robust process, consider techniques to ensure comprehension and voluntary participation, such as:
  • plain language documents; visuals, graphics;
  • steps to minimize coercion or undue influence; &
  • teach back questions to assess understanding.

• Potential participants must be allowed ample time to read, review, discuss and consider participation.
• While the informed consent process is prospective and takes place prior to any research activity. Consent should also be an ongoing educational interaction between the investigator and the research participants that continues throughout the study. Enrolled participants must be provided information arising during the study, which may affect their willingness to continue to participate.

What is the difference between Informed Consent, and the process of obtaining Assent and Parental Permission?

Because children and some adults with impaired consent capacity are not legally considered capable of providing consent, regulations do allow a parent or legally authorized representative (LAR) to give “permission” for the individual to participate when assent or “affirmatively agreement” to participate is obtained from the child (or adult with impaired consent capacity).  Depending on the risk level of the study, provisions may be necessary for permission of both parents.

• For guidelines on when assent needs to be documented based on age and maturity, as well as parental permission requirements for research involving children, see the UK IRB Policy on Children in Research.
• Refer to the UK Impaired Consent Capacity Policy for guidelines on developing a plan that evaluates level of impairment given the context of the research.  Researchers can respect even limited autonomy by obtaining participant assent and recognizing that individuals are always considered competent to refuse.

What is Informed Consent Key Information?

One of the new regulatory requirements from the Revised Common Rule states that:

“Informed consent must begin with a concise and focused presentation of the Key Information that is most likely to assist a prospective subject in understanding the reasons why one might or might not want to participate.” [45CFR46.116(a)(5)(i)]

Key Information is not defined in the Common Rule, but the regulation indicates that it should be brief, presented first, and zero-in on the key pros and cons a reasonable person would weigh rather than having that information buried deep in a detailed consent document.   

It is generally NOT inclusion or exclusion criteria except when the criteria affect choice.  For instance, if a key factor involves criteria that may be undesirable to the reasonable person (e.g., “you might not want to participate if you would be unable or unwilling to abstain from alcohol for the next 30 days.”).    

Key Information Samples for Simulated Studies are available on the Sample Applications and Protocol Development Resources webpage.

Does the Key Information need to be a full page if the entire consent is not much longer than a page?

The regulation is not prescriptive or rigid about the format or content of Key Information.  The intent is to allow consent documents (and the process) to be tailored to the particular research.  The Preamble to the Revised Common Rule acknowledges that, for some relatively simple studies, the entire document will be brief.  In such cases, the key information may fit within a paragraph vs. an entire page given the context of the study.

Under what condition can informed consent be altered or waived for minimal risk research?

Some research projects would not be possible if informed consent were required. The IRB may approve a consent procedure that does not include, or which alters, some or all of the elements of informed consent, or may waive the requirements to obtain informed consent, if it finds and documents that the research meets the Common Rule Regulatory conditions:

1. The research involves no more than minimal risk to the subject.
2. The rights and welfare of subjects will not be adversely affected.
3. The research could not practicably be carried out without the requested waiver or alteration.
4. Whenever possible, the subjects or legally authorized representatives will be provided with additional pertinent information after they have participated in the study.
5. If the research involves using or accessing identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format. Private information/specimens are “identifiable” if the investigator may ascertain the identity of the subject or if identifiers are associated with the information (e.g., medical records). This could be any of the 18 HIPAA identifiers including dates of service.

NOTE: FDA also allows waiver of informed consent for FDA-regulated minimal risk research.  Where HIPAA applies to the research, a HIPAA waiver of Authorization may also be required. 

Under what circumstances can documentation of informed consent be waived?

IRB regulations allow the IRB to waive the requirement to obtain a signed consent document for some or all the subjects if certain conditions are met. 

The IRB waives the signature requirement but may require the investigator to provide participants with a document or written statement regarding the research.

The following are options for waiving documentation:

1. The only record linking the subject and the research would be the consent document and the principal risk would be harm resulting from breach of confidentiality. Under this option, each participant (or legally authorized representative) must be asked whether (s)he wants to sign a consent document; if the participant agrees to sign a consent document, only an IRB approved version should be used.
2. The research presents no more than minimal risk and involves no procedures for which written consent is normally required (i.e., a cover letter on a mailed survey or phone script)
3. Subject or LAR is a member of a distinct cultural group or community in which signing forms is not the norm. The research is no greater than minimal risk and there is an alternative mechanism for documenting that informed consent was obtained.

NOTE: HIPAA regulations do not have an equivalent waiver of documentation of HIPAA Authorization.  FDA currently allows waiver of documentation only under Option 2 [21CFR56.109(c)].