Altering or Waiving Elements of Informed Consent/Waiver of Consent
Preparatory to Research
Waiver of Consent (no consent)
Waiver of Documentation of Consent (verbal consent)
Significant Differences in FDA and DHHS Regulations
Preparatory to Research: This term covers a number of activities that may take place before research approval. An example of this type of activity is to have someone in medical records provide the number of patients treated treated for x during a particular time. No identifiers are collected during this sort of activity. See below for additional information
No Consent: this means that you will use information from a person without getting their agreement to use their information. The language used in the federal regulations to describe this situation is “Waiver of Consent” meaning there is no consent form document and you will not be informing the person that their information is being used in research.
Oral (Verbal) Consent: this means that you will talk with the subject and they will verbally agree to participate. No document (consent form) is used. The language used in the federal regulations to describe this situation is “Waiver of Documentation of Consent” meaning there is no consent form document to document that consent was obtained.
Written Consent: this means that you will talk with the subject, and allow them time to read or have read to them a consent form document. If the person agrees to participate in the study they will sign the consent form document.
The IRB may approve a consent procedure which omits or which alters some or all of the elements of informed consent. A Principal Investigator may request a waiver of one or more elements of informed consent by indicating this request to the IRB.
PREPARATORY TO RESEARCH
There are certain activities, in preparing for research, that can be done without IRB approval. For information see Activities That Can be Done Under the HIPAA Preparatory to Research Criteria.
Preparatory to Research Activities
The IRB for Health Sciences Research (IRB-HSR) serves as both the HIPAA Privacy Board and the IRB at UVa.
It is critical to keep in mind that even though some activities might be allowed without a HIPAA Privacy Board approval, they may not be allowed without an IRB approval under DHHS regulations.
Preparatory to Research and Researchers Will NOT Record HIPAA Identifiers
If the researcher wishes to review charts to design a research study or to assess the feasibility of conducting a study, IRB approval is NOT required if no HIPAA identifiers will be collected. The researcher must however complete a Request for Medical Records or Statistical Data Form and submit this to the UVa Health System Department of Health Information Services (HIS).
In this form the researcher will represent that the use or disclosure of the protected health information is solely to review protected health information, as necessary, to prepare a research protocol or for similar purposes preparatory to research, and that this information is necessary for research purposes.
Preparatory to Research and Researchers WILL Record HIPAA Identifiers
If you need to collect information to design a research study or to assess the feasibility of conducting a study and you will also need to record HIPAA identifiers, IRB approval IS required. Submit a new protocol application to the IRB using the IRB-HSR program called Protocol Builder. The IRB will provide you with an Approval/Assurance Form which may be submitted to Health Information Services to obtain the charts you need.
- Under HIPAA regulations the researcher is allowed to collect such things as the name and contact information of the potential subjects.
- HOWEVER, under DHHS regulations, this activity meets the definition of human subject research.
- THEREFORE, the researcher must obtain IRB approval if they wish to obtain any HIPAA identifiers and/or contact the subjects.
For additional information see DHHS Guidance Document: Clinical Research and the HIPAA Privacy Rule
Waiver of Consent(NO CONSENT)
The Common Rule (45CFR46) allows the IRB to approve a waiver, or an alteration, of the requirement for informed consent to the research if the proposed protocol meets the following specific criteria found at 45 CFR § 46.116(d):
- The research involves no more than minimal risk to the privacy of the subjects.
- The research could not practicably be carried out without the waiver or alteration.
- The research could not practicably be conducted without access to and use of this identifiable protected health information.
- Whenever appropriate (generally, when there is a health justification), the subjects will be provided with additional pertinent information after participation.
The regulations governing waiver of informed consent are found in 45CFR46.116 (DHHS), 21 CFR 50.23 and 21CFR50.24 (FDA) ,and 32CFR219.116 (DoD). Regulations regarding waiver of HIPAA authorization are found in 21CFR164 (HIPAA).
In addition, if Protected Health Information (PHI) (health information with identifiers) will be obtained, HIPAA (21CFR160 and 164) regulations must be met in order to waive HIPAA authorization. At UVa, the HIPAA authorization is embedded in our consent forms.
- Because the UVa agreement with DHHS via the Federal Wide Assurance (FWA) states that we will follow DHHS regulations regardless of funding, a waiver of consent must always be reviewed and approved under the DHHS waiver regulations.
- If the protocol includes research on a drug, device or biologic, a waiver of consent must also be reviewed and approved under the FDA waiver regulations.
- If the protocol includes research of an in-vitro diagnostic device, additional information may be found in the FDA Guidance document " Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable"
- If the protocol is funded by the Department of Defense, the waiver of consent must also be reviewed and approved under DoD regulations.
The IRB carefully reviews such requests and determines whether alteration or waiver is appropriate and permissible in each situation.
The Privacy Rule also permits the IRB to alter the required form of authorization, if the IRB makes a separate set of findings and determines that the waiver criteria contained in the privacy rule are satisfied.
WAIVER OF DOCUMENTATION OF CONSENT (verbal consent)
If you propose to obtain informed consent for the research activity without obtaining the subject’s signature on a consent form you are requesting a waiver of documentation of consent.
According to 45 CFR 46.117(c), an IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:
- Research presents no more than minimal risk*
- Research involves procedures that do not require written consent when performed outside of a research setting
45 CFR 46.117(c)(2)
Waiving the requirement for a written form does not eliminate the requirement for informed consent. Subjects must be informed of the nature of the research, and their consent (or the consent of their legal representatives) must be obtained whenever appropriate. This type of waiver is useful for some telephone or internet surveys, questionnaires, or when signing the consent document could have a negative consequence for the subject.
The IRB will require the use of an Information Sheet to be given to the potential subject. The information sheet should include the following information:
- State that the study involves research
- Explain the purposes of the research and the expected duration of the subject's participation
- If applicable: describe any foreseeable risk or discomforts to the subject
- If applicable: describe any benefits to subjects or to others that may reasonably be expected from the research.
- If applicable: disclose alternatives
- Describe the extent to which confidentiality of records identifying subjects will be maintained, where the records will be stored and who will have access to them.
- Provide contact information for answers to pertinent questions about the research, and participants' rights.
- Include that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which participants are otherwise entitled, and also that participants may discontinue participation at any time without penalty or loss of benefits to which they are otherwise entitled.
The IRB will also require the use of a script for obtaining verbal consent. A template for obtaining verbal consent is found on the following website page – midway down the page: http://www.virginia.edu/vpr/irb/hsr/advertising.html
The script and the information sheet must be provided to the IRB at the time of original protocol submission for review and approval.