Waiver of Consent or Documentation
Wavier of Consent
The HSC may approve a request for a consent process that omits or alters some or all of the required elements of informed consent in certain circumstances.
For example, omitting or altering some elements of consent may be used research where the research design may require that participants be left unaware of a particular aspect of the research, because knowing the full nature and/or purpose may bias their opinions or responses if they know in advance what the investigators are seeking. Note: Such research designs do not preclude offering potential subjects some information about the research and giving them the opportunity to decide whether to participate.
In rare circumstances, a waiver of consent may be granted for studies where secondary participants (i.e., parental permission) may be involved and it would either be prohibitive or potentially dangerous to obtain consent.
The HSC may approve a waiver of consent under the one (1) of the three (3) following circumstances, provided that the HSC finds that the research meets the criteria for approval identified by the regulations:
- Waiver for minimal risk studies when all of the following conditions are met:
- The research involves no more than minimal risk to subjects;
- The waiver or alteration will not adversely affect the rights and welfare of the subjects;
- If the research involves using identifiable information or identifiable biospecimens, the research could not be carried out without using such information or biospecimens in an identifiable format; AND
- The research could not practicably be carried out without the waiver or alteration;
- Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
- Public benefits or service programs research that is conducted by or subject to the approval of the state or local government official(s) and is designed to study, evaluate or examine:
- Public benefit or service programs;
- Procedures for obtaining benefits or services under those programs;
- Possible changes in or alternatives to those programs or procedures; OR
- Possible changes in methods or levels of payment for benefits or services under those programs; AND
- The research could not practicably be carried out without the waiver or alteration.
- Emergency situations where a waiver of the applicability of the regulatory requirement for obtaining and documenting informed consent for a strictly limited class of research, that is, research that may be carried out in human subjects who are in need of emergency therapy and for whom, because of the subjects’ medical condition and the unavailability of legally authorized representatives of the subjects, no legally effective informed consent can be obtained.
Note: The requirement for waiving consent in emergency situations applies to adults and children only and may also be subject to additional FDA regulations not described above.
Waiver of Documentation of Consent
The HSC may approve a request for a consent process that waives the requirement for documentation of the process (i.e., physical signing of the consent form), provided that the participants are still presented with (either verbally or in writing) the same information that is required in a consent document.
This process is often used in minimal risk research involving the administration of online or mailed questionnaires, surveys, telephone interviews, or when sensitive information is collected and anonymity would prevent linking the participants to the research study.
The HSC may approve a waiver of documentation of consent under the one (1) of the three (3) following circumstances, provided that the HSC finds that the research meets the criteria for approval identified by the regulations:
- The principal risks are those associated with a breach of confidentiality concerning the subject’s participation in the research AND the consent document is the only record linking the subject with the research.
- The research presents no more than minimal risk and involves procedures that do not require written consent when they are performed outside of a research setting.
- The subjects are members of a distinct cultural group or community in which signing forms is not the norm.