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:
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.
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 two (2) following circumstances, provided that the HSC finds that the research meets the criteria for approval identified by the regulations: