What are the UCSC IRB's reporting responsibilities?

Waiver of Informed Consent

A waiver of informed consent is a waiver of the requirements to obtain informed consent, or a waiver or alteration of some of the required elements of informed consent.

The UCSC IRB may waive the requirement to obtain informed consent, or it may approve a consent procedure that alters some of the elements of informed consent described above. Before the UCSC IRB does so, the researcher must include sufficient information in the research protocol for the IRB to determine that the waiver requirements have been met. The researcher must show that:

  • The research presents no risks of harm, considering probability and magnitude, greater than those ordinarily encountered in daily life or during the performance of routine examinations or tests; and
  • The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
  • The research could not practicably be carried out without the waiver or alteration; and
  • When appropriate, the subjects will be provided with additional pertinent information after participation; or
  • The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine:
    • Programs under the Social Security Act, or other 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.

Waiver of Parental Consent

Alternatively, under 45 CFR §46.408 (c), parental consent may be waived if the IRB determines that parental or guardian permission is not a reasonable requirement to protect the subjects, such as in cases of neglected or abused children. In these cases, an appropriate mechanism for protecting the children must be substituted.

Waiver of Documented Consent

In some cases, the consent process is still required but a written consent form may not be appropriate. Examples of such cases include:

  • Research participants are not literate.
  • Participants live in a community where signing documents is looked at with suspicion.
  • In situations where the consent form is the only link to participation in study (further outlined below).

 The UCSC IRB may waive the requirement for the researcher to obtain signed written consent for some or all subjects. Before the UCSC IRB does so, the researcher must satisfy the UCSC IRB requirement that either:

  • The only record in the researcher's possession linking the subject and the research would be the consent document, and the principal risk would be potential harm resulting from a breach of confidentiality. The UCSC IRB requires that each subject be asked whether they want documentation linking them with the research, and the subject's wishes will govern; OR
  • The research presents no risks of harm, considering probability and magnitude, greater than those ordinarily encountered in daily life or during the performance of routine examinations or tests, and the research involves no procedures for which written consent is normally required outside of a research context.

When the documentation requirement is waived, the UCSC IRB requires that the researcher provide subjects with a written or oral statement (or 'script') containing the elements of informed consent, when appropriate.