Informed Consent

Informed Consent Written, signed consent forms Oral consent Waiver of documentation of consent Assent HIPAA Authorization Waiver of consent Waiver of parental consent Passive consent

Elements of Consent Identify the study as a UW-Madison research project

Elements of Consent Provide details as to exactly what participation will involve Total time commitment Location Description of all procedures that will be involved

Elements of Consent Risks Risk is that which is beyond what participants experience in their daily lives Emotional Breach of confidentiality

Elements of Consent Benefits Typically, “there are no direct benefits for participating in this research”

Elements of Consent Confidentiality List all steps that the researcher(s) plan to take to ensure confidentiality of the data Encryption Pseudonyms Password protected laptop Anonymous

Elements of Consent Compensation Drawings, raffles Extra credit Parking pass Gift cards If cash is offered– is the amount coercive?

Elements of Consent Contact Information Who the participants can contact with questions Principal Investigator Student researcher (optional) IRB office For international research– a local contact is required

Elements of Consent A statement that participation is voluntary, participants can quit/withdraw at any time and that they can refuse to answer and/or skip any questions they do no wish to answer.

The Consent Form Wizard The IRBs strongly recommend that you use the Consent Form Wizard to draft consent documents.

Informed Consent Examples of parental consent, assent for minors and oral consent for those aged 10 and under.

Combined Consent and HIPAA Authorization HIPAA regulations define health information as “any information, whether oral or recorded in any form or medium that: Is created or received by a health care provider, health plan, public health authority, employer, life insurer, school or university, or healthcare clearinghouse; and Relates to past, present, or future physical or mental health or condition of an individual; health care to an individual; or the past, present, or future payment for the provision of health care to an individual.

Combined Consent and HIPAA Authorization Protected Health Information (PHI) includes any individually identifiable health information. Identifiable refers not only to data that is explicitly linked to a particular individual. It also includes health information with data items which reasonably could be expected to allow individual identification.

Combined Consent and HIPAA Authorization Names All geographic subdivisions smaller than a state (up to and including zip codes). Dates directly related to an individual, including birth date, admission date, date of death. Phone Numbers Fax Numbers E-mail addresses Social Security Number Medical Record Numbers Health Plan Beneficiary Numbers Account Numbers Certificate/License Numbers Vehicle Identifiers, including license plates Device Identifiers and Serial Numbers URL’s IP Numbers Biometric Identifiers Full Face Photographic Images Any other unique identifying code

Combined Consent and HIPAA Authorization In order to use PHI in a research study, the research participant must grant authorization. The privacy rule authorization can be included in the informed consent document. The authorization must be written in plain language and must included all of the required elements.

Combined Consent and HIPAA Authorization Authorization Elements: Description of PHI to be used or disclosed. The name(s) of person(s) authrorized to make the requested use or disclosure. The name(s) of persons who may use the PHI or to whom the covered entity may make the requested disclosure. Description of each purpose of the requested use or disclosure. Researchers should note that this element must be research study specific, not for future unspecified research.

Combined Consent and HIPAA Authorization Authorization Elements (Cont.): Authorization expiration date or event that relates to the individual or to the purpose of the use or disclosure (“end of research study” or “none” can be used for research purposes. Signature of individual and date. The individual’s right to revoke the authorization in writing. The potential for the PHI to be re-disclosed by the recipient and no longer protected by the privacy rule

Additional Info Exculpatory language Proofread. Double and triple-check to ensure that the details in the protocol application match the details on the consent form. Signed consent forms should be retained for 7 years after the end of the study.