2 Informed Consent Written, signed consent forms Oral consent Waiver of documentation of consentAssentHIPAA AuthorizationWaiver of consentWaiver of parental consentPassive consent
3 Elements of ConsentIdentify the study as a UW-Madison research project
4 Elements of ConsentProvide details as to exactly what participation will involveTotal time commitmentLocationDescription of all procedures that will be involved
5 Elements of Consent Risks Risk is that which is beyond what participants experience in their daily livesEmotionalBreach of confidentiality
6 Elements of Consent Benefits Typically, “there are no direct benefits for participating in this research”
7 Elements of Consent Confidentiality List all steps that the researcher(s) plan to take to ensure confidentiality of the dataEncryptionPseudonymsPassword protected laptopAnonymous
8 Elements of Consent Compensation Drawings, raffles Extra credit Parking passGift cardsIf cash is offered– is the amount coercive?
9 Elements of ConsentContact InformationWho the participants can contact with questionsPrincipal InvestigatorStudent researcher (optional)IRB officeFor international research– a local contact is required
10 Elements of ConsentA 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.
11 The Consent Form Wizard The IRBs strongly recommend that you use the Consent Form Wizard to draft consent documents.
12 Informed ConsentExamples of parental consent, assent for minors and oral consent for those aged 10 and under.
13 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; andRelates 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.
14 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.
15 Combined Consent and HIPAA Authorization NamesAll 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 NumbersFax NumbersaddressesSocial Security NumberMedical Record NumbersHealth Plan Beneficiary NumbersAccount NumbersCertificate/License NumbersVehicle Identifiers, including license platesDevice Identifiers and Serial NumbersURL’sIP NumbersBiometric IdentifiersFull Face Photographic ImagesAny other unique identifying code
16 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.
17 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.
18 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
19 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.