Human Research Protection Office Waivers: What You Need to Know Erin Holmes Grabowski, BS, CIP Quality Assessment Specialist
Objectives of this Presentation • Review the different types of waivers that can be requested • Review the justifications and requirements for each waiver • Discuss the basic applicability of each waiver 2
Federal Regulations • Federal regulations require signed inform ed consent from subjects • Waiver/ alteration of consent may be granted with adequate justifications • Exempt studies do not require consent 3
Types of waivers that can be requested • Waiver of the requirement to obtain a signed consent (i.e. waiver to document consent) • Waiver/ Alteration of informed consent • Waiver of HIPAA Authorization • Note: Exception to the requirement to obtain informed consent for research involving the evaluation of an 'emergency' procedure will not be discussed today. 4
Waiver of the requirem ent to obtain a signed consent (i.e. waiver to docum ent consent) 5
Waiver to docum ent consent • There is a process for obtaining consent • The script, process, or handout must include ALL of the required elements of informed consent • This is not a waiver to obtain consent, you are still obtaining consent. This is a waiver of the requirement to obtain a signed informed consent. 6
Waiver to docum ent consent (cont) • There are two possible criteria to choose from: – 45 CFR 46.117(c)(1) That the only record 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. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or – 45 CFR 46.117(c)(2) That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context. 7
Waiver to docum ent under criteria 2 • Investigators may use this approach for minimal risk research activities • In your waiver justifications you must justify/ explain: – That the research activity presents no more than minimal risk of harm to subjects – That the research activity involves no procedures for which written consent is normally required outside of the research context 8
Waiver to docum ent under criteria 2: (cont) • Must involve NO procedures for which written consent/ permission is normally required outside of the research context • Not applicable to activities that require signed permission outside of the research context – blood draws (PA battery state) or – medical records (HIPAA has no provision for verbal authorization) 9
Waiver to docum ent under criteria 2: (cont) Commonly used for: – phone screens (verbal consent), – online consent (click to consent – d ifferent from electronic consent), – requesting a participant to fast prior to obtaining written consent In a minimal risk study, could potentially be used for complete study participation (examples: interviews, focus groups, surveys) * 10
11 Waiver of Inform ed Consent
Waiver of Inform ed Consent • Activity must be m inim al risk • Investigators must be able to justify waiver criteria • Note: the FDA (per July 2017 guidance) DOES allow a waiver of informed consent in similar minimal risk situations to the Common Rule. (It is not yet codified but the guidance allows it.) – https:/ / www.fda.gov/ downloads/ RegulatoryInformation/ Guidances/ UCM566948.pdf 12
Waiver of Consent Criteria 45 CFR 46.116 (d) • Research activity involves no more than minimal risk • Waiver will not adversely affect the rights and welfare of the subjects • Research activity could not practicably be carried out without the waiver * • Whenever appropriate, the subjects will be provided with additional pertinent information after participation 13
Waiver of Inform ed Consent Prim ary reasons for requesting a waiver of inform ed consent: • Medical record review for ONLY the identification of potential subjects for recruitment • Review of identifiable medical records (a chart review) • Parental permission and/ or child assent • Other Minimal Risk activity * 14
Medical record review for ONLY the identification of potential subjects for recruitm ent • Sole purpose is identifying potential subjects to approach for recruitm ent • Investigator must have legitimate, normal access to protected health information (investigator is also clinician) • Investigator (or designated study team member with their own access) may review and record the data * 15
Medical record review for ONLY the identification of potential subjects for recruitm ent – (cont) • Informed consent is required for subjects to enroll in the study • A HIPAA W a iv er is not a p p lica ble, a s HIPAA consid ers this p rep a ra tory to resea rch • This activity should also be indicated as a recruitment method in the recruitment section • The subject must be approached by someone who is part of their clinical care/ known to them 16
Review of identifiable m edical records (a chart review) • A common application: submission for a chart review with a Waiver of Consent and a Waiver of HIPAA – both must be requested and justified • Investigator must have legitimate, normal access to protected health information • Investigator (or designated study team member with their own access) may review and record the data • With appropriate waiver justifications, data are not required to be in existence at time of submission • Be careful of the use of the word RETROSPECTIVE – means in existence at time of the IRB submission 17
Waiver of parental perm ission • An IRB may waive the requirements for obtaining parental permission if either of the following two conditions is met: * • The IRB makes and documents the required findings under either 45 CFR 46.116(c) or (d); OR • The IRB determines that a research protocol is designed to study conditions in children or a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), and the following 2 additional criteria are also met: – An appropriate mechanism is in place to protect the children, and – The waiver is not inconsistent with federal, state, or local law (45 CFR 46.408(c)). 18
Other m inim al risk activity Example Case where an investigator could request a waiver of informed consent for the initial blood sample: Dr. X is a clinician in the ER at UPMC. Dr. X is studying patients who present to the ER with traumatic brain injury. For the research study, a blood sample is needed from these patients within the first hour of presentation to the ER. Many times these patients are unconscious and/ or unaccompanied by a family member. Dr. X would like to obtain the research blood sample by taking an extra tube of blood during the patient’s clinical blood draws, and then approach the patient (or their proxy) for consent later when they are awake/ available. * 19
Alteration of Consent • The regulations give the IRB the ability to approve a waiver or alteration of informed consent. • The IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent… or waive the requirement to obtain informed consent • A very common use of an Alteration of Consent is when the study involves deception. An alteration must be requested for the use of deception. (Note that the consent form cannot lie.) 20
21 Waiver of HIPAA Authorization
HIPAA • If you are collecting information from medical records for research (or placing information into medical records), you must either obtain a signed HIPAA Authorization, or request and justify a waiver. 22
Waiver of HIPAA Authorization Criteria 45 CFR 164.512 (i)(2)(ii)(A) • Use or disclosure of PHI involves no m ore than a m inim al risk to the privacy of individuals based on plan to protect the identifiers from improper use and disclosure • Plan to destroy the identifiers at the earliest opportunity consistent with the conduct of the research • Written assurances that the PHI will not be reused or disclosed to any other person or entity • Research could not practicably be conducted without the waiver • Research could not practicably be conducted without access to and use of the PHI • Why the nature and amount of the medical record information that will be collected is felt to be the minimum necessary in order to conduct this research study 23
Waiver of HIPAA Authorization • Investigators accessing, recording, and/ or obtaining identifiable information must have normal legitimate access • Investigator (or designated study team member with their own access) may review and record the data • A common utilization of this HIPAA waiver is in conjunction with a waiver of consent for a chart review • A HIPAA Waiver can also be requested in an Exempt chart review in limited circumstances 24
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