Common Rule Advanced Notice of Proposed Rulemaking (ANPRM)
IRB Investigator
Advanced Notice Advanced Notice Notice of Notice of of Proposed Rule of Proposed Rule Rule Rule Proposed Rule Proposed Rule Making Making Open Comment Open Comment Period and Review Period and Review of Comments of Comments Process
• Ensuring Risk-Based Protections • Single IRB review for domestic multi-site studies • Consent forms and process • Data Security and Information Protection • Improve Collection and Analysis of Unexpected Problems and Adverse Event Data • Expand Federal Regulatory Protections • Harmonize Regulations and Guidance across federal agencies Proposed Changes
• Full Convened IRB • All studies greater than minimal risk • Many minimal risk studies • Expedited Review (Review by single IRB member) • Must be no more than minimal risk • Must be a research type eligible for expedited under Regs • Exempt from IRB Review • Six exemption categories • OHRP recommends IRB review to confirm exempt status Current Levels of Review
• Mandatory data security and information protections for identifiable information • Continuing review eliminated for minimal risk studies • Regular updates to minimal risk categories • New “excused” category of research to replace “exempt” with expansion of categories and new security and consent requirements • Written consent for research use of any biospecimens E nsuring Risk-Based Protections
• Mandatory Standards for data security and information protection whenever data is collected, generated stored, or used • Calibrated to the level of identifiability of the information (using HIPAA standards of identifiability) • IRB no longer responsible for assessing the adequacy of a study’s procedures for protecting against informational risks. New Mechanism for Informational Risk Protection
• Full IRB Review for studies involving greater than minimal risk remains unchanged. • Revised approach to Expedited Review • Revise current categories eligible for expedited review • Every two years, the list would be revised based on systematic, empirical evidence on level of risk (provides further specificity regarding minimal risk procedures) • Presumption that those activities on the “list” are minimal risk • Considering whether all eight regulatory “findings” should be required for expedited studies Calibrating Level of Review to Level of (Non-informational) Risk
• Risks to subjects minimized • Risks to subjects are reasonable in relation to anticipated benefits • Subject selection is equitable • Informed Consent will be sought • Informed Consent will be appropriately documented • When appropriate, provision for monitoring of data to ensure safety of subjects • When appropriate, adequate provisions to protect subject privacy and maintain confidentiality of data • Safeguards to protect those who are vulnerable to coercion or undue influence The 8 “findings”
• Eliminating continuing review of Full IRB studies if they meet certain criteria • Eliminating continuing review of expedited studies • Streamlining documentation requirements for expedited studies • Focus on documenting why research qualifies for expedited review • Eliminate documents (i.e. full protocol) that may not be necessary for studies of this type Calibrating Level of Review to Level of (Non-informational) Risk
• Is the current definition of “minimal risk” appropriate? If not, how should it be changed? • Should the regulations be changed to indicate that IRBs should only consider “reasonably foreseeable risks or discomforts? • For Full Board research, should continuing review be eliminated if the remaining study activities fall within the expedited or excused categories? Questions
• Are there survey instruments or specific types of questions that should be classified as greater than minimal risk? How should the characteristics of the study population (e.g. mental health patients) be taken into consideration in the risk assessment? Questions
• What research activities, if any, should be added to the published list of activities that can be used in a a study that qualifies for expedited review. Should the following be considered minimal risk?: • Allergy skin testing • Skin punch biopsy (limited to 2) • Glucose tolerance testing in adults • Additional biopsy during a clinical test (i.e. colonoscopy) • Should there be a threshold for radiologic procedures and should it be calibrated in some way to background radiation? Questions
• Research conducted in established or commonly accepted educational settings that involve normal educational practices, such as (A) research on regular and special education instructional strategies, or (B) research on the effectiveness of or the comparison among instructional techniques, curricula or classroom management methods. • Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement) if information is recorded so that subjects cannot be identified directly or through identifiers linked to the subjects. • Research involving survey or interview procedures, except when (A) information obtained is recorded so that subjects can be identified directly, or through identifiers linked to the subjects; and (B) any disclosure of the subjects ’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to subjects ’ financial standing, employability, or reputation. Note : This category does not apply to minors. E E xempt Review xempt Review
• Research involving the observation of public behavior, except when: (A) information obtained is recorded in such a manner that subjects can be identified directly, or through identifiers linked to the subjects; and (B) any disclosure of subjects ’ responses outside the research could reasonably place subjects at risk of criminal or civil liability, or be damaging to the subjects ’ financial standing, employability, or reputation. Note : This category does not apply to minors if the investigator participates in the activities being observed. • Research and demonstration projects which are conducted by or subject to the approval of DHHS department or agency heads, and which are designed to study, evaluate, or otherwise examine: (A) public benefit or service programs; (B) procedures for obtaining benefits or services under those programs; (C) possible changes in or alternatives to those programs or procedures; or (D) possible changes in methods or levels of payment for benefits or services under those programs. E E xempt Review xempt Review
• Research involving the collection or study of existing data, documents, records, pathological specimens or diagnostic specimens, if these sources are • publicly available or • If the information is recorded in such a manner that subjects cannot be identified directly or through identifiers linked to the subjects. • Note: This category does not apply to psychiatric records . E xempt Review
• Moving away from the concept of exempt to the concept of “excused” • New data security requirements would apply to research that is currently exempt • Retain the six existing categories, but revise so that they are sufficiently clear that investigators could readily determine if a study was excused • Eliminate some of the qualifiers in the six categories (i.e. requirement to record data in a way that subject can’t be identified and that specimens or data needs to be existing) • Expand list to include specified types of social and behavioral research • Studies with a plan to provide individual results to subjects would not qualify as excused E xempt vs. E xcused Research
• Consent rules for excused research • Pre-existing Data collected originally for non-research purposes would not require consent IF de-identified • A general written consent will be required for use of biospecimens (even if collected for non-research purposes and even where identify of subject is not known to researcher • Data originally collected for one research purpose will require consent for use in other research regardless of whether researcher obtains identifiers—this general consent will usually be obtained at time of original research • This consent requirement could be met with a general consent signed by all persons entering hospital, coming to clinic, etc. • Some excused research could use oral consent without written documentation E xcused Research
• IRB review would not be necessary prior to starting • Excused research would be registered with the IRB (one- page form) prior to starting • Mechanism for audit of (some) excused research to assure that it does meet the criteria for excused E xcused Research
• Are there expansions to the types of studies that should qualify as “excused” and would not reduce protections of subjects? • Should research involving surveys and similar methods qualify for excused only if they do not involve topics that are emotionally charged, such as abuse? If so, who should determine this? • Should certain types of work (history, language studies, literature, journalism) be specifically identified as excused because they do not create generalizable knowledge? Case Reports? E xcused Research: Questions
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