Common Rule Advanced Notice of Proposed Rulemaking (ANPRM) IRB - - PowerPoint PPT Presentation

Common Rule

Advanced Notice of Proposed Rulemaking (ANPRM)

Investigator IRB

Process

Advanced Notice

• f Proposed Rule

Making Advanced Notice

• f Proposed Rule

Making Notice of Proposed Rule Notice of Proposed Rule Rule Rule

Open Comment Period and Review

• f Comments

Open Comment Period and Review

• f Comments

Proposed Changes

• 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

Current Levels of Review

• 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

E nsuring Risk-Based Protections

• 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

New Mechanism for Informational Risk Protection

• Mandatory Standards for data security and information

protection whenever data is collected, generated stored,

• r 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.

Calibrating Level of Review to Level of (Non-informational) Risk

• 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

The 8 “findings”

• 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

Calibrating Level of Review to Level of (Non-informational) Risk

• 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

Questions

• 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?

E xempt Review E xempt Review

• Research conducted in established or commonly accepted educational

settings that involve normal educational practices, such as (A) research

• n 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 xempt Review E 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 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 vs. E xcused Research

• 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 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

• riginal 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: Questions

• 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

• Should there be a brief waiting period (e.g. one week)

following submission of the registration form to allow institutions to review it?

• Is there a better term than “excused”? Perhaps

“registered”?

• Will audits be sufficient to provide protection
• Is there a frequency of auditing that should be required?
• For excused studies, who determines whether results

should be returned to participants?

IRBs: Questions

• Should IRBs be required to have an appeal mechanism?
• Review by a second IRB
• An Appellate IRB
• Should IRBs be required to specifically identify any

activities that are not required by regulation?

Proposed Changes

• 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

Improving Informed Consent

• Improve consent forms to make them more

accessible to subjects

Improving Consent F

• rms
• Greater specificity with regard to what content must be

included

• Restricting inappropriate content
• Limiting acceptable length of various sections of the

consent form

• Prescribing how information should be presented (i.e.
• rder, appendices, etc)
• Reducing institutional boilerplate language designed to

protect institutions (or sponsors) but not participants

• Making available standardized templates that would

satisfy regulatory requirements

Consent: Questions

• Are there specific changes that could be made to reduce

the burden imposed on researchers and their staffs in terms of meeting the requirements to submit documents to an IRB, without decreasing protections to subjects?

• Elements of Consent of protocols?
• Other documents?
• Should anything be added to enhance protection?

Consent: Questions

• What factors contribute to excessive length of consent

forms and how might they be addressed?

• Are there elements that should be eliminated?
• Are there additions that should be made (e.g. clear

description of why it may or may not be in someone’s interest to participate in research study; financial relationships of PI with sponsor)?

Consent: Questions

• Should regulations require that, for certain types of

studies, investigators assess how well potential research subjects comprehend the information provided them?

Informed Consent Waivers and Documentation

• Clarify criteria for waiver of consent and waiver of

documentation of consent (and possibly provide more flexibility with regard to documentation)

• Define research where oral consent without written

documentation would be appropriate

Consent: Questions

• Where oral consent is required, what information should

investigators be required to provide subjects? Are all of the elements of informed consent required?

• Are there additional circumstances under which it ought

to be permissible to waive the usual requirements for

• btaining and documenting consent?
• Are there types of research involving surveys,

interviews, or focus groups where oral consent without documentation should not be permitted?

Consent for E xisting “Data”

• Strengthen consent protections related to re-use or further

analysis of existing data and biospecimens (either clinical

• r research related)

Response to Notice

• Notice poses 74 specific questions on which comments

are desired (cite specific question when addressing these)

• Free to make additional general comments as well
• Comments will be posted and publicly available
• Deadline: October 26, 2011; 5PM
• http://www.regulations.gov
• Enter Docket number in the “Enter Keyword or ID” field:

HHS-OPHS-2011-0005

• Click “Submit a Comment” and follow instructions