The Impact of the Final Rule Changes - PowerPoint Presentation

Slide1

The Impact of the Final Rule Changes

Reilly Auditorium

December

7 and 12,

2017Slide2

Effective January 19, 2018Updates to the human subjects regulations (45 CFR 46 Subpart A) are effective

January 19, 2018.

Promoting individual autonomy

Changing requirements of informed consent

Reducing administrative burden and streamlining IRB processes

Removing activities from the definition of research

Expanding exempt research

Updating and simplifying expedited review

Eliminating certain continuing reviews

Using single IRB review

Slide3

Transition to revised Common RuleSlide4

What’s included in the final ruleRevisions to the following sections:Definitions

IRB Membership (in relation to vulnerable populations)

Initial Application

Criteria for Approval

Informed Consent

Continuing Review

Expedited Review Processes

Exempt CategoriesSlide5

What’s NOT includedSubparts addressing additional protections for pregnant women, human fetuses, and neonates, children, and prisoners*

FDA 21 CFRs

Future efforts to harmonize HHS and FDA through 21st Century Cures law

HIPAASlide6

Update: Definition of ResearchThe Final

Rule

removed

the activities from the definition of research, including:

Scholarly and journalistic activities

 that focus directly on the specific individuals from whom the information is collected.

Public health surveillance activities

 that are necessary to allow a public health authority to "identify, monitor, assess, or investigate potential public health signals, onset of disease outbreaks, or conditions of public health importance."

Collection and analysis of information or

biospecimens

required by or for a criminal justice agency for 

criminal justice purposes.

Activities in support of 

intelligence, homeland security, defense, or other national security missions.Slide7

Update: Definitions

The definition of “human subject” has been changed to include “identifiable biospecimens” as well as how data and/or biospecimens have been collected or will be used.

Impact

New criteria for approval and exempt categories related to biospecimens

Require updates to policies, forms, reviewer sheets, initial applicationSlide8

Tool: Decision Tree

*

Review notes section for explanation of this slide.Slide9

Update: Definitions

Clinical Trials definition updated

A research study in which

one or more human subjects

are prospectively assigned 

to one or more interventions

 (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

Impact - Social behavioral researchers who conduct clinical trials are now subject to the same requirements as biomedical clinical trials. For example, GCP training required, registering clinical trials and reporting results.Slide10

Tool: NIH Decision Tree

Go to the NIH tool to determine if your study is considered an NIH clinical trial. Answer a few simple questions to help determine if your study is a clinical trial.

https://grants.nih.gov/ct-decision/index.htmSlide11

Clinical Trials.gov

New requirement to post to

www.clinicaltrials.gov

, a copy of an IRB-approved version of the consent form that was used for enrollment purposes for each clinical trial conducted or supported by a federal department or agency.

One consent form for each study must be posted on the federal website after recruitment closes but not later than 60 days after the last study visit by any subject. Slide12

Clinical Trials.govProtocol registration and results systemSlide13

Update: IRB Membership

Final Rule no longer includes pregnant women or ‘‘handicapped’’ or physically disabled individuals as examples of populations that are potentially vulnerable to coercion or undue influence within 45 CFR 46 Subpart A. However, subpart B is unchanged.

Revised for sensitivity

Replaced cognitively impaired individuals with individuals with impaired decision making capacity

clarified

Added economically or educationally disadvantaged individuals

new

Impact: IRB member experience must cover new vulnerable population; special protections for new population

Require updates to policies, forms, member roster and applicationsSlide14

Update: Initial ApplicationFunding Source: Elimination of grant congruency for IRB

Study population: economically and educationally disadvantaged added; cognitively impaired individuals replaced with individuals with impaired decision making capacity. Slide15

Update: Initial ApplicationWaiver or alteration of consent:

Allowed in research involving public benefit and service programs conducted by or subject to the approval of state or local officials.

Per the 21st Century Cures Act and FDA Guidance Waivers or Alteration of Informed Consent for Clinical Investigations Involving No more Than Minimal Risk to Human Subjects are allowed.Slide16

Update: Initial ApplicationCertificate of Confidentiality (

CoC

)

NIH awardees no longer have to apply for a

CoC

.

Effective October 1, 2017, all research that was commenced or ongoing on or after December 13, 2016 that is collecting or using identifiable, sensitive information in which subjects can be identified or has risk of being identified is automatically issued a

CoC

.

Impact: If the research qualifies, it is automatically protected by a

CoC

from NIHSlide17

Update: Criteria for ApprovalPrivacy and Confidentiality

Additional IRB approval criterion added for research that involves accessing or using private information or identifiable biospecimens.

This new requirement is that the research could not practicably be carried out without accessing or using such information or biospecimens in an identifiable format.

Non-identified information should be used whenever possible to respect subjects’ interests in protecting the confidentiality of their information and biospecimens.Slide18

Update: Consent FormNew requirement states that the informed consent process must begin with “key information” (abstract)

Impact: Key Information Consent Form template (IA)

New basic and additional elements of consent form

Impact: Revisions to the Informed Consent Form template (IB)Slide19

Update:

Key Information Consent

Part IA AdultsSlide20

Update: Revised Informed consent

IB (Adult)Slide21

Update: Continuing Review

Rule eliminates the requirement for the traditional continuing review (CR) for many minimal risk studies unless the IRB determines otherwise.

However, a transition to the new rule is required for all existing studies before the IRB institutes the “no CR rule” for eligible studies

FDA CR requirement unchangedSlide22

Update: CR Application

For pre-2018 approved research

, o

nce

your continuing review is submitted, the IRB will devise a comprehensive transition plan for your study to encompass the new regulation requirements.

If you are requesting to

NOT

have your study transition, you

will be required to

provide a

justification.*

The

IRB will consider your justification and make the final determination. Slide23

Update: Status Report

A

status report

is

required every three years for expedited studies and every five years for exempt studies if you are not submitting a continuing review report.

Reminder to report major deviations, unanticipated problems (unexpected incident, unanticipated adverse device effects or unexpected adverse event), amendments and complaints

as they occur.Slide24

Update: CR Existing Studies

Exempt

: After the rule is effective, we will expedite the continuing review in order to transition study to 2018 requirements. After transition, a status report is due every

five

years. If the study closes before the five year status report, please inform the IRB by submitting a closure report. Modification is required if the change alters the risk or there is a change in the scope of the project.

Expedited:

At the time of Continuing Review, the project will be reviewed and approved under the 2018 Requirements. Submit continuing review as usual. IRB will outline changes required for transition. After transition, a status report is due every

three

years. Annual update due each year.

Does not apply to FDA regulated studies.Slide25

Update: CR Existing Studies

Full Board:

At the time of Continuing Review, the project will be reviewed and approved under the 2018 Requirements. Submit continuing review as usual. IRB will outline changes required for transition. After transition, continuing review is

still required annually

. (no change)

Transition Examples:

Ongoing

Full Board/Expedited/Exempt projects approved Prior to January 19, 2018 remains on the Pre-2018 Requirements until Continuing Review.Slide26

Update: Exemptions

Further explanation of the exemption categories are on the next few slides.Slide27

Update: Exemptions

Exemption 1

–

Educational Exemption

Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices

Must consider “adverse affects” on student learning of required educational content or on assessment of educationsSlide28

Update: Exemptions

Exemption 2 – Surveys/Interviews/Educational Tests/Public Observation ONLY

What’s new?

Research

that only includes interactions

involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior

(including visual or auditory recording)

Projects collecting

sensitive

and

identifiable

data may be exempt after “limited IRB review” (for privacy/confidentiality protections)

Clarifies that the exemption

does not apply

to projects involving:

Interventions

Collection of biospecimens

Linking to additional personally-identifiable data

Children (except for educational tests or some public observations)Slide29

Update: Exemptions

Exemption 3 – Benign Behavioral Interventions

What’s new?

This exemption is completely new

Limited to research with adults

What is a benign behavioral intervention?

Brief in duration

Harmless and painless

Not physically invasive

Not likely to have a significant adverse impact on subjects

Not offensive or embarrassingSlide30

Update: Exemptions

Exemption 3 – Benign Behavioral Interventions

Information is collected via

Verbal or written responses (surveys/interviews)

Data entry

Observation of subject (including audiovisual recording)

Does not permit data collection via physical procedures

Physical sensors (e.g. blood pressure monitors, EEG,

FitBits

)

Minimally invasive procedures (e.g. blood draw or saliva collection)Slide31

Update: Exemptions

Exemption 3 – Benign Behavioral Intervention

Must obtain “prospective agreement to the intervention and information collection”

No deception

, except where the subject is told that they will be unaware or misled about the nature or purposes of the research and they agree

Debriefing still encouraged

Self-exemption permitted for projects that do not involve deception and where information collected is not identifiable or not sensitive

“Limited IRB Review” required for projects collecting sensitive and identifiable dataSlide32

Update: Exemptions

Exemption 4 – Secondary Research Uses of Identifiable Private Information or Identifiable Biospecimens

What’s new?

No longer limited to retrospective data review

Permits secondary use of identifiable protected health information (PHI) (with HIPAA privacy board review)Slide33

Update: Exemptions

Exemption 5 – Federal Research and Demonstration Projects

Research and demonstration projects that are conducted or supported by a Federal department or agency, … and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs

New requirement: Each agency must maintain a public list of these projects, to be published prior to conducting the research.Slide34

Update: Exemptions

Exemption 6 –

Taste and food quality evaluation and consumer acceptance studies

No changesSlide35

Update: Exemptions

Exemptions 7 & 8 – Storage and Secondary Use of Data/Biospecimens

Exemption 7 covers the storage and maintenance of identifiable data and/or biospecimens for future research collected under broad consent (i.e. creation of a repository). More on broad consent later…

“Limited IRB review” required to assess the terms of the broad consent

Exemption 8 covers the use of data or biospecimens collected under broad consent

“Limited IRB review” required to confirm that the proposed use is consistent with the broad consent and that privacy of subjects and confidentiality of data is appropriateSlide36

Update: Exempt ResearchThe Final Rule allow the exemptions to apply to prisoners (Subpart C) for research involving a broader subject population if the research only incidentally includes prisoners.Slide37

Making a Determination of Non-Exempt Human Subjects ResearchSlide38

Cooperative ResearchStreamlining IRB review is accomplished in part

by a

mandate for the use of a single IRB for cooperative research conducted in the US. Revisions to cooperative research and the use of single Institutional Review Boards (

sIRBs

) will take effect January 20, 2020

.

The

National Institutes of Health (NIH) policy on “Use of a Single Institutional Review Board for Multi-Site Research” goes into effect January 25, 2018 for NIH-funded multi-site research.

The Pennington IRB

is

a

member of SMART IRB for online reliance

agreements and IRB Choice. Membership

significantly furthers our efforts to successfully comply with NIH requirements for single IRB (

sIRB

) and the upcoming 2020

sIRB

Final Rule requirements.Slide39

Smart IRBSlide40

IRB ChoiceSlide41