Everything you Need to Know About the Common Rule Changes

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Presentation transcript:

Everything you Need to Know About the Common Rule Changes Susan Kornetsky Matt Stafford Yvette Marts

It’s Been in the Works for Some Time ANPRM 7/2011 NPRM 9/2015 Final Rule 1/2017 1/2018 but implementation delayed until 1/2019 1/2020 ( Federally funded cooperative research single IRB) All Federally Funded Research

Major Changes For PIs New categories of exempt research/not human subject research Removes the requirement to conduct continuing review of some minimal risk research Informed Consent Changes Format Elements Posting Requirements for Clinical Trials Requirement for a single IRB for U.S.-based institutions engaged in cooperative research

This is Not Research: No Submission Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship) Public health surveillance activities (note there are other forms of public health research) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or investigative purposes Authorized operational activities in support of intelligence, homeland security, defense, or other national security missions

Exemption Reminder Activities that ARE considered human subject research BUT… They do not need to follow all of the other human subject rules (for example obtain consent, waive consent, satisfy all the criteria for approval).

Exemptions New RESTRICTED Normal Education Setting The research must not adversely impact the student’s opportunity to learn required educational content or the assessment of educators who provide the instruction. Educational Tests, Surveys, Interviews, Public Observation Can be identified and sensitive if IRB determines there are adequate privacy and confidentiality protections in the study. Children not allowed for surveys . Benign Behavioral Intervention (adults only) Brief in duration, intervention must be harmless, painless, and not physically invasive, not be likely to have significant adverse lasting impact on subjects, not offensive or embarrassing Secondary Research of Identifiable Information or Specimens Collected for Other Purpose for which Consent Not Required RESTRICTED EXPANDED New EXPANDED

Exemptions Research conducted supported by Federal Agency Taste & Food Quality Storage or Maintenance for Which Broad Consent Is Required Secondary research for which Broad Consent Required EXPANDED No Change New Will Not Use We will continue to have IRB reviewed protocols and consents contain provisions for broad research use of data and specimens . Will not use categories 7 & 8.

Exemption 4 Change Secondary research for which consent is not required: use of identifiable private information or identifiable biospecimens if at least one of the following is met: o Information or biospecimens are publicly available Recorded information cannot be readily identified (directly or indirectly) and investigator does not attempt to contact subjects and will not reidentify subjects Information collection and analysis involving identifiable health information when use is regulated by HIPAA* Research by or behalf of Federal dept/agency using government generated or collected information; compliant with relevant privacy policies *HIPAA covers data not specimens but most PIs use specimens with data

Primary vs. Secondary Use of Biospecimens and Data Introduce concept secondary use instead of “existing” specimens/data Re-using information or biospecimens that are collected for some other “primary” or “initial” activity. Examples: chart review study, using leftover biospecimens from routine clinical care Private information and biospecimens no longer have to be in existence prior to the start of the research to be considered exempt

Options Under the Pre-2018 Requirements Nonidentifiable biospecimens, nonidentifiable private information? Not human subjects research under 45 CFR part 46 Identifiable biospecimens or identifiable private information? Human subjects research under 45 CFR part 46 Research may be exempt if: If research is non-exempt, IRB review required. Options: Already existing publicly available information or specimens or Seek a waiver of informed consent from the IRB + IRB approval or Already existing information or specimens recorded by the investigator in nonidentifiable form OR Seek informed consent for this new activity from subjects + IRB approval Certain research and demonstrations conducted by or subject to the approval of department or agency heads Thanks to Marianna Bledsoe, Elizabeth Buchanan, Lauren Hartsmith

Secondary Research Options Under the 2018 Requirements Nonidentifiable biospecimens, nonidentifiable private information? Identifiable biospecimens or identifiable private information? Not human subjects research under 45 CFR part 46 Human subjects research under 45 CFR part 46 Research may be exempt if: If research is non-exempt, IRB review required. Options: Publicly available information or Seek a waiver of informed consent from the IRB + IRB approval or Information (including information about biospecimens) recorded by the investigator in nonidentifiable form or Seek informed consent for this new activity from subjects + IRB approval If activities covered by HIPAA-regulated or HIPPA authorization and waivers still required Certain activities by or on behalf of the federal government or Certain research or demonstration projects conducted or supported by the federal government, or otherwise subject to the approval of department or agency heads Thanks to Marianna Bledsoe, Elizabeth Buchanan, Lauren Hartsmith

How Exempt Changes Implemented CHeRP Exemption form has been changed to address new categories and requirements There are some pediatric limitations Any research limited to secondary use of specimens/data will still need to be submitted on limited research form - staff will determine Not human subjects Exempt Review (expedited or full)

Continuing Review Changes No regulatory required continuing review when The study qualifies for expedited review as specified on list of categories in the regulations. The study has research that has reached the state of involving only the analysis of data or accessing follow-up clinical data from procedures that the subjects would undergo as part of clinical care (even with identifiers). BUT BCH will substitute Administrative Update Notification in CHeRP Simplified form Consent approval and expiration dates will still be updated CR form revised No longer completion report in CHeRP it will be included in CR form CR has new category to determine if can move to an administrative update

How Continuing Review Implemented CR form changed to collect information to allow us to close out or change protocol to administrative reviews. New administrative review form and notification in CHeRP. You will be sent appropriate forms in CHeRP.

Continuing Reviews One Last Point On 1/21/2019 the continuing review form will change If one was started, completed or submitted BUT NOT approved by 1/21/2019 you will need modify and complete new questions Therefore WE WILL SHUT DOWN ability to create or submit CR SUBMISSIONS AS OF midnight January 15, 2019 There will special IRB meeting for CRs only January 18, 2019. CHeRP opens January 21, 2018 and some CRs will be sent back for updating if required

Informed Consent Changes New concept of “concise summary” New basic and additional elements to disclose Public posting of consent documents Changes to waivers of consent

Informed Consent Changes The intent of these changes is: To facilitate the subjects' understanding of the proposed research AND Ensure that the subject understands how their data and biospecimens may be used Emphasis is on the subject’s comprehension

General Requirements for Informed Consent Following remains unchanged: Obtain legally effective Informed Consent Under circumstances that: Provide opportunity to discuss and consider participation Minimize possibility of coercion or undue influence In a language understandable to the subject No exculpatory language language understandable: English or other language (Spanish, sign language), but also reading level and terminology used

General Requirements for Informed Consent Newly added: Must provide information that a reasonable person would want to have in order to make an informed decision about participation. REASONABLE PERSON STANDARD Rule

General Requirements for Informed Consent Newly added: Informed consent must begin with a concise and focused presentation of key information Assist in understanding the reasons why one might or might not want to participate. Must be organized in a way that facilitates comprehension. Informed consent as a whole must: Present information in sufficient detail related to the research. Organized and presented in a way that does NOT merely provide lists of facts. Facilitates understanding of reasons why one might or might not want to participate. IC as a whole -> not limited to Consent Form itself, but the entire consent process This is not “new” -> but now that it is defined in the regulations it allows auditors to ding researchers during audits

Concise Summary Is a summary of information that is most crucial to making a decision whether or not to participate. Is presented first rather than being dispersed in the document. Is an opportunity for the PI to consider or seek input on the key pros and cons that a prospective participant would need to weigh, in making a decision. Type of information is not defined in rule – depends on the nature of the study. Length is not defined – BCH -> keep it to 2 pages or less. Does not need to include all 9 Basic and/or 9 Additional Elements. Does not limit pros and cons to just risks and benefits. Does not have to look exactly like it is presented in the template. Pros/cons: risk/benefit but also burden/inconvenience (# or size of oral pill vs weekly infusion, time commitment, visit frequency/length) Source: UK IRB website

BCH template “Summary of Important Information” Concise Summary is included in the revised Informed Consent Template available on the IRB website. There are 3 examples available on the IRB website. Clinical trial randomized study Minimal risk study Biorepository

BCH template “Summary of Important Information” Remember: Concise Summary is only one part of the consent document and the informed consent process. It is NOT acceptable to only review the Summary to obtain informed consent.

Basic Elements of Informed Consent Newly added: Future use: Research collecting identifiable private information and/or identifiable biospecimen must include one of two statements about future use. Note: Nearly all studies collect identifiable private information Survey studies

Basic Elements of Informed Consent Newly added (cont): Collecting identifiable private data or biospecimen then must include one of the following statements: - That identifiers might be removed from identifiable private information or identifiable biospecimen and - That, after such removal, it can be used for future research studies without obtaining additional Informed Consent. OR That the subject’s information or biospecimen collected as part of the research, even if identifiers are removed, will NOT be used or distributed for future research studies. Survey studies

Additional Elements of Informed Consent Newly added: Commercial profit: Statement that subject’s biospecimen may be used for commercial profit and Specify whether the subject will or will not share in the profit. Clinically relevant research results: Statement regarding clinically relevant research results, including individual results, will be disclosed to subjects, And if so, under what conditions.

Additional Elements of Informed Consent Newly added: Whole Genome Sequencing: For biospecimen, specify whether the research will or might include whole genome sequencing Note: Be realistic about future use, sharing and the possibility of using the biospecimen for whole genome sequencing

Informed Consent Document Summary of Important Information Detailed Consent Signature Page Required Concise Summary first Main Body Updated Informed Consent Template/Document Source: UK IRB website

Posting requirements for clinical trials One IRB approved consent form used to enroll subjects must be posted on a publically available Federal Website. Applies only to clinical trials that are Federally funded. The purpose of this requirement is to be more transparent about the consent forms being used and, over time, improve the quality of consent forms.

Posting requirements for clinical trials Currently identified publically available Federal Website: Clinicaltrials.gov Regulations.gov More may follow in the future BCH will require posting on Clinicaltrials.gov

Posting requirements for clinical trials The informed consent document must be posted after the trial is closed to recruitment and no later than 60 days after the last study visit by any subject, as required by the protocol 60 days after last visit any subject* Database lock – data analysis Study and data analysis complete Start trial Enrollment first subject Enrollment last subject Trial closed to recruitment Last visit any subject Ideally enrollment last subject = study closed to recruitment. Sometimes enrollment target is not reached and study will close to enrollment prematurely, so there may be a gap. timeline Period in which 1 consent must be posted Note: Last visit by ANY subject is not by default the last enrolled subject, but of the last ‘ACTIVE’ subject in the trial

Posting requirements for clinical trials 60 days after last visit any subject* Trial closed to recruitment Period in which the consent must be posted PI responsibility: Keep track of when this window opens and closed. Posting 1 consent form used for enrollment during this window.

Posting requirements for clinical trials Only 1 consent document posting would be required for each multi-institution study. Things to consider at the beginning of the multi-site trial: Who will be responsible for posting the IC? How will this site/person keep track of overall enrollment closure and last study visit by last active subject across all sites? What kind of tracking/reporting structure needs to be in place? Responsibility of the coordinating center? What if there is no coordinating center?

Posting requirements for clinical trials If Federal department or agency determines that certain information should not be made publically available (e.g. confidential commercial information, they may permit redactions on the information posted.

General Implementation Applies to all research with approval dates as of January 21, 2019 going forward. Protocols previously approved will not change - with exception of transitioning over existing protocols in data analysis only at time of continuing review.

Transition: On 1/21/2019 Protocols in Preparation New Protocols ( any type) in Draft Scientific review Department review Analyst review Assigned to meeting or expedited review (IRB Chair) New Rule will APPLY May need to revise/include consent changes possibly answer some new questions post consent if clinical trial and federally funded

Transition: On 1/21/2019 Full Review If protocol underwent full IRB - but no final approval Conditional Approval This is because approval date will be before 1/21/2019 , activation afterwards Deferrals Will need to revise/include consent changes possibly answer some new questions post consent if clinical trial and federally funded OLD

Transition: On 1/21/2019 Expedited Undergoing expedited review If IRB final approval has been released. If in process or questions May need to revise/include consent changes possibly answer some new questions post consent if clinical trial and federally funded OLD

Now What About FDA Regulated? FDA has not revised regulations: Many changes will not apply to research with Drugs Devices ( significant risk and non significant risk) Biologics Mobile medical apps Continuing review still required Since consent changes are not inconsistent with current FDA regulations - BCH will implement consent changes for FDA regulated research unless sponsors object

What About Other Funding Sources? Will apply most changes on a voluntary basis to assist in consistency Will help reduce regulatory burden Will implement consent changes for FDA regulated research unless sponsors object Will not implement posting of consents for clinical trials

Common Rule Implementation at BCH smaller no New Exemptions Eliminate Continuing Reviews Change Consent Format and Elements Post Consents on CT.gov Required Single IRB NIH Federal Voluntary until Jan 2020 FDA NA Still requires CR review Do not need to post clinical trials Voluntary at present Other With exceptions

Other IRB Changes 1/21/2019 Single patient expanded access form Now includes emergency use and single patient expanded access outside clinical trial New requirement for annual update if therapy is continuing ( you will get CHeRP notification) New updated genetics questions on all protocols Separated incidental findings for genetics from other types of testing CheRP will throw an error and you will need to complete new questions for Any protocol in process of review that has genetics questions answered Before you submit an amendment if protocol has existing genetic questions answered

In Conclusion We have tried to make as many changes transparent in the forms and CHeRP notifications – but this means new forms and notifications. Plan ahead – the fewer protocols, amendments, continuing reviews in process on Jan 21, 2019 the better. Either finish up now or wait to start. The requirement for key information in consent forms will likely be the biggest burden for PIs/research teams. Help us figure out what “key information” is for consent. You are the experts. Start using new template now. We need you to do your part to minimize delays in approval. Things may change as we receive more guidance from the regulators . We have had to implement the changes in CHeRP with no regulatory guidance. Expect some bumps: Let us know when things do not work or seem odd. Changing CHeRP is complex but we will course correct ! Lastly please be patient with the IRB staff and committee- this is as new to us as it is to you; we will do our best!

Thank you this takes teamwork! Questions ?