JAN 24, 2018, UPDATE: The effective date of the new rule is now July 19, 2018, with the prospect of an additional 6-month delay to January 21, 2019. Even.

JAN 24, 2018, UPDATE: The effective date of the new rule is now July 19, 2018, with the prospect of an additional 6-month delay to January 21, 2019. Even with the delay, the IRB is implementing: The consent form changes outlined in this presentation Three-year approval periods for some minimal risk new studies NIH policy changes related to single IRB review and Certificates of Confidentiality are also still in effect.

2018 New Human Subject Regulations – Getting Started
Allison Blodgett, PhD, CIP Director of IRB Operations UMass Medical School 20 December 2017

Key Areas for Getting Started
Informed Consent Exemptions Approval Periods Federally-Funded Research Transitioning (or not) Website: Templates & Short Summaries by Topic This slide deck covers key areas related to the 2018 human subject regulations. Please supplement the information here with frequent visits to the IRB website for updated material.

12.20. 2017 01.18. 2018 01.19. 2018 … “Pre-2018 Regulations” “2018 Regulations” “The New Rule” Let’s get oriented. At the top of the slide is a timeline. Today – – we are under “Pre-2018 Regulations.” On the “2018 Regulations” or the “New Rule” takes effect. For studies approved before , they will largely stay under the Pre-2018 Regulations. Studies that are FDA-regulated or funded or supported by the National Institute of Justice will also stay under the Pre-2018 Regulations. This means that until all agencies harmonize and research approved before closes, the IRB will track whether research is subject to the Pre-2018 Regulations or the 2018 Regulations. Both sets of rules will be in effect depending on initial date of approval and funding source.

Informed consent will be better
12.20. 2017 01.18. 2018 01.19. 2018 … “Pre-2018 Regulations” “2018 Regulations” “The New Rule” Informed consent will be better One of the biggest changes in the New Rule affects informed consent. These are changes for the better and the expectation is that all research here at UMMS will use the new consent template that was just posted today ( ). We have temporarily removed the fact sheet just until we can update it to include the new elements of consent that are required under the 2018 Regulations.

12.20. 2017 01.18. 2018 01.19. 2018 … “Pre-2018 Regulations” “2018 Regulations” “The New Rule” Informed consent will be better One form combines consent and HIPAA authorization We have taken this opportunity to transition to one template that combines the informed consent and the HIPAA authorization. We are now permitting compound consent and authorizations. **You must maintain signed and dated HIPAA authorizations – and consent documents that include HIPAA authorizations – for at least six years after completion of the research.**

12.20. 2017 01.18. 2018 01.19. 2018 … “Pre-2018 Regulations” “2018 Regulations” “The New Rule” Informed consent will be better One form combines consent and HIPAA authorization Start with concise summary in simple language Key information that is most likely to help someone understand why they might or might not want to participate Research, voluntary, purpose, duration, procedures, risks, benefits, & alternatives The new template is organized into a Key Information section and a Study Details section. Each consent must start with the information listed above – with a focus on presenting key information in a concise and organized fashion. For example, in the Key information you will not present every risk, but the important risks that a reasonable person would want to know. More detailed discussion of risks can be reserved for the Study Details.

12.20. 2017 01.18. 2018 01.19. 2018 … “Pre-2018 Regulations” “2018 Regulations” “The New Rule” Informed consent will be better One form combines consent and HIPAA authorization Start with concise summary in simple language Key information that is most likely to help someone understand why they might or might not want to participate Research, voluntary, purpose, duration, procedures, risks, benefits, & alternatives Address Sharing or future use with or w/o identifiers Commercial profit Return of clinically relevant research results Whole genome sequencing There are new required elements to inform research participants whether materials will be shared or used for future research activities – even if identifiers are removed. There are new required elements to address whether biospecimens may be used for commercial profit and whether research participants will share in those profits. Investigators must also address whether clinically relevant research results – including at the individual level – will be disclosed, and if so, under what conditions, and whether research will (if known) or might include whole genome sequencing.

12.20. 2017 01.18. 2018 01.19. 2018 … “Pre-2018 Regulations” “2018 Regulations” “The New Rule” Informed consent will be better One form combines consent and HIPAA authorization Start with concise summary in simple language Key information that is most likely to help someone understand why they might or might not want to participate Research, voluntary, purpose, duration, procedures, risks, benefits, & alternatives Address Sharing or future use with or w/o identifiers Commercial profit Return of clinically relevant research results Whole genome sequencing IRB has already started asking for some of these The IRB has already started asking some studies to incorporate these new requirements.

12.20. 2017 01.18. 2018 01.19. 2018 … “Pre-2018 Regulations” “2018 Regulations” “The New Rule” Informed consent will be better One form combines consent and HIPAA authorization Start with concise summary in simple language Key information that is most likely to help someone understand why they might or might not want to participate Research, voluntary, purpose, duration, procedures, risks, benefits, & alternatives Address Sharing or future use with or w/o identifiers Commercial profit Return of clinically relevant research results Whole genome sequencing IRB has already started asking for some of these Pre-2018 consents may be required to add new elements but will not convert to new format overall As the IRB continues to review consent forms from already approved research, or new research under review through , the IRB may require that the new elements be incorporated into the consents. Use the updated consent form template and you’ll be sure to hit all required elements.

Researchers benefit from additional exemptions
12.20. 2017 01.18. 2018 01.19. 2018 … “Pre-2018 Regulations” “2018 Regulations” “The New Rule” Researchers benefit from additional exemptions Researchers will benefit from additional exemptions.

12.20. 2017 01.18. 2018 01.19. 2018 … “Pre-2018 Regulations” “2018 Regulations” “The New Rule” Researchers benefit from additional exemptions IRB still responsible for prior review and approval Compliant with “Limited Review” requirements  At UMMS human subjects research that fits one or more exemption categories has always required – and will continue to require – prior IRB review and approval. This is already in compliance with the 2018 requirement that only an IRB issue exemptions that require “limited review.” Under the New Rule, when conducting a “limited review,” the IRB is checking to ensure there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of the data. This also is not new for UMMS. The exemption criteria already include such considerations.

12.20. 2017 01.18. 2018 01.19. 2018 … “Pre-2018 Regulations” “2018 Regulations” “The New Rule” Researchers benefit from additional exemptions IRB still responsible for prior review and approval Compliant with “Limited Review” requirements At UMMS - Exempt research still has some consent expectations and no expiration   As outlined in the Worksheet for Exemptions (HRP-423 WORKSHEET: Exemptions, exempt research may still require a process of informed consent. See the Worksheet for a small set of information that should be conveyed to research participants when you ask them to be in your exempt research. Exempt research at UMMS does not expire.

12.20. 2017 01.18. 2018 01.19. 2018 … “Pre-2018 Regulations” “2018 Regulations” “The New Rule” Researchers benefit from additional exemptions IRB still responsible for prior review and approval Compliant with “Limited Review” requirements At UMMS - Exempt research still has some consent expectations and no expiration NEW: Annual reminder of obligations Obtaining prior IRB review and approval for all Modifications that involve HIPAA or that potentially change the risks, exemption category, or scope of the research Closing the study via Modification HRP-800 INVESTIGATOR GUIDANCE: Investigator Obligations   UMMS is implementing a new annual reminder of obligations for all open research – including exempt research. The annual reminder will highlight just some of the Investigator Obligations outlined in HRP-800 INVESTIGATOR GUIDANCE: Investigator Obligations ( Most importantly for exempt research, investigators must still obtain prior IRB review and approval for all Modifications that involve HIPAA or that potentially change the risks, exemption category, or scope of the research. Investigators are also required to Submit a Modification to close the study once the research is complete. Existing exemptions will start to receive annual reminders after January 29, 2018.

12.20. 2017 01.18. 2018 01.19. 2018 … “Pre-2018 Regulations” “2018 Regulations” “The New Rule” Researchers benefit from additional exemptions Let’s switch to the new exemption categories themselves.

12.20. 2017 01.18. 2018 01.19. 2018 … “Pre-2018 Regulations” “2018 Regulations” “The New Rule” Researchers benefit from additional exemptions Uses of secondary data and biospecimens that are already subject to HIPAA Uses of secondary data and biospecimens that are already subject to HIPAA are now exempt.

12.20. 2017 01.18. 2018 01.19. 2018 … “Pre-2018 Regulations” “2018 Regulations” “The New Rule” Researchers benefit from additional exemptions Uses of secondary data and biospecimens that are already subject to HIPAA Educational tests, surveys, interviews, or observations of public behavior even if identifiers are recorded and accidental disclosure poses minimal risk Educational tests, surveys, interviews, or observations of public behavior even if identifiers are recorded and accidental disclosure poses minimal risk are now exempt. Cases in which these data were recorded anonymously, or these data were recorded with identifiers but for which accidental disclosure did not put subjects at risk, are already exempt.

12.20. 2017 01.18. 2018 01.19. 2018 … “Pre-2018 Regulations” “2018 Regulations” “The New Rule” Researchers benefit from additional exemptions Uses of secondary data and biospecimens that are already subject to HIPAA Educational tests, surveys, interviews, or observations of public behavior even if identifiers are recorded and accidental disclosure poses minimal risk Benign behavioral interventions with adults Brief, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing Excludes medical tests, procedures, devices (e.g., no EEG) Tell participants if unaware/misled re: research Benign behavioral interventions with adults is a completely new category. A benign behavioral intervention is brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Medical tests, procedures, and devices (e.g., EEG recording) are excluded. Research participants must be prospectively informed if they will be unaware of or misled regarding the nature or purposes of the research.

12.20. 2017 01.18. 2018 01.19. 2018 … “Pre-2018 Regulations” “2018 Regulations” “The New Rule” Researchers benefit from additional exemptions Uses of secondary data and biospecimens that are already subject to HIPAA Educational tests, surveys, interviews, or observations of public behavior even if identifiers are recorded and accidental disclosure poses minimal risk Benign behavioral interventions with adults Brief, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing Excludes medical tests, procedures, devices (e.g., no EEG) Tell participants if unaware/misled re: research Previously required expedited review These new exemption categories were previously reviewed as expedited.

Researchers benefit from longer approval periods
12.20. 2017 01.18. 2018 01.19. 2018 … “Pre-2018 Regulations” “2018 Regulations” “The New Rule” Researchers benefit from longer approval periods Researchers will benefit from longer approval periods.

12.20. 2017 01.18. 2018 01.19. 2018 … “Pre-2018 Regulations” “2018 Regulations” “The New Rule” Researchers benefit from longer approval periods Exempt No expiration, do submit Modification to close  At UMMS, there continues to be no expiration for exempt research. However, we will require investigator to submit a Modification to close the research once it’s complete.

12.20. 2017 01.18. 2018 01.19. 2018 … “Pre-2018 Regulations” “2018 Regulations” “The New Rule” Researchers benefit from longer approval periods Exempt No expiration, do submit Modification to close Expedited FDA-regulated: 1 year National Institute of Justice: 1 year All others: 3 years    With respect to Expedited review, research that is FDA-regulated or funded or supported by the National Institute of Justice will continue under the pre-2018 regulations. For this reason, the approval period will remain at one year. All other minimal risk expedited research will have a three-year approval period with annual reminders.

12.20. 2017 01.18. 2018 01.19. 2018 … “Pre-2018 Regulations” “2018 Regulations” “The New Rule” Researchers benefit from longer approval periods Exempt No expiration, do submit Modification to close Expedited FDA-regulated: 1 year National Institute of Justice: 1 year All others: 3 years Full Committee Max 1 year    Research that undergoes Full Committee review is generally greater than minimal risk and will continue to be approved for no more than one year. 

    12.20. 2017 01.18. 2018 01.19. 2018 … “Pre-2018 Regulations”
“The New Rule” Researchers benefit from longer approval periods Exempt No expiration, do submit Modification to close Expedited FDA-regulated: 1 year National Institute of Justice: 1 year All others: 3 years Full Committee Max 1 year    Why any expiration at all? You may be wondering why expedited minimal risk research has a three-year approval period when the 2018 regulations actually do not require continuing review. The 2018 regulations continue to hold UMMS responsible for all research that the institution conducts. A three-year approval period reduces burden on investigators, while allowing UMMS to maintain oversight of non-exempt research and the capability to generate reporting metrics required by accrediting bodies and funding agencies. In the future, UMMS may consider extending the approval period or removing expiration dates entirely for minimal risk research. 

Federally-funded research is special
12.20. 2017 01.18. 2018 01.19. 2018 … “Pre-2018 Regulations” “2018 Regulations” “The New Rule” Federally-funded research is special Federally-funded research is special and has special requirements.

12.20. 2017 01.18. 2018 01.19. 2018 … “Pre-2018 Regulations” “2018 Regulations” “The New Rule” Federally-funded research is special All NIH research that was commenced or ongoing on or after December 13, 2016, and will collect identifiable sensitive information as defined here ( OD html) now has a Certificate of Confidentiality. Research that is actively enrolling or due to enroll must include CoC language from consent form template In effect now There have been recent changes in NIH policy (not the 2018 regulations) under which a Certificate of Confidentiality (CoC) is now automatically granted to NIH research that was commenced or ongoing on or after December 13, A CoC permits the institution to refuse to release identifiers and is often obtained for research that collects sensitive identifiable information, for example, illegal drug use. If your research is NIH funded or supported and is actively enrolling research participants, check to see if your consent form needs to be updated with the CoC language from the consent form template.

12.20. 2017 01.18. 2018 01.19. 2018 … “Pre-2018 Regulations” “2018 Regulations” “The New Rule” Federally-funded research is special All NIH research that was commenced or ongoing on or after December 13, 2016, and will collect identifiable sensitive information as defined here ( OD html) now has a Certificate of Confidentiality. Research that is actively enrolling or due to enroll must include CoC language from consent form template Submit new short forms if enrolling limited English proficiency, the research is federally funded, and approved on or after January 19, 2018. In effect now Short forms – which may apply when obtaining consent from individuals with limited English proficiency – must state that key information was presented first before other information. Revised UMMS short forms are pending. Use the existing short forms for now (1) if research is not federally funded or (2) if research is federally funded and approved before January 19, Submit new short forms with your research if the research is federally funded and approved on or after January 19, 2018.

12.20. 2017 01.18. 2018 01.19. 2018 … “Pre-2018 Regulations” “2018 Regulations” “The New Rule” Federally-funded research is special Let’s move to requirements for posting consent forms for clinical trials.

12.20. 2017 01.18. 2018 01.19. 2018 … “Pre-2018 Regulations” “2018 Regulations” “The New Rule” Federally-funded research is special Each clinical trial that is conducted or supported by a Federal department or agency is required to post one consent form used to enroll subjects to a public Federal Web site. Location TBD. Each clinical trial that is conducted or supported by a Federal department or agency is required to post one consent form used to enroll subjects to a public Federal Web site. The location of that Web site has not been identified but may be clinicaltrials.gov.

12.20. 2017 01.18. 2018 01.19. 2018 … “Pre-2018 Regulations” “2018 Regulations” “The New Rule” Federally-funded research is special Each clinical trial that is conducted or supported by a Federal department or agency is required to post one consent form used to enroll subjects to a public Federal Web site. Location TBD. Posting is required after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol. Posting is required after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol

12.20. 2017 01.18. 2018 01.19. 2018 … “Pre-2018 Regulations” “2018 Regulations” “The New Rule” Federally-funded research is special Each clinical trial that is conducted or supported by a Federal department or agency is required to post one consent form used to enroll subjects to a public Federal Web site. Location TBD. Posting is required after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol. Clinical trial means 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 the interventions on biomedical or behavioral health- related outcomes. Clinical trial means 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 the interventions on biomedical or behavioral health-related outcomes. UMMS conducts federally-funded social & behavioral research that fits the definition of a clinical trial. The posting requirement applies to new research that is approved on or after

12.20. 2017 01.18. 2018 01.19. 2018 … “Pre-2018 Regulations” “2018 Regulations” “The New Rule” Federally-funded research is special Let’s transition to single IRB review.

12.20. 2017 01.18. 2018 01.19. 2018 … “Pre-2018 Regulations” “2018 Regulations” “The New Rule” Federally-funded research is special NIH policy mandates single IRB review for non- exempt multi-site studies for submissions with due dates on or after January 25, ( policy-multi-site-research.htm) NIH policy mandates single IRB review for non-exempt multi-site studies for submissions with due dates on or after January 25, ( This includes competing renewals.

12.20. 2017 01.18. 2018 01.19. 2018 … “Pre-2018 Regulations” “2018 Regulations” “The New Rule” Federally-funded research is special NIH policy mandates single IRB review for non- exempt multi-site studies for submissions with due dates on or after January 25, ( policy-multi-site-research.htm) Effective January 20, 2020, the 2018 regulations require Federally-funded cooperative research to use a single IRB for the portion conducted in the US, unless otherwise precluded (e.g., by tribal law) or deemed by Feds as not required. Effective January 20, 2020, the 2018 regulations require Federally-funded cooperative research to use a single IRB for the portion conducted in the US, unless otherwise precluded (e.g., by tribal law) or deemed by the sponsoring agency as not required.

12.20. 2017 01.18. 2018 01.19. 2018 … “Pre-2018 Regulations” “2018 Regulations” “The New Rule” Federally-funded research is special NIH policy mandates single IRB review for non- exempt multi-site studies for submissions with due dates on or after January 25, ( policy-multi-site-research.htm) Effective January 20, 2020, the 2018 regulations require Federally-funded cooperative research to use a single IRB for the portion conducted in the US, unless otherwise precluded (e.g., by tribal law) or deemed by Feds as not required. Contact the UMMS IRB if you are seeking to use an external IRB or to use the UMMS IRB as the single IRB. Contact the UMMS IRB if you are seeking to use an external IRB or to use the UMMS IRB as the single IRB.

Transitioning (or not)
The UMMS IRB will determine on a case-by-case basis whether research approved before January 19, 2018, stays under the pre-2018 regulations or transitions to the new rules. The UMMS IRB will determine on a case-by-case basis whether research approved before January 19, 2018, stays under the pre-2018 regulations or transitions to the new rules.

The UMMS IRB will determine on a case-by-case basis whether research approved before January 19, 2018, stays under the pre-2018 regulations or transitions to the new rules. The current goal is to transition eligible research only when it does not require Modification to the approved informed consents or study plans. The current goal is to transition eligible research only when it does not require Modification to the approved informed consents or study plans. Research that is FDA-regulated or funded or supported by the National Institute of Justice is not eligible to transition at this time. These may change in the future.

The UMMS IRB will determine on a case-by-case basis whether research approved before January 19, 2018, stays under the pre-2018 regulations or transitions to the new rules. The current goal is to transition eligible research only when it does not require Modification to the approved informed consents or study plans. In most cases, this is research that obtained informed consent, is not FDA regulated or federally funded, and has only data analysis or long-term follow-up left to complete. In most cases, the research that transitions will be research that obtained informed consent, is not FDA regulated or federally funded, and has only data analysis or long-term follow-up left to complete. If your research is approved before , you should plan to remain under the pre-2018 regulations.

Short Summaries by Topic Available on the Website
Short Summaries by Topic Available on the Website Bare Essentials Key Definitions Who, What, When, Where, Why, How What is yet to come from the Feds Informed Consent Transition Table For Federally Funded Annual Reminder Investigator Obligations Exemptions and Waivers Designated Review and Committee Review Expedited Review Broad Consent Visit the IRB website for short one- to-two page summaries available by topic.

Questions? http://www.umassmed.edu/ccts/irb/ irb@umassmed.edu
IRB Office:

JAN 24, 2018, UPDATE: The effective date of the new rule is now July 19, 2018, with the prospect of an additional 6-month delay to January 21, 2019. Even.

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JAN 24, 2018, UPDATE: The effective date of the new rule is now July 19, 2018, with the prospect of an additional 6-month delay to January 21, 2019. Even.

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Presentation on theme: "JAN 24, 2018, UPDATE: The effective date of the new rule is now July 19, 2018, with the prospect of an additional 6-month delay to January 21, 2019. Even."— Presentation transcript:

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