2018 New Human Subject Regulations Informed Consent

2018 New Human Subject Regulations Informed Consent
January 2018 Version 2

The new rules were scheduled to take effect on January 19, 2018
On January 17, 2018, HHS issued an interim final rule with a six-month delay The new rules are now scheduled to take effect on July 19, 2018 The interim final rule raises the possibility of an additional notice of proposed rulemaking with a public comment period regarding a delay to January 21, 2019

Where does that leave us?
All new studies are still required to use the new consent template that was posted 12/20/2017 The new consent template will foster a better consent process for investigators and research participants It also fits the new and old regulations

Research that is FDA regulated or has any federal funding or support will continue to have a one-year approval period Where possible, UMMS will move ahead with three-year approval periods for some minimal risk new studies

We will not use the new exemption categories All research will be evaluated against the existing pre-2018 exemption categories

What do researchers need to do?
Make sure that the Funding Sources for your research are appropriately captured in eIRB If you are part of a multi-site study and the overall project has federal funding or support, it is important to list that federal funding or support in eIRB even if no money reaches UMMS

Download all forms and templates fresh from the IRB website whenever you need to prepare a submission

Continue to obtain prior IRB review and approval for all human subjects research — including research that fits one or more of the exemption categories IRB staff automatically consider the lowest possible review category based on a single application

Note the expiration dates indicated in your approval letters Create a reminder system to ensure timely submission of continuing reviews and study closures Submit a closure to the IRB when your research is completed, even if it’s deemed exempt

The most noticeable changes under the New Rule include:
A new consent template – posted For some minimal risk new studies Three-year approval periods [UMMS: limited roll-out] Additional exemption categories [UMMS: on hold] Annual reminders from eIRB of investigator obligations

Even if the New Rule takes effect July 19, 2018 or January 21, 2019
It does not yet include FDA and Department of Justice (DOJ) as signatories Research that is regulated by the FDA or is funded or supported by DOJ Will use the new consent template, but will otherwise remain subject to the pre-2018 regulations Is not eligible for extended approval periods or new exemption categories The new consent template is designed to improve the informed consent process for research participants. For this reason, all new studies at UMMS are required to use the new consent template if they are approved on or after January 19, This includes research that is FDA-regulated and research that is funded or supported by the Department of Justice (e.g., by the National Institute of Justice). Because these agencies have not yet harmonized their regulations with the New Rule, investigators do not yet have access to extended approval periods or new exemption categories.

This rest of this session focuses on informed consent changes
Requirements to use new consent template Overall design of new consent template Additional required elements of consent disclosure Short form requirements Certificate of Confidentiality changes Requirement for federally-funded clinical trials to post consent form

All new studies will use the new consent template
New studies approved on or after January 19, 2018, must use the new consent template posted December 20, 2017 The new consent template is designed to improve the informed consent process for research participants. For this reason, all new studies at UMMS are required to use the new consent template if they are approved on or after January 19, This includes research that is FDA-regulated and research that is funded or supported by the Department of Justice (e.g., by the National Institute of Justice). Because these agencies have not yet harmonized their regulations with the New Rule, investigators do not yet have access to extended approval periods or new exemption categories.

New studies approved on or after January 19, 2018, must use the new consent template posted December 20, 2017 Research that is regulated by the FDA or is funded or supported by the Department of Justice Will also use the new consent template, but otherwise remains subject to the pre-2018 regulations Is not eligible for extended approval periods or new exemption categories The new consent template is designed to improve the informed consent process for research participants. For this reason, all new studies at UMMS are required to use the new consent template if they are approved on or after January 19, This includes research that is FDA-regulated and research that is funded or supported by the Department of Justice (e.g., by the National Institute of Justice). Because these agencies have not yet harmonized their regulations with the New Rule, investigators do not yet have access to extended approval periods or new exemption categories.

New studies approved on or after January 19, 2018, must use the new consent template posted December 20, 2017 It is not unusual for the IRB to periodically update forms and template. You can facilitate the review process by always downloading forms and templates fresh from the IRB website when preparing any submission. Continuing to recycle prior submissions may slow down the approval process.

New studies approved on or after January 19, 2018, must use the new consent template posted December 20, 2017 Studies approved before January 19, 2018, are not required to transition to the new consent template It is not unusual for the IRB to periodically update forms and template. You can facilitate the review process by always downloading forms and templates fresh from the IRB website when preparing any submission. Continuing to recycle prior submissions may slow down the approval process.

New studies approved on or after January 19, 2018, must use the new consent template posted December 20, 2017 Studies approved before January 19, 2018, are not required to transition to the new consent template At time of Continuing Review or Modification, the IRB may require the addition of new elements to Pre-2018 consents It is not unusual for the IRB to periodically update forms and template. You can facilitate the review process by always downloading forms and templates fresh from the IRB website when preparing any submission. Continuing to recycle prior submissions may slow down the approval process.

The new rule aims to improve the consent process for research participants
The new rule requires Reasonable person standard Opportunity for discussion Presentation of key information first in a concise, focused, and organized fashion to facilitate understanding 45 CFR (a)(4): The prospective subject or the legally authorized representative must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information. 45 CFR (a)(5)(i): Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension. HRP-800 INVESTIGATOR GUIDANCE: Investigator Obligations – Section 2.22 (Data Retention),

The new rule aims to improve the consent process for research participants
The new rule requires Reasonable person standard Opportunity for discussion Presentation of key information first in a concise, focused, and organized fashion to facilitate understanding We have taken the opportunity to combine the consent form and HIPAA authorization Note that signed and dated HIPAA authorizations – including compound consents – have a 6-year data retention requirement 45 CFR (a)(4): The prospective subject or the legally authorized representative must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information. 45 CFR (a)(5)(i): Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension. HRP-800 INVESTIGATOR GUIDANCE: Investigator Obligations – Section 2.22 (Data Retention),

Consents longer than 3 pages must start with a summary of the main information that a reasonable person would want to know when deciding whether to participate If the body of the consent form will be longer than three pages, the consent must start with a summary of the main information that a reasonable person would want to know when deciding whether to participate. The federal regulations identify the elements listed above as key information. The new regulations emphasize the need to present information in a way that help someone understand and make a decision about whether or not to participate.

Consents longer than 3 pages must start with a summary of the main information that a reasonable person would want to know when deciding whether to participate Key Information Being invited to take part in research Participation is voluntary Time and the number of visits/interactions Main purposes Main procedures Risks/Benefits Alternatives If the body of the consent form will be longer than three pages, the consent must start with a summary of the main information that a reasonable person would want to know when deciding whether to participate. The federal regulations identify the elements listed above as key information. The new regulations emphasize the need to present information in a way that help someone understand and make a decision about whether or not to participate.

Consents longer than 3 pages must start with a summary of the main information that a reasonable person would want to know when deciding whether to participate Key Information Being invited to take part in research Participation is voluntary Time and the number of visits/interactions Main purposes Main procedures Risks/Benefits Alternatives Present the information so that it helps people to understand and make a decision Concise, focused, organized, in simple language Summary is limited to three pages maximum If the body of the consent form will be longer than three pages, the consent must start with a summary of the main information that a reasonable person would want to know when deciding whether to participate. The federal regulations identify the elements listed above as key information. The new regulations emphasize the need to present information in a way that help someone understand and make a decision about whether or not to participate.

The key information is limited to three pages
The key information is limited to three pages. Keep key risks concise, focused, and simple. …identify the most important risks, similar to the information that a doctor might deliver in the clinical context in telling a patient how sick the chemotherapy drugs will make them, but with a particular emphasis on how those risks are changed by participating in the study. Federal Register /Vol. 82, No. 12 /Thursday, January 19, 2017 /Rules and Regulations 7213 Do not include the complete list of reasonably foreseeable risks in the key information section of the consent form. This section should identify only the most important risks. The key information and study details should be integrated in a way that limits redundancy and helps research participants ask questions and make a decision.

The 2018 regulations include new required elements of consent disclosure
When appropriate, indicate whether clinically relevant research results - including at the individual level - will be disclosed, and if so, under what conditions The template includes prompts to address all required elements of consent disclosure.

When appropriate, indicate whether clinically relevant research results - including at the individual level - will be disclosed, and if so, under what conditions If research involves collection of identifiable private information or identifiable biospecimens: Include a statement that identifiers might be removed and material shared or used in future research without additional consent or a statement that no sharing or use in future research will occur even if identifiers are removed The template includes prompts to address all required elements of consent disclosure.

If collecting biospecimens: And if a possibility: includes a statement that specimens (even if identifiers are removed) may be used for commercial profit & whether subjects will share in the profits If research participants will share in profits, you would adjust the template language accordingly.

If collecting biospecimens: And if a possibility: includes a statement that specimens (even if identifiers are removed) may be used for commercial profit & whether subjects will share in the profits Indicate whether research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen) If research participants will share in profits, you would adjust the template language accordingly.

If collecting biospecimens: And if a possibility: includes a statement that specimens (even if identifiers are removed) may be used for commercial profit & whether subjects will share in the profits Indicate whether research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen) If research participants will share in profits, you would adjust the template language accordingly. Documentation of consent in writing is expected for research that involves sharing of identifiable information or identifiable biospecimens

2018 short forms must state that the key information was presented first to the subject, before other information, if any Short forms are used with prior IRB approval to document consent in languages other than English Would translate consent if expecting significant number of speakers of a given language ON HOLD

UMMS is working to obtain new short forms
2018 short forms must state that the key information was presented first to the subject, before other information, if any Short forms are used with prior IRB approval to document consent in languages other than English Would translate consent if expecting significant number of speakers of a given language UMMS is working to obtain new short forms If a new study is federally funded and is approved on or after January 19, 2018, researchers must submit compliant short forms for IRB review and approval For all other research, UMMS will permit the use of its existing short forms until new ones become available ON HOLD

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17- 109.html
Effective October 1, 2017, NIH instituted changes related to Certificates of Confidentiality All NIH research that was commenced or ongoing on or after December 13, 2016, and will collect identifiable sensitive information as defined at the link below now has a Certificate of Confidentiality (CoC) 109.html Previously, CoCs were usually implemented for studies that tracked sensitive information, such as illegal drug use. The new definition seems to treat all identifiable data and biospecimens as sensitive.

Effective October 1, 2017, NIH instituted changes related to Certificates of Confidentiality All NIH research that was commenced or ongoing on or after December 13, 2016, and will collect identifiable sensitive information as defined at the link below now has a Certificate of Confidentiality (CoC) 109.html The process is automatic. There is no longer a need to apply. Previously, CoCs were usually implemented for studies that tracked sensitive information, such as illegal drug use. The new definition seems to treat all identifiable data and biospecimens as sensitive.

Effective October 1, 2017, NIH instituted changes related to Certificates of Confidentiality All NIH research that was commenced or ongoing on or after December 13, 2016, and will collect identifiable sensitive information as defined at the link below now has a Certificate of Confidentiality (CoC) 109.html The process is automatic. There is no longer a need to apply. The definition seems to treat all identifiable data and biospecimens as sensitive. Previously, CoCs were usually implemented for studies that tracked sensitive information, such as illegal drug use. The new definition seems to treat all identifiable data and biospecimens as sensitive.

A Certificate of Confidentiality (CoC) prohibits disclosure of identifiable research information, documents, or biospecimens except under very specific circumstances

Disclosure exceptions
A Certificate of Confidentiality (CoC) prohibits disclosure of identifiable research information, documents, or biospecimens except under very specific circumstances Disclosure exceptions Research that is in compliance with Federal regulations for human subjects research With the consent of the research participant Federal, State, or local law requirements (e.g., communicable disease reporting) – but not civil, criminal, administrative, legislative, or other proceeding

Disclosure exceptions
A Certificate of Confidentiality (CoC) prohibits disclosure of identifiable research information, documents, or biospecimens except under very specific circumstances Disclosure exceptions Research that is in compliance with Federal regulations for human subjects research With the consent of the research participant Federal, State, or local law requirements (e.g., communicable disease reporting) – but not civil, criminal, administrative, legislative, or other proceeding Research that is actively enrolling or due to enroll must include CoC language from the consent form template

Federally-funded or supported clinical trials approved under the 2018 regulations have an obligation to post a consent form used to enroll subjects to a public Federal Web site Web site location is TBD (may be clinicaltrials.gov) 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 ON HOLD

Federally-funded or supported clinical trials approved under the 2018 regulations have an obligation to post a consent form used to enroll subjects to a public Federal Web site Web site location is TBD (may be clinicaltrials.gov) 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 Investigators are responsible to know their clinical trial status and posting obligations. ON HOLD

Reminders Always download forms and templates fresh from the IRB website 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.

Reminders Always download forms and templates fresh from the IRB website If you need to reconsent research participants, use a consent addendum that includes just the new information 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.

Reminders Always download forms and templates fresh from the IRB website If you need to reconsent research participants, use a consent addendum that includes just the new information Studies approved before January 19, 2018, are not required to transition to the new consent template; the IRB may require the addition of new elements to Pre-2018 consents during Modifications or Continuing Reviews 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.

Reminders Always download forms and templates fresh from the IRB website If you need to reconsent research participants, use a consent addendum that includes just the new information Studies approved before January 19, 2018, are not required to transition to the new consent template; the IRB may require the addition of new elements to Pre-2018 consents during Modifications or Continuing Reviews See the IRB website for instructions on how to print the stamped consent form from eIRB 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.

Transitioning (or not)
The UMMS IRB will determine on a case-by-case basis whether research approved before the effective date of the New Rule stays under the pre-2018 regulations or transitions to the New Rule 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.

The UMMS IRB will determine on a case-by-case basis whether research approved before the effective date of the New Rule stays under the pre-2018 regulations or transitions to the New Rule The current goal is to transition eligible research only when it does not require rewriting the approved informed consents or Modification to the study plans. 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.

The UMMS IRB will determine on a case-by-case basis whether research approved before the effective date of the New Rule stays under the pre-2018 regulations or transitions to the New Rule The current goal is to transition eligible research only when it does not require rewriting the approved informed consents or Modification to the 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 Fed Govt 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.

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2018 New Human Subject Regulations Informed Consent

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