Single IRB requirement intended to streamline multi-site clinical research

NIH national institutes of health logo single IRBBeginning September, 2017, the National Institutes of Health (NIH) will require that a single IRB (sIRB) of record be used in the ethical review for all NIH-funded non-exempt, multi-site human subjects research protocols in the United States (NOT-OD-16-094). The sIRB policy applies to all multi-site human subjects research regardless of the NIH funding mechanism (e.g., SBIR/STTR awards, grants, cooperative agreements, contracts or other mechanisms such as Cooperative Research and Development Agreements (CRADAs), and Interagency Agreements (IAA)).

The goal of this policy is to enhance and streamline the IRB review process, in the context of multi-site research, so that research can proceed as effectively and expeditiously as possible. In addition to streamlining some aspects of IRB reviews, the new sIRB policy presents an opportunity to harmonize the standards used in clinical research in the United States and streamline future administrative responsibilities.

The sIRB policy takes effect on September 25, 2017. This date is four months later than the effective date that appears in the sIRB policy document. NIH extended the effective date to allow additional time for successful implementation.

Finally, beginning in January 2020, the revised Common Rule will expand the studies to which this requirement will apply. The revised rule will require single IRB review for all multi-site studies conducted in the United States, rather than having each site’s IRB bear regulatory responsibilities. This had been a controversial provision of the NPRM, but became less so following the issuance of the NIH policy for research it funds.

Resources and guidance are available on the NIH Office of Science Policy website (http://osp.od.nih.gov/office-clinical-research-and-bioethics-policy/clinical-research-policy/models-irb-review). But for now, the question remains on whether the requirement for sIRB review will be equally protective of subject interests and actually demonstrate to be more effectual.

Pearl IRB will keep you updated on future developments impacting clinical research through our blog. For immediate updates, follow us on Twitter or send your inquiries to our experts directly.

Common Rule changes will impact informed consent, IRBs, and more

HHS changes Common RuleOn January 18th, the US Department of Health and Human Services (HHS) and 15 other federal departments and agencies issued a final rule to revise the federal Policy for the Protection of Human Subjects. The Policy for the Protection of Human subjects, aka the Common Rule, outlines all federal regulations concerning clinical research involving human subjects. The final rule contains significant departures from the Notice of Proposed Rulemaking, issued in September of 2015, as a result of public feedback and concerns to the original notice of changes. The final revisions to the Common Rule can be found here, but continue reading for a condensed summary of the critical changes.

Regarding informed consent:

  • A requirement for simplifying research consent forms. Study consent forms must concisely state a study’s scope, risks, and benefits so that individuals can make informed decisions regarding participation.
  • Consent forms for certain federally funded clinical trials must be posted on a public website.

Regarding IRBs:

  • The Final Rule includes new requirements to use a single IRB for multi-institutional research studies. However, there is flexibility in allowing large groups of studies to be removed from this requirement. Researchers will have the option of relying on broad consent obtained for future research as an alternative to seeking IRB approval to waive the consent requirement (e.g. for studies on stored identifiable data or biospecimens). Researchers will not be required to obtain consent for studies on de-identified, stored data, or biospecimens. The provision that would have required researchers to obtain consent before using a study participant’s de-identified blood and tissue samples for secondary research was removed from the NPRM.

Regarding risk-based monitoring:

  • There are new exempt categories of research based on the level of risk they pose to participants. For example, there is a new exemption for secondary research involving identifiable private information if the research is regulated by, and participants protected under, HIPAA.
  • Removal of the requirement to conduct continuing review of ongoing research studies in certain instances where such review does little to protect subjects (e.g. low risk studies).

These changes are set to take place in January of 2018 with the exception of the single IRB review requirement (slated for January of 2020). The political landscape remains uncertain with the possibility that Congress may overturn these and other regulations recently initiated by the previous administration. We at Pearl IRB recommend that you familiarize yourself with the full list of regulations and begin preparations for the new Common Rule. Our team of experts can help facilitate this process and meet the needs of your current and upcoming clinical trials.

Pearl IRB’s co -chair, Dr. Gretchen Parker published in Cureus

Gretchen Parker, PhD, RAC, CIP, and Pearl IRB Co-Chair, has completed another article published by Cureus.  The title of the article is “A Framework for Navigating Institutional Review Board (IRB) Oversight in the Complicated Zone of Research”.  The article provides Parker’s unique perspective on IRB processes and review types, offers insight into the IRB decision-making process, and emphasizes the importance of engaging an IRB consultant early in the clinical study design process.

IRB Written Procedures Draft Guidance released

Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs draft was released recently by the FDA and the Office for Human Research Protections (OHRP). This new draft guidance includes an IRB Written Procedures Checklist developed with the intent to assure all important activities are considered and completed by IRBs as they ensure the protection of human research subjects.

Pearl IRB strives every day to provide our customers top quality service, unyielding ethics and efficient services.  Protecting human subjects and driving improved value and efficiency in protocol reviews and implementation shapes our behaviors each day.

Contact Pearl IRB – we are assuring all important activities are considered and completed. ✔

Streamlining IRB review process for multi-site research

On 6/21/16, the National Institutes of Health (NIH) issued a final policy to streamline IRB review. Expectations are that a single IRB (sIRB) will be used for all non-exempt multi-site research at U.S. sites for research funded by NIH.  There may be exceptions only if the sIRB cannot meet requirements.  The goal is to make the IRB review process more lean and efficient for the benefit of research timelines – all while protecting patients.  This policy will take effect on May 25, 2017.  Click here to read the NIH notice from the Federal Register.

Contact Pearl IRB’s team at this link to help with your IRB review process. We ensure that a quality, timely review of proposed studies is conducted in the best interest of the patient, sponsor and research institution.

NPRM released outlines changes to Common Rule

A Notice of Proposed Rulemaking (NPRM) released 8 Sep 2015 outlines revisions to the Common Rule (45 CFR 46 subpart A) meant to modernize, strengthen, and make it more effective.

The most significant changes to the Common Rule proposed in the NPRM are as follows:

  1. Improve informed consent by increasing transparency and by imposing stricter new requirements regarding the information that must be given to prospective subjects, and the manner in which it is given to them.
  2. Generally require broad informed consent for the use of stored biospecimens in secondary research, even if the investigator is not being given information that would enable him or her to identify whose biospecimen it is.
  3. Exclude from coverage under the Common Rule certain categories of activities that should be deemed not to be research, are inherently low risk, or where protections similar to those usually provided by IRB review are separately mandated.
  4. A new process would allow studies to be determined to be exempt without requiring any administrative or IRB review. Certain exempt and all non-exempt research would be required to provide privacy safeguards for biospecimens and identifiable private information.
  5. Change the conditions and requirements for waiver or alteration of consent such that waiver of consent for research involving biospecimens (regardless of identifiability) will occur only in very rare circumstances.
  6. Mandate that U.S. institutions engaged in cooperative research rely on a single IRB for that portion of the research that takes place within the United States, with certain exceptions and holding unaffiliated IRBs directly responsible for compliance with the Common Rule.
  7. Eliminate the continuing review requirement for studies that undergo expedited review and for studies that have completed study interventions and are merely analyzing data or involve only observational follow-up in conjunction with standard clinical care.
  8. Extend the scope of the policy to cover all clinical trials, regardless of funding source, conducted at a U.S. institution that receives federal funding for non-exempt human subjects research.

Comments on the NPRM must be received by OHRP no later than December 7, 2015. Please click here to read the NPRM in its entirety.

FDA Releases Draft Guidance on Use of Electronic Information Consent in Clinical Studies

In order to present related information to a clinical study and acquire and document informed consent, electronic systems and processes such as text, audio, and graphics are increasingly being employed. According to FDA per their new draft guidance, this is referred to as electronic informed consent (eIC). To provide recommendations when using an eIC to help ensure and enhance human subject protection, comprehension of the information presented, appropriate documentation of obtained consent, and the quality and integrity of eIC data, FDA has released a new draft guidance entitled Use of Electronic Information Consent in Clinical Investigations.

FDA believes that simply obtaining a written signature is not conclusive of what is meant by informed consent. According to FDA, “informed consent must include a process that facilitates the subject’s comprehension of the information and allows adequate opportunity for the subject to ask questions and consider where or not to participate.” The use of electronic processes allow for an interactive exchange allowing the subject to have more involvement which can lead to additional comprehension regarding the study before obtaining the electronic informed consent.

This draft guidance, released in March 2015, provides recommendations for sponsors, site personnel, and IRB’s regarding several key topics/issues regarding the use of electronic informed consent. The following include a few categories included in the draft guidance:

  • Presentation of information to the subject
  • Delivery of eIC processes
  • Desired steps to ensure subject’s understanding and confidentiality of all information
  • Special considerations for pediatric studies
  • IRB’s responsibilities in the eIC process
  • Required eIC documentation for FDA applications and inspections

For additional information, read FDA’s complete draft guidance. Need help with your approach or content for an informed consent document?  Contact us for more information.

New forms and resources for IRB submissions on the Pearl IRB website

We are pleased to announce our recent updates to the Pearl IRB website. In the Resources section, you will find new and revised forms to serve you in the IRB submission process. Some of these changes include:

Contact us at info@pearlirb.com with any questions, to provide feedback, and for assistance with an IRB submission.

Important Clinical Trial Facts

Cameron from Total Biopharma introduces an interesting artical about how clinical trials are being designed and executed to fit the changing needs of the industry.  With costs and complexity increasing in clinical reseach, Total Biopharma offers their own A-Z guide for clinical trials. See the start of their guide below.

A-     Adaptive Clinical Trials

B-     Big Data

C-     Clinical Outsourcing & Partnering World

To read the full article click here.  Need help with your design or execution of your clinical trial?  Contact us at info@pearlirb.com.