Category Archives: Policy

NIH Issues Final Policy on Use of Single IRB

Institutional review boards, Policy, Regulatory issues, , , ,

The NIH has issued a final policy requiring the use of a single institutional review board (sIRB) for multi-site non-exempt human subjects research funded by the NIH. The policy will take effect May 25, 2017.

According to the policy announcement, “while the NIH anticipates that that there will be challenges associated with implementation, we expect these to be short-lived. Once the transition to the new way of operating is made, the benefits of widespread use of sIRBs will outweigh any costs and, ultimately, reduce burdens to the research process.”

In proposals submitted to the NIH, applicants will be expected to include a plan identifying the sIRB that will serve as the IRB of record for all study sites. It will be the applicants’ responsibility to assure that the sIRB is qualified to serve. NIH acceptance of the submitted plan will be incorporated as a term and condition in the award. Awardees will be responsible for ensuring that the authorization agreements between IRBs (“reliance agreements”) are in place.

According to the policy, “The additional costs associated with sIRB review may be charged to grants or contracts as direct costs, provided that such costs are well-justified and consistently treated as either direct or indirect costs according to applicable cost principles in the NIH Grants Policy Statement and the FAR 31.202 (Direct Costs) and FAR 31.203 (Indirect Costs).”

Before the policy takes effect, the NIH will be issuing guidance and resources to assist with implementation.

Read the full policy for additional details.

FDA releases draft guidance for using electronic health records in clinical research

Data privacy, Data quality, Data sharing, Data standards, Electronic health records, Policy, Regulatory issues, ,

The FDA has released a Draft Guidance for Industry to facilitate the use of data from electronic health record (EHRs) in clinical investigations. The draft guidance provides recommendations on how to use EHRs as a source of data for research, ensure data quality and integrity, and satisfy the FDA’s inspection, recordkeeping, and record retention requirements. An additional goal of the draft guidance is to promote interoperability, or the ability to exchange and use information between EHR systems that capture information during patient care visits and electronic data capture (EDC) systems that support clinical investigations. Sponsors of clinical research must also consider whether there are any reasonably foreseeable risks involved in using the EHR for research—such as an increased risk of data breaches—that should be disclosed in the informed consent document.

Read the full draft guidance here.

Modernizing the Common Rule for the 21st Century

Clinical trials, Informed Consent, Policy, Regulatory issues, , , , , , , ,

The New England Journal of Medicine today published a perspective by NIH Deputy Directory Kathy L. Hudson, PhD, and NIH Director Francis S. Collins, MD, PhD, in which they outline the major reforms proposed for regulations governing the ethical conduct of research involving humans, known as the Common Rule (45 CFR 46, Subpart A).

The proposed changes are meant to enhance respect for research participants, calibrate oversight to level of risk, simplify consent documents, streamline IRB review, increase privacy and security safeguards, and facilitate broad participation in research.

“These long-overdue reforms will bring the Common Rule into the 21st century. They should help the scientific community take a giant leap forward in showing respect for research participants, without whom the biomedical research enterprise would cease to exist.”

The NIH is encouraging all stakeholders—the public, researchers, and patients—to closely review the proposed changes and participate in the comment process by the December 7, 2015, deadline.

For more information on the proposed revisions:

Grand Rounds Presentation, Kathy Hudson (video)

Department of Health and Human Services' website on the NPRM 

OHRP Webinars on the NPRM

Living Textbook Chapter: Informed Consent: Emerging Issues and Controversies

OHRP Town Hall Meeting to Discuss NPRM

Clinical trials, Informed Consent, Policy, Regulatory issues, , , , , ,

The Office for Human Research Protections (OHRP) has announced a public Town Hall Meeting to be held October 20, 2015, to respond to questions related to the Federal Policy for the Protection of Human Subjects Notice of Proposed Rulemaking (NPRM) published on September 8, 2015.

The goal of the NPRM is to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991. The NPRM seeks comments on proposals to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.

The purpose of the Town Hall Meeting (agenda) is for OHRP, HHS agencies, and other Common Rule departments and agencies to provide responses to questions from the public about the NPRM in order to clarify the NPRM proposals and better inform public comment on the NPRM. The public will be able to ask questions during the Town Hall Meeting, and to submit questions before the meeting. Watch via webinar.

Public Town Hall Meeting 
October 20, 2015, 9 am to 5 pm
Hubert H. Humphrey Building, Great Hall
200 Independence Ave SW
Washington, DC 20201

This PDF document (#2015-25564) contains details about the format of the public Town Hall Meeting and how to register or submit questions prior to the meeting.

Important deadlines:

  • While there is no registration fee, individuals planning to attend the Town Hall in person must register by 5:00 pm October 13, 2015. Registration will be accepted on a first-come, first-served basis and may be completed by sending an email to OHRP@hhs.gov, with the subject line “Registration for OHRP Town Hall Meeting.”
  • The deadline for submission of questions about the NPRM prior to the Town Hall Meeting must be received no later than 5:00 pm October 13, 2015.
  • Details on the NPRM are at the OHRP website. To be assured consideration, comments on the NPRM must be received no later than the extended deadline of January 6, 2016.

 

OHRP Offers Webinars on Proposed Revisions to the Common Rule

Informed Consent, Institutional review boards, Policy, Regulatory issues, , , ,

The Office for Human Research Protections (OHRP) has posted a series of six webinars explaining the recent Notice of Proposed Rulemaking (NPRM) regarding revisions to the Common Rule (the federal policy for human subjects protection). The presentations by policy experts can be viewed anytime; they cover the following topics:

  • Overview of the NPRM
  • Exclusions and exemptions
  • Informed consent
  • IRB review and operations
  • Research with biospecimens
  • Secondary research use of data

For more information on the NPRM, visit the OHRP website. The deadline for comments on the proposed revision has been extended to January 6, 2016.

Notice of Proposed Rulemaking (NPRM): Protection of Human Subjects

Informed Consent, Policy, Regulatory issues, , ,

The U.S. Department of Health and Human Services (HHS) and 15 other federal departments and agencies have announced proposed revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule (45 CFR 46, Subpart A)  in 1991. A Notice of Proposed Rulemaking (NPRM) was published in the Federal Register on September 8, 2015 (see the press release).

The NPRM seeks comment on proposals to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. Comments must be received no later than the extended deadline of 5 pm on January 6, 2016. Visit the HHS page for a summary of the proposed changes and instructions on submitting or browsing comments.

Webinars are available explaining the changes proposed in the NPRM, and a town hall meeting is planned to be held in Washington, DC, in October.

Among the major changes being proposed in order to better protect research subjects and help build public trust are modifications to rules affecting patient informed consent. With regard to informed consent in general (such as consent to participate in a clinical trial), the rules would be significantly tightened to ensure that the process becomes more meaningful. Consent forms in particular would be affected. A common complaint about informed consent forms is that they are often unduly lengthy and cumbersome, with important information often buried and hard to find. Under the proposed changes, such documents would need to be streamlined in ways that provide appropriate details about the research that is most relevant to a person’s decision to participate in the study, such as information a reasonable person would want to know, and present that information in a way that highlights the key information.

The proposed modifications are designed to continue to uphold the ethical principles upon which the Common Rule is based, as applied to the current social, cultural, and technological environment. In brief, the most significant changes proposed in the NPRM include:

  1. Improve informed consent by increasing transparency and by imposing stricter new requirements regarding the information that must be given to prospective subjects.
  2. Generally require informed consent for the use of stored biospecimens in secondary research.
  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. Add additional categories of exempt research to accommodate changes in the scientific landscape and to better calibrate the level of review to the level of risk involved in the research.
  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.
  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.

 

ClinicalTrials.gov Analysis Dataset Available from CTTI

Clinical trials, Data quality, Data sharing, Policy, Regulatory issues, Research reporting standards, Research tools, , , ,

Tools for ResearchAs part of a project that examined the degree to which sponsors of clinical research are complying with federal requirements for the reporting of clinical trial results, the Clinical Trials Transformation Initiative (CTTI) and the authors of the study are making the primary dataset used in the analysis available to the public. The full analysis dataset, study variables, and data definitions are available as Excel worksheets from the CTTI website and on the Living Textbook’s Tools for Research page.

New Search Feature for FDA Guidance Documents

Policy, Regulatory issues,

A new feature on the FDA.gov website allows you to search for FDA guidance documents on all topics from one convenient location:

FDA Guidance Document Search Feature

Guidance documents represent the FDA’s current thinking on particular topics and are used by stakeholders to understand the agency’s interpretation of regulations and policies.

There are approximately 3,000 guidance documents available on the site, which can be searched by keyword or filtered by date issued, FDA organizational unit, subject, draft or final status, and comment period.

The search feature was implemented in January 2015 in response to site visitor feedback.

Comment Period Extended for NPRM: Transparency of Clinical Trial Results

Clinical trials, Policy,

The Department of Health and Human Services is extending the public comment period for the Notice of Proposed Rulemaking (NPRM) on Clinical Trials Registration and Results Submission. The comment period for the proposed rule 79 FR 69566, published on November 21, 2014, will close at 5 p.m. Eastern Standard Time (EST) on March 23, 2015.

Developed by NIH in close coordination with the FDA, the proposed rule details procedures for meeting the requirements established by the Food and Drug Administration Amendments Act (FDAAA) to improve public access to clinical trial information. FDAAA and the proposed rule apply to certain interventional studies of drugs, biological products, and devices that are regulated by the FDA but, generally, not to phase 1 trials of drugs and biological products and small feasibility studies of devices. The proposed rule specifies how data collected and analyzed in a clinical trial would be required to be submitted to ClinicalTrials.gov. It would not affect requirements for the design or conduct of clinical trials or for the data that must be collected during clinical trials.

Of particular importance in the NPRM is FDAAA Section 801 (expanded clinical trial registry and results data bank), which  includes information about the responsible party, applicable clinical trials, deadlines for submitting required information, and penalties.

Individuals and organizations interested in submitting comments on the NPRM, identified by RIN 0925-AA52 and Docket Number NIH-2011-0003, may do so by mail or electronically. Details and addresses for submitting comments are here.

RELATED LINKS 

ClinicalTrials.gov

Summary of Proposed Changes - NPRM/NIH Policy 

JAMA Viewpoint: Sharing and Reporting the Results of Clinical Trials

 

NIH Issues Draft Policy Proposing Use of Single IRB for Multisite Clinical Research Studies

Clinical trials, Guidance document, Institutional review boards, Policy, , ,

On December 3, 2014, the National Institutes of Health (NIH) issued a draft policy promoting the use of a single institutional review board (IRB) for multisite studies. IRBs play a critical role in assuring the ethical conduct of research, and studies must be reviewed and approved by an IRB before they can begin. Yet over time, the clinical research landscape has become increasingly complex, expanding from studies formerly conducted at single institutions to large, diverse studies across networks and multiple sites. This situation challenges the practicality of using local IRBs to conduct initial and ongoing reviews for such studies.

The goal of permitting use of a single IRB—also called a central IRB or IRB of record—is to enhance and streamline the process of IRB review for multisite studies so that research can proceed efficiently without compromising ethical principles and protections. While both the FDA and Office for Human Research Protections support the use of a single IRB, too few institutions involved in multisite studies are taking advantage of the option.

 Read the NIH draft policy here.

“By using single IRBs in multi-site studies, we reduce duplication of effort, speed the initiation of important research, and save time and taxpayer funds.”
Francis S. Collins, MD, PhD, NIH Director

Among the current NIH programs incorporating the use of a single IRB are:

  • National Cancer Institute’s Central Institutional Review Board (CIRB)
  • National Institute of Neurological Disorders and Stroke’s Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT)
  • Network for Stroke Research (NIH StrokeNet)

Dr. Sally Rockney, NIH deputy director for extramural research, explains the NIH perspective in her blog. Public comment on the draft policy extends for 60 days, through January 29, 2015. When finalized, the policy will apply to all NIH-funded multisite studies carried out in the United States, whether supported through grants, contracts, or the NIH intramural program.