We are pleased to announce that Sterling IRB convenes full board meetings every day


Sterling is expanding our full board meeting calendar to help you meet your study timelines. IRB panels now meet daily, and every panel has the expertise to review research protocols in all phases and therapeutic areas. In addition to our 24-hour expedited review service for eligible submissions, Sterling now offers shortened lead times for submissions requiring full board review. Taking advantage of Sterling’s new daily meetings is simple:
  • Submissions may be made 24/7
  • Secure web portal ensures total confidentiality
  • Electronic documents are available real-time
  • Your Sterling Account Manager will contact you right away with a review schedule
It’s just one more innovation at Sterling IRB – where every day we work harder to earn your business and your trust.

SilverLink Temporarily Down After Business Hours on Monday, February 29th

SilverLink will be down due to scheduled maintenance beginning at 9 p.m. EST on Monday, February 29th. Access will be temporarily unavailable for approximately 10 minutes during the maintenance window. We apologize for any inconvenience that this may cause.

Sterling IRB 2016 Holiday Closures

Sterling IRB will be closed in observance of the following holidays:

  • Memorial Day – Monday, May 30, 2016
  • Independence Day (4th of July) – Monday, July 4, 2016
  • Labor Day – Monday, September 5, 2016
  • Thanksgiving – Wednesday, November 23, 2016 (Closing at 1:00 PM EST)
  • Thanksgiving – Thursday, November 24, 2016
  • Thanksgiving – Friday, November 25, 2016
  • Christmas – Friday, December 23, 2016 (Closing at 1:00 PM EST)
  • Christmas Day (Observed) – Monday, December 26, 2016
  • New Year’s – Friday, December 30, 2016 (Closing at 1:00 PM EST)
  • New Year’s Day (2017) (Observed) - Monday, January 2, 2017

Developments in Regulation of Laboratory Developed Tests

On October 2, 2014 FDA issued its “Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories: Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” (“LDT Guidance”) to clarify FDA’s enforcement objectives with regard to LDTs. An LDT is a subset of in vitro diagnostic devices (“IVDs”), and FDA will consider an IVD an LDT when it is used, designed, and manufactured by only a single laboratory. Since 1976, when the U.S. Congress amended the Food Drug and Cosmetics Act (“FD&C”) and made explicit that IVDs were devices under the Act, FDA has generally exercised enforcement discretion with respect to LDTs.

Under the current regulatory scheme, The Centers for Medicare and Medicaid Services (“CMS”) regulates laboratories under the Clinical Laboratory Improvement Amendments (“CLIA”), but not LDTs or their accuracy. In the LDT Guidance, FDA notes its “concerns regarding the lack of independent review of the evidence of clinical validity of LDTs,” and indicates the Agency’s intent to phase select categories of LDTs into the regulatory curtilage of devices.

Reference is made to the role of institutional review boards (“IRBs”) as they relate to studies of LDTs. For clinical investigations of LDTs conducted under clinical protocols requiring IRB approval, the Draft Guidance indicates the Agency’s intent to continue its enforcement of investigational device requirements under 21 CFR Part 812. For IVD studies not exempt from Part 812, the IRB will make a device risk assessment as part of its study review. Language within the Draft Guidance tracks language from the “Criteria for IRB Approval of Research” found in 21 CFR 56.111 as well as elements of informed consent found in regulations governing protection of human subjects at 21 CFR 50.25, further highlighting the IRB’s role of ensuring that subjects have adequate information to make an informed decision about participation in clinical research involving LDTs.

While studies of many LDTs may be exempt from 21 CFR 812’s requirements, research participants must still be apprised of the investigational nature of unapproved medical devices as well as alternatives to study participation. As changes to FDA’s LDT oversight framework take effect, Sterling will continue to focus on unique issues impacting the welfare of participants in studies involving LDTs. If you would like to learn more about Sterling services, please This email address is being protected from spambots. You need JavaScript enabled to view it. .


Article submitted by Royce DuBiner, JD, LLM

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The Future of Homeopathic Product Regulation

On March 27, 2015 FDA solicited comments on the future of Homeopathic Product Regulation via a Notice of Proposed Rulemaking (“NPRM”) that sought input on current enforcement policies from scientific, risk, and process perspectives. Homeopathic drugs are currently exempt from many of the requirements of non-homeopathic drugs under the Food Drug & Cosmetic Act, and FDA regulates based on the Compliance Policy Guide (CPG) 400.400, “Conditions Under Which Homeopathic Drugs May Be Marketed.”

The research community might one day see homeopathic products undergoing the same approval and labeling process as non-homeopathic drugs. If this happens, IRBs must be prepared to address the issues of informed consent and subject safety. Question #8 in the NPRM asks, “do consumers and health care providers have adequate information to make informed decisions about drug products labeled as homeopathic.” This question is at the heart of the informed consent process and IRBs reviewing studies of homeopathic drugs would apply the same elements of informed consent found in regulations at 21 C.F.R. § 50.25 as used in the informed consent process for studies of other FDA-regulated products. Any informed consent must include a description of reasonably foreseeable risks, benefits to the subject which may be reasonably expected, and disclosure of appropriate alternative procedures or courses of treatment that might be advantageous (among other required elements). Also, when IRBs approve a study protocol the Board adheres to the requirements found in 21 CFR 56.111 for “Criteria for IRB Approval of Research.” In order for research to be approved the risk to the subjects must be minimized and risk to the subjects must be reasonable in relation to anticipated benefits. Because of the untested nature of many homeopathic products, the IRB’s responsibilities for ensuring adequate informed consent and making risk-based determinations would be essential.

Ensuring that any future clinical trials involving homeopathic drugs respect the subjects’ safety and right to be fully informed through an approved informed consent may prove challenging for a previously unregulated industry, but Sterling IRB’s primary concern is the welfare of study participants in ethically sound research. If you would like to learn more about Sterling services, please This email address is being protected from spambots. You need JavaScript enabled to view it. .


Article submitted by Royce DuBiner, JD, LLM

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WHY CHOOSE STERLING?

Innovation. Passion. Commitment. We believe these are the essential components of strong teamwork.

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REVIEW BOARD

A diverse group of scientific and non-scientific members with nearly a century of collective IRB experience.

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RESEARCH IN CANADA

Sterling IRB has formed a strategic partnership with Veritas IRB.

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