About Salus IRB

Our board members offer expertise as physicians, pharmacists, psychologists, nurses, attorneys, toxicologists and more. They review all phases of clinical trials in all therapeutic areas, including strong specialties in oncology, early-phase pharma, device development, social-behavioral research and educational methods.

Their industry experience in drug safety, drug development, regulatory and medical affairs, protocol development and monitoring, research and social sciences, education, patient/research participant advocacy, and support of vulnerable populations drives our mission to be the partner you expect.

As your partner, we also understand that you do not always control the timelines under which you are working. To support you in meeting your deadlines, we make sure that we are ready when you are. Salus boards meet five times a week and are supported by an administration that is responsive, readily available to provide you with guidance, and that produces industry leading turn-around times.

A lot of valuable research takes place every day, in all kinds of settings. Not all of it is subject to IRB oversight. Only regulated human subjects research (HSR) requires involvement of an IRB.

The three key elements for making an HSR determination include:

• Does the activity rise to the regulatory definition of research?
• Does the activity include human subjects?
• Is the activity regulated?

Of those activities that are determined to be regulated HSR, not all require IRB approval. Although IRB involvement is needed, only non-exempt human subjects research requires approval by the IRB.

There are two key elements when determining if research is exempt from the requirement of IRB approval:

• Does the research present no greater than minimal risk to participants?
• Does the research fit within one or more of the HHS Exemption Categories?

Applying the regulatory requirements to these determinations can be challenging, and even when applied correctly, researchers may still be asked by funding sources, publishers or regulatory agencies to provide written verification from an IRB. When applied incorrectly, an oversight could result in the need to repeat research activities, or even regulatory non-compliance.

As your partner, Salus IRB can assist in making the process easier, and offers written determinations of HSR and exemption to ensure that your regulatory obligations are met and documented.

For your convenience and to facilitate IRB review, we have developed template study documents that may be used to assist in the development of the proposed protocol and informed consent documents. The templates include the required elements of informed consent according to 21 CFR 50.25, 45 CFR 46.116 and ICH Guidelines. Although not required, utilizing these tools minimizes the need for extensive changes to study documents, allowing for the fastest review and turnaround.

In investigator-initiated and/or sponsored research, the principal investigator is responsible for all aspects of initiating and conducting the research. They must comply with both investigator and sponsor-specific regulation, in addition to adhering to the appropriate standards of their discipline.

When conducting this research outside of an academic or institutional setting, an investigator may not have readily available access to the same level of resources or regulatory support that is typically found within those larger organizations.

As your partner, Salus IRB is readily available to you and your research team throughout the life of your study to answer questions, supply instruction, give regulatory guidance or provide education.

Salus understands that our availability and support directly contribute to the protection of your participants.

Salus understands that an ounce of prevention is worth a pound of cure.

When possible, Salus IRB encourages early advisory engagement on developing studies or modifications to approved research. As a partner in the protection of your participants, we offer several options designed to make guidance available while your study is still in the development stage and prevent potential costly delays to your study start up.

• Administrative Guidance Meeting
  A virtual meeting can be requested to talk through your design, approach and/or concerns relating to participant protections and/or regulatory requirements.
• Pre-Review Assessment of Protocol Feedback
  By request, a preliminary assessment of your protocol can be provided by the IRB chairperson to obtain feedback and opinions on the protocol and/or specific elements within it.
• Pre-Read of Consent Document with Suggested Edits
  By request, a Salus consent form editor will provide a quality assurance assessment of your consent document(s) to assure appropriate application of all regulatory elements and readability.

Some research may require the use of translation services. In accordance with 21 CFR 50.20, 45 CFR 46.116 and 45 CFR 46.117, the informed consent documents shall be in a language understandable to the research participant. When the research population includes non-English-speaking participants or the investigator anticipates that the consent interviews will be conducted in a language other than English, translation services will be necessary.

Upon request, Salus IRB coordinates translation of your study documents with our preferred vendor or yours.

Salus IRB partners with both large and small research institutions, where we provide services as the local IRB for review of the institution’s research, or as the central IRB (or sIRB) in multi-site studies.

Our review services can be customized to fit the specific needs of a given institution, to support a few studies during peak periods, to only apply toward a specific type of research (e.g., SBER), to provide HSR and exemption determinations, or to provide an option for institutions (or organizations) to serve as the reviewing sIRB in a multi-site study through their partnership with Salus.

Let us know what your needs are. We can provide a right-sized solution.

Looking for more assistance in the development or management of your study? Let us know if we can assist with your regulatory, quality compliance, clinical or CRO service needs.

Although subject to the same regulations, the same principles for participant protections, and the same core determinations for IRB approval, the review of social, behavioral and educational research (SBER) requires board members and the IRB administration to have specific knowledge and experience to ensure regulatory adherence without overburdening the submission and review process.

Salus understands that the process of IRB review should not be a one-size-fits-all approach.

With a focus on human behavior, attitudes, learning and social interactions, SBER studies often employ very different research methods than those used in clinical research. They typically present less direct physical risk to participants, with more concern being given to possible harms in relation to privacy, confidentiality and emotional state, as well as risks that might extend to family members, communities or society as a whole. Ethical considerations might include issues involving the use of deception, methods of de-identification, psychological distress and suicidality, embarrassment, and social stigma.

With more than 35 years of experience, Salus IRB is an expert in the review and administration of SBER projects. We offer comprehensive reviews that appropriately prioritize participant protections, without overburdening the research by trying to make it fit into a process built for clinical trials.

Salus understands that not all research is the same, and the process for ethics review shouldn’t be either.

Research that presents no greater than minimal risk to participants is easy to overburden when forced to undergo the same submission and review processes used for higher-risk clinical trials. To prevent this problem, Salus IRB has developed specific processes for minimal-risk research, supported by a minimal-risk administrative team and board.

Minimal-risk research includes research activities where the probability and magnitude of anticipated harm or discomfort to human subjects is not greater than that ordinarily encountered in daily life, or during the performance of routine physical or psychological examinations or tests.

Regulation permits certain categories of minimal-risk research to be reviewed by the IRB chairperson or one or more designated experienced members of the convened board, using a process called expedited review. Expedited review is not a rush service, but an alternative review process designed to reduce burden and delays for qualified minimal-risk studies. Salus IRB elects to apply expedited reviews of research, whenever permitted.

A multi-site study involves the implementation of the same protocol at two or more independent investigational sites where participants are seen for an intervention and/or outcomes assessment. IRB administration of a multi-site study requires expertise to avoid unnecessary redundancies that lead to delays.

Salus IRB has been providing single/central IRB services for multi-site research for more than 35 years. We work with you prior to study initiation to establish communication flow and study timelines, discuss unique study requirements, and assist in streamlining document creation and investigator approvals across all study sites.

Our experience as a central IRB has allowed us to develop processes that include:

• Experienced administrative contact assigned to each project from study start-up to close-out
• Expedient review and response times
• Streamlined submission process
• Rapid study start-up
• Study start-up meeting
• Same-day site review and approval packet distribution
• Same-day approval for minor modifications to approved research
• Development of site-specific informed consent documents

Additional key points to consider with multi-site research:

• Single IRB (sIRB) Policy
  The primary method for managing IRB review in multi-site studies is to designate one IRB as the "single IRB of record" that will review and approve the protocol for all study sites. This approach is intended to reduce redundancy, delays and additional costs associated with multiple IRB reviews of a single study. It is a regulatory requirement when research is federally funded.
• Reliance Agreements and Local Context
  When using a single IRB, reliance agreements need to be executed between the reviewing IRB and the relying institutional sites where research will occur to establish responsibilities of both parties, and to assure that local institutional policies, state laws and relevant community context is included as part of the reviewing IRB’s determinations. Salus is willing to work directly with the relying institutions to obtain these agreements on your behalf.
• Protocol Development
  The study protocol should be written with consideration toward the prospect that potential variations may be necessary to accommodate requirements across the study sites. Where possible, the use of parameters to establish a range or scale may lend necessary flexibility as opposed to absolutes. As part of our early engagement services, Salus offers assistance in protocol development.
• Informed Consent
  Template consent documents are approved study-wide, but site-specific language should be anticipated to allow for local requirements or cultural considerations. Salus will work directly with you to manage this process.
• Adverse Event Reporting
  Salus provides a mechanism for prompt reporting and of unanticipated problems or non-compliance, as well as distribution of reporting documentation, where needed.