Research Review Services

Research Review Services

Salus IRB provides single-site, multi-site (single IRB/central IRB), and international research review services for clinical trials, including pharmaceutical and biotech.

Versiti Clinical Trials’ Salus IRB has experience serving as the local IRB for research sites across the U.S. that are not affiliated with an academic institutional or local IRB. Salus IRB is flexible in working with research sites, ensuring that site policies and other local concerns are appropriately addressed.

Single-Site Services

Salus IRB Offerings

  • An experienced, qualified client services manager assigned to each project from study start-up to close-out
  • Expedient review and response times
  • Streamlined submission process
  • Rapid study start-up
  • Same-day approval for minor modifications to approved research
  • Development of site-specific informed consent documents
  • GlobeSync™ Virtual Workspace allowing 24/7 secure access to the complete IRB study file


Regional Considerations

Salus IRB considers community attitudes toward research in the region where the research will take place. This may include the religious, economic or cultural viewpoints of potential research participants. Salus acknowledges that certain state and local laws pertaining to research may be more restrictive than federal regulations. Providing this information to Salus is essential to the protection of research participants and is intended to contribute to the meaningful consideration of various local factors.

Final IRB Approval

Research cannot begin until Salus IRB has granted final approval in writing. The Salus IRB-approved informed consent document(s) must be used when consenting research participants.

Investigator-Initiated/Sponsored Research

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

Why Salus?

When Salus IRB reviews investigator-initiated/sponsored research, it aims to foster a consultative relationship with investigators. During the pre-review process, an experienced, qualified client services manager (CSM) guides the investigator/sponsor through the submission and review process, assisting with protocol and informed consent form development when needed.


Protocol Review

The board evaluates protocols by ensuring they are scientifically sound so that the results may likely develop or contribute to generalizable knowledge. The board considers the adequacy of the following in evaluating whether research design and conduct are sound and will meet the stated objectives of the protocol:

  • Dosage of investigational drug or the use of an investigational device
  • Type(s) of procedure(s), length of enrollment and number of participants
  • Sufficiency of study design
  • Safeguarding of sensitive information collected

Monitoring

The principal investigator must develop a data safety monitoring plan or comply with the existing data safety monitoring plan of the study. Such plans must be disclosed to Salus IRB. Monitoring may be conducted by the principal investigator, the sponsor or an independent monitoring board. In studies where the sponsor has a plan to monitor the research, the board requires the sponsor or investigator to report, directly to Salus IRB, any findings detected during the monitoring process that could directly affect participant safety, rights or welfare, or alter the board’s approval of the study.

Template Study Documents

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.

Final IRB Approval

Research cannot begin until Salus IRB has granted final approval in writing. The Salus IRB-approved informed consent document(s) must be used when consenting research participants.

Single/Central IRB Review Services

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

Salus IRB Offerings

  • An experienced, qualified client services manager 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
  • GlobeSync™ Virtual Workspace allowing 24/7 secure access to the complete IRB study file


International Review Services

Salus IRB has experience providing IRB review for international sites. When Salus reviews research in countries other than the U.S., it considers information on local laws and attitudes and welcomes the assistance of the investigator and/or sponsor in obtaining this information.

International Research

For international research, Salus IRB prefers to coordinate with a local IRB or other review committee overseeing the research, in order to ensure that the research is culturally acceptable. However, we will consider international research in which there is no local IRB, provided the board is able to receive adequate information about the cultural acceptability of the research. This may be accomplished by consulting with experts about local laws and attitudes related to the research, obtaining information from a knowledgeable source, and/or referring to the International Compilation of Human Research Protections compiled by the Department of Health and Human Services.

Research in Canada

Salus IRB assists sponsors by facilitating the IRB review of sites in Canada by partnering with an accredited Canadian research ethics board (REB). While Salus does not provide monitoring or oversight for research sites in Canada, we have an alliance agreement with a Canadian REB that provides review and oversight for Canadian sites.


Translation Services

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.