Getting Started with Salus IRB

If you are new to Salus IRB, we will assign one of our experienced and qualified client services managers (CSMs) to serve as your project manager for the duration of your study. Your CSM will:

• Discuss your protocol, unique study requirements and timelines
• Assist in determining which submission forms and supporting documents are required for the type of research being submitted
• Assist in determining what level of IRB review is required for your research

Returning clients with a new project similar to one previously submitted to Salus IRB may submit directly following appropriate submission procedures. If you are submitting a new type of project or if you have questions, contact your CSM for assistance.

Salus offers:

• Client management services to ensure unmatched customer service and consistency between studies. A qualified, experienced client services manager is assigned to your project from study start-up to close-out
• Industry-leading review and response times
• Streamlined submission process
• Rapid study start-up
• Study start-up meeting
• Immediate notification of board decisions following meetings
• Same-day site review and approval packet distribution
• Same-day approval for minor modifications to approved research
• International review, including Canada
• Translation services
• GlobeSync™ Virtual Workspace, allowing 24/7 secure access to the complete IRB study file

Investigators

Salus IRB is flexible in working with investigators, ensuring that site policies and other local concerns are appropriately addressed.

IRB of Record

Salus IRB serves research sites that are not affiliated with an institutional or a local IRB. In these cases, Salus may serve as your IRB of record.

Academic Institutions 

For multi-site clinical trials, sponsors may ask local IRBs to cede IRB oversight to a central IRB for industry-sponsored research. Salus IRB works with academic institutions to assume the IRB obligation or to provide a cooperative review of a particular study or all outsourced studies.

Salus IRB is flexible in working with institutions, ensuring that institutional policies and other local concerns are appropriately addressed. In cases where the local IRB wishes to remain involved in receiving communication regarding Salus IRB actions, in monitoring the investigator, etc., these determinations are addressed prior to initial review and formally documented in a written agreement between both parties.

Salus IRB considers community attitudes toward research in the region the research takes place. This may include religious, economic or cultural viewpoints of potential research participants and state and local laws pertaining to research. 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.

Salus IRB provides review for:

• All phases of research in a variety of therapeutic areas and study designs in the pharmaceutical, biotech and medical device industries; and for single site, multi-site and large-scale trials
• Behavioral and social sciences research, educational methods research, data collection, repository, surveys, outcomes research, and registries
• FDA-regulated products research (21 CFR Parts 50 and 56) involving human subjects, including drugs and medical devices for human use, biological products, dietary supplements bearing a nutrient or medical claim, and cosmetics
• Research conducted or supported by the Department of Health and Human Services (45 CFR Part 46), and other federal agencies

Pre-Review

Upon submission, Salus IRB provides pre-review of the protocol and informed consent documents prior to board review. This review identifies any regulatory or ethical issues that may prevent or delay IRB review.

Board Advisory Review

Salus IRB offers a board opinion and advisory review of a draft protocol upon request.

Protocol and Informed Consent Document Development

Salus IRB can assist in developing protocols or informed consent documents upon request.

Salus IRB requires that investigators and key research team members be adequately trained to meet the requirements of the federal regulations and expectations of the board. Investigators and their research teams must have a working knowledge of Good Clinical Practices (GCPs) in conducting clinical trials in human research participants.

Salus IRB provides access to training resources to ensure that investigators are prepared to fulfill their responsibilities. Such education and training may include web-based tutorials and/or verification that appropriate training was obtained prior to initiation of research. 

Salus IRB’s affiliation with the Collaborative Institutional Training Initiative (CITI) allows us to offer our investigators and research team web-based training modules covering GCPs at no cost to you, including: 

• GCP Course (ID: 6590)
  1. Basic Course (ID: 46781)
• Principal Investigator and Research Staff (ID: 21316)
  1. Basic Course (ID: 80345)
  2. Refresher Course (ID: 80346)
• Social-Behavioral Investigators and Staff (ID: 185225)
  1. Basic Course (ID: 290344)

Other offerings for additional training include:

• Artificial Intelligence (AI) and Human Subject Protections
• Conflicts of Interest
• GDPR & Human Subjects Research in the U.S.
• Technology, Ethics and Regulations

To enroll, register on the CITI site and select “Salus IRB” from the dropdown menu under “Subscriber Organizations.”

CITI will notify Salus upon your completion of the modules. CME/CEU credit documentation for this training is available through the CITI website.

 Additional Educational & Training Resources

• OHRP Resources
• Pharmaceutical Education & Research Institute (PERI)
• Association of Clinical Research Professionals (ACRP)
• Drug Information Association (DIA)

SafeSync is Salus IRB’s web-based IRB submission delivery portal. It uses 256-bit public key encryption, allowing for secure submission without requiring a username and password. SafeSync accommodates submissions of sizable attachments not normally supported by email.

GlobeSync™ Virtual Workspace is Salus IRB’s web-based IRB document delivery repository. It provides real-time access to IRB study documents enabling more efficient document delivery. With advanced security features, including 128 bit encryption, GlobeSync™ is 21 CFR Part 11 compliant.