IRB and Human Subjects Research

The Catawba Valley Medical Center Institutional Review Board (IRB) is responsible for ethical and regulatory oversight of research at CVMC involving human subjects. All research involving human subjects or information about human subjects, which are patients or employees of CVMC, must be reviewed and approved by the IRB before research begins.

The purpose of IRB review is to assure human subjects are ethically and responsibly treated. CVMC is committed to protecting the rights and welfare of human subjects. Consistent with this commitment, the IRB ensures that:

The rights and safety of human subjects are adequately protected
The risks to subjects are outweighed by the potential benefits of the research
Research investigators are properly trained in the protection of human research subjects
Research conducted with human subjects conforms to all applicable local, state, federal laws and regulations, and CVMC policies

About the Institutional Review Board

The IRB is the committee designated by CVMC to review research studies involving human subjects conducted by CVMC employees and affiliated students. CVMC respects its patients, their rights, and the confidentiality of their medical information in human subjects research. The IRB reviews research and clinical investigations/trials that are conducted at CVMC involving subjects who are currently, have been, or could by study design become patients of CVMC and/or subjects who are currently or have been CVMC employees. The IRB acts in accordance with the ethical principles of respect for persons, beneficence, and justice in its review and monitoring of human subject research.

The Organization’s IRB holds a Federal Wide Assurance (FWA) from the Office for Human Research Protections (OHRP) in the Department of Health and Human Services (HHS). The FWA is a written assurance of compliance with HHS regulations, 45 CFR part 46. FWAs are approved by OHRP for federalwide use meaning other federal departments and agencies that have adopted the Federal Policy for the Protection of Human Subjects (also known as the Common Rule) may rely on the FWA for research they regulate, conduct, or support. Our Federal Wide Assurance, FWA00008614, is updated at regular intervals.

Membership Policy & Procedures

Applying for IRB Review

IRBApplyReview Whether you are a seasoned or novice investigator interested in conducting research at CVMC, the resources needed for developing your proposal for IRB review can be found here. Protecting Human Research Participants (PHRP) training is required for the primary investigator, co-investigator(s), and key study personnel prior to submitting an IRB application. If requesting review of a FDA-approved clinical trial, Good Clinical Practice (GCP) training is required. The Roche TransCelerate-approved GCP course is online and free of charge.

To access the Investigator Manual, IRB Application, Submission Cover Memo, Informed Consent Checklist, Consent Waivers Request, Continuing Review & Closure Form, etc., click on the following links. Consult Kimberly Yates, Department for Research and Evidence-Based Practice Administrator, prior to beginning the research process at research@cvmc.us or 828.326.3251.

Medical Chart Review IRB Application Tests/Surveys/Interviews/Observation IRB Application IRB Application Informed Consent Checklist Informed Consent or Assent Waiver Request Student Project/Concept Request Continuing Review Form Study Closure Form Study Amendment Request Form Study Withdrawal Form

Becoming a Research Volunteer

You or a family member may want to participate in a research study at some point. If so, you should become well informed before deciding. Learn more in the Office for Human Research Protections (OHRP) brochure provided below:

Becoming A Research Volunteer: It’s Your Decision

Research and Evidence-Based Practice

Research and evidence-based practice support the CVHS Mission – Exceptional healthcare. Every Patient. Every Time. CVMC, though not a large academic medical center, is committed to providing resources for employees and affiliated students to conduct research that has clinical relevance to the organization. The Department for Research and Evidence-Based Practice assists with study design, proposal development, IRB submission, data analysis, abstract and presentation preparation and critique, and manuscript composition. Novice researchers benefit from an assigned clinical mentor and an experienced research sponsor.

New knowledge is constantly being generated and the rate at which research is published is phenomenal. This makes it challenging for healthcare providers to remain abreast of the growing body of evidence. Implementing best evidence does not always keep pace with scientific discovery. So how does one keep his/her practice current? Evidence-Based Practice. Our EBP Model depicts the steps of the evidence-based practice process. The Model provides the framework for evaluating and implementing EBP interventions. The Department for Research and Evidence-Based Practice provides direction for EBP projects to promote new practices and warranted practice changes.

CVMC EBP Model