Office of Research Integrity

SOP Manual updated

Virginia Painter — Tue, 18 Jun 2013 18:26:14 +0000

The Office of Research Integrity’s Human Research Protection Program (HRPP) Standard Operating Procedures (SOP) have been updated.

If you have any questions or comments about the new manual, please feel free to call 304.696.4303.

Promoting ethical conduct of research and ensuring the university’s solid commitment to compliance with all applicable regulations and accreditation standards

Virginia Painter — Mon, 04 Mar 2013 21:51:25 +0000

Application Forms updated

Virginia Painter — Thu, 19 Apr 2012 14:00:14 +0000

The Initial Application Forms for IRB #1 and IRB #2 have been updated.

Please be sure you are using the most recent versions of the forms by downloading them from our website at the following links: IRB #1 IRB #2.

If you have any questions or comments about the new forms, please feel free to call 304.696.4303.

New Investigator’s Manual for Human Subject Research

Virginia Painter — Wed, 22 Feb 2012 13:31:12 +0000

New Human Research Protection Program brochure released

Virginia Painter — Wed, 13 Apr 2011 18:33:19 +0000

Office of Research Integrity to present Conflicts of Interest in Clinical Research workshop

Virginia Painter — Thu, 20 Jan 2011 19:17:59 +0000

Human Research Protection Program awarded reaccreditation

Virginia Painter — Fri, 01 Oct 2010 18:07:50 +0000

Are Chart Reviews Expedited or Exempt?

John Cummings — Mon, 16 Aug 2010 20:18:40 +0000

There is often confusion as to the category of chart reviews.

The Code of Federal Regulations (45CFR46.101(2)) states that a study can not be exempt if “information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and ii) Any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.”

The key here is what information will be recorded. If you are going to record any identifiers (or links) and the information recorded is of a sensitive nature, then you should submit the study for Expedited review.

When submitting a chart review for Institutional Review Board (IRB) approval, a list of information that will be recorded must be included so the chair can make a determination as to whether the study can be Exempted or Expedited.

If the study will be submitted for Expedited approval, remember to include the Expedited Protocol Assessment Form as part of your submission packet.

New Closure Request Form

John Cummings — Mon, 16 Aug 2010 12:50:55 +0000

A Closure Request Form has been added to each IRB page to assist in the information needed to close a study.

You should not only use this form but should also attach a brief summary of the study results. This will benefit you for future reference since the data from the website is never deleted.

Federal Guidance on Protecting Human Subjects

John Cummings — Fri, 30 Oct 2009 16:41:57 +0000

The Food and Drug Administration (FDA) has issued the final version of a guidance titled, "Investigator Responsibilities – Protecting the Rights, Safety, and Welfare of Study Subjects."

The guidance addresses investigator responsibilities in research with drugs, biologics, and medical devices.

The guidance can be found by clicking here.