The federal Department of Health and Human Services, Office for Human Research Protections, has established “Code of Federal Regulations (C.F.R.)” relating to federal funding for research involving human subjects which "applies to all research involving human subjects conducted, supported or otherwise subject to regulation by any federal department or agency which takes appropriate administrative action to make the policy applicable to such research." State and private funding agencies may follow federal guidelines when considering human subject research or, they may have adopted their own guidelines. 45 C.F.R. § 46.
Accordingly, principal investigators who are preparing proposals for funding of research that involves human subjects must investigate whether the sponsor/funding agency will require compliance with policy regarding human subject research.
A substantial amount of research is exempt from federal policy involving protection of human subjects. Exempt research includes normal educational practices, educational tests, studies using existing data, certain public demonstration projects and certain studies involving taste, for equality and consumer acceptance. 45 C.F.R. § 46.
The specific details of these exemptions can be found in the federal regulations. The regulations are available at: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.
Research Covered by Human Subject Protection
If the proposed research is covered by federal, state or private funding agency policy relating to the human subject protection, it is the responsibility of the principal investigator (with the assistance of the Research & Grants Administration) to meet the standards required by the funding agency. Most often this will require an Institutional Review Board approval of the proposed research prior to submission for funding.
Robert Morris University maintains a registered Institutional Review Board and has filed appropriate assurances with the Office for Human Research Protections. The Robert Morris Institutional Review Board meets periodically to consider proposed nonexempt research. The principal investigator should take the Institutional Review Board's meeting schedule and time frames for making decisions into account when planning a research funding submission that requires its approval.
The Robert Morris University Institutional Review Board policies, procedures and forms are located at: http://sentry.rmu.edu/web/cms/departments-offices/research-outreach/irb/Pages/default.aspx
Specifically, the Institutional Review Board requires submission of proposals for full board review at least two weeks prior to the Institutional Review Board's meeting at which the proposal will be considered.
Certain “research” activities that present no more than minimal risk to human subjects, and involve only procedures listed in [federally approved] categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 45 § 46.
These categories include:
• certain drug studies, some collection of blood samples,
• collection of biological specimens,
• some collections of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice (with exceptions),
• non- exempt research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis),
• collection of data from voice, video, digital, or image recordings made for research purposes,
• research on individual or group characteristics or behavior or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies
• continuing review of some research previously approved by the IRB
The Robert Morris University Institutional Review Board has an application for expedited review (labeled "Exempt Review Application") and has adopted procedures relating to expedited review. They can be found at: http://sentry.rmu.edu/web/cms/departments-offices/research-outreach/irb/Pages/default.aspx
In general, participants in research studies subject to standards promulgated by the Office for Human Research Protections (parents for children under the age of 18) or otherwise subject to Institutional Review Board jurisdiction must provide informed consent for their participation.
Robert Morris University has promulgated guidelines for informed consent which may be found at: http://sentry.rmu.edu/web/cms/departments-offices/research-outreach/irb/Pages/default.aspx