Conducting Research at SPC Approval Process and Procedures

April 2011

Conducting Research at SPCApproval Process and Procedures

Center of Excellence for Teaching and Learning

http://www.spcollege.edu/

St. Petersburg College

Conducting Research

All research conducted at SPC involving human participants must be approved.

In lieu of a formal Institutional Research Board (IRB), SPC has a Research Review Committee (RRC).

Committee was started in 2007 and is composed of faculty, program administrators, and other college staff.

April 29, 2011 Conducting Research at SPC 2


Purpose of the Committee

“To review, approve, and monitor research studies conducted by employees or others outside the College involving students, faculty, staff, alumni, or other College resources for purposes of protecting human rights and supporting the interests of the College.”

Board of Trustee Rule 6H.23.908, Conducting Educational Research


http://www.spcollege.edu/central/BOTrules/R3/3_908.doc




Website


http://www.spcollege.edu/central/AE/Research/




Research Review Committee

DeeDee Watts, Faculty, Co-Chair Jesse Coraggio, AE, Co-Chair Beth Carlson, Faculty Carol Weideman, Faculty Richard Flora, Dean Conferlete Carney, Tarpon Springs Provost Suzanne Gardner, General Counsel Anne Cooper, Leadership Sponsor



Definitions

Research study is defined as “research” (See Code of Federal Regulations, 45 CFR 46.102 (d)) that involves “human subjects” (See Code of Federal Regulations, 45 CFR 46.102(f)).

Research is defined as "a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge" according to the Code of Federal Regulations, 45 CFR 46.102 (d).



Definitions

Human subject is defined as an “individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual or identifiable private information” according to the Code of Federal Regulations, 45 CFR 46.102(f).



Definitions

Minimal risk is defined as the “probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests,” according to the Code of Federal Regulations, 45 CFR 46.102 (i).



Forms

Application for Research Study



Application for Research Study

Researcher Information Sponsor Information Type of Proposed Research Research Proposal and Design Assurances



Assurances

Request to conduct research that is governed by Board of Trustees Rules of St. Petersburg College, as well as state and federal law concerning educational research, privacy and confidentiality.

Agree to follow all guidelines and regulations of this institution, and will maintain the confidential nature of records and the privacy rights of all participants.

Agree that St. Petersburg College will be provided a copy of the completed research study product.

Agree that under no circumstances can research proceed until given notification of approval of this Application by the Research Review Committee, and have executed the “Access to Confidential Data Researcher Agreement.”



Forms

Access to Confidential Data



Access to Confidential Data Form

Unauthorized disclosure of confidential information is illegal

Data, data sets or output reports are confidential and the information is to be protected

Final reports may only report on students in aggregate summaries and not individually.



Forms

Research Review Committee Checklist



Research Review Process

All requests must be filed with the AEA Department with a signed Application for Research Study along with the following: Signed Access to Confidential Information agreement; Copy of the research proposal; Copies of any consent forms; Copies of any assessment instruments (tests, surveys,

questionnaires, or interview scripts); Copy of the Institutional Research Board (IRB) application, if

any, submitted to another institution; Copy of the IRB approval letter, if applicable; and Evidence of Human Participant Training.




RRC will convene to assess completed application packets and will determine whether the application will be approved or denied based on the level of risk to participants and the best interests of the college.

RRC will review to ensure that the research shall not violate any state or federal law pertaining to the protection of privacy and present only a minimal risk to participants.




Co-chairs of the RRC (or designee) will notify the applicant(s) of the approval or rejection of the application.

If further participation in the project is considered to be not in the best interest of the college, the researcher will be notified of the rejection immediately.

The researcher(s) submitting the application will be required to supply the AEA department with a complete, final version of the research report for placement in the central research files.




An Annual Update Form will be required to be filed by the research applicant with the AEA Department.

Where the research has not been completed within the allotted twelve months, the applicant(s) may request an extension of time.



Timeline

Due to the involvement of many participants in the process, application review make take up to a month or longer to complete.

Frequently, applicants are asked follow-up questions by the RCC to ensure a thorough understanding of the research



Exceptions…

Student course assignments are generally not considered “research” under the federal definition as these course assignments are not “systematic data collection” efforts intended to “develop or contribute to generalizable knowledge.”

Therefore, student course assignments generally do not require the RRC review, approval, and monitoring.



Exceptions…

However, when student course assignments are in fact systematic data collection efforts intended to “develop or contribute to generalizable knowledge,” they are considered a research study and are subject to RRC review, approval, and monitoring.



Research Intent

One clear example that the activity is a research study is the intent to publish or otherwise disseminate the results of the research activity.

Faculty and/or students intending to publish such course assignments must complete an Application for Research Study and submit it to the RRC for review and approval prior to beginning the assignment.



Institutional Research

Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as: research on regular and special education

instructional strategies, or research on the effectiveness of or the

comparison among instructional techniques, curricula, or classroom management methods



Moratorium

Due to the amount of research applications and the limited resources, a moratorium exists on all research conducted at SPC by outside parties



Related Web Resources

Compliance and Integrity Links The Office of Human Research Protections The Office of Research Integrity (ORI) The Belmont Report Nuremberg Code Protecting Human Subjects Training University of South Florida IRB


http://www.hhs.gov/ohrp/

http://www.ori.dhhs.gov/

http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html

http://www.hhs.gov/ohrp/archive/nurcode.html

http://www.hrsa.gov/humansubjects

http://www.research.usf.edu/cs/irb.htm

http://www.research.usf.edu/cs/irb.htm


Related Web Resources

Federal Documents Title 21 CFR - Part 50 - FDA Policy on Inform

ed Consent Title 21 CFR - Part 50D - FDA: Additional Safe

guards for Children Title 21 CFR Part 56 - FDA Policy on IRBs Title 45 Public Welfare, Part 46, Protection of

Human Subjects


http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr50_01.html

http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr50_01.html

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50&showFR=1&subpartNode=21:1.0.1.1.19.4

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50&showFR=1&subpartNode=21:1.0.1.1.19.4

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=56

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html


Next Steps

Designing a standardized rubric to evaluate research

Creating a ‘expedited’ process for research that constitutes only a ‘very’ minimal risk to participants (e.g., survey with no identifiable participant information)

Establishing Program Administrator assurance of research rigor




Questions

April 2011

Conducting Research at SPCApproval Process and Procedures

Center of Excellence for Teaching and Learning

http://www.spcollege.edu/