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Institutional Policies

Policy RSCH-VP-004

logo of The University of Southern Mississippi  
Responsible University Administrator: Vice President for Research
Responsible Officer: Director of the Office of Research Integrity
Origination Date: N/A
Current Revision Date: 05/21/18
Next Review Date: 05/21/22
End of Policy Date: N/A
Policy Number: RSCH-VP-004
Status: Effective

 

HUMAN SUBJECTS RESEARCH


 


Policy Statement


Human Subjects Research at The University of Southern Mississippi should advance knowledge through well-designed and approved projects. Such research must be conducted in compliance with sound ethical principles, applicable laws and regulations, and only with the approval and oversight of the University’s Institutional Review Board.

Reason for Policy/Purpose


The University of Southern Mississippi is committed to the integrity of research, scholarship, and creative activity. As such, it requires research on human beings to be conducted only in accord with widely accepted best practices and ethical principles and applicable laws and regulations. 

The policy and procedures described herein are intended to define and describe The University of Southern Mississippi’s expectations and responsibilities with respect to human subjects research. It is consistent with the University’s obligations under federal regulations, including Federal Policy for the Protection of Human Subjects (last updated 1/19/2017). The University’s Institutional Review board operates under a Federalwide Assurance (FWA) on file with the Office for Human Research Protection (OHRP, Registration number: FWA00002393) in the U.S. Department of Health and Human Services.

Who Needs to Know This Policy


This policy applies to all members of the University Community involved in human subjects research: faculty members; teaching and support staff; research coordinators, technicians, and postdoctoral and other fellows; graduate and undergraduate students; volunteers; agents; and contractors, sub-recipients, and their employees. In addition, all members of the University Community involved in human subjects research are responsible for participating in the University’s Research and Scholarly Integrity Assurance Program and for being well-informed of the relevant best practices for human subjects research.

Website Address for this Policy


usm.edu/institutional-policies/policy-rsch-vp-004

Definitions


 

Human Subject         A living individual about whom an investigator obtains 1) data through intervention or interaction with the individual, or 2) identifiable private information.
Investigator

Anyone who participates in the design, conduct, or reporting of a research or scholarly project, regardless of discipline, title, or position. The Principal Investigator (PI) is the lead researcher and bears primary responsibility for the project.

Generally, student advisors and committee members are not co-investigators and should not be listed as such on IRB applications.  However, it is advisable to designate advisors and other mentors as co-investigators when they may be co-authors on publications derived from student projects.

Institutional Review Board (IRB)   The University’s Institutional Review Board.
Office of Research Integrity (ORI)  Administrative Unit at the University of Southern Mississippi responsible for overseeing Human Subjects Research conducted by University-affiliated personnel.
Office of Human Research Protections (OHRP)   The Office within the federal Health and Human Services Agency responsible for monitoring federally funded research involving human subjects.
Protected Health Information (PHI) Protected Health Information, as defined by the Privacy Rule at 45 CFR parts 160 and 164.
Research  A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. 

Policy/Procedures


1.0       General Principles

 

1.1        Human subjects research conducted at or supported by the University will honor the three ethical principles enshrined in the “Belmont Report”: respect for persons, beneficence, and justice. These general principles require that human research subjects, a) will not participate in research unless and until they have given voluntary and informed consent, b) persons under the age of 18, legal incompetents, and those unable to consent may participate in research only with consent from a parent or legal guardian and, when possible, their assent, c) confidential information received from participants will be fully protected within the limits of the law, both during and after research is conducted, d) subjects may withdraw their participation at any time without penalty or loss of benefits to which they would otherwise be entitled, e) burdens put on research participants must be reasonable relative to anticipated benefits to themselves and to society as a whole, f) the selection of research participants must be equitable and defensible in terms of both the goals of the research and general considerations of fairness.

 

2.0       Oversight

 

2.1        Human subjects research at The University of Southern Mississippi falls under the purview of the IRB and the Office of Research Integrity, both of which report to the Vice President for Research. The IRB has the authority to review, approve, disapprove, and request modifications to all human subjects research performed under the aegis of the University. Other University officials may review, approve, disapprove proposed or ongoing research, however, these officials do not have the authority either to approve research that has not been approved by the IRB or to overrule the judgment of the IRB. 

 

2.2        IRB review and approval is required for all projects that both constitute research and involve human subjects in the senses defined above.

 

IRB review is required for graduate theses and Honors theses involving human subjects. Oral history projects, even when they involve interviews, are not considered research. Most student projects and class assignments also are not research and do not require review. However, academic programs or departments may request IRB review of projects that do not necessarily satisfy the above definitions. Investigators who are uncertain as to whether their projects require IRB approval should seek clarification from the IRB or ORI.

 

2.3        In the considered judgment of the IRB, Chair of the IRB, or the Vice President for Research, if at any time research puts human subjects in imminent danger or violates subjects’ rights, the relevant activities may be suspended until concerns have been adequately addressed. If at all possible, this will occur only after notification and consultation with the Principal Investigator.

 

2.4        Unapproved use of human subjects or unauthorized deviation from an approved IRB protocol may constitute scholarly misconduct according to the University’s Scholarly Misconduct Policy and thus may result in disciplinary action. Students conducting human subjects research without an approval protocol will not be allowed to use this work towards fulfillment of degree requirements of the Graduate School or Honors College.

 

2.5        If directly relevant to its responsibility to protect human subjects, the IRB has a right to request research records from investigators at any time.

 

2.6        IRB approval for multi-site research projects depends on the details of the project and is best approached by first contacting ORI for coordination and consultation. Multi-site, non-exempt research funded by NIH is subject to guidance requiring the use of a single IRB (sIRB). (See NOT-OD-16-094).

 

3.0       Responsibilities

 

3.1     Institutional Review Board Responsibilities

 

3.1.1    The IRB is responsible for ensuring that human subjects research complies with applicable ethical principles, laws and regulations. It has the right to decline, withdraw or suspend approval of any proposed or ongoing human subjects research.

 

3.1.2    The IRB is responsible for reviewing submitted protocols and protocol modifications in a timely fashion and for providing constructive feedback to investigators when relevant to the protection of human subjects

When unanticipated problems and adverse events occur, the IRB is responsible for reviewing the events, for recommending corrective actions and protocol modifications when appropriate, and for prompt reporting to the Office of Human Research Protections (OHRP) when required. 

 

3.1.3    Members of the IRB must respect the confidentiality of information about participants and investigators learned while reviewing submitted protocols.

 

3.1.4    Members of the IRB must complete and keep current the appropriate training relevant to human subjects research. This includes completing both the designated CITI “Common Course” and the CITI Human Subjects Research Course in the University’s Research and Scholarly Integrity Assurance Program (formerly RCR) or their equivalents. 

 

3.2       Investigator Responsibilities

 

3.2.1    Investigators are responsible for acknowledging the authority of the University’s IRB and for complying with its determinations.  They must conduct human subjects research in accord with best practices and sound ethical principles, protecting the rights, safety and welfare of research participants. 

 

3.2.2    Principal Investigators are responsible for submitting accurate and detailed Human Subjects Research Applications to the IRB. Descriptions of planned research must not materially conflict with or deviate from information provided to extramural funding agencies or other committees.  Data collected for faculty or student research purposes that are not covered by an active, IRB-approved protocol cannot be used no matter what; retroactive approval will not be granted under any circumstances. 

 

Until data collection and analysis is completed, investigators must submit renewal forms to the IRB at least annually and more frequently if specifically requested by the IRB. Data collection and analysis not covered by a currently approved protocol must terminate. Human subjects research conducted by students prior to formal IRB approval cannot be used towards fulfillment of degree requirements or for Latin designations.

 

When conducting human subjects research away from the USM campus, such as at a public school or another university, investigators are expected to secure all appropriate permissions before collecting data.  Depending on the external entity involved and applicable policies, this may require permission letters from non-USM authorities or approval from other institutions’ IRBs.      

 

3.2.3    Investigators must not initiate research until a formal IRB approval letter has been received. Retrospective IRB approval will not be granted under any circumstances.

           

Informed consent must be received from research subjects before conducting research, unless a waiver of consent has been received from the IRB. Prior to the use or disclosure of Protected Health Information (PHI), researchers must obtain valid authorization for its use or disclosure or must have received a waiver of authorization from the IRB.  

 

For studies requiring pre-registration through ClinicalTrials.gov, research subjects must be informed of and understand that the study will be pre-registered at this site. 

 

3.2.4    Any changes from an approved IRB protocol, including changes involving participants, collaborating investigators, informed consent procedures or research instruments, must be reported to and approved by the IRB before implementation, using the protocol modification form.

 

3.2.5    Investigators must report unanticipated problems and adverse events to the IRB promptly using the unanticipated and adverse event reporting form. In response to the incident, investigators also must take whatever corrective actions and modifications are recommended by the IRB.

 

3.2.6    Investigators are responsible for completing and keeping current the appropriate training prior to conducting human subjects research. This includes completing both the designated CITI “Common Course” and the CITI Human Subjects Research Course in the University’s Research and Scholarly Integrity Assurance Program (formerly RCR) or their equivalents.  Completion of optional Human Subjects Research Course modules may be required, depending on the nature of the research.

 

3.2.7    Investigators must at all times respect the confidentiality and privacy of participant information in their possession. Research records, including signed consent documents, must be maintained for at least three years, in accord with 45 CFR 46.115(b) and 45 CFR 46.117, and longer, if necessary to comply with discipline specific guidelines. Authorizations for the use and/or disclosure of PHI must be kept for a period of six years. Investigators must comply with reasonable requests to provide pertinent information to oversight bodies, consistent with participants’ confidentiality and privacy rights.

 

3.2.8    Unless required by the grant sponsor, submitting an IRB application is not required prior to submitting grant applications involving human subjects research through the University’s Office of Research Administration. However, investigators should be mindful that grant funds may not be expended until IRB approval for the funded research has been received.  PIs are thus encouraged to submit IRB applications soon after receiving positive indications from the grant sponsor (such as a favorable NIH score) that their proposals will be funded. (For additional information regarding the NIH “Just-in-Time” (JIT) system, consult NIH/OER/OPERA 12/21/2016 Request for Just-In-Time Information.)

 

3.2.9    It is the responsibility of the Principal Investigator (PI) to ensure that all personnel involved in research procedures are adequately trained and competent to perform their assigned roles.  When studies involve invasive or biomedical procedures, such as blood draws, vigorous exercise, or urine screenings, the competence of the investigators, students and other assistants to perform their assigned duties must be documented and approved by the IRB prior to initiating such research.  For many kinds of relatively low risk Category 1 procedures (such as those described in the Appendix below), competency may be established adequately by the trainer or PI by observing and documenting satisfactory performance. In general, undergraduate students may be competent to perform certain Category 1 procedures on their own, pending appropriate training and evidence of proficiency, but will not be permitted to conduct higher risk procedures without direct supervision.

           

In addition, the IRB expects that adequate medical emergency provisions and personnel will be in place when invasive procedures are being performed.  In some research contexts, the IRB may determine that calling 911 is sufficient as an emergency medical procedure, but only if there are two investigators present whenever procedures are being performed and both have current CPR certification through the American Red Cross or the American Heart Association.  In other contexts, these provisions may not be sufficient, and the presence of other medically licensed and registered personnel will be necessary. Relevant to such determinations by the IRB will be guidance from authoritative bodies, such as the American College of Sports Medicine.

 

3.3          Department Chairs and Student Advisors

 

3.3.1      After reading them carefully and approving them, IRB applications must be submitted by Department Chairs or Unit Directors and signed by Chairs or Directors and research advisors (if applicable).

 

3.3.2      As with investigators, submitting Chairs, Directors and Student Advisors must have completed the University’s designated CITI Common Course and the CITI Human Subjects Research Course or their equivalents. CITI certificates for Student Advisors need to be attached to student submissions; CITI certificates from department chairs and unit directors need not be attached.

 

3.4          Office of Research Integrity

 

3.4.1      ORI is responsible for ensuring that IRB oversight of human subjects research at the University is effective and timely and that problems pertaining to human subjects research are addressed and resolved promptly. 

 

3.4.2      ORI is responsible for ensuring that appropriate training opportunities are available for committee members and researchers alike. 

 

3.4.3      ORI is responsible for administering IRB submissions and scheduling IRB meetings.

 

3.4.4      ORI must ensure that the IRB’s Federalwide assurance is maintained and up to date and that it keeps abreast of relevant regulatory updates. 

 

3.4.5      With the advice of the IRB, ORI is responsible for updating this policy and the relevant website materials as necessary.



Review


The Director of the Office of Research Integrity is responsible for the review of this policy every four years (or whenever circumstances require immediate review).


Forms/Instructions


Human Subjects Review Forms: http://www.usm.edu/research/human-subjects-review



Appendices


Classification of Research Procedures*

 

Category I Biomedical Procedures

The following are non-diagnostic and non-therapeutic measures performed in an investigator’s laboratory or other non-clinical setting. Conditional upon satisfactory training and documentation of competency, the IRB may determine that personnel lacking formal medical certification may perform these procedures on their own, without further certification.  However, depending on other factors, such as the participant population being studied, the IRB may also require enhanced safeguards, as determined on a case-by-case basis. The list below is not comprehensive:

 

Vital signs; Skin folds measures and waist circumference; Dip urinalysis; Finger sticks; DXA and pQCT scans with ISCD certification; Resting electrocardiogram (ECF), no interpretation of results; Resting metabolic rate; Screening urine pregnancy test; Pulmonary function testing, non-diagnostic; Treadmill usage (population dependent); Exercise stress test (per ACSM standards, population dependent, and depending on intensity/duration of test); Spirometry, non-diagnostic;  Electroencephalogram (EEG), non-diagnostic; Surface electromyography (EMG), non-diagnostic; Bioimpedance; Underwater weighing; Bod Pods; Metabolic Chamber.

 

Category II Biomedical Procedures

These biomedical procedures will be evaluated by the IRB on a case-by-case basis:

Blood draws by venipuncture; Compartment pressure; Micro-dialysis; Ultrasound; Dietary restrictions and nutritional supplements; Exercise intervention; Microneurography; Esophageal probe/nasogastric tube insertion; Fine wire/intramuscular electromyography (EMG), non-diagnostic.

 

Category III Biomedical Procedures

These biomedical procedures are to be performed only by certified, appropriately licensed personnel: 

Clinician assessment, medical history and examination; Medications; Off-label use; Intravenous catheter (IV) insertion and maintenance; Blood draw by IV; IV drug infusion; Titration; Magnetic Resonance Imaging (MRI); Sutures; Physician’s orders

 

*These materials adapted from Penn State’s IRB Guideline VIII – Biomedical Procedures Performed in a Non-Clinical Setting, accessed September 4, 2014, at http://www.research.psu.edu/policies/research-protections/irb/, approved January 11, 2011. 

 


Related Information


Title 45 CFR Part 46: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html

 

Federal Policy for the Protection of Human Subjects: https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-01058.pdf

 


History


Amendments: Month, Day, Year – summary of changes

02/24/1997: Amended.

5/30/15: Substantially Revised.

03/07/13: Initially formatted for template.

09/21/17: Modified, clarifying that training certificates need to be kept current (3.1.4, 3.2.6). 05/21/18: Clinical Trials registration (3.2.3).


 

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