Institutional Review Board

The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in research. To accomplish this purpose, IRBs review research proposals, protocols, and related materials. All research must be submitted to and receive approval from the IRB prior to initiation of the research. The IRB Chair, Vice-Chair, or a designated authority will review the submission and determine what level of review is necessary according to OHRP guidelines.

Specifically, the IRB will review the proposed research project to ensure:

• the risks to human research subjects are minimized by using procedures that are consistent with sound research design and that do not unnecessarily expose the research participants to risk, and whenever appropriate, by using procedures already being performed on subjects for diagnosis or treatment purposes.
• the risks to human research subjects are reasonable in relation to the anticipated benefits (if any) to the individual, and the importance of the knowledge that may be expected to result.
  • For the purpose of IRB consideration, “benefit” is defined as a valued or desired outcome; an advantage.
  • For the purpose of IRB consideration, “risk” is defined as the probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. In evaluating risk, the IRB is to consider the conditions that make the situation dangerous, per se (i.e., as opposed to those chances that specific individuals are willing to undertake for some desired goals).
  • In evaluating risks and benefits, the IRB considers only those risks and benefits that may result from the research (i.e., as distinguished from risks and benefits of treatments or procedures that the patient would undergo if not participating in the research).
  • In evaluating risks and benefits, the IRB does not consider possible long-range effects of applying knowledge gained in the research (e.g., the possible effects of research on public policy).
• the selection of human subjects for research participation is equitable.
• human research subjects are adequately informed of the risks and benefits of research participation and the procedures that will be involved in the research; and that informed consent is obtained from each prospective human research subject, or his/her legally authorized representative, in accordance with, and to the extent required by federal regulations and IRB policies.
• informed consent of human research subjects is obtained in advance of research participation and appropriately documented in accordance with, and to the extent required by federal regulations and IRB policies.
• the research plan, when appropriate, makes adequate provisions for monitoring the data collected to ensure the safety of human research subjects.
• there are adequate provisions to protect the privacy of human research subjects and to maintain the confidentiality of research data.
• appropriate additional safeguards have been included in the study to protect the rights and welfare of human research subjects who are likely to be vulnerable to coercion or undue influence (e.g., children, prisoners, pregnant women, decisionally impaired persons, or economically or educationally disadvantaged persons).

Thus, the IRB ensures that the University, affiliate institutions, and the investigators that it serves are compliant with the ethical standards and regulations governing human subject research.

The President of Capitol Technology University has delegated authority, through the Vice President for Academic Affairs (the designated Institutional Official) to establish the Capitol Technology University Institutional Review Board (IRB) to review, to approve, require modifications to (to secure approval), or disapprove all research activities falling under the human research protection program of Capitol Technology University.

The Capitol Technology University’s human research protection program encompasses all activities wherein Capitol Technology University faculty, students, staff or facilities are engaged in the conduct of research.

The executive management of the IRB will consist of an IRB Chair and IRB Vice-Chair appointed by Vice President for Academic Affairs. Members of the IRB will hold earned doctoral degrees within their academic disciplines, serve on the college faculty (full time or adjunct), and have a proven successful history of research and peer reviewed publications. Additional Members will be recruited from outside of the university to meet federal guidelines and expertise requirements. The IRB membership will adhere to OHRP guidelines regarding make up, background, and affiliation. IRB committee members do not receive any additional direct monetary compensation for participation on the board.

Authority of the IRB

The IRB shall review and have the authority to approve, require modifications in (to secure approval), or disapprove all research activities that fall under its authority.

1. Research activities approved by the IRB are subject to further appropriate review and approval or disapproval by the Official of Sponsored Programs and Research. However, this office may not approve human subject research to be conducted that has not received prior approval by the IRB.
2. Unresolved questions or issues between the IRB and human subject investigators shall be referred to the Office of the Vice President for Academic Affairs for additional discussion. Comments and recommendations of the Vice President shall be considered by the IRB in its subsequent decision to approve or disapprove the respective human subject research.

The IRB shall have the authority to determine that a project submitted by an investigator does not meet the regulatory definition of human subject research under 45 CFR 46.102(f) and 21 CFR 56.102(f).

The IRB shall have the authority to require progress reports from investigators and to conduct continuing reviews of approved human subject research studies at intervals appropriate to the degree of risk, but not less than once per year. Research studies qualifying for “exempt” status in accordance with 45 CFR 46.101(b) will not be subject to continuing review.

The IRB shall have the authority to approve prospectively all modifications to previously approved research protocols and/or informed consent documents; the only exception being a protocol deviation that may be necessary to eliminate an apparent immediate hazard to a given research subject.

The IRB shall have the authority to observe or have a third party observe the conduct of approved human subject research studies, including the informed consent process.

The IRB shall have the authority to suspend or terminate the approval of, human subject research activities that are not being conducted in accordance with the IRB’s requirements or have been associated with unexpected serious harm to subjects.

The IRB shall have the authority to place restrictions on human subject research activities.

Responsibilities of the IRB Chair

The IRB Chairs shall hold leadership responsibility for IRB review and approval of human subject research in accordance with current guidelines, institutional policies, and federal and state regulations governing human subject protections.

In addition, the IRB Chair shall:

• oversee the recruitment, orientation, continuing education and retention of IRB members.

• oversee the development and implementation of appropriate policies, procedures and guidelines directed at human subject protections and the functions and activities of the IRB. The IRB Chair is responsible for reviewing the IRB’s policies and procedures for currency, accuracy and consistency on an ongoing basis but not less than every three years. Ad hoc committees will be formed to review guidance issued by regulatory agencies to determine whether updated to the policies and procedures are required.

• preside over IRB Executive Committee meetings.

• communicate IRB Executive Committee decisions, directives, and sanctions relating to known or suspected problems in the conduct of human subject research to involved investigators.

• have authority to request audits of human subject research activities.

• have the authority to suspend some or all research activities if exceptional human subject safety issues are identified. (Note that this authority is only exercised if an action is required prior to a convened meeting and it is not feasible to assemble an emergency meeting) When this authority is exercised, it shall be reported at the next convened IRB meeting.

• represent the IRB in interactions related to issues surrounding the ethical and regulation-compliant conduct of human subject research.

• approve written correspondence to state and federal regulatory agencies having jurisdiction over human subject research.

• represent the IRB at national and local meetings related to institutional review board activities and human subject protections All deans, department chairs, program directors, and/or other unit administrators of the institutional sites that fall under the authority of the IRB are responsible for ensuring that the human subject research activities of faculty, staff and students under their span of responsibility are carried out in compliance with IRB guidelines and directives. These individuals shall take direction from the IRB Chair in fulfilling these responsibilities. All research investigators involved in the conduct of human subject research that falls under the authority of the IRB shall take direction from the IRB Chair.

Responsibilities of the IRB Vice-Chair

The Vice-Chair is a member of the IRB as outlined under the responsibilities of IRB Members and shall act in place of the Chair as requested by the President or the IRB Chair.

Responsibilities of IRB Members

• Reviewing research study proposals and evaluating them from the perspective of the regulatory criteria for approval addressed under 45 CFR 46.111, 21 CFR 56.111 (if applicable); and any other relevant ethical, scientific or compliance considerations.

• Reviewing informed consent documents and evaluating them from the perspective ofaddressing the required and additional elements of informed consent addressed under45 CFR 46.116, 21 CFR 50.20 (if applicable) and any other relevant ethical orcompliance considerations.

• Attending IRB meetings in person, unless exigent circumstances prevent suchattendance on an occasional basis; reporting promptly at the designated time that themeeting convenes; and remaining in attendance at the meeting until the full agenda hasbeen addressed.

• Participating in IRB deliberations concerning issues inherent to proposed researchstudies and related informed consent documents, and making recommendations forreducing risk and improving the informed consent process and otherwise forimproving human subject protections.

• Voting for full approval, approval subject to modification(s), reconsideration, ordisapproval of the human subject research.

• Evaluating the risk level (i.e., minimal or greater than minimal) of the proposedresearch. In performing this evaluation, IRB members shall use the following absolutedefinition for “minimal risk” at 45 CFR 46.102(i) unless the research is directed atprisoner-subjects: “Minimal risk means that the probability and magnitude of harm ordiscomfort anticipated in the research are not greater in and of themselvesthan those ordinarily encountered in daily life (i.e., of the general population)or during the performance of routine physical or psychological examinationsor tests.”

• Deciding, for research studies of greater than minimal risk, if IRB continuing review of the research is warranted on a more frequent basis than the requisite annual review.

• Deciding, for research studies involving greater than minimal risk, complexity, or conflict-of-interest concerns, if the informed consent process and/or other aspects of the research study should be audited by the University.

• Deciding, for research studies involving an unapproved device, if the device and its proposed use constitute a non-significant or significant risk to research subjects.

• Deciding, for research studies subject to IRB continuation approval, if verification is required from sources other than the investigator that no material changes haveoccurred since previous IRB review.

• Recommending improvements to IRB policies and procedures so as to enhance the IRB review process and/or human subject protections.

• Informing the IRB Chairs of human subject research noncompliance problems or ethical issues of which they become aware.

• Conforming, at all times, their behavior to be within legal and ethical principlesaccepted by the IRB; including, but not limited to, maintaining confidentiality/nondisclosure of human subject research submitted for IRB review and approval, and good faith participation in IRB deliberations without appearance of discrimination or conflict-of-interest.

The IRB adheres to the following regulations and policies for human subject research activities that fall under its authority:

1. The Federal Policy regulations for the protection of human research subjects (45 CFR Part 46; “Common Rule”).

2. When research involves articles subject to regulation by the FDA, the FDA regulations for the protection of human subjects (21 CFR Parts 50) and Institutional Review Boards (21 CFR Parts 56).

3. Research is defined by the U.S. Department Health and Human Services as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” (45 CFR 46)

Investigators involved in the conduct of human subject research that falls under the authority of the IRB shall be provided with instructions and guidelines for the submission of research studies and informed consent documents for IRB review and approval. The following are general procedures for the IRB in processing all IRB submissions.

1. Submitting. Principal investigators must complete the IRB application form and email to irb@captechu.edu
    
2. Initial Screening. All submissions are initially screened to ensure completeness of the submission and to determine whether the submission can be forwarded to the IRB. The submission must, at a minimum, include:
    
   1. The IRB Application form
   2. Related instrumentation
   3. Informed consent (if applicable)
   4. The investigator’s research certification (CITI program competition)
       
3. Scientific Review. All proposed human subject research shall undergo IRB committee review, except for (i) research qualifying for “exempt” or “expedited” review status; (ii) industry initiated and sponsored clinical trials; and (iii) research reviewed by a peer scientific review committee as a condition of research funding (e.g. another IRB committee at another institution).

These forms will be available for download through the website soon. At this time please contact your faculty chair to receive appropriate forms. We apologize for the inconvenience and thank you for your patience.