Human Research Protection Program News Updates
Human Research and Protection Program
The Creighton University Human Research Protection Program (HRPP) encompasses all research involving human subjects conducted by any student, employee, or faculty member of the university or its medical center. The HRPP works closely with the both the Biomedical and Behavioral Sciences Institutional Review Boards.
The Human Research Protection Program Mission Statement is as follows:
The Mission of the HRPP is to protect the rights, dignity, welfare, and privacy of humans who participate in research programs governed by Creighton University and Creighton University Medical Center. The mission of the HRPP at Creighton University is rooted in the Catholic and Jesuit principles that guide the institution as a whole and in the principles set out in the Belmont Report. These standards include honesty, justice, integrity, respect, and a sense of responsibility to others. The HRPP adheres to federal, state and local laws that govern human participant research programs and ensuring the right of every human being to voluntary, informed consent. Creighton University and its HRPP expect compliance with all applicable laws related to research activity and to meet the high ethical standards of a Jesuit Catholic University.
About the Creighton University Human Research Protection Program
I. Ethical Principles Described in the Belmont Report
III. Written Assurance
IV. Types of Activities under the HRPP
VII. Component for HRPP
VIII. Responsible Institutional Official
IX. Responsible Individual for Implementation of HRPP
XII. Education and Training Program
Information on Becoming a Research Volunteer
Research Volunteer's Rights
If you are asked to consent to be a subject in a research study, you have the right to:
- Learn about the nature and the purpose of the study, experiment, or clinical trial;
- Receive an explanation of the procedures, and of any drug device that may be used;
- Learn about any benefits you might expect from the study;
- Receive a description of any discomforts and risks that you may experience from the study;
- Learn about the risks and benefits of any other available procedures, drug, or devices that may be helpful to you;
- Learn what medical treatment will be made available to you if you should be injured as a result of the study;
- Decide to consent or not to consent to a study without feeling force, obligation, pressure, or coercion;
- Receive a copy of the signed and dated consent form;
- Quit the Study at any time, your decision may not be used as an excuse to hold back necessary medical treatment; and
- Ask any questions about the study or the procedures involved.
Research Volunteer's Responsibilities
- Completely read the consent form and ask the Principal Investigator (PI) any questions you may have. You should understand and comprehend what procedures will occur before you agree to participate;
- Know the beginning and ending dates of your participation;
- Carefully weigh potential benefits of participation (if any) and risks of participation;
- Contact the PI if you desire to terminate, end, or quit your involvement in any research study;
- Contact the PI and/or the Creighton University IRB with complaints or concerns about the study participation;
- Report any and all unanticipated problems to the PI immediately;
- Comply with the responsibilities of participation as described on the consent forms unless your are discontinuing participation in the study;
- Confirm receipt of extra-credit points or monetary compensation;
- Request study results if desired; and
- Retain a copy of the consent form for your records.
Investigator's Responsibilities
The Principal Investigator (PI) is the individual who assumes full responsibility for a research study. The PI is required to:
- Conduct the Creighton University IRB approved protocol;
- Obtain legally effective informed consent;
- Maintain subject confidentiality;
- Quickly respond to all participant concerns and questions;
- Inform participants of changes to risks or benefits in a study;
- Obtain approval from the Creighton University IRB for any proposed changes, additions, or deletions to the study;
- Promptly report all unanticipated problems or injury to the IRB;
- Retain research records for three (3) years after the study completion date;
- Effectively train/mentor student researchers in ethical conduct of research; and
- Comply with all Creighton University procedures for the ethical conduct of human subject research.
Complaints
If a person is not satisfied with the manner in which a study is being conducted at Creighton University, compliants may be made (anonymously, if so chosen) to the IRB by calling 402-280-2126, or by calling the Research Complaince Hotline (anonymous phone line) 402-280-3200 or by addressing a letter to the Office of Human Research Protection, Creighton University, 2500 California Plaza, Omaha, NE 68178
HRPP Information
I. Ethical Principles Concerning the Human Research Protection Program (HRPP)
The Ethical principles described in the Belmont Report include: 1) respect for persons; 2) beneficence; and 3)justice. These are the basic underlying ethical principles that the CUHRPP has incorporated in all policies and procedures which guide researchers who conduct research involving humans.
II. What Constitutes Research
Research is defined as a "systematic investigation, including research development, testing, and evaluation. It is designed to develop or contribute to generalized knowledge, or a clinical investigation.
III. Written Assurance
Creighton University adheres to the assurance prescribed in its Federal Wide Assurance (FWA) FWA00001078.
IV. Types of Activities under HRPP
The HRPP has the authority and responsibility to oversee all human research conducted by any Creighton University faculty, staff, or student. The Creighton University IRB has sole authority to review, approve, disapprove, or require changes in research or related activities involving human subject research conducted by Creighton University's investigators.
V. Institutional Review Board
Creighton University has one IRB of record registered with the OHRP. IRB00000155. The Creighton University Institutional Review Board is duly constituted (fulfilling OHRP and FDA requirements for diversity), allows only those IRB member who are independent of the investigator and the sponsor of the trial to vote/provide opinion on the trial, has written procedures for initial and continuing review of clinical trials; prepares written minutes of convened meetings, and retains records pertaining to the review and approval processes. The Creighton University IRB's policies and procedures are based on federal regulations published by the U.S. Department of Health and Human Services (DHHS) Office for Human Research Protection and the U.S Food and Drug Administration.
VI. Safety Monitoring
When reviewing research that is more than minimal risk, the IRB is responsible to determine that the protocol includes adequate provisions for monitoring the data collected to ensure the safety of the4 humans enrolled.
VII. Component for HRPP
The components of the program include the IRB, the people who volunteer for research, the investigators who design, oversee, and conduct the research and the research staff who support them and carry out all necessary protection functions for a particular protocol.
VIII. Responsible Institutional Official
The responsible Institutional Official for Creighton University is the President of the University. He is responsible for ensuring the independence of the IRB, the support and the standing within the institution.
IX. Responsible Individual for Implementation of HRPP
The Assistant Vice President for Research and Compliance is responsible for 1) implementation of the institution's HRPP policy; 2) review and evaluation of reports and results of compliance assessment and quality improvement activities; 3) implementation of needed improvements and follow-up on actions as appropriate; and 4) monitoring changes in federal and state regulations and policies that relate to human research protections.
The Creighton University's Conflict of Interest Committee (CIRC) reviews annual investigator disclosures and decides if a conflict of interest exists. The CIRC will prepare a resolution plan to manage, reduce or eliminate any identified conflict of interest before the research can proceed. If the project involves human subject research, the IRB may impose additional requirements before granting IRB approval.
The Research Compliances Quality Assurance Program is a component of Creighton University's Research Compliance Program. The purpose of the Research Compliance Quality Assurance Program is to benefit and support the research programs at Creighton University involving human subjects and animals to 1) Achieve quality, performances and efficiency; 2) Ensure compliances with University Polices and federal laws and regulations; and 3) Identify education/training initiatives for Investigators, their research staff, and others
XII. Education and Training Program
Creighton University requires that all individuals working with human subjects in research complete an educational program in the protection of human subjects. Creighton University has developed the Human Subjects Research Education Program to assist investigators and staff in meeting federal regulations and University education requirements. The Human Subjects Research Education Program includes initial certification as well as ongoing education and recertification.
