The Catholic University of America

Committee for the Protection of Human Subjects

Any questions related to this or other IRB issues please contact Ralph Albano in the Office of Sponsored Programs (albano@cua.edu or 202-319-5218).

The Office of Sponsored Programs provides administrative support for the Institutional Review Board (IRB), the university's Committee for the Protection of Human Subjects (CPHS). The members of the IRB are responsible for insuring all research using human subjects conducted at CUA or by CUA faculty/staff, and/or students at any location, including research conducted as part of classroom exercises or course requirements complies with federal/state regulations. OSP is the responsible administrative unit for all human subjects research. Forms for documenting a specific research project and receiving approval can be obtained from OSP.

Note: Work with laboratory animals, biohazardous or cell culture materials will require permits or approvals by other CUA review boards, such as the Institutional Animal Care And Use Committee (IACUC) or Environmental Health and Safety office.

1) According to the Office of Human Research Protection (OHRP) "under Federal Policy (Common Rule) at Section 102 (f) awardees and their collaborating institutions are 'engaged' in human subject research whenever their employees or agents intervene or interact with living individuals for research purposes; or obtain, release, or access individually identifiable private information for research purposes".

2) All CUA researchers and administrators are required to complete training in the protection of human subjects.

This free, web-based course presents information about the rights and welfare of human participants in research. The tutorial is designed for those involved in conducting research involving human participants. It satisfies the NIH human subjects training requirement for obtaining Federal Funds. You will have the option of printing a certificate of completion from your computer upon completing the course.

The primary training course is administered by CITI and offered free of charge to CUA users.  You can access the course as follows:

To logon to the CITI site for the first time:

Go to citiprogram.org, click on "Create an account".

Under "Select your institution or organization", select “The Catholic University of America” in the "Participating Institutions" drop down box.

Next, proceed to create your own username and password and select the Learner group.

A certificate will be issued upon completion of the computer-based training.

3) Investigators who believe their research projects involving human subjects are exempt must complete and submit an "Exemption Certificate" and a "Justification for Exemption Form" to the IRB, through the Office of Sponsored Programs. The "Justification for Exemption Form" includes an area for researchers to provide a description of the protocol of their study and how the regulation applies.

4) If the research project is not exempt, the investigator must submit the Human Subjects Protocol application to the IRB, through the Office of Sponsored Programs for full review. Evidence that participants gave consent must be maintained in the investigator's files.

Investigators must complete and submit to the Office of Sponsored Programs copies of the CPHS Human Subjects Protocol Application form along with copies of the statement before they start investigations or research involving human subjects. The project cannot be started until approve is received from the CPHS. The forms may be obtained from the Office of Sponsored Programs located in Room 213, McMahon Hall or by scrolling down to the bottom of this page.

The protocol form must have information spelling out the following:
    a)     Name and department(s) of the investigator(s)
    b)     Title
    c)     Signature of responsible faculty members
    d)     Whether or not external funding is proposed
    e)     Purpose of the study
    f)      Description of the subjects
    g)     Description of the methodology
    h)     Potential scientific benefits of the research
    i)      Qualifications of the investigator(s)
    j)      Description of any deception
    k)     Procedures for protecting the anonymity of the subjects
    l)      Methods for ensuring informed consent, including a copy of the proposed informed consent statement.

5) In summary, CUA researchers are required to inform all participants in written or verbal form of the primary purpose of the research project and of any procedures which they will undergo. Additionally, participants must be informed of their rights regarding the study (voluntary participation, protecting anonymity and privacy) and risks or benefits associated with the project.

Note that the exemption categories DO NOT APPLY at CUA when the research activities include:

  • Prisoners, fetuses or pregnant women;
  • The review of medical records if the information is recorded in such a way that subjects can be identified, directly or through identifiers linked to the subjects;
  • Survey or interview techniques which include minors as subjects;
  • Techniques which expose the subjects to discomfort or harassment beyond levels encountered in daily life;
  • The deception of the subjects.

DHHS Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan

Committee for the Protection of Human Subjects Meeting Schedule

The Committee for the Protection of Human Subjects (CPHS) will meet according to the following schedule during the FALL 2016 semester. Please note the deadline for submission of research protocols that require CPHS review*.

 

The Committee for the Protection of Human Subjects (CPHS) will meet according to the following schedule during the FALL 2017 semester. Please note the deadline for submission of research protocols that require CPHS review*.

 

                        Meeting Date                                               Material Due

                        September 12                                               September 1

                        September 26                                               September 15

                        October 10                                                   September 29

                        October 24                                                   October 13

                        November 7                                                  October 27

                        November 28                                                November 17

                         December 12                                                December 1

 

Please note that CPHS approvals are only valid for one calendar year from the date of first review.  Continuing research must be resubmitted to CPHS for review in order to stay in compliance with federal regulations.

*CPHS reviews faculty and student research protocols to ensure compliance with established standards for research involving human subjects. Guidelines to assist you in the preparation of materials required by CPHS to complete its review are available from the Office of Sponsored Programs. Strict compliance with these guidelines will facilitate approval of the research protocol for use with human subjects.