Committee for the Protection of Human Subjects

Please note:

If a protocol includes an online survey that will be housed on a non-CUA site, the researcher must submit information on the survey and the survey company to the university's Information Security Officer (Dr. William Lantry, CPIT) prior to submitting the protocol to the IRB.

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. A way to do this is to visit the NIH Training Link at:

http://phrp.nihtraining.com/users/login.php

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 expedited or full review. Evidence that participants were informed must be maintained in the investigator’s files.

 

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 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.

 

Certificate Training Required

This free, web-based course presents information about the rights and welfare of human participants in research. The two-hour 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.

 

http://phrp.nihtraining.com/users/login.php

 

 

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

http://grants2.nih.gov/grants/funding/phs398/HumanSubjects.doc

 

 

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 first semester of 2009-2010.  Please note the deadline for submission of research protocols that require CPHS review*.

 

Meeting Date                                              Receipt Date for Proposals 

 

September    8,   2009                                   August          28,   2009

September   22,      ”                                     September    11,      ”

October         6,      ”                                    September    25,      ”

October       20,      ”                                     October          9,      ”

November     3,      ”                                      October        23,      ”

November   17,      ”                                       November      6,      ”

December     1,      ”                                       November     20,     ”

December    15,     ”                                        December        1,    ”  

 

 

 

 

General Note on Human Subjects Protection

Guidlines for Review of Research Involving Human Subjects

Reseach Consent Form

Application for Human Subject Protection Review

Exemption Certificate

Justification for Exemption Form

Request to Renew an Approved Protocol

Decision Trees for Exemption Determination