The Certification Film is intended as an alternative means of completing the on-line Human Subjects Certification Program (HSCP). The Film was developed from a human subjects compliance seminar series presented by the Research Integrity and Compliance Unit of Rutgers University’s Office of Research and Sponsored Programs (ORSP). Funding for the seminar series and the Certification Film was provided by a Human Subjects Enhancement Program grant (NIH Grant # 0D-02-003).

Use of the Certification Film is encouraged for classroom presentations for research methodology courses, departments that frequently conduct human subjects research, and investigators wishing to provide key personnel with a refresher about human subjects protections. The Certification Film offers an excellent opportunity for numerous individuals to complete the Human Subjects Certification requirement as a group under the oversight of an academic departmental chair or faculty member.

The Certification Film is compiled from a human subjects presentation given by Dr. Thomas Puglisi, former Director of Human Subjects Protections for the federal Office for Protection from Research Risks (OPRR), currently called the Office for Human Research Protections (OHRP). The Film consists of two video tapes, each approximately an hour and 50 minutes in length. The first tape, “Basics of Human Subjects Research”, provides a general overview of the regulations and ethical considerations that must be addressed for such research. The second tape, “Advanced Topics”, covers regulatory and ethical guidance for vulnerable research populations, such as pregnant women and fetuses, children, and prisoners.

Power Point slides providing reference information as depicted in the Certification Film are available for download below. They must be handed out to individuals present at the screening of the Certification Film. Note that some of the slides in the Power Point presentation are not included in the Certification Film.

In order to gain Certification equivalency through the film, attendees must be present for both parts of the film, which must be presented in its entirety.

A departmental chair, administrator, or faculty member must request a copy of the Certification Film, and be responsible for the appropriate conduct of the session.

1. Contact Cathy Rivera, Acting Administrative Assistant, and request a copy of the HSCP Certification Film at:  Tel: 732 932 0150 ext. 2120. In your request, please include the date and location of the presentation.

2. The Film will be forwarded to the department seeking this alternative certification. The accompanying Power Point slides, other required materials, procedures for the screening of the Human Subjects Certification Film, and an attendance table should be downloaded and printed from the links below.

3. Departments may wish to present the Certification Film in one session in order to ensure appropriate attendance and retention of educational information.

4. Ensure that all the procedures outlined in the Procedure Checklist have been completed and that attendance has been appropriately documented.  Please note that attendance tables must be typewritten.  It is important that the attendees email addresses be legible and accurate.

5. Discussion about the regulations and ethics of research involving human subjects, in particular the informed consent process, is encouraged for attendees after the showing of the Film. Questions from the discussion may be forwarded to Cathy Rivera.

6. The Certification Film must be returned one week after the presentation along with the completed Attendance and Procedures Checklist. Please forward the Procedures Checklist and Attendance table via email to Cathy Rivera, and return copies of the film to ORSP. Additionally, please forward the completed evaluation sheets of the Certification Film to ORSP.

7. Attendees will receive an email from ORSP within two weeks of the receipt of the attendance table notifying them of their Certification status. For this reason, it is important that individuals provide their correct email addresses. Those who have successfully completed the program (i.e. were present for the entire presentation), will receive an email including their password in order to access a copy of the Certificate on-line.

8. Questions or comments regarding the Certification Film can be addressed to:

· Cathy Rivera, Acting Administrative Assistant, Email: rivera@orsp.rutgers.edu    Telephone: (732) 932 0150 ext. 2120

· Karen Janes, Associate Director, Research Integrity and Compliance, Email: janes@orsp.rutgers.edu  Telephone: (732) 932 0150 ext. 2105.

 

Those needing information on the on-line HSCP exam can access the following web page: <http://orsp.rutgers.edu/stage/HSCPLetter.php>.

You may download the required materials below :

Power Point Slides: ( To print these Power Point slides you must save them first. Right-click on the link and select "Save Target As....".   When the standard "save" window opens, select where you want it to be saved and click "Okay".  You can then open it in Power Point).

• General Session ( ppt )
• Advanced Session ( ppt )

Procedure Checklist and Attendance Table ( Word )

Evaluation Form ( pdf )

IRB Fact Sheet  (pdf )

HSCP Film Addendum  (pdf )

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