COMMONLY ASKED QUESTIONS AND ANSWERS CONCERNING

THE HUMAN SUBJECTS ASSESSMENT INITIATIVE

General Information

It is the intent of this document to provide a clear understanding to the Rutgers Community regarding the Assessment Initiative.  If you feel any other questions/answers would benefit other researchers, please contact our office.

   What is the purpose of the assessment initiative?

The federal Office for Human Research Protections (OHRP) mandates that the University conduct a human subjects monitoring program. The Assessment Initiative at Rutgers was developed to serve as an educational tool and give researchers the opportunity to review their protocols and assess future needs.  In addition, IRB administrators will learn about the concerns of investigators regarding human subjects research.  There are two primary questions that the assessment program should address: 

1. Are human subjects being protected? and

2. Is what was approved by the IRB, the same as what is actually taking place?

 How does the assessment initiative work?

There are two aspects of the assessment initiative:

1.      Self-assessment – All investigators must organize their human subjects research that relates to each of their active non- exempt protocols.

2.      Face-to-face assessment – In addition to participating in the self-assessment aspect of the program.  Investigators with greater than minimal risk protocols will participate in the face-to-face assessment program, as detailed below.  They will first organize their documents, and then complete the on-line self-assessment form.

 Do I participate in the assessment initiative if my protocol has been classified to be exempt from IRB review?

If your protocol has been classified as exempt by the IRB, there is no need for you to participate in the assessment initiative.

 Do I need to participate in the assessment if the protocol is nearing completion?

Protocols nearing completion of the research and not requesting continuation review will not be required to participate in the assessment program.

 What specific records should I organize?

The web page Documentation Required for the Assessment Initiative Program, outlines the key items that would be reviewed at the face-to-face meeting.

 How do I organize my records?

All investigators should maintain their protocol files in a binder or in an organized filing system.  This will help ensure completeness of the IRB approved materials and allow an easy reference for the research team. This not only will be important during the assessment process, but also in the event a federal site visit is conducted.  Modifications to this procedure are acceptable, as long as the organization of the documents is clear to an outside reviewer.  This is required of all investigators whether or not they are selected for the face-to-face assessment.

 What if I am missing documentation?

In an ideal world, all papers would be in place.  In the event that some minor documentation may have been misplaced, copies of documentation that were submitted to the IRB can be provided to the principal investigator either at the time of the meeting or shortly thereafter.  It is important that the principal investigator maintain all documentation regarding the project in their files.  Sharing this information with others working on your research team is essential, so that the project can be carried out in accord with what was approved by the IRB.  It is important that once the protocol file is completed that the investigator continues to maintain the integrity and completeness of it.

Details about the two types of assessment are outlined under the specific headings noted below.  Please read carefully.

Self-Assessment

How do I prepare for the self-assessment aspect of the program?

It is a requirement that all investigators immediately participate in a self-assessment of their human subjects protocols. The self-assessment is required of all greater than minimal risk or minimal risk protocols, as classified by the IRB.  Documentation will be required. Now is the time to begin the self-assessment process. 

 A suggestion list of some of the things that you should be doing follows:

1.Get your materials, as listed in Documentation Required for the Assessment Initiative Program, together in an organized manner.

2. Read what is written in your protocol.  Remember - if it is not documented - it does not exist.

3. Check that you are using the current stamped consent form.

4. Determine if you need to update a consent form, or send in an amendment.

5. Meet with your research staff and review the research and consent process.

6. Check to see that if you list an emergency number, that there is someone who will answer it all the time.

7. Compare the grant and the referenced protocol.  What is covered in the grant must match the protocol.

8. If you keep your confidential information in a locked file cabinet, as you may have described in the protocol, is it locked?  Is the key secure?

 How do I obtain the self-assessment form?

Our office has tried to make the process as user friendly as possible.  A web site has been created for completing the easy to use self-assessment form. Please go to https://www.rci.rutgers.edu/~orsp/selfassess/selfassess.php

At the site you will find instructions for completing the form.  Once completed, your responses to the assessment will remain as last indicated, until it is reviewed and modified the next time you conduct the assessment.

How often should I conduct the self-assessment?

The self-assessment will be required at the time of continuing review.  It is recommended that you conduct the self-assessment twice a year, perhaps at the beginning of each semester.

 Face-to-Face Assessment

Who will be selected to participate in the face-to-face assessment program?

There are over 1,000 active non-exempt protocols at Rutgers.  Therefore, to best utilize our limited resources, protocols determined to be greater than minimal risk will be given priority for participating in the face-to-face aspect of program.   In most cases the selection will be done at random.  However, the IRB or the Compliance Evaluation Subcommittee to the IRB may conclude that a protocol determined to be greater than minimal risk should be reviewed through the face-to-face assessment process.  Anyone who would like the benefit of participating in the program can contact either Karen Janes or Michelle Gibel. Voluntary self-assessment is the most time efficient way to comply with the mandatory Assessment Initiative.

 How do I determine if my protocol is greater than minimal risk?

Indicated by a “R” for greater than minimal risk, or a “M” for minimal risk in the protocol number.

 How will I be notified that I have been selected for a face-to-face assessment?

If you have been selected to participate in the program, you will be notified by email.  A mutually agreeable time will be established for the meeting within a two-week period of the notification.

 Who conducts the face-to-face assessment?

The face-to-face assessments will be conducted by administrators from the Research Integrity and Compliance unit, a division of the Office or Research and Sponsored Programs. In addition, a voting member of the IRB, who served as the Chair for many years of the IRB will assist in conducting the assessments. It is important to remember that the assessments will be conducted in a friendly and consultative manner.  To have a successful program at Rutgers it is important for researchers and administrators to work together.

 Where will the assessment visit be held?

The assessment will be conducted in the researcher’s office, or location where the records are kept. 

 Who should be present during the assessment meeting?

It is important for the principal investigator to be present at the meeting and preferable for any of the investigator’s key personnel who work on the project to be in attendance. It is our intent that this be a friendly visit that educates both the researchers and the administrators. 

 If I am selected to do the face-to-face assessment, why do I have to do the self- assessment?

Whether or not you are selected to do the face-to-face assessment, you must complete the self- assessment. The self-assessment aspect helps you prepare for the face-to-face assessment.  If your protocol is classified as a greater than minimal risk protocol, it does not mean that each year you will have an assessment meeting.  However, self-assessment is required each year, at the time of continuing review.

 If my protocol is greater than minimal risk, how often will I be asked to participate in a face-to-face assessment?

At this time it is anticipated that for each one greater than minimal risk protocol, a face-to-face assessment will be requested every 3 years.

 What can I expect during the assessment initiative?

During the assessment you will be asked to present your documents relating to the protocol being assessed along with your completed self-assessment form.  There will be an open discussion between the researchers and the reviewer regarding the protocol.  The reviewer will have the official copy of the IRB approved protocol with them.

Besides discussing the protocol, the reviewer would like to learn what administrators could do to help you with the IRB process.  It is anticipated that the meeting will last approximately 1.5 hours.

 How many years of my research project will be looked at?

During the assessment, the most current research, that is what is currently being done, is of utmost importance.  You may be asked to provide documentation for the last 3 years of the protocol.

How will I know the results of my face-to-face assessment visit?

Since there will be a friendly open dialogue during the meeting, the results should be evident during the course of the discussion.  However, a follow-up letter will be sent to the principal investigator within 3 weeks of the meeting.

Contact Information

 Who can I contact for more information about the program?

Our office welcomes any questions and comments. Please direct them to either:

Karen Janes, Associate Director, Research Integrity and Compliance
janes@orsp.rutgers.edu or 732-932-0150 ext. 2105 or

Michelle Gibel, CIM, IRB Administrator
gibel@orsp.rutgers.edu or 732-932-0150 ext. 2104

Institutional Review Board for the Protection of Human Subjects
Listing of members is posted at http://orsp.rutgers.edu/Humans

Liaisons to the Institutional Review Board for the Protection of Human Subjects

Listing of members is posted at http://orsp.rutgers.edu/Humans

Answers to questions we receive of a general nature will be posted on the human subjects web site to benefit other researchers about this process. The web site is http://orsp.rutgers.edu/Humans .