OHSP Frequently Asked Questions

WIRB

What is the procedure for requesting changes in previously approved consent forms?

Effective January 1, 2009, WIRB will require all requests for changes in previously approved consent forms to be submitted in one of two ways:

1. The changes can be submitted using the currently approved WIRB consent form with only the new changes tracked in redline format or handwritten on the form.
2. The changes can be detailed in a document specifying the requested changes.

In general, a statement justifying changes is very helpful and can reduce the need for WIRB to contact sites for explanations. Whenever revisions are requested to previously Board-approved language, the submission must include a rationale.

After January 1, 2009, whenever WIRB receives a request for a revised consent form in any format other than the two formats described above the submission will be returned to the submitter with a request that the changes be sent to WIRB as described above.

If the changes are to be submitted for a multi-site study, the same changes might have already been approved by WIRB for another site. If you agree to accept the changes already approved, the review will take place more quickly. You can contact WIRB Client Services to determine if pre-approved language exists for this change in research at the following toll free number: 800-562-4789.

An industry sponsor asked me if I could use a different central IRB – the one that they contract with for all their other sites. Do we have to use WIRB for review of all industry-sponsored research? What is the U of R’s policy on this?

The only external IRB the University uses is Western IRB. WIRB is the University of Rochester’s IRB of record for FDA-regulated, industry-initiated drug and device trials involving greater than minimal risk. This is mandated by an agreement between the University and the U.S. Department of Health and Human Services (DHHS) Office of Human Research Protection (OHRP). The agreement builds in reciprocal visitation, policy reviews, joint training efforts and other activities to ensure the collaboration between the University and its external review board are compliant with federal regulation, State law and University policy.

If I have amendments, adverse events reports or continuing review reports for my WIRB-reviewed and approved study do I need to submit them to your office?

No. Only the initial WIRB submission needs to be reviewed by our office to ensure that the study is entered into our tracking system and proper University policies and procedures have been followed. If everything is in order, we send out the submission by express mail within 24 hours – often even on the day the submission is received.

As a service, we will send out any other documents you want to go to WIRB by express mail. Our office does not review these documents. They usually will go out within one to two days of receipt in our office.

I have a study I am submitting to WIRB. Because we are required to submit the application through your office and we are not able to submit the application electronically, can we provide the information on a CD?

Yes. We will review the information on the CD and print-off any documents that we require for OHSP hardcopy files.

Compensation for Injury

A sponsor asked me to make changes to the compensation for injury standard paragraphs in the consent form. Who can I contact to review and approve the changes?

The University is committed to the highest regulatory and ethical standards to protect research subjects and has developed these paragraphs to meet these standards. The clinical trial agreements that ORPA negotiates are aligned with these consent statements. Thus, our contracts and consent reflect the level of compensation the University considers to be a minimum for conducting sponsored trails here. Unless the contract is amended because of unusual circumstances, we cannot change the wording. The standard paragraphs were developed to avoid lengthy delays for a case-by-case review of sponsor requests for changes. If the investigator is unable to have the sponsor agree to use the standard wording, OHSP, ORPA and OCMC can become involved to achieve that end.

Human Subject Protection Programs

I am going to be part of a research team involved in a clinical study and was told I need to take a human subject protection program. What's the difference between the HSPP and EPRP training and which one should I take?

The University has developed formal human subject protection programs to protect the safety and well being of research subjects. By University policy, the study principal investigator, co-principal investigator, sub-investigator(s), study coordinator(s) and any persons obtaining consent for a study involving human subjects must successfully complete the appropriate program. OHSP administers this program. Additionally, the University supports and believes in strong mentoring programs, on-the-job training and collaborative efforts at improving researcher skills.

There are two programs: The Human Subject Protection Program (HSPP) and the Ethical Principles in Research Program (EPRP).

The HSPP program is required for those persons involved in conducting research that poses greater than minimal risk to human subjects (e.g. clinical trials). The HSPP program has two tracks, a biomedical and behavioral. The biomedical track provides training for research involving investigational drugs, devices and medical procedures such as surgery. The behavioral track covers research that involves the use of interviews, surveys and questionnaires, which ask study participants questions of a sensitive nature (i.e., could be damaging to employability, reputation or result in criminal or civil liability). The HSPP is a self-study program consisting of an informational textbook, “Protecting Study Volunteers In Research: A Manual for Investigative Sites” and an examination. If you successfully pass the exam you are assigned an HSPP number with 3-year expiration date. The HSPP number allows you to participate as study personnel in studies of all risk levels (i.e., you don’t need both HSPP and EPRP).

The EPRP program is required for those persons involved in conducting research that poses no greater than minimal risk to human subjects. Examples of minimal risk procedures include most surveys, record reviews, moderate exercise testing, and administration of psychological tests involving a minor level of stress. The EPRP is a self-study program, which consists of reading the Belmont Report and additional supporting articles and an examination. If you successfully pass the exam you are assigned an EPRP number with a 3 year expiration date. Passing the EPRP only permits the involvement in studies that present no greater then minimal risk.

I am going to renew my HSPP number. If I do the HSPP Biomedical modules on the CITI web site, do I need to do also the HSPP Behavioral modules? The studies in which I am involved cover both areas.

No, you don’t need to do both. The HSPP biomedical modules cover all the material contained in the behavioral modules.

How do I obtain the continuing education credit offered for completing the program?

The HSPP program offers both CME category 1 credit and nursing contact hours. Simply check the box on the answer sheet for the credit you want. Nursing credits are offered at no charge and are issued by our office. CME credits are offered from the University Office of Continuing Professional Education for a modest fee.

I have misplaced my certification letter stating that I successfully completed the EPRP program, which contained my EPRP number and expiration date. I do not remember my number or expiration date and my administrator is requesting verification that I have a current number. Can you send me a copy of the letter?

We do not keep copies of the individual certification letters. We can generate a new letter if necessary, however, if an individual only needs to know their number and expiration date, they can call our office. We will also provide this information directly to your administrator, coordinator or principal investigator.

If your human subject certification information is required for a federal grant, the Office of Research and Project Administration (ORPA) has a form letter that they prepare verifying this information, which is submitted with the grant.

I renewed my HSPP number in the CITI program. I did not receive an e-mail confirmation. Did your office receive the e-mail confirmation?

To successfully complete the CITI renewal program, you must achieve an overall score of at least 85% on the quizzes. OHSP will receive a confirmation only if you achieve a score of at least 85%. You will know that you have achieved this when you see on your screen in bright red message saying, “Modules Completed ” Also in bright red, you will see “Print Completion Report” which allows you print the report. If you do not see these, it indicates that you either did not complete all the modules or that you did not receive an overall score of at least 85%. You can go back online and complete any incomplete modules, as well as go back and look at your quiz scores for each module and answer any incorrect questions.

General Questions

I was notified by the FDA that they are going to audit one of my industry-sponsored studies, what should I do?

First you should notify the study sponsor and inform them of the pending audit. The sponsor may want to send a quality assurance officer to your site to check that everything is in order before the FDA inspection. You can also request that OHSP conduct a quality review of the study. You should gather all the study documentation together, check to be sure it is complete (especially look for approval letters and consent forms) and put these in a place that is easily accessible.

A sponsor’s site monitor asked if we have Standard Operating Procedures (SOPs) during his monitoring visit. Is having SOPs a University requirement?

The University does not have a policy requiring SOPs for clinical research sites. Some sites develop SOPs for their research staff for specific study procedures, e.g., informed consent process. There are pros and cons on having site SOPs. They help to ensure that all research staff are conducting study procedures in a consist manner according to set standards. The downside of having formal, signed-off SOPs, is that monitors and auditors (including FDA auditors) will review your studies to ensure that you are following your SOPs in addition to the protocol and federal regulations. The research staff must be trained to follow the SOPs as written. SOPs must be updated as procedures change, which can require additional staff training.

Where can I find the form FDA 1572?

It can be found on the FDA website.