#9_Justif Memo & Attach A_3-7-2011

Date: March 2, 2011

To: Office of Management and Budget (OMB)

Through: Seleda Perryman, Report Clearance Officer, HHS

Mikia Currie, Program Analyst, Project Clearance Branch, OPERA, NIH

Vivian Horovitch-Kelley, OMB Project Clearance Liaison, OMAA, NCI

From: Jacquelyn Goldberg, IRB Administrator,

Division of Cancer Treatment and Diagnosis (DCTD), and

Nina Goodman, Project Officer

Office of Communications and Education (OCE), National Cancer Institute/NIH

Subject: Bundled Generic Sub-study, “Survey to Determine IRB Policy Regarding NCI Action Letters” under “Formative Research, Pretesting, and Customer Satisfaction of NCI’s Office of Communications and Education,”

OMB No. 0925-0046-09, Expiry Date 02/28/2013

Background, Need and Use of Information

The Operational Efficiency Working Group (OEWG) was established December 2008 to advise the National Cancer Institute (NCI) on strategies to "Identify the institutional barriers that prolong the time from concept approval to accrual of the first patient, and develop solutions for overcoming these barriers." The collaborative effort includes representation from the Cooperative Groups, Cancer Centers, and other NCI Programs and Divisions. In the past several years, the Cancer Therapy Evaluation Program (CTEP), which funds/oversees Phase 2 and 3 treatment trials conducted by NCI’s extramural Cooperative Groups, has focused on operational efficiency in such areas as collapsing timelines for the development, implementation and completion of trials. One major area of concern is increasing the number of patients accrued to trials so that research will lead directly to new and improved treatments in cancer.

Over 2000 sites across the country conduct CTEP trials. We have anecdotal information that the Institutional Review Boards (IRBs) at some of these sites are incorrectly interpreting OHRP policy regarding CTEP Action Letters and therefore inadvertently inhibiting patient accrual at their sites. CTEP issues an Action Letter when new or modified risk information necessitates changes to the protocol and/or informed consent document (ICD). The requested changes can be minor or major. We plan to survey institutions to determine how widespread this occurrence is. If this is occurrence is widespread then the numbers of patients accrued nationally is being impacted and NCI will need to develop a strategy to address it.

Participants

Survey participants will consist of two individuals, the IRB Chair and the IRB Director, at approximately 300 extramural clinical research sites (cancer centers, community hospitals, academic medical centers). They will receive an email with a link to Survey Monkey and asked to respond to 5 questions. The survey will take less than five minutes to complete.

Research Instrument and Methodology

Web-based surveys represent a standard state-of-the-art formative research methodology, adapted from marketing and communications research. For this research, a self-administered web-based survey will be used, as it is a methodology frequently used by NCI to conduct satisfaction surveys with stakeholders that is reliable, efficient, and economical. This survey will be accessed on-line at a designated, secure Internet site.

An email will be sent (Attachment 9A) explaining NCI’s need for information. Five questions will be asked one time only via Survey Monkey (Attachment 9B). CTEP will use IRB contact information already maintained in its database.

Other Considerations

Consent will be implied—if the respondents follow the link to Survey Monkey then they have agreed to consent. The email to the respondents explains that consent is implied upon response and that the data will be securely stored. Office of Human Subjects Research (OHSR) approval is in process.

The NCI Privacy Act Coordinator, Suzanne Milliard, has been contacted to see if a Privacy Impact Assessment is needed.

The project time schedule is six weeks. Tabulation will take place over two weeks. Information provided through this survey will remain internal to HHS. There is a lot of interest around CTEP’s activities and the results from this sub-study may be mentioned in articles regarding clinical trials or Office of Human Subjects Research Protection (OHRP) policy with the explicit statement that the results from this study are not generalizable to all institutions.

Burden

The survey should take each of the participants approximately 5 minutes (0.083 hours) to complete. The total respondent burden for this effort is estimated to be 50 hours. This effort will account for less than 1% percent of the total burden hours granted in the full generic OMB clearance package. To date, a total of 1691 burden hours have been used of the 7050 hours that were requested.

Estimates of Hour Burden and Respondent Cost
Types of Respondents	Number of Respondents	Frequency of Response	Average Time Per Response (Hours)	Total Hour Burden
IRB Chairs and Directors	600	1	5/60 (0.083)	50

List of Attachments

9A. Email to Respondents.doc (Attached below)

9B. Survey to Determine IRB Policy regarding NCI Action Letters.doc (Attached separately)

Attachment 9A: Email to Respondents

Dear IRB Chair/Administrator,

 

We are contacting you to determine how your IRB handles NCI Action Letters. As you are probably aware, NCI issues an Action Letter when new or modified risk information necessitates changes to the protocol and/or informed consent document (ICD).  The IRB is required to review and approve the changes requested in the Action Letter prior to their implementation, except when urgent implementation is necessary to eliminate immediate hazard to subjects already enrolled on the trial.  In general, enrollment of new patients must also be temporarily suspended until IRB approval is obtained unless the changes to the informed consent meet certain criteria (e.g., clarifications of risks already included and/or providing additional details of a risk already described, re-wording the risk in the consent using a synonym, decreases or slight increases in the occurrence of a risk, decreases in the severity of a risk from that originally described, etc.).  OHRP issued a statement some time ago clarifying the IRB’s and investigator’s responsibilities regarding Action Letters http://www.hhs.gov/ohrp/policy/Correspondence/nci200870929.html. Briefly, OHRP’s position is that proposed changes to the ICD on new or modified risk information that would result in suspension of accrual of new patients can receive expedited review if NCI has determined the changes are minor because the new information does not adversely impact the risk-benefit ratio, and the IRB chair or designee concurs.

Your response implies consent and data will be securely stored.

We would appreciate your response by month/day/year. Thank you in advance for completing this survey in a timely manner.

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