#16_Justif Memo Attach 16A Consent_CIRB

Date: May 2, 2011

To: Office of Management and Budget (OMB)

Through: Mary Forbes, Report Clearance Officer, HHS

Seleda Perryman, Program Officer, Project Clearance Branch, OPERA, NIH

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

From: Holly A. Massett, PhD

Associate Director, Office of Market Research and Evaluation

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

Nina Goodman, Project Officer

Office of Communications and Education (OCE),

National Cancer Institute (NCI)/NIH

Subject: Generic Sub-study, A Pilot Study to Test a Proposed New Model for the NCI’s CIRB Participating Institution under “Formative Research, Pretesting, and Customer Satisfaction of NCI’s Office of Communications and Education,” (OMB No. 0925-0046-16, Expiry Date 02/28/2013).

Background/Need and Use of Information

This information collection request described in this memo supports the Clinical Investigations Branch of the Cancer Therapy and Evaluation Program in the Division of Cancer Treatment and Diagnosis (DCTD). The process to obtain IRB approval for new clinical trials has historically contributed to a delay in trial activation and to timely accrual of clinical trial participants. The primary objective of the Central Institutional Review Board (CIRB) is to reduce the local administrative burdens through improved efficiency, while maintaining a high level of human subjects’ protection. The current NCI CIRB process is a “shared responsibility”model: the CIRB conducts an initial review and approval of the trial protocol, followed by a subsequent review by the local IRB chair/subcommittee that concentrates on local context issues, called a ‘facilitated review’. The local IRB notifies the CIRB Administrative Office of its facilitated review acceptance via a website. The CIRB then becomes the reviewing IRB for this study and is responsible for continuing review and review of amendments and serious adverse events.

Recently, the Association for the Accreditation of Human Research Protection Programs (AAHRPP) recommended that the NCI change its CIRB review model to an “independent” model, where local IRBs would delegate all regulatory requirements to the CIRB and the CIRB would be the only IRB on record. Local sites would retain administrative accountability but would only be required to submit two annual forms to the CIRB that detail information on local context matters and one study-specific form by PIs when opening a new study.

In response to the change recommended by AAHRPP, NCI’s Central Institutional Review Board (CIRB) program is considering adopting a new model to use with its 300+ enrollees. Although this change was recommended for accreditation and improved efficiencies, it will require substantial resources for NCI to implement. Therefore NCI is first planning to pilot test the new model to identify how well the new model worked. The purpose of the survey is to systematically assess program implementation and perceptions of the original model compared to the piloted, independent CIRB model across the 25 sites to determine the feasibility of the new model across all 300+ sites, and if it produces a more efficient and satisfactory outcome on IRB processes for NCI cooperative group studies. The purpose of the worksheets is to collect the necessary information required to implement the new pilot model being evaluated. The worksheets collect contact information and local context information that is necessary for the new pilot model to operate. Because this is a new recommendation, this project does not duplicate any other previous or current data collection effort.

No known research efforts have been done in this area as NCI has used a shared responsibility model from the onset, and there are no comparable IRB models used within the government that have been assessed. The findings will be critical in deciding whether or not the NCI should invest additional resources to fully transition to the “independent” model or continue to use the shared responsibility model. The CIRB will consider adopting the “independent” model based on a variety of factors including findings of the survey indicating: 1) greater satisfaction with its functioning by pilot participants, 2) a positive impact on local staff workload (i.e., perceived burden reduction) and resources (fewer required), and 3) reduced time required by local institutions to approve cooperative group studies. NCI also is interested in learning how changes to the pilot program can lead to greater adoption of the new model.

Participants

The NCI will conduct a 9-month pilot study with twenty-five cooperative group sites that will implement and follow the new model’s processes and commitments. Twenty of the groups will be randomly selected from among those already using the CIRB, with two-thirds being selected from high users of the CIRB (13-14 sites) and one-third from low using sites (6-7 sites). Sites randomly selected will be invited to participate until we have the number of sites needed for the pilot. Five of the sites are not currently enrolled in CIRB but were selected based on their decision to volunteer to be part of the pilot study of the new model. Each site will identify five participants as being involved in their local IRB processes to participate in the survey during the pilot test of the new model. It is expected that these five will be: the institution’s IRB Chair, an IRB staff person, the IRB Administrator/Director, the primary Principal Investigator (PI), and the Research Coordinator. The estimated universe of potential respondents is 125 participants.

The participants will be nominated through their institution based on their knowledge and experience with IRB procedures and ability to react to the new model. Therefore, no screener will be used. See attached consent form in Attachment 16A and copy for the three questionnaires in Attachment 16B. Each participating institution enrolled in the pilot study will complete a form providing their contact information and local context boilerplate language in Attachment 16C. Principal Investigators will provide information related to the PIs, research staff, and local processes for addressing items related to local context for pilot study conduct in Attachment 16D. When PIs have studies they want to open with the CIRB pilot, they will describe these in a study-specific worksheet in Attachment 16E. Attachment 16F will be used to collect information about studies and PIs that have had facilitated reviews performed under the current CIRB model, but will be transferring to the CIRB pilot model. The information collected within the Attachements 16C-F is necessary for the conduct and operations of the CIRB pilot study model. Collecting this information will allow for the CIRB pilot model to operate and ultimately be evaluated with the proposed surveys.

Methodology and Research Instrument

Local institution information (overall satisfaction, perceived benefits and challenges, workload, and time expenditure) will be collected through a web-based survey with the institutional officials and research staff outlined above. Participants identified by each site as being involved in their local IRB processes will be sent an email link directing them a survey link. Though their link will be unique to each individual and connected to the data for their institution, their names and identifying information will not be connected to survey responses, thereby assuring confidentiality to each respondent.

NCI proposes a series of three web-based surveys administered from baseline to the completion of the pilot (baseline, midpoint, and endpoint). The proposed surveys will consist of largely close-ended questions, with open-ended boxes available for further explanation as needed.

• Satisfaction. Across surveys, equivalent items will be used to allow assessment of attitudes toward the “shared responsibility” and “independent” models at baseline and attitudes toward the “independent” model over time in terms of satisfaction, perceived benefits, and perceived challenges.

• Efficiency. The respondents will also be asked to report the duration of days for submitting and receiving approvals through the IRB and CIRB to see if the timeliness of approval improves with the new model.

• Program Implementation. Lastly, the surveys will ask respondents to react to their experience on the pilot study; this in part will help identify issues and facilitating factors that can be addressed during implementation should the new model be adopted for the entire Clinical Trials Cooperative Group Program. It will also enable the pilot staff to address any possible attrition during the study.

Quantitative survey data (e.g., satisfaction time investment, effort) will be analyzed using descriptive statistics, ANOVA, and Student’s t-test. Categories of analysis will include individual characteristics (e.g., role of individuals, level of experience with IRB) and institution characteristics (e.g., size, length of time participating, level of use). Quantitative survey data will be supplemented with open-ended qualitative questions. Qualitative data will be analyzed using a general inductive approach that focuses on condensing raw textual data into brief ‘chunks,’ establishing clear links between research objectives and the data, and developing a framework to describe what the data indicate.

The surveys will be conducted with staff from each institution pre-study immediately before beginning the pilot (baseline), half way through the pilot study (between 4-5 months), and post-study immediately following the conclusion of the 9-month pilot. The pilot is expected to begin mid-summer, 2011 (pending OMB approval) and end late spring, 2012.

It is anticipated that the findings of the survey will be submitted for publication in a journal such as the Journal of Clinical Oncology, which is expected to be read by individuals overseeing their IRB processes and in consideration of adopting a central model or changing their existing model to improve efficiencies. It is understood that the information collected and reported for the pilot study will be useful to aid decision-making to those who oversee IRB processes for clinical trials, the results will be from a sample of 25 sites and not representative of the overall population’s perceptions and attitudes toward the new model and its adoption. The publication will include specific discussion of this limitation as well as others related to the pilot process.

Other Considerations

• A request for Office of Human Subjects Research exemption was submitted on May 2, 2011 and we are awaiting approval.

• No PII from respondents will be collected beyond the information that is available to the public as a result of their professional role. The only personal information collected will be: the person’s first and last name, organization, and role at the organization. There will be a database behind the survey web-link, but this database is not designed to allow NCI staff, or others connected to the project, the ability to access or search, and it will not have information stored that identifies the people in any way other than to know how to contact them for a follow-up survey to the baseline.

Burden

Each survey should take each of the Cooperative Group participants approximately 20 minutes (0.33 hours) to complete. With three rounds of surveys (baseline, midpoint, endpoint) we expect the total respondent burden for this proposed effort to be 125 hours. In addition, institutional staff and Principal Investigators will complete other documents as part of the pilot study that include the four documents for a total of 305 burden hours. The total burden hours are expected to be 431 hours.

There have been 13 previous sub-studies approved by OMB under Generic submission OMB No. 0925-0046, totaling 1,876 burden hours requested to date. Approval by OMB of this sub-study would bring the total burden hour requested to date to approximately 2002, which is 33% of the total burden hours allowed (7050). Estimated cost to the Federal Government is $50,000 (contract submitted by vendor to complete the three surveys, analysis and reporting).

Estimates of Burden Hours
Types of Respondents	Instrument	Number of Respondents	Frequency of Response	Average Time Per Response (Hours)	Total Hour Burden
Individuals: Cooperative Group Staff working with IRB Issues	Baseline Survey (Attachment 16B, pages 2-6)	125	1	20/60 (0.33)	42
	Midpoint Survey (Attachment 16B, pages 7-10)	125	1	20/60 (0.33)	42
	Endpoint Survey (Attachment 16B, pages 11-14)	125	1	20/60 (0.33)	42
Institutions	Institution Worksheet (Attachment 16C)	25	1	30/60 (.50)	13
Principal Investigators	Principal Investigator Worksheet (Attachment 16D)	125	1	60/60 (1 hour)	125
Principal Investigators	Study-Specific Worksheet (Attachment 16E)	250	1	15/60 (.25)	63
Study Transfer Worksheet	Study Transfer Worksheet (Attachment 16F)	625	1	10/60 (.166)	104
Total					431

Attachments (attached below)

16A: Informed Consent Document for CIRB Pilot

Attachments (separate files)

16B. CIRB Model Pilot Surveys 5-2-11

16C. Institution Worksheet for CIRB Pilot.

16D. Principal Investigator Worksheet for CIRB Pilot

16E. Study-Specific Worksheet for CIRB Pilot

16F. Study Transfer Worksheet for CIRB Pilot

Informed Consent Form

Identification of Project	Pilot Study to Test a Proposed New Model for the NCI’s CIRB Participating Institution
Purpose	The National Cancer Institute (NCI) is conducting a pilot of a new model for the Central Institutional Review Board (CIRB). The purpose of the survey is to systematically assess program implementation and perceptions of the original model compared to the piloted, independent CIRB model across the 25 sites to determine the feasibility of the new model across all 300+ sites, and if it produces a more efficient and satisfactory outcome on IRB processes for NCI cooperative group studies. The findings will be critical in deciding whether or not the NCI should invest additional resources to fully transition to the “independent” model or continue to use its current, shared responsibility model.
Procedures	NCI will ask you to complete three confidential web-based surveys asking your opinions about the new CIRB model and level of effort required to participate in the pilot. You will receive an email with a link to each survey at the following times: Pre-study immediately before beginning the pilot (baseline), Half way through the pilot study (between 4-5 months), and Post-study immediately following the conclusion of the 9-month pilot.
Confidentiality	All information collected in this study will be kept secure to the extent permitted by law. I understand that the data I provide will be grouped with data others provide for the purpose of reporting and presentation and that my name will not be used.
Risks	I understand that the risks of my participation are expected to be minimal in nature.
Benefits, Freedom to Withdraw, & Ability to Ask Questions	I understand that this study is not designed to help me personally but that the investigators aim to assess the feasibility of a new CIRB model to manage NCI cooperative group studies. I am free to ask questions or withdraw from participation at any time and without penalty.
Contact Information of Investigators	Name: Holly Massett, PhD Position: Associate Director, OMRE/OCE/NCI Telephone: 301-594-8193 Email: massetth@mail.nih.gov FAX to: 301-480-3441

Printed Name of Research Participant _____________________________

Signature of Research Participant ________________________________

Date______________________

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