2 Consent Form

Attachment 3: Informed Consent for the Stakeholder Satisfaction with the National Cancer Institute’s Mouse Models of Human Cancers Consortium (NCI-MMHCC) Services and Products

OMB Number: 0925-0046

Expiration Date: 05/31/2016

Public reporting burden for this collection of information is estimated to average 5 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0648). Do not return the completed form to this address.

Purpose and Benefits

Mouse and human-in-mouse models are employed in the continuum of cancer research activities. The quality of that research depends on the reliability of the data that are generated, appropriate selection of models, and standard practices that ensure robust experimentation. Recently there have been concerns about the reliability and robustness of mouse models and how well the resulting data inform clinical practice. The National Cancer Institute (NCI) Mouse Models of Human Cancers Consortium (NCI-MMHCC) launched a project on standard practices and operating procedures to guide cancer researchers who are new to using mouse models and experienced modelers using their models for different applications. The resulting methods book (http://cshprotocols.cshlp.org/content/2013/11/pdb.top078774.long) guides translational applications. The NCI-MMHCC program requires an assessment of the academic and private sector cancer research community to identify important research resource, training, and collaboration opportunities for mouse and human-in-mouse models of human cancer.

You have been identified as a key stakeholder who can provide important insights to inform how to improve and promote the use of mouse models and continue the evolution of standard practices for mouse model use in the fields of basic, translational, clinical, and epidemiological research in academia and the private sector. We appreciate your voluntary participation in this stakeholder satisfaction interview.

Procedures

The Scientific Consulting Group, Inc. (SCG) will conduct the interview on behalf of the NCI-MMHCC. SCG will select interviewees from five stakeholder groups: Academic basic, translational, clinical, and epidemiological researchers, and private sector researchers. SCG will conduct Interviews with selected stakeholders via telephone. If you consent to participate, we will contact you by email to schedule a 30-minute telephone interview. Research questions will relate to your current use of mouse and human-in-mouse models and your insights into the cancer research community’s needs. SCG will record your responses to ensure accuracy. The audio files will be deleted following the interview. The information that you provide will be kept secure to the extent provided by law. Only the NCI-MMHCC and contractor project staff will have access to the interview responses. The information we collect from you will be combined with information from other research participants to help develop a profile of community needs. We will not attribute any information obtained to a specific individual.

Risks and Benefits

The overall benefits of the stakeholder satisfaction assessment for the cancer research community will be significant. We expect that it will improve the translation of research involving mouse models to clinical applications that reduce the burden of cancer in humans. You can refuse to answer any question, and you can stop your participation in the interview at any time if you feel uncomfortable. If you have any questions about this interview, including potential risks and benefits, please contact the project coordinator at SCG, Dr. Jennifer McCulley ([email protected] or 301-670-4990).

Informed Consent

The interviews regarding the services and products of the National Cancer Institute’s Mouse Models of Human Cancers Consortium (NCI-MMHCC) have been explained to me. I voluntarily consent to participate. I have had an opportunity to have my questions answered. I know that I may refuse to participate or to stop my participation in the interview at any time. I understand that if I have questions about this project or my rights as a respondent, I may contact the project coordinator.

Participant Signature Date

Interviewer Signature Date

2