SPIROMICS Ancillary Study Proposal Form
To propose an ancillary study in SPIROMICS, please complete this form and attach the requested brief narrative. Proposing investigators should read the SPIROMICS Ancillary Studies Policies and Procedures, available at http://www2.cscc.unc.edu/spiromics/, since these may be helpful in preparing the application and understanding the review process.
Investigators who are not affiliated with SPIROMICS are welcome to propose ancillary studies. These investigators, however, need to work with a SPIROMICS investigator (sponsor). A list of potential sponsors appears on the SPIROMICS web site at http://www2.cscc.unc.edu/spiromics/.
Contact information:
For questions regarding the ancillary study review process and budgets related to GIC services:
SPIROMICS GIC
(919) 962-3223
For questions regarding biological specimens:
Patricia Basta, Ph.D.
SPIROMICS Biospecimen Processing Facility
(919) 843-3860
Submission deadlines:
Genetics proposals: minimum 9 weeks prior to grant deadline
All other proposals: minimum 8 weeks prior to grant deadline
Agreement with the Genomics and Informatics Center (GIC) and, if applicable, the SPIROMICS Central Blood Laboratory, Clinical Sites and Reading Centers about the costs needed to perform an ancillary study is required for Steering Committee approval.
Please send the completed proposal by e-mail to using the subject line “SPIROMICS Ancillary Studies Proposal”
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PART 1: Basic Study Information and Projected Impact on SPIROMICS
1) Title of study:
2) Initiating investigator(s) (name, address, phone and fax numbers, e-mail address):
3) SPIROMICS sponsor and all other collaborators:
4) Funding
a) Source:
b) If NIH, funding mechanism and target study section:
c) Grant due date:
d) Proposed grant start date: end date:
e) Grant title (if different from study title):
f) Does this study involve the support or collaboration of a for-profit corporation?
g) Estimated direct costs per year (please provide an estimate even if a final figure is not available):
FY01 / FY02 / FY03 / FY04 / FY05$ / $ / $ / $ / $
5) SPIROMICS involvement:
If this proposal poses any burden to the participants, the Clinical Centers, or the Blood Laboratory, please provide specifics about the expected burden as requested below.
a) Participants: Yes No If yes,
i) Explicitly state the size and any special characteristics of the participant sample.
ii) Will participants be contacted, interviewed, or examined? If so, describe participant involvement and estimate the time required of each participant.
iii) Will participants be exposed to any ionizing radiation (e.g., from a CT scan)? If so, describe the dose in mAs, efforts to minimize dose, and briefly summarize the specifics of the protocol.
b) Biological Specimens: Yes No If yes,
Describe biological specimens to be used. If blood, DNA, urine or other biospecimens are requested, please refer to the review criteria section of the Ancillary Study Policies and Procedures (available online at http://www.cscc.unc.edu/spir) in consideration of your description of the following:
i) Is DNA to be used?
(a) Specify amount of DNA:
ii) Are blood, urine or other biospecimens to be used?
(a) Study year(s) for which the samples were collected:
(b) Sample type (e.g., blood: serum, EDTA, citrate):
(c) Specify sample volumes or sizes:
(d) Requirement for frozen vs. previously thawed samples (if the latter, please indicate whether there are any limitations on the number of freeze-thaw cycles):
(e) Efforts to integrate sample needs with those of other studies to conserve sample and/or limit freeze-thaw cycles:
(f) Where will the lab work be conducted? If you are requesting the Central Lab to do the sample analysis, please communicate with a Lab Investigator.
(h) Projected timeline for:
1. pulling samples and shipping:
2. sample analysis:
3. return of samples to Lab:
Investigators are encouraged to contact the SPIROMICS Central Blood Laboratory to discuss these considerations before submitting their proposals.
c) SPIROMICS Reading Centers: Yes No If yes,
Describe materials (including scans, tapes, digital images, tracings, …) from a SPIROMICS Reading Center to be used. Data already derived from readings are available without the involvement of a Reading Center.)
d) SPIROMICS Clinical Centers: Yes No If yes,
Indicate which Clinical Centers have agreed to participate, and describe the effort and estimated time required of SPIROMICS staff at each participating Field Center.
e) SPIROMICS GIC: Yes No If yes,
Describe the effort and estimated time required of SPIROMICS GIC staff. Specifically:
i) Will the following work be done at the GIC? (please check all that apply)
(1) Sample selection
(2) Data set preparation
(3) Consultation
(4) Statistical analysis
ii) Do you want the GIC to verify the results of statistical analyses conducted by ancillary study investigators?
iii) How many manuscripts do you estimate will be written from the ancillary study?
iv) Will the GIC be involved in data collection or preparation of forms or software?
v) If a Reading Center is involved, will data be sent directly from the Reading Center to the GIC for processing?
6) State the data from the SPIROMICS main study (demographics, risk factors, events, etc.) and analyses needed for the ancillary study:
7) Genetic information (defined as any data from a participant’s DNA):
a) Does your proposal contain the use of genetic data? (please check one)
No (go to question 8) Yes (see questions 7 b-d)
b) Name the gene(s) to be investigated:
c) Is genetic information used to address a primary aim or secondary aim of the SPIROMICS? (please check one or both)
Primary aim (lung disease)
Secondary aim (other health conditions)
d) Should genetic results be reported to patients’ physicians?
Base your response on your knowledge of existing literature and current practice regarding increased risk and availability of treatment for adverse outcomes associated with the gene mutations to be studied. Describe the plan for addressing any relevant clinical or other (ethical, legal, or social) implications of the findings.
e) If your proposal requires genetic informed consent, state the estimated number of participants who have the appropriate consent.
8) Will the findings have clinical implications? If so, describe the plan for reporting results to participants and providing recommendations for follow-up.
9) Do you intend to use the data to patent any process, aspect or outcome of the analysis?
10) Advantage of conducting the study within the SPIROMICS cohort:
11) Justification of not including all SPIROMICS clinical sites:
PART 2: Description of the Proposed Ancillary Study
Please provide a brief (maximum 4 pages not including citations) description of the proposed study. Include the following:
1. Abstract
Summarize background information and literature, and state how they lead to the question(s) of interest. Include a concise justification and explanation of the research question(s) to be addressed. End by stating the aim of the ancillary study and summarizing the method(s) that will be used to address the questions.
2. Background and Rationale
Explain in detail, the background information summarized in the Abstract paragraph. Explain why this information is lacking with regard to the ancillary study question(s) of interest, and how the proposed study will address that gap. Finally, explain how the methods and/or information from the SPIROMICS will address the ancillary study question(s). Acknowledge any limitations or concerns related to the proposed methods, and explain how they have been or will be dealt with.
3. Specific Aims
Detail the research questions or hypotheses to be addressed by the ancillary study
4. Methods
1) Study Population
Describe the sample of interest (the entire SPIROMICS cohort or certain subgroups). Include the anticipated time frame of participant involvement (if any).
2) Data Collection
Describe information to be collected and any methods or equipment to be used. Include detailed explanations and protocols for each method in the ancillary study. Explain how the information from the method or equipment will address the question(s) of the study. Attach copies of any study instruments (questionnaires and forms) that SPIROMICS participants or administrators will be expected to complete. Include an estimate of the time necessary to complete them. Describe the data needed from the SPIROMICS main study (including outcomes/events).
3) Statistical Analysis
Explain how each study hypothesis (from section 3 - Specific Aims) will be analyzed. Include any current hypotheses or information that might influence the approach to the analysis or the question itself.
5. Sample Size Calculations
6. Literature References
Sample Type (plasma, serum, BAL, etc) / Visit / Number of Participants / Volume / Notes (e.g., number needed from each stratum, GOLD status, etc) / Proposed Assay(s)Example:
EDTA Plasma / Visit 1 / 1000 / 150 uL / 700 from stratum 3 and 300 from stratum 4
Are you requesting sputum samples (Y/N)? ______
If yes, please specify acceptable level of squamous cells (e.g., less than 80%, 40%, 20%, etc): ______