Nephrotic Syndrome Study Network (NEPTUNE) Ancillary Studies … · 2001. 10. 17. · NEPTUNE...

V20150903

Nephrotic Syndrome Study Network (NEPTUNE) Ancillary Studies Policy and Procedures

Contents I. General Policy and Process Overview ............................................................................ 1

II. Definition of Ancillary Study ............................................................................................. 1

III. Ancillary Study Review Committee (ARC) ....................................................................... 2

IV. Steering Committee (SC) ................................................................................................ 2

V. Procedures for Submission and Review of Ancillary Study Proposals ............................. 2

A. Proposal Development Process................................................................................. 3

B. Ancillary Committee Review ...................................................................................... 3

D. Funding Proposal Submission ................................................................................... 4

VI. Criteria Used to Review Ancillary Studies ........................................................................ 4

A. Study Burden............................................................................................................. 4

The ARC will evaluate study burden to NEPTUNE using the following guidelines: .......... 4

B. Scientific Merit ........................................................................................................... 5

VII. NEPTUNE Site Responses to Ancillary Submissions ...................................................... 5

VIII. Ancillary Studies Requesting Limited Biomaterial Resources .......................................... 5

A. Application ................................................................................................................. 5

B. Review ...................................................................................................................... 7

C. Limitation of ancillary study approval period where biomaterials are requested ......... 7

IX. Handling of NEPTUNE Data and Specimens .................................................................. 7

X. Management of Ancillary Study Data .............................................................................. 8

A. Standards .................................................................................................................. 8

B. Data Transfers ........................................................................................................... 8

XI. Funding Timeline ............................................................................................................. 9

XII. Ancillary Study Approval Extensions ............................................................................... 9

A. Policy ........................................................................................................................ 9

B. Purpose ..................................................................................................................... 9

C. Process ..................................................................................................................... 9

XIII. Changes to a Proposed Study ....................................................................................... 11

A. Policy ...................................................................................................................... 11

B. Purpose ................................................................................................................... 11

C. Process ................................................................................................................... 12

NEPTUNE Ancillary Studies Policy and Procedures

V20150126v1 2

XIV. Human Subjects/Data Confidentiality ............................................................................ 12

XV. Feedback of Results of Ancillary Studies to Participants ............................................... 12

XVI. Ancillary Studies included in a Training/Career Development Proposal ......................... 12

XVII. Publications and Presentations ..................................................................................... 13


V20170110 1

Nephrotic Syndrome Study Network (NEPTUNE) Ancillary Studies Policy and Procedures

I. General Policy and Process Overview

The Nephrotic Syndrome Study Network (NEPTUNE) welcomes and encourages investigators with diverse interests and expertise to use NEPTUNE's intellectual resources, observational clinical data, biosamples, and derived data sets for their research. NEPTUNE facilitates this data sharing through an Ancillary Studies (AS) Program. In order to protect the integrity of the overall study, prioritize the utilization of its resources for scientific advancement, ensure regulatory compliance, and monitor participant burden, however, the NEPTUNE Ancillary Study Review Committee (ARC) and the Steering Committee (SC) must review and approve ancillary studies (AS) before inception of research activities or submission of a proposal for external funding.

There are fivesteps in this approval process. Applicants should: 1) explore the potential of their proposal concept or hypothesis and the feasibility of addressing this hypothesis with representatives of the ARC and of the NEPTUNE Data Analysis and Coordinating Center (DACC); 2) work with the NEPTUNE consortium project manager and the DACC to assure availability of data or samples and to establish a budget for the proposed study; 3) submit an application for review; 4) obtain feedback and approval from the ARC; and 5) obtain SC review and approval. Appendix A provides an overview of the ancillary proposal development and review process.

See Section V for the procedural steps involved in the application process. Section VI details the criteria used in review.

II. Definition of Ancillary Study

An ancillary study is a study that uses information or specimens from NEPTUNE participants and/or the NEPTUNE infrastructure in an investigation or analysis which is relevant to, yet not described in, the NEPTUNE study protocol. The NEPTUNE infrastructure includes the following: a) scientific and analytical expertise, b) an administrative unit, c) operational structure for NEPTUNE recruitment and retention, d) operational structure organized for collection of NEPTUNE data and biomaterials, and e) a web-based platform.

A typical ancillary study may propose collection of additional data/biomaterials; generation of additional data from existing biomaterials; research analyses not included in the main NEPTUNE study; or an interventional study utilizing the NEPTUNE cohort as a basis for recruitment. These studies may be submitted by the investigators within or outside of the NEPTUNE investigator consortium.

All ancillary studies must have sufficient non-NEPTUNE funding to support the goals of the ancillary study including costs for study personnel, labs, administration, shipping, data extraction, preparation of data files, statistical analyses, and integration of new data/biomaterials/analyses into the NEPTUNE infrastructure. Administrative costs born by the DACC to support the ancillary study application will be charged to the ancillary study investigator upon start of research activities and/or receipt of Letter of Award (for external funding), whichever comes first. Costs incurred during execution of the research (e.g., sample


V20170110 2

extraction and shipment, analysis, etc.) will be charged to the ancillary study investigator when incurred.

Potential sources of funding include but are not limited to: investigator-initiated research awards from the NIH (e.g. RO1), academic institutions, private foundations and pharmaceutical companies (see Appendix G. Guide for Private Partner Interactions for additional details). Since all ancillary proposals will be directly relevant to the main NEPTUNE study, it is strongly recommended that NEPTUNE investigators with relevant expertise are invited to participate in the development and conduct of research activities in ancillary proposals.

III. Ancillary Study Review Committee (ARC)

The role of the Ancillary study Review Committee (ARC) is to provide feedback to a potential Ancillary Investigator regarding the suitability of the ancillary protocol for integration into NEPTUNE and its likelihood of approval by the SC. The ARC will be comprised of the following members:

Co-Chairs: Lawrence Holzman, MD and Jeffrey Kopp, MD

Statistician: Peter Song, PhD

NIH representatives: Marva Moxy-Mims, MD; Rebekah Rasooly, MD, PhD

NEPTUNE Consortium Representatives: These members will be selected from the participating clinical sites. If a current clinical site representative is from the site submitting the ancillary proposal, he/she will be recused from the review of that proposal.

Outside Reviewer (1-2): The Chairs may request the input from 1-2 outside peer reviewers, with expertise in the proposed topic, for each ancillary proposal that will not be subjected to a peer scientific review, e.g. proposal with intramural funding.

IV. Steering Committee (SC)

The NEPTUNE SC is comprised of one NEPTUNE Clinical Site PI from each site, NIH project officers from NIDDK and the Office of Rare Disease (ORD), foundation representatives from NephCure Kidney International, PIs of the Histopathology Reading Center and the Histopathology Digital Archiving Center Pathology Reading.

Prior to initiating an ancillary study or submitting to an external sponsor for funding consideration, an ancillary study must have SC approval. For the purposes of this process, approval is defined as a 70% majority of the SC voting members for a multicenter ancillary study and 60% majority of the SC voting members for a single center ancillary. Even with SC approval, the participation of each individual site in an ancillary study is optional. However, if a study is based on participation of all sites, then approval of the study must be unanimous.

V. Procedures for Submission and Review of Ancillary Study Proposals

There are five steps to developing an ancillary study proposal. Applicants should: 1) explore the potential of their proposal concept or hypothesis and the feasibility of addressing this hypothesis with representatives of the ARC and DACC or data exploration in tranSMART; 2) work with the NEPTUNE project manager and the DACC to assure availability of data or samples and to establish a budget for the proposed study; 3) prepare an application for review; 4) obtain feedback and approval from the ARC; and 5) obtain SC review and approval.


V20170110 3

A. Proposal Development Process

The overall proposal approval process is outlined in Appendix A and a process checklist is provided in Appendix B.

1. Investigators are strongly encouraged to discuss study ideas with the NEPTUNE PI (Matthias Kretzler), ARC Co-chairs (Drs. Larry Holzman and Jeffrey Kopp), or an ARC member. If necessary, a conference call can be arranged for a larger group discussion prior to proposal submission. Input and advice from these NEPTUNE investigators will provide important guidance in the development of a successful proposal. The use of a Concept Sheet (Appendix C) can help facilitate conversations.

2. Fact finding and consultation should be initiated three months ahead of the external sponsor’s deadline. Complex studies, particularly those involving human subjects, the involvement of NEPTUNE clinical sites, and/or requests for limited biospecimens may take longer to review.

3. Following initial discussion, applicants may submit an Ancillary Study Application. Applicants should use the template and instructions in Appendix D, and use the Checklist (Appendix B) to assure that the AS application is complete. This checklist should be included with the application. Incomplete proposals will be returned to the investigator. The Ancillary Studies Program Manager will work with the Ancillary Investigator to coordinate initial discussions on availability of samples, exploration of NEPTUNE data in tranSMART, evaluation of study feasibility, burden to the patient, and estimated cost.

4. The DACC will provide an initial review of the proposal for feasibility: a) biospecimen availability and appropriateness, b) analytic resources, c) need for joint CureGN application, d) participant and/or site burden, and e) budgeting considerations.

5. In addition to the resource considerations in 5 above, for studies requiring participation of clinical sites, investigators must seriously consider feasibility and the interest of NEPTUNE clinical site PIs. Proposals for such studies must include an additional abstract (similar to an NIH abstract) that includes a brief Background, Hypothesis, Specific Aims or Objectives, Methods, and Relevance. This additional abstract will be distributed to all NEPTUNE sites for consideration.

6. The DACC may require revision of the proposed application; in this situation, revised AS applications should be submitted with a brief cover letter explaining the revision.

B. Ancillary Committee Review

1. Once the DACC assessment is completed, investigators submit an Ancillary Study Application to the ARC for formal consideration. The application initially will be reviewed by two members of the ARC and/or external experts. These reviewers write a brief review of the proposal for distribution to all ARC members, usually within a 2-3 week window (see Instructions to Reviewers and Review Template, Appendix E).

2. Reviewers will present their critique to the full ARC at a monthly meeting. The ARC will discuss, make recommendations for revision, and/or vote to approve.

3. The ARC may require revision of the proposed application. If revisions are requested, ARC Co-chairs will summarize critiques and make recommendations based on proposal reviews. Ancillary Study Investigators will have an opportunity to


V20170110 4

revise the proposal. Revised AS applications should be submitted with a brief cover letter explaining the revision.

4. The investigator should plan to submit a proposal to the ARC well ahead of the external sponsor’s deadline (at least two months) in order to accommodate the review steps detailed above.

5. Once approved by the ARC, recommendations of the ARC will be submitted to the SC for final discussion and formal approval. SC members will be provided with the ARC summary and recommendations. If a majority of the SC approves the ancillary study, a letter documenting the ancillary study approval will be sent to the ancillary study investigator for inclusion with application for external funding support. Dissenting members of the SC are encouraged to submit concerns in writing to the ancillary study investigator, especially if the ancillary study receives majority approval. This will give the investigator an opportunity to revise/improve their submission to an external sponsor.

D. Funding Proposal Submission

If approved by the SC, the investigator may then submit a full proposal to external sponsors for consideration of funding. In developing the proposal, the investigator should work closely NEPTUNE DACC to ensure that the proposed study will be fully integrated into the main study/project.

VI. Criteria Used to Review Ancillary Studies

A. Study Burden

The ARC will evaluate study burden to NEPTUNE using the following guidelines:

1. The proposed study must require the unique characteristics of the NEPTUNE cohort to accomplish its goals;

2. The proposed study must put minimal demand on scarce NEPTUNE resources such as blood samples (a clear effort to minimize this burden should be documented);

3. The proposed study must detail all distributions of specimens, including generation of further data from existing samples. Ancillary Study Investigators must agree to all elements in the NEPTUNE Ancillary Study Data Use and Material Transfer Agreement (Appendix F), including but not limited to providing a copy of the complete ancillary data set back to the NEPTUNE Study (see Section X for further details);

4. The proposed study must not create a serious diversion of NEPTUNE study resources (personnel, equipment, biosamples) or investigator/staff time, locally or centrally;

5. The proposed study must be acceptable to the participants (e.g. time, discomfort, privacy);

6. The proposed study must not adversely affect participant cooperation or compliance with NEPTUNE;

7. The proposed study must not interfere with other parts of the main NEPTUNE Study;


V20170110 5

8. The proposing investigators must have adequate resources to effectively complete the project, including but not limited to:

a. Sufficient budget

b. Feasibility of utilizing existing NEPTUNE study personnel versus hiring additional personnel will be rigorously reviewed

c. Staff having the requisite expertise to meet the objectives of the project.

9. The proposed study must not jeopardize the public image of the NEPTUNE study.

B. Scientific Merit

If the applicant will seek external peer review, the AS proposal will be reviewed only for feasibility of approach and burden to NEPTUNE.

If the proposed AS project will be funded by the applicant without extramural peer review, however, the ARC will be responsible for evaluating scientific merit and impact of the proposed work. The proposed study must meet requirements of the highest scientific merit and the strength and feasibility of the approach.

VII. NEPTUNE Site Responses to Ancillary Submissions

If the proposed study involves participation from affiliated NEPTUNE clinical sites, the AS application should contain a summary in which the interest of each site in participating in the ancillary study is formally registered. In addition to voting either ‘No’, ‘Yes’, or a ‘qualified Yes’ (with attached comments) each site will indicate one of three levels of desired involvement: 1) ‘No interest;’ 2) ‘Partial interest’ (scientifically engaged, wish to contribute intellectual content, but do not wish to perform additional data collection at our site; no budgetary needs); or 3) ‘Full interest’ (scientifically engaged, wish to contribute intellectual content and to collect data at our site; include in budgetary considerations as appropriate for data collection and/or investigator salary support).

VIII. Ancillary Studies Requesting Limited Biomaterial Resources

NEPTUNE strives to make its clinical data and its biomaterials collected during longitudinal observation available to all. Nevertheless, many biomaterials collected by NEPTUNE are limited in number or volume.

Limited NEPTUNE biomaterials are defined as non-renewable, irreplaceable biomaterials in restricted supply that, in the judgment of the NEPTUNE Ancillary studies Committee (ARC) and the NEPTUNE Steering Committee, are considered as having unique scientific value. These limited biomaterials must be rationed to support studies judged most likely to advance science relevant to the mission of the NEPTUNE consortium. Judging value is clearly subjective and is best done in committee after review of an application that defends the scientific value of the request.

A. Application

In general, requests for one particular type of sample at any study time point should not exceed 10% of the sample number or volume initially collected by NEPTUNE at that time point.


V20170110 6

The ancillary PI is encouraged to begin conversations with the DACC about her/his research idea as early as possible, to determine whether there is sufficient sample available for the proposed study. The DACC will provide the ancillary PI with detail about current sample availability, as well as possible alternate sample types, alternate collection time points, or existing measurements that are available from previous ancillary studies that used the same limited biomaterials of interest. These discussions may help redefine sample requirements or strengthen justification for use of the limited samples.

The recommendation is to allow four to six weeks for such conversations and exploration, prior to ARC meeting in which a vote for recommendation of approval will be made. The ARC meets the first Friday of every month. Applicants are urged to plan accordingly.

The ancillary study application should provide the following details:

1. A compelling justification for the request of limited and irreplaceable biomaterials. The justification should discuss how the proposed project will take advantage of the depth of larger NEPTUNE clinical data set and it should make the case clearly that the proposed study will have significant scientific impact.

2. Where at all possible, preliminary data to support the proposal’s hypothesis and the technical feasibility of the approach proposed.

3. Evidence that a meaningful effort has been made to use non-NEPTUNE sources of similar biomaterial to obtain preliminary data. The ancillary studies committee might accept the use of NEPTUNE biosamples to develop preliminary data in an iterative fashion in some cases. Here, the applicant should explain why alternative samples cannot be obtained from other sources and should work with the DACC to identify similar NEPTUNE samples that are less limited (e.g., from visits where samples of the type required are less limited or less valuable for other reasons).

4. Consideration of the source and condition of requested biospecimens, such as how they were collected, prepared and stored if this might affect the proposed analysis.

5. Detailed information about the requested samples in a table summarizing this request. The ancillary study investigator can work with DACC for this information. If the proposed project will use samples in addition to NEPTUNE samples, these samples should be listed separately in the table (e.g., important controls from healthy subjects or people with other diseases).

6. Assay details and methodology, including: amounts and type of samples (applicants should request the minimum volume required for their assay), anticipated assay variability, information about how quality control (assay "robustness") will be assessed.

7. Where at all possible, a required sample size estimate using power analysis that shows that the requested samples will be sufficient to answer the question posed.

8. A detailed plan for data analysis, including personnel who will perform the analysis. This analysis might require a biostatistician.


V20170110 7

B. Review

1. Reviewers must be provided with an updated summary of existing NEPTUNE biomaterials at the time of review to allow them to make an independent assessment of sample availability.

2. All ancillary studies that propose to use biomaterials must be discussed by the ancillary study committee during a committee phone call. Electronic voting to approve such ancillary studies without formal discussion is not acceptable.

C. Limitation of ancillary study approval period where biomaterials are requested

Ancillary study approval is good for one year.

If the applicant anticipates that approval period will expire prior to the beginning of a funded grant period, then a formal request for renewal must be submitted and approved prior to submission of a new or revised grant proposal. For example, should a proposal be submitted to the NIH for funding and not be recommended for funding, then a request for extension must be approved by the Ancillary Studies Committee prior to resubmission of a grant proposal that employs NEPTUNE biomaterials. Extension requests will require a written update to the original ancillary study application that describes changes in knowledge, preliminary data, experimental approach or request for sample type or amount that might have occurred during the time of initial application.

IX. Handling of NEPTUNE Data and Specimens

All requests, distribution, and analysis of NEPTUNE specimens must be clearly described in the proposal for consideration during review. A NEPTUNE Ancillary Study Data Use and Material Transfer Agreement (Appendix F) must be in place prior to the release of NEPTUNE samples.

At the time of distribution of NEPTUNE specimens and/or information, the DACC will make explicit arrangements with the ancillary study investigator (in accordance with the NEPTUNE Ancillary Study Data Use and Material Transfer Agreement) for the security of these study materials, and for their final disposition at the conclusion of the ancillary study. The safety and confidentiality of the NEPTUNE data at the collaborating institution is the responsibility of the ancillary study investigator, as is the appropriate disposition of these materials after the study has been completed. Leftover DNA and laboratory specimens are destroyed or returned, and files of NEPTUNE data are returned or deleted, as established at the outset of the collaboration.

If the submitting ancillary Investigator proposes to have a laboratory assay performed on NEPTUNE serum, plasma, urine or DNA in a lab outside of the NEPTUNE Consortium, it is recommended that the Investigator discuss this in advance with one of the ARC Co-chairs, Drs. Larry Holzman and Jeffrey Kopp. For an assay to be done outside the NEPTUNE Consortium the submitting Investigator will need to submit both adequate documentation of Quality Control methods at the proposed assay site, and sufficient details on how sample processing will be handled (amounts, type, shipping, frequency, etc.) in an appendix to the application. In addition, both the submitting Investigator and receiving 3rd party are bound by the NEPTUNE Ancillary Study Data Use and Material Transfer Agreement.

The ARC and SC reserve the right to request preliminary data validating an investigator’s laboratory method against an external standard. In addition, they may also request outside review by independent experts in the area to certify the QA data presented.


V20170110 8

All costs associated with the collection, transfer, analysis and oversight of data collected by an ancillary study will be borne by the ancillary study. Budgets in support of ancillary studies must be sufficient to address all of these requirements regarding ancillary study data. Proposals that do not have sufficient budgets to assure these data management activities will in general not be approved.

X. Management of Ancillary Study Data

A. Standards

All data collected under the auspices of an ancillary study is expected to adhere to the same high standards of quality applied to data collected in the NEPTUNE study. All data from ancillary studies will be scrutinized for quality and consistency using the same mechanisms as are in place for the NEPTUNE.

B. Data Transfers

All data from ancillary studies must be made available to the DACC through frequent data transfers. From there, it will be made available to the larger NEPTUNE consortium and other requesting third parties. The frequency and timing of these transfers are established prior to the initiation of any ancillary study and included in the study proposal; at a miniumum this at the time of publication or 24 months after transfer of samples or raw data sets in order to assure the highest quality of data from ancillary studies and enable the tracking of recruitment follow-up of NEPTUNE participants in ancillary studies. The format of data transfer to the DACC must conform to standards compatible with the NEPTUNE data management platform and the NEPTUNE data management group.

Any requested period of exclusivity for the data generated by the ancillary study must be documented in the study proposal. Unless stated otherwise, the data will be made available to the larger NEPTUNE consortium (via tranSMART or other ancillary study). See Appendix G, Guide for Private Partner Interactions for additional details regarding Intellectual Property.

At the conclusion of the data analysis and publication of the main (ancillary) study hypothesis, an archival copy of the newly collected data and/or laboratory results not already held at the DACC will be sent to the DACC. This transfer is the responsibility of the ancillary study investigator(s).

Once transferred to the NEPTUNE DACC, all ancillary data will become part of the aggregate NEPTUNE data and available to NEPTUNE participant sites and other requesting third parties. Subsequent access to these data will be governed by the NIH ORD data sharing policies.

C. Reporting

The Ancillary Study Investigator is responsible for presenting the study to the SC and/or NIH/ORD as appropriate, monitoring the study to assure continuing compatibility with NEPTUNE Study, and serving as a liaison to the NEPTUNE SC. The NEPTUNE SC and the DACC will monitor the development of the ancillary studies, receipt of funding, initiation dates, and progress. A written progress report on ancillary studies must be made annually to the ARC, SC and/or NIH/ORD. Failure to comply with this policy will be used to prevent publication of results via action of the publication committee.


V20170110 9

XI. Funding Timeline

Approved ancillary studies must be funded to initiate the study protocol. A written report of the funding status of an approved proposal will be required annually, starting one year after application approval. If the ancillary study investigator has not acquired funding or started the project one year after approval, the ancillary study investigator must request approval renewal (based upon active efforts to acquire funding and/or start research) or withdraw the ancillary study. Approval renewal for unfunded or unstarted proposals is not guaranteed. The approval renewal request is detailed below.

XII. Ancillary Study Approval Extensions

A. Policy

Ancillary studies Review Committee (ARC) approvals granted to Principal Investigators (PIs) for studies that employ NEPTUNE resources are valid for one year. ARC approval must be renewed for the use of NEPTUNE resources if the PI has not received a notice of grant award that commences prior to the end of the first year after Committee approval. If a study does not require extramural funding, the PI must request NEPTUNE resources and the DACC must release those resources before the end of the first year after Committee approval.

B. Purpose

Authorization to conduct a NEPTUNE ancillary study provides the PI with assurance that NEPTUNE resources are present to fulfill the approved study. Where these resources are limited, the NEPTUNE DACC will encumber these resources to protect the approved ancillary project. The term limit placed on commencing use of these resources ensures that others seeking to use these resources will not be prevented from doing so should approved studies not commence in a timely fashion. Resources that are not limited, such as the clinical data archive, can be used more freely without limiting opportunity to other investigators in the future.

The NEPTUNE ancillary study approval process provides the consortium assurance that NEPTUNE resources will not be inappropriately used for duplicate studies. The one-year time limit assures that PIs wishing to conduct duplicate studies are not prevented from doing so if an approved study does not commence in a timely fashion.

C. Process

1. For studies that require limited NEPTUNE biomaterials (see Section VIII above for definition) and have not received extramural funding or where resources have not been released prior to the end of the approval period:

a. The PI should request a one-year project approval extension at least 21 days prior to approval termination using the “project approval extension application” (See Appendix H for Extension/Change Form). If the PI is planning to request a change in materials or patient/site burden with the extension request, the request for extension and change should occur at least 45 days prior to approval termination to ensure sufficient time for the Committee Chair and the Committee to review.

b. The NEPTUNE program manager under the authority of the Committee will review this application administratively to assure that the requested limited resources remain available and have not been requested by others to investigate the identical


V20170110 10

research question. The NEPTUNE program manager will additionally review for a change in materials/burden:

i. If there is no significant change in materials/burden since the prior approval, the Committee Chairman is authorized to provide a one-year extension without formal committee review. There will be no change to the cost estimate provided with the original approval.

ii. If there is a request for additional clinical data since the prior approval, the Committee Chairman is authorized to provide a one-year extension and approval for data without formal committee review. The additional data extraction may incur additional costs if the new request is significant in scope.

iii. If there is a request for biospecimens and/or patient or site involvement since the prior approval, the PI will update his/her approved study application to show the proposed changes. This application will be reviewed by the Committee before an extension and approval for the additional burden are granted. The additional biospecimen request may incur additional costs to cover preparation and shipping of the additional samples.

2. For studies that do not require limited NEPTUNE biospecimens and have not received extramural funding or where data have not been released prior to the end of the approval period:

a. The PI should request a one year project approval extension at least 21 days prior to approval termination using the Project Approval Extension Application (Appendix H). If the PI is planning to request a change in materials or patient/site burden with the extension request, the request for extension and change should occur at least 45 days prior to approval termination to ensure sufficient time for the Committee Chair and the Committee to review.

b. The NEPTUNE program manager under the authority of the Committee will review this application administratively to determine if there is a change in needs for clinical data, biospecimens and/or patient or site involvement:

i. If there is no request for materials and/or patient or site involvement, the Committee Chairman is authorized to provide a one-year extension without formal committee review. There will be no change to the cost estimate provided with the original approval.


iii. If there is a request for biospecimens and/or patient or site involvement since the prior approval, the PI will update his/her approved study application to show the proposed changes. This application will be reviewed by the Committee before an extension and approval for the additional burden are granted. The additional biospecimen request may incur additional costs to cover preparation and shipping of the additional samples.


V20170110 11

3. For studies that have not yet obtained required extramural funding and that require resubmission of a grant application for a project start date that occurs after termination of the one year approval period:

a. The PI should request a one year project approval extension 21 days prior to the grant application due date using the project approval extension application. If the PI is planning to request a change in materials or patient/site burden with the extension request, the request for extension and change should occur at least 45 days prior to approval termination to ensure sufficient time for the Committee Chair and the Committee to review.

b. The NEPTUNE program manager under the authority of the Committee will review this application administratively to assure that the requested limited resources remain available and have not been requested by others to investigate the identical research question. The NEPTUNE program manager will additionally review for a change in materials/burden:

i. If there is no significant change in status since the prior approval, the Committee Chairman is authorized to provide a one-year extension without formal committee review. There will be no change to the cost estimate provided with the original approval.


iii. If there is a request for biospecimens and/or patient or site involvement since the prior approval, the PI will update his/her approved study application to show the proposed changes. This application will be reviewed by the Committee before an extension and approval for the additional burden are granted. The additional biospecimen request may incur additional costs to cover preparation and shipping of additional samples.

XIII. Changes to a Proposed Study

Once an ancillary study is approved, if a change occurs in the structure or concept of the study, including any change in data elements to be collected or analyzed, or any change to study aims, such changes must be disclosed to the ARC and SC, for review and approval before the proposal is submitted to a funding agency or initiation of changes in protocol. Only one such application amendment is allowed: further changes must be done via retraction of approved application and submission of a new application.

A. Policy

ARC approval is granted to PIs for studies that employ specific NEPTUNE resources. ARC approval must be obtained if the PI changes the project aims that, in turn require additional biosamples, or require a change in burden to NEPTUNE subjects or to NEPTUNE clinical study sites.

B. Purpose

This policy ensures that the Committee has opportunity to carry out its responsibility to evaluate ancillary study burden to NEPTUNE, its subjects, investigators, or its accumulated


V20170110 12

resources. Following Ancillary Policy, the proposed study revisions must not create a serious diversion of NEPTUNE study resources locally or centrally. Further, many biomaterials collected by NEPTUNE are limited in number or volume and are considered as having unique scientific value. The consortium strives to prevent duplication in the consumption of limited materials for similar purposes. Resources that are not limited, such as clinical data archive, can be used more freely without limiting opportunity to other investigators in the future.

C. Process

1. Ancillary Study PIs will update their approved study applications to show the proposed changes to the original study. Ancillary Study PIs will request permission for additional resources or for an anticipated change in burden at least 45 days prior anticipated change in order to allow sufficient time for the established review process.

2. The requested amendment will be reviewed by the DACC and the ARC in a fashion similar to the original application (See Appendix H for Project Approval Extension/ Change Application).

XIV. Human Subjects/Data Confidentiality

Confidentiality of NEPTUNE participants must be guaranteed. Individually identifiable data may not be released. Per the NEPTUNE Ancillary Study Data Use and Material Tranfer Agreement, no attempt shall be made to link subject data to a NEPTUNE participant.

A signed consent must be obtained from every participant in the ancillary study, if the data collection/request is not covered in the original informed consent process for the NEPTUNE study.

Any investigator or personnel having access to NEPTUNE subject data should have received an orientation on the NEPTUNE Study confidentiality policy. Key personnel of the ancillary study must be certified in the NIH OHSR or equivalent training course.

The Ancillary Study Investigator must to provide a copy of the IRB approval or exemption letter prior to release of data or samples. If a separate consent form is required for the ancillary study, a copy of the signed ancillary study consent form for each study participant must be included in the NEPTUNE study record. A data file tracking all signed ancillary consent forms must be maintained by the ancillary study and an electronic copy of that file must be delivered to the NEPTUNE Study.

XV. Feedback of Results of Ancillary Studies to Participants

Results of ancillary studies shall be reported to participants and/or their physicians if medically useful and in agreement with IRB approval. Such reporting should follow standard NEPTUNE protocol for notification of participants.

XVI. Ancillary Studies included in a Training/Career Development Proposal

Ancillary projects proposed as a part of the NEPTUNE Training and Career Development Program will be reviewed by the ARC after the NEPTUNE Scientific Advisory Board has reviewed and prioritized the full proposal. Those proposals prioritized and approved for funding


V20170110 13

by the full Steering Committee will be reviewed by the DACC and ARC for adjudicated for experimental burden prior to disbursal of funds.

XVII. Publications and Presentations

All publications and presentations resulting from ancillary studies must adhere to the requirements of the NEPTUNE Publications and Presentations Policy.

Appendix A. Ancillary Study Overview

Appendix B. Checklist for Anciallry Study Concept Form and Application

Appendix C. Concept Form

Appendix D. Application Form

Appendix E. Instructions to Reviewers

Appendix F. NEPTUNE Ancillary Study Data Use and Material Transfer Agreement

Appendix G. NEPTUNE Guide for Private Partner Interactions

Appendix H. NEPTUNE Study Extension Request Form

Appendix J. Roster of Ancillary study Review Committee Members

Appendix A. Ancillary Study Development and Review Process

Ancillary Investigator: Development NEPTUNE Consortium: Review

Start Early: Allow for 3 months prior to your funding source deadline to explore study concepts.

1. Study Concept Development

• Discuss your study concept with ARC Chairs and/or an ARC Member

• Contact the NEPTUNE DACC for:

Bio-sample availability

Limited bio-sample requests (also see the NEPTUNE ancillary study policy)

Public-private partnerships (also see the NEPTUNE ancillary study policy)

Data exploration in tranSMART and nephVS

Working with NEPTUNE infrastructure

NEPTUNE RDCRN Registry contacts

Budgeting for NEPTUNE resource use

Start Early: Allow 3 months prior to funding source deadline to explore study concepts.

3. NEPTUNE DACC Review

The DACC is responsible for assessing feasibility:

• Biospecimen availability and appropriateness

• Strength of analytic resources

• Plan for new data and/or new sample generation

• Participant burden

DACC meets every Monday. Submit by previous Thursday to get onto agenda.

2. Ancillary Study Application

• The application is short form to describe NEPTUNE resource needs and study design. Download from NEPTUNE website.

• Using information collected from NEPTUNE DACC, tranSMART, nephVS, and other NEPTUNE resources, complete the ancillary application

• Review and sign the NEPTUNE data sharing policy statement

• Send to [email protected]

Allow 2+ months before funding deadline for Review.

4. Ancillary study Review Committee (ARC) Assessment

ARC responsible for assessing:

• Suitability for integration into NEPTUNE

• Burden to the consortium

• Scientific merit, if the study will not have external funding review

• Recommendation to SC for approval

Two cmte members review

Committee votes for recommendation to SC to approve

Cmte members have 2 weeks to review proposals. ARC meets the 1st Friday of

the month. Plan to get proposal to DACC a month before.

5. Steering Committee (SC) Approval

SC reviews ARC's recommendation and votes to approve.

SC meets the third Friday of the month.

Appendix B. Ancillary Study Proposal Checklist

Submitted my application 2-3 months before funding deadline or desired project start date

Obtained study application from NEPTUNE website or NEPTUNE Ancillary Studies Program Manager (to ensure most recent version)

Discussed my NEPTUNE resource needs with the NEPTUNE Ancillary Studies Program

(If requesting biosamples): Requested the minimum amount of sample needed to run my assays, and no more than 10% of existing volume in the NEPTUNE Biobank

(If requesting clinical site involvement): Included an abstract (similar to an NIH abstract) that includes a brief Background, Hypothesis, Specific Aims or Objectives, Methods, and Relevance that can be sent to participating clinical sites

Obtained a budget from NEPTUNE Ancillary Studies Program for proposed resource request

Signed the NEPTUNE Data Sharing Agreement

Appendix C. Ancillary Study Concept Form NEPTUNE Data Analysis and Clinical Studies Coordinating Center (DACC) * 734.615.5020 * [email protected]

Study Title

PI Name

Affiliation

E-mail Address

Mailing Address

Co-Investigators’ Names

Proposed Start date

Proposed End date

Funding Source and Application Date:

Internal funds from your own institution

NephCure Kidney International-NEPTUNE grant program

Private sector funding (specify source)

Extramural/Intramural funding

If already funded, specify agency and grant number:

If planned submission, specify agency and application date:

Abstract (limit to one paragraph):

Part 1. Study Design (2-page limit excluding references) 1. Background and Rationale 2. Hypotheses and Specific Aims 3. Summarize your request for existing clinical data, including visits. 4. Design and Methods

5. Do you need NEPTUNE biospecimens or use of the NEPTUNE study infrastructure?

YES Continue to Part 2 NO END HERE

Part 2. Use of NEPTUNE Biomaterials and Infrastructure 1. Define the patient population for your ancillary study, including inclusion and exclusion requirements.

2. Provide the number of adult and pediatric NEPTUNE patients meet your study requirements defined in Question #1 above? We encourage you to use tranSMART or work with a DACC member to assess case counts for your study design. If you need access to TranSMART to review NEPTUNE data, please contact [email protected].

Biopsy Cohort: cNEPTUNE Total

Adult Pediatric

Number of participants:

3. In the table below, provide the minimum sample amount, at each visit, you are requesting for your proposed study.

Please contact the DACC to determine current availability in the NEPTUNE biorepositories. The Ancillary Studies Policy states that investigators should request the absolute minimum amount to complete the proposed study.

If your proposed project will use samples in addition to NEPTUNE samples (e.g., controls from healthy subjects or people with other diseases), list them separately in the table by adding rows, as needed.

Visit Sequence Biopsy

Base line

4 Mos.

8 Mos.

12 Mos.

18 Mos.

24 Mos.

30 Mos.

36 Mos.

42 Mos.

48 Mos.

54-60 Mos.

Plasma

available

Serum

available

24-hour Urine

available

Spot Urine

available

DNA

available

RNA

available

Unstained section

available

mailto:[email protected]

4. Does your proposed study involve additional study visits, additional procedures or specimen acquisition beyond the core NEPTUNE protocol?

YES NO END

4a. Describe the rationale for additional procedures, specimens or visits. 4b. Use the table below to specify the proposed visit schedule and procedures (questionnaires, intervention,

laboratory sampling and tests). Provide a subject level time estimate of additional study procedures (e.g. self-administered questionnaire x 10 minutes).

Procedure Visit (Time) Visit (Time) Visit (Time)

4c. Use the table below to specify the proposed additional blood or urine collection beyond that collected in the

NEPTUNE protocol:

Specimen (Plasma, Serum, Urine, Other, specify)

Sampling Times:* Volume

Requested

*Specify NEPTUNE visit or specify additional (a) visit time

Appendix D. Ancillary Study Application (including Data Only Request) NEPTUNE Data Analysis and Clinical Studies Coordinating Center (DACC) * 734.615.5020 * [email protected]

Study Title

PI Name

Affiliation

E-mail Address

Mailing Address

Co-Investigators’ Names

Proposed Start date

Proposed End date

Funding Source and Application Date:

Internal funds from your own institution

NephCure Kidney International-NEPTUNE grant program

Private sector funding (specify source)

Extramural/Intramural funding

If already funded, specify agency and grant number:

If planned submission, specify agency and application date:

Abstract (limit to one paragraph):

Part 1. Study Design (5-page limit excluding references) 1. Background and Rationale 2. Hypotheses and Specific Aims 3. Summarize your request for existing clinical data, including visits. Please refer to tranSMART for data collected at

baseline and follow up visits. If you need access to tranSMART to review NEPTUNE data, please contact [email protected]

4. Design and Methods

5. Statistical Analysis

a. Power analysis and sample size justification

b. A detailed plan for data analysis

6. Anticipated Results and Project Timeline 7. Data Sharing Plan

The NEPTUNE Ancillary Studies Policy states that all data from ancillary studies will be made available to the larger NEPTUNE consortium.

At the conclusion of the data analysis and publication of the main ancillary study hypothesis, or 24 months after transfer of samples or data sets, the ancillary investigator shall send the newly collected data and/or laboratory results to the NEPTUNE DACC. Once transferred to the DACC, all ancillary data will become part of the aggregate NEPTUNE data and available to NEPTUNE participant sites and other requesting third parties (via tranSMART or other ancillary study). Subsequent access to these data will be governed by the NIH ORD data sharing policies. Any requested period of exclusivity for the data generated by the ancillary study must be documented in the study proposal.

I agree to the NEPTUNE Data Sharing Policy (Please sign):

8. References 9. Do you need NEPTUNE biospecimens or use of the NEPTUNE study infrastructure?

YES Continue to Part 2, Next Page NO END HERE



Part 2. Use of NEPTUNE Biomaterials and Infrastructure 1. Define the patient population for your ancillary study, including inclusion and exclusion requirements.

2. Provide the number of adult and pediatric NEPTUNE patients meet your study requirements defined in Question #1 above? We encourage you to use tranSMART or work with a DACC member to assess case counts for your study design. If you need access to TranSMART to review NEPTUNE data, please contact [email protected].

Biopsy Cohort: cNEPTUNE Total

Adult Pediatric

Number of participants:

3. In the table below, provide the minimum amount of sample, at each visit, you are requesting for your proposed

study. Please contact the DACC to determine current availability in the NEPTUNE biorepositories. The Ancillary Studies Policy states that investigators should request the absolute minimum amount to complete the proposed study.

If your proposed project will use samples in addition to NEPTUNE samples (e.g., controls from healthy subjects or people with other diseases), list them separately in the table by adding rows, as needed.

Visit Sequence Biopsy

Base line

4 Mos.

8 Mos.

12 Mos.

18 Mos.

24 Mos.

30 Mos.

36 Mos.

42 Mos.

48 Mos.

54-60 Mos.

Plasma

available

Serum

available

24-hour Urine

available

Spot Urine

available

DNA

available

RNA

available

Unstained section

available

3a. Please specify required sample storage conditions:

4. Are you proposing use of limited biospecimens?

YES GO TO Question 4a, Next Page NO GO TO Question 5, Next Page


Justification for the request of limited and irreplaceable biomaterials:

4a. Discuss how the proposed project will take advantage of the depth of larger NEPTUNE clinical data set and it should make the case clearly that the proposed study will have significant scientific impact.

4b. Provide preliminary data to support the proposal’s hypothesis and technical feasibility. The ancillary studies committee may consider the use of NEPTUNE biosamples to develop preliminary data in an iterative fashion in some cases. In this case, explain why alternative samples cannot be obtained from other sources.

4c. Provide consideration of the source and condition of requested biospecimens, such as how they were collected, prepared and stored if this might affect the proposed analysis.

4d. Describe assay details and methodology including: amounts and type of samples (applicants should request the minimum volume required for their assays), anticipated assay variability, quality control (assay "robustness") assessment.

5. Will you need a statistician or data analyst from the DACC for you proposed ancillary study?

YES The DACC will contact you to set up a time to discuss the details of the biostatistical support and will

generate a cost estimate NO Please provide a description of the biostatistical expertise that will be available from your team for this

proposed study

6. Does your proposed study involve additional study visits, additional procedures or specimen acquisition beyond

the core NEPTUNE protocol?

YES NO END 6a. Describe the rationale for additional procedures, specimens or visits. 6b. Use the table below to specify the proposed visit schedule and procedures (questionnaires, intervention,

laboratory sampling and tests). Provide a subject level time estimate of additional study procedures (e.g. self-administered questionnaire x 10 minutes).

Procedure Visit (Time) Visit (Time) Visit (Time)

6c. Use the table below to specify the proposed additional blood or urine collection beyond that collected in the

NEPTUNE protocol:

Specimen (Plasma, Serum, Urine, Other, specify)

Sampling Times:* Volume

Requested

*Specify NEPTUNE visit or specify additional (a) visit time

Appendix E: Neptune Ancillary Study Evaluation Form

Study Title:

Funding Source:

Applicant:

Review Date:

1. How will the proposed study strengthen the Neptune mission? 2. Will the proposed study appropriately use resources of Neptune?

Please consider: Will the proposed project take advantage of the depth of the larger NEPTUNE clinical data set in

order to maximize its scientific impact?

Does the proposal include preliminary data to support the study hypotheses and the technical feasibility? If not, do you still feel that the use of NEPTUNE resources is justified?

(If samples are requested) Was it clear that the applicant was requesting the minimum volume of samples necessary?

Is the proposed study appropriately powered to answer the research questions?

3. Will the proposed study negatively affect the core Neptune infrastructure? Assess if the proposed study

has a significant potential to negatively impact the main study. For example, a study that requires high intensity visit schedule of the study patients at the time of enrollment may be too large a burden on the patient or the local study team and negatively impact recruitment or retention.

Yes

No 4. How will the use of the Neptune resources strengthen the proposed study? 5. Is the proposal scientifically valid? Studies that will be submitted for extramural review and funding (e.g.

NIH, NKI, National Kidney Foundation) do not need a detailed scientific review.

Assess the strengths and weaknesses, for example, are the hypotheses and scientific questions significant and of high impact? Are the methods for data acquisition, sample assays, and experiments scientifically justified? Is the proposed study adequately powered? Is the data-sharing plan adequate?

Overall Recommendation: Please provide a short paragraph (2-4 sentences) that succinctly summarizes your assessment of the strengths and weaknesses of the study, in context of the overall NEPTUNE goals. Your comments will be shared with the ARC Committee at the time of vote.

Approve

Reconsider After Revisions

Disapprove

v201304.1

APPENDIX H: NEPTUNE DATA USE AND MATERIAL TRANSFER AGREEMENT The Regents of the University of Michigan, a constitutional corporation of the State of Michigan with a principal address at 3003 S. State Street, Room 1028, Ann Arbor, MI 48109 (“Provider”), acting as the Data Analysis and Coordinating Center (“DACC”) for the Nephrotic Syndrome Study Network (“NEPTUNE”), agrees to provide ____________________________________ (“Recipient”) with certain research material for use by its scientist, ________________________ (“Scientist”), subject to the terms and conditions set forth in this Material Transfer Agreement (the “Agreement”). 1. This Agreement applies to the transfer of specimens, any progeny and unmodified derivatives thereof, and/or data that have been de-identified pursuant to the requirements of the Health Insurance Portability and Accountability Act (collectively, the “Material”) for use by Scientist to conduct an activity (the “Research”) that has been reviewed by the NEPTUNE Ancillary Study Review Committee (“ARC”) and approved by the NEPTUNE Steering Committee (“SC”). 2. The transfer of the Material constitutes a non-exclusive license to use the Material solely for the Research. 3. Recipient and Scientist agree that the Material shall only be used for purposes of the Research within Scientist’s lab under conditions as articulated in the NEPTUNE Ancillary Studies Policy and Procedures (attached and incorporated herein as Appendix A). Uses of the Material beyond those anticipated in the Research require submission of an amendment for review and approval to the ARC and SC. 4. Recipient agrees that no person authorized to use the Material under this Agreement shall make available any portion of the Material to any person or entity other than laboratory personnel under the Scientist’s immediate and direct control. No person authorized to use the Material shall be allowed to take or send the Material to any location other than the Scientist’s laboratory without the Provider’s prior written consent. 5. Under no circumstances shall Recipient or any person to whom Recipient directly or indirectly discloses the Material make any attempt to link the Material to any individual, whether living or deceased, associated with the Material. In the event Recipient inadvertently identifies an individual whose information is part of the Material, Recipient shall promptly notify Provider of such identification. 6. Recipient will promptly report to Provider any identified use or disclosure of the Material that is inconsistent with the terms and conditions of this Agreement. 7. PROVIDER MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESSED OR IMPLIED. THERE ARE NO EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR THAT THE USE OF THE MATERIAL WILL NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK, OR OTHER PROPRIETARY RIGHTS. Unless

2

prohibited by law, Recipient assumes all liability for claims for damages against them by third parties that may arise from the use or disclosure of the Materials except that, to the extent permitted by law, the Provider shall be liable when the damage is caused by the gross negligence or willful misconduct of the Provider. 8. Recipient shall establish appropriate safeguards to ensure that the Material are used or disclosed only in compliance with the terms and conditions of this Agreement and with all applicable statutes and regulations, including without limitation current NIH guidelines and any regulations or guidelines pertaining to research with recombinant DNA, that may be applicable to the Material. 9. Recipient agrees, per the NEPTUNE Ancillary Studies Policy and Procedures, to provide Provider with copies of all data generated by Recipient’s Research. Recipient and Scientist understand and agree that such data will be maintained by the DACC and made available to NEPTUNE participant sites and other requesting third parties. 10. This Agreement is not assignable. 11. This Agreement is effective when signed by an authorized representative of Recipient and shall terminate when all of the Material provided by Provider to Recipient are destroyed or returned to Provider, or, if it is infeasible to return or destroy the Materials, protections, reviewed and approved by Provider, are extended to such Materials. WHEREFORE, the Recipient, through its authorized representative, hereby accepts and agrees to the terms and conditions of this Agreement.

FOR RECIPIENT [Note: must be signed by an authorized officer.] By: Name: Title: Date: Read and Acknowledged [Enter Name of Recipient’s Scientist] Scientist: Date:

V201305.2

Nephrotic Syndrome Study Network (NEPTUNE) Guide for Private Partner Interactions

NEPTUNE welcomes collaborations with Private Partners to advance the understanding and treatment of nephrotic glomerular diseases. As a consortium of academic institutions, however, NEPTUNE itself does not directly establish collaborations with Private Partners as an entity separate from its constituency. The following policy and procedures guide the interaction of Private Partners with NEPTUNE in order to preserve the scientific validity and data integrity of the consortium.

1. For purposes of these policies, Private Partners are defined as third party entities with a vested interest in the outcome or results of the interaction. For example, a company interested in validating a new proprietary test would qualify as a Private Partner. A central laboratory running an assay would NOT qualify as a Private Partner (only a service provider).

2. Interactions with Private Partners must be done under the Ancillary Study mechanism established

within the NEPTUNE consortium and follow all policies and procedures (see NEPTUNE Ancillary Studies Policy and Procedures).

3. Ancillary studies involving Private Partners must be proposed to the NEPTUNE consortium by an academic Principal Investigator (PI).

4. An academic PI-Private Partner collaborative ancillary study must be approved by the NEPTUNE

consortium using the NEPTUNE mechanism for approval of ancillary studies, prior to initiation of the study. This applies to studies deemed to be initiated by the academic PI or by the Private Partner.

5. A Private Partner interested in proposing their own ancillary study that will use NEPTUNE infrastructure or resources (i.e., NEPTUNE bio-specimen resources and/or NEPTUNE resources held in silico) must interface with NEPTUNE via an academic investigator already within NEPTUNE. This investigator will be recognized by NEPTUNE as the academic PI proposing the ancillary study, in which the Private Partner is a scientific collaborator.

6. The academic PI of the ancillary study will administer the responsibility for adherence to NEPTUNE

Ancillary Studies Policy and Procedures by the Private Partner. This administrative responsibility of the academic PI to NEPTUNE must be formalized before the initiation of the ancillary study by agreement between the academic PI’s home institution and the Private Partner to incorporate the following:

o NEPTUNE cannot be bound by any exclusive rights to the use of NEPTUNE infrastructure

and/or resources by a Private Partner.

o The intent to derive Intellectual Property from the use of NEPTUNE infrastructure and/or resources by a Private Partner cannot restrict in any way the use of NEPTUNE infrastructure and/or resources by others towards their own interests.

o Intellectual Property can be developed from the use of NEPTUNE infrastructure and/or

resources by a Private Partner. However, if requested, an unrestricted research use license of this Intellectual Property must be provided to other academic investigators for their own use of NEPTUNE infrastructure and/or resources towards their own research interests.

o All data derived from the use of NEPTUNE infrastructure and/or resources by a Private Partner

must ultimately be shared with NEPTUNE for use in the public domain. Data is to be deposited with the NEPTUNE DACC. A timeline for data transfer to NEPTUNE and rationale for proposed timeline may include a proprietary period to develop Intellectual Property from the data. The timeline and rationale must be stated in the ancillary study proposal, for review by the

V201305.2

NEPTUNE Ancillary Study Committee and final approval by vote of the NEPTUNE Steering Committee.

o Publication of the results of the ancillary study in the public domain must be a goal of the

ancillary study. Use of NEPTUNE infrastructure and/or resources solely to derive Intellectual Property for a Private Partner in the absence of attempts to publish the results of the ancillary study in the public domain is counter to the charter of NEPTUNE. Manuscript(s) resulting from the ancillary study must be reviewed and approved for submission for external review by the NEPTUNE Publications and Presentations Committee prior to submission for external review.

Appendix H: NEPTUNE Ancillary Study Extension Request

Study Title:

Investigator:

Co-Investigators:

Original Approval Date:

1. Since your ancillary study approval, have you received any data or samples from the NEPTUNE DACC?

NO GO TO QUESTION 2 BELOW.

YES Briefly describe progress on your study (e.g., tests underway, analyses underway,

manuscript or abstract preparation).

2. Why are you requesting an extension of approval for your ancillary study?

3. Are you proposing a change in your original request for existing NEPTUNE data?

NO GO TO QUESTION 4 BELOW.

YES Briefly describe why you are proposing a change to your data request and what that

change entails (include change in disease cohorts, visits, data elements).

4. Are you proposing a change in your original request for biospecimens or burden to sites and/or patients?

NO END.

YES In your original ancillary stud proposal, please update Section 1 with your change in

requirements. If you are asking for additional biospecimens, please update the Section 2, item 3 to describe rationale, preliminary data, and details on assays/tests.

APPENDIX J. NEPTUNE ANCILLARY STUDIES REVIEW COMMITTEE (ARC)

First Name Last Name Institution Larry Holzman* University of Pennsylvania Jeffrey Kopp* NIDDK Serena Bagnasco Johns Hopkins Laura Barisoni Miami Pietro Canetta Columbia University Daniel Cattran University Health Network Fernando Fervenza Mayo Clinic Debbie Gipson University of Michigan Marie Hogan Mayo Clinic Rick Kaskel Montefiore Matthias Kretzler University of Michigan Richard Lafayette Stanford University Kevin Lemley CHLA Laura Mariani University of Michigan Marva Moxey-Mims NIDDK Patrick Nachman University of North Carolina Cindy Nast Cedars Sinai John O'Toole Case Western University Kalyani Perumal Stroger Rebecca Rasooly NIDDK Kim Reidy Montefiore Heather Reich University Health Network John Sedor Case Western University Peter Song University of Michigan Tarak Srivastava Children’s Mercy Howard Trachtman NYUMC Chia-Shi Wang Emory

*Chairs: Larry Holzman, MD (University of Pennsylvania) and Jeffrey Kopp, MD (NIDDK)

Nephrotic Syndrome Study Network (NEPTUNE) Ancillary Studies … · 2001. 10. 17. · NEPTUNE...

Documents

Transcript of Nephrotic Syndrome Study Network (NEPTUNE) Ancillary Studies … · 2001. 10. 17. · NEPTUNE...