Terms and Conditions
The Coriell Institute website is intended to provide general educational information and to help users more easily find Coriell Institute-provided data and tools.
This site is not an attempt to practice medicine or provide specific medical advice, and should not be used to make a diagnosis or to replace or overrule a qualified healthcare provider's judgment. We strongly encourage users to consult with a qualified healthcare professional for answers to personal questions.
You assume full responsibility for using the information on this site, and you understand and agree that the Coriell Institute is not responsible or liable for any claim, loss, or damage resulting from its use by you or any user. While we try to keep the information on the site as accurate as possible, we make no warranty concerning its accuracy, timeliness, and completeness, and any other warranty, express or implied, including warranties of merchantability or fitness for a particular purpose. The Coriell Institute also does not warrant that access to the site will be error-free or virus-free.
We provide access to other web sites for your convenience, but the Coriell Institute is not responsible for the availability, accuracy, or content of those external sites.
Material on the Coriell Institute website is protected by copyright law. Unless otherwise stated, users may print or download information from this site for personal, non-commercial use only, provided they identify the source of the material (Coriell Institute for Medical Research) and include a statement that the materials are protected by copyright law. Permission to reprint or otherwise reproduce any document in whole or in part is prohibited, unless prior written consent is obtained from the copyright owner (email request to: communications(at)coriell.org).
By choosing to use the Coriell Institute website, you acknowledge and agree to these Terms and Conditions and our Privacy Policy. We encourage you to read them. We reserve the right to modify these terms and policies and recommend that you periodically review them because your continued use of this site signifies your agreement these terms.
Your access to and use of this site, and these terms and conditions are governed by the laws of the State of New Jersey and applicable U.S. federal laws. You consent to the jurisdiction and venue of the state and federal courts located within New Jersey and agree that any action related to your access to or use of this site and these terms and conditions must be brought in a state or federal court located within New Jersey.
Nothing on this site grants any license or right to use any trademarks, logos or other names, including but not limited to those identifying the Coriell Institute or any officer, director, employee, affiliated investigator, or agent of the Coriell Institute, without express written consent of the Coriell Institute or other such owner (email request to: communications(at)coriell.org).
Use of the Coriell Institute blog is also subject to the additional terms and conditions specified for our blog. By choosing to use or post any material or information on our blog, you agree to those additional terms and conditions.
Privacy Policy
The following discloses our information gathering and dissemination practices for the Coriell Institute website (http://www.coriell.org):
Information gathering: We may use your IP address to help diagnose problems with our server and to administer our website by identifying (1) which parts of our site are most heavily used, and (2) which portion of our audience comes from within the Coriell Institute network. We do not link IP addresses to anything personally identifiable. This means that user sessions will be tracked, but the users will remain anonymous.
Use of information: The Coriell Institute’s Communications staff uses the information gathered above to tailor site content to user needs, and to generate aggregate statistical reports. At no time do we disclose site usage by individual IP addresses. Web server logs are retained on a temporary basis and then deleted completely from our systems.
Security: This site has security measures in place to protect the loss, misuse and alteration of the information under our control. The Coriell Institute however, is not liable for the loss, misuse or alteration of information on this site by any third party. If you have any questions about this privacy statement, the practices of this site, or your dealings with this site, you can contact us at communications(at)coriell.org
The Coriell Institute website contains links to other websites within the “coriell.org” domain and to some sites outside this domain. Coriell Institute is not responsible for the privacy practices or the content of such websites.
Effective date: The effective date of this policy was June 1, 2011.
Policy on Conflicts of Interest
Introduction
In their central roles in the operation of the Coriell Institute for Medical Research ("Coriell Institute"), officers, executives, and especially scientific staff members assume responsibility for the ethical and legal conduct of the Institute's research programs. Together these groups hold a public trust for assuring that all of the Institute's programs will be conducted with the highest integrity.
The Coriell Institute recognizes that those selected to serve it may have diverse financial and professional interests. However, in agreeing to join the Coriell family, officers, executives, and professional staff members and research investigators make a commitment to the Coriell Institute to take particular care that no adverse effect results from any unavoidable conflicts between the individual's interests and those of the Institute. Moreover, those persons serving the Coriell Institute on a full-time basis are expected to accord their primary professional loyalty to the Institute and must not permit any outside interests or commitments to conflict with their obligations to Coriell Institute. The Board of Trustees of the Coriell Institute have adopted this policy to delineate the kind of conflicts that are of concern, to establish a system for identifying significant interests that may lead to conflicts, and to help resolve potential conflicts.
This Policy is intended to comply with the best practices emanating from the federal Sarbanes-Oxley Act, the Office of Management and Budget Circular A-110, the New Jersey Nonprofit Corporation Act, Section 4958 of the Internal Revenue Code and related Treasury Regulations, the Public Health Service, United States Department of Health and Human Service ("HHS") Regulations on objectivity in research codified at 42 CFR 50.601 et seq. and 45 CFR 94.1 et seq. as amended by 76 Fed.Reg.165, pp. 53256-53293 (August 23, 2011), and the National Institutes of Health Grants Policy Statement, Part II Terms and Conditions of NIH Grant Awards (collectively, "NIH Conflicts Policies").
Definitions
Conflicts of Interest – Conventional conflicts of interest may arise in two situations: 1) where an individual has the opportunity to influence the business decisions of the Coriell Institute in a way that could lead to personal, financial, or professional gain for the individual, his or her family or a business entity in which the individual or a family member is a principal or holds an equity interest; 2) where an individual's interests and activities are actually or potentially adverse to the interests of the Coriell Institute, including, but not limited to, situations where the individual sits on the board of directors or trustees of a corporation with which Coriell Institute desires to engage or has engaged in a transaction or agreement, or a situation where the individual, his or her family member or a entity in which the individual or family member is a principal or holds an equity interest, is in competition with Coriell Institute. A Conflict of Interest is broader than a "Significant Financial Interest" (which is defined below) which is intended to be one type of Conflicts of Interest.
Case by Case Disclosure – Certain potential or actual Conflicts of Interest may arise between filings of disclosure statements or may arise with regard to certain transactions that would not be revealed by a disclosure statement. Such actual or potential Conflicts of Interest must be reported on a case by case basis. Questionable situations should always be resolved in favor of disclosure. Specifically, it is the responsibility of each individual to disclose to the Coriell Institute if, to his or her knowledge:
- the individual or the individual's family is a party to a proposed transaction;
- an entity with which the individual or the individual's family is associated is a party to a proposed transaction;
- the individual or a member of the individual's family may benefit financially by virtue of a proposed transaction;
- an entity with which the individual or a member of the individual's family is associated may benefit financially by virtue of a proposed transaction;
- the individual or the individual's family may be or is in competition with the Coriell Institute;
- a concern with which the individual is associated may be or is in competition with the Coriell Institute; and
- the nature or extent of an individual's outside professional, business, political, or volunteer activities appear to be substantial enough to detract from or interfere with the individual's obligations to the Coriell Institute.
Committee on Conflicts of Interest – There shall be established a Committee on Conflicts of Interest, consisting of the Chairman of the Board of Trustees and the Vice Chairman of the Board of Trustees. The Committee on Conflicts of Interest shall be responsible for reviewing the disclosure statement of the Executive Vice President.
Disclosure Statement – The identification and fair resolution of conflicts depends on complete and accurate disclosure of potential conflicts. The means to this disclosure shall be an annual reporting of an individual's Conflicts of Interest that fall or may fall within the concerns of this policy.
Disqualified Person – Shall mean with respect to persons covered by this Policy, anyone who, at any time during the 5 year period ending on the date of a subject transaction, was in a position to exercise substantial influence over the affairs of Coriell Institute (provided such persons qualify as "highly compensated employees" under Section 414(q)(1)(B)(i) of the Internal Revenue Code), as well as family members of such persons and entities in which such persons hold a 35% voting interest or greater.
Investigator – Means principal investigator and any other person who is responsible for the design, conduct or reporting of research funded by or proposed to be funded by Public Health Service of the United States Department of Health and Human Services, the National Institutes of Health and/or the National Science Foundation.
Responsible Officer – The Executive Vice President of the Coriell Institute is the officer responsible for assuring compliance with this policy and reviewing Conflicts of Interest disclosures made in accordance with this Policy.
Research Conflicts of Interest – Professional staff members of the Coriell Institute are encouraged to develop consulting relationships, industrially-sponsored research programs, technology licensing, or other relationships with industry. This commercial activity may increase the opportunities for creation of beneficial products, but it may also increase the potential for conflicts of interest for the professional staff. The potential for conflict may arise in the form of offers of equity or other financial interests that could compromise the primary obligations to the Coriell Institute.
Significant Financial Interest – Means anything of monetary value, including but not limited to, salary and other payments for services, such as consulting fees, honoraria, or income from lectures, teaching engagements or for service on advisory or review panels, and reimbursed or sponsored travel which is paid on behalf of an individual (except for income from seminars, lectures or teaching engagements sponsored by and for service on advisory or review panels for, a federal, state, or local governmental agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education, or for travel that is reimbursed or sponsored by any of these), and received from sources other than the Coriell Institute (or an institution of higher education affiliated with the Coriell Institute), if the value of the salaries or other payments (when aggregated for the individual and his or her spouse and dependent children) for the preceding twelve month period exceeds $5,000.
A Significant Financial Interest also means any equity interests (stocks, stock options or other ownership interests), received from a publicly traded entity, if the value of the equity interest as determined through reference to public places or other reasonable measures of fair market value, and when aggregated with any remuneration received as described above, by the individual and his or her spouse and dependent children for the preceding twelve month period, exceeds $5,000.
A Significant Financial Interest also means any equity interests (stocks, stock options or other ownership interests), or any intellectual property rights and interests (e.g., patents, copyrights), upon the receipt of income related to such intellectual property rights and interests, received from a non-publicly traded entity, other than the Coriell Institute (or an institution of higher education affiliated with the Coriell Institute), by an individual or his or her spouse and dependent children. There is no $ 5,000 threshold on these interests.
A Significant Financial Interest shall not include income from investment vehicles such as mutual funds and retirement accounts, provided the individual does not directly control the investment decisions made in these vehicles.
Disclosure
The Executive Vice President, as Responsible Officer, shall distribute annually a copy of this Policy and the Disclosure Statement attached as Exhibit A to each officer, executive, professional staff member and any Investigator. Promptly, each such individual required to submit to the Executive Vice President the Disclosure Statement shall list any interest which may create a Conflict of Interest as defined above, specifying in detail Significant Financial Interests that the individual or his/her spouse and dependent children may have. All individuals required to submit a Disclosure Statement are responsible to ensure that it is accurate and complete, as the Executive Vice President of the Coriell Institute will be relying on it to make required certifications under the NIH Conflicts Policies as a pre-condition to receiving research funding. All individuals required to submit a Disclosure Statement shall also have the responsibility to make such additional written Case By Case Disclosures in writing to the Executive Vice President within thirty (30) days of any changed circumstances or new facts which may create a Conflict of Interest or Significant Financial Interest. In addition, each Investigator who is planning to participate in Public Health Service-funded research must disclose Significant Financial Interests no later than the time of application for the Public Health Service-funded research.
The Coriell Institute is sensitive to the issue of disclosure of personal financial information, so the information in a Disclosure Statement will be kept strictly confidential and no information will be revealed beyond this review, except in so far as may necessary by mutual agreement to resolve an actual or potential Conflict of Interest, or as follows: a) information will be transmitted to the Committee on Conflicts of Interest if it points to a potential or actual Conflict of Interest that requires resolution at that level; and b) Coriell Institute may also be required to make the completed Disclosure Statement available to HHS in connection with funded research or an application for funding for research.
The Executive Vice President shall be responsible for maintaining records of all Disclosure Statements and other disclosure information provided to him/her for a period of at least three years from the date of submission of the final expenditures report on any funding subject to the NIH Conflicts Policies.
All staff members of the Coriell Institute shall take care in disclosing all "Significant Financial Interests" as defined above in sufficient detail as requested by the Executive Vice President so that the Coriell Institute can ascertain its duties to report the same to the research grant awarding unit of Public Health Service of the United States of Health and Human Services. In particular, such staff shall disclose, with respect to all reimbursed or sponsored travel, the purpose of the travel, the identity of the sponsor/organizer, the destination and the duration, and as requested by the Executive Vice President, such further information related to the travel so as to enable Coriell Institute determine a monetary value on the sponsored or reimbursed travel.
All staff members must also disclose any other relationships with commercial concerns and others which may not rise to the level of a "Conflict of Interest" or "Significant Financial Interest" as defined above, but which may affect the independence or which may appear to affect the independence with which an individual approaches his or her institutional obligations or research results. A professional staff member shall disclose any support for his/her research program which may be received independently of the Institute, any concern with which he or she has a consulting relationship, or any other actual or potential Conflicts of Interest between the individual's research activities and his/her outside interests. Finally, a staff member shall disclose in advance any proposed acquisition of equity by himself, by his family, or by a concern in which he/she has an equity interest, in a concern whose business is closely related to the individual's area of research.
Resolution
A. Research Conflicts of Interest
This Policy is predicated on the belief that disclosure of potential Conflicts of Interest as they occur and annually will effectively address the vast majority of situations. Similarly, most other potential or actual Conflicts of Interest can be resolved if the interested individual identified, after disclosing all material facts, is not involved in the review of the Conflict of Interest and the determination of what steps are needed to manage, reduce or eliminate the Conflict of Interest if it appears to affect the independence with which the individual approaches his/her obligations for research.
The Executive Vice President, or the Committee on Conflicts of Interest, in the case of the Executive Vice President's disclosure, shall recommend a course of action for resolving Conflicts of Interest related to research. If the Executive Vice President reasonably determines that a Significant Financial Interest exists which could directly and significantly affect the design, conduct or reporting of any research, the Executive Vice President must: (1) make an initial and an annual Financial Conflict of Interest ("FCOI") report to the Public Health Service, including a description of how the Significant Financial Interest relates to the Public Health Service-funded research and the basis for the determination that such interest could conflict with the research; and (2) develop a management plan, which may include one or more of the following, in the reasonable judgment of the Executive Vice President, in order to manage, reduce or eliminate the Conflict of Interest: a) public disclosure of Significant Financial Interest when presenting or publishing the research; b) if the research involves human subjects, disclosure of the Significant Financial Interest to the participants; c) appointment of independent monitor for the research; d) modification of the research plan; e) disqualification of the individual with the Significant Financial Interest from participation in all or a portion of the research; f) mandating divestiture of the Significant Financial Interests by the interested individual; and/or g) mandating severance of relationships that create actual or potential Conflicts of Interest. The Executive Vice President's decision on Conflicts of Interest under this Policy (or the Committee on Conflicts of Interest decision in the case of Conflict of Interest involving the Executive Vice President) shall be final.
Upon discovering that a Significant Financial Interest exists, the Executive Vice President has sixty (60) days to make the determination whether the Significant Financial Interest could directly and significantly affect the design, conduct or reporting of any research, and if so, implement an interim management plan. If an Investigator fails to timely report a Significant Financial Interest, if the Executive Vice President fails to timely make a determination on the Significant Financial Interest and implement an interim management plan, or the Investigator fails to comply with the terms of a management plan, the Executive Vice President is required within one hundred twenty (120) days of Coriell Institute's determination of noncompliance, to do a retrospective review of the Investigator's activities and the Public Health Service-funded research to determine whether during the period of noncompliance any Public Health Service-funded research was biased in the design, conduct or reporting of such research, and if so, to file a mitigation report with the Public Health Service awarding the funds for the research.
B. Non-Research Conflicts of Interest
As in the research area, disclosure of potential Conflicts of Interest annually and, as new circumstances arise, is paramount for effectively dealing with Conflicts of Interest related to non-research, specific transaction Conflicts of Interest. The interested individual, after making full disclosure, cannot be involved in the review of the Conflicts of Interest. The Executive Vice-President, after consultation with the Committee on Conflicts of Interest if deemed necessary by the Executive Vice-President, shall recommend a course of action for any Conflict of Interest involving a specific transaction and persons covered by this Policy who are not Disqualified Persons. The Executive Vice President's decision in such matters shall be final.
The Executive Committee of the Board of Trustees of Coriell Institute, after recommendation from the Committee on Conflicts of Interest, shall recommend a course of action for any specific transaction involving Conflicts of Interest related to persons covered by this Policy who are Disqualified Persons.
Conflicts of Interest with respect to a specific transaction involving the transfer of real property or the right to use real property to, or compensation being paid to, a Disqualified Person covered by this Policy must be: (1) approved in advance by a majority vote of those members of the Executive Committee who themselves have no Conflict of Interest of any kind; (2) after review of "appropriate data of comparability," such as appraisals for the transfer of real property interests or relevant and appropriate salary surveys for compensation issues; and (3) documented in the written minutes of the Executive Committee meeting considering the approval, but in any event prior to the next full Board or Trustees meeting.
All other Conflicts of Interest involving a material transaction, such as the purchase or leasing of goods or services from a Disqualified Person, the Executive Committee must: a) consider at least two alternative, competitive, disinterested proposals solicited to provide the requisite goods or services, b) determine that two such competitive proposals do not exist or it would be impractical to obtain them, or determines, by a majority of disinterested trustees, that, notwithstanding the conflict, after review of the competitive proposals, that there is no transaction as advantageous as the proposed transaction with the Disqualified Person; and c) determines that the transaction with the Disqualified Person is fair and reasonable and in the best interests of Coriell Institute, and therefore, should be entered into.
All disinterested trustees reviewing a proposed transaction that involves a Conflict of Interest under this Policy are encouraged to exercise a vote on the matter and not to abstain from voting, as an abstention will be counted as a "yes" vote by the Internal Revenue Service for purposes of excess benefit excise tax liability for individual trustees under Section 4958 of the Internal Revenue Code.
All transactions approved by the Executive Committee involving Conflicts of Interest are final and shall be disclosed to the full Board at the next meeting of the Board and information on the actions taken by the Executive Committee shall be made available to any Board member whenever requested.
C. Continuing Conflicts of Interest
Conflicts of Interest with respect to a specific transaction will normally be addressed and resolved by disclosure, abstention, and consideration of alternatives. However, sometimes, where an individual's interests create the possibility of continuing Conflicts of Interest, the individual should thoroughly review the matter with the Executive Vice President or the Committee on Conflicts of Interest. If, after consideration of the impact of the conflict on the welfare of the Coriell Institute and the ability of the individual to keep paramount the interests of the Coriell Institute, the continuing Conflict cannot be resolved, the matter shall be referred to the Board of Trustees with the Committee's recommendation. The Trustees shall take whatever action they deem appropriate to protect the interest of the Coriell Institute.
D. Failure to Abide by Policy
Failure to adhere to this Policy may also result in the termination of an individual's employment, appointment, or service to the Coriell Institute.
E. Public Accessibility
The most current version of this Policy and a listing of any Significant Financial Interests which were disclosed and are still held by key personnel which could directly and significantly affect the design, conduct or reporting of any research as determined in accordance with this Policy shall be made available on a publicly accessible website. The website shall be updated at least annually and within sixty (60) days of the identification of new Significant Financial Interests which could directly and significantly affect the design, conduct or reporting of any research.
F. Training
Each Investigator shall be informed of this Policy and his/her responsibilities regarding disclosure of "Significant Financial Interests" under this Policy. Investigators shall be provided training prior to engaging in any research related to any Public Health Service - funded grant and at least every four years and whenever this Policy is modified in a manner that affects the requirements on Investigators, a new Investigator begins at the Coriell Institute, or the Coriell Institute finds that an Investigator is not in compliance with this Policy.
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