410.010 Research Involving Humans in Experiments

kuscheld — Thu, 27 May 2010 16:47:06 +0000

410.010 Research Involving Humans in Experiments kuscheld Thu, 05/27/2010 - 16:47

Executive Order No. 10, 8-10-72, Amended 8-28-07.

Human Subject Research, Defined --
1. Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains
  1. Data through intervention or interaction with the individual, or
  2. Identifiable private information
2. Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Human Subject Research Subject to Review and Approval -- It shall be the policy of the ��ϲʹ�� that all research projects which involve human subjects shall be subject to review and approval by an appropriate, officially appointed, Institutional Review Board registered with the Office of Human Research Protections (or other office designated by the United States Department of Health and Human Services) prior to project initiation, and without respect to the source of funding or sponsorship. This policy shall include all faculty, staff, and student research regardless of source of support.

410.020 Institutional Conflicts of Interest in Human Subjects Research

kuscheld — Thu, 27 May 2010 16:48:51 +0000

410.020 Institutional Conflicts of Interest in Human Subjects Research kuscheld Thu, 05/27/2010 - 16:48

Executive Order No. 37, 03-24-10.

This policy is established to meet the institutional conflict of interest requirements of the Association for the Accreditation of Human Research Protection Programs (AAHRPP), specifically Standard I-6, under which the University must have and follow written policies and procedures to ensure that research is conducted so that financial conflicts of interest are identified, managed, and minimized or eliminated. It is intended to provide appropriate institutional safeguards to sustain a climate in which human subjects research at the University can be carried out responsibly without undue influence from its entrepreneurial and its financial aspirations. Each institutional financial interest that presents a potential for financial conflicts of interest, whether real or perceived, must be fully disclosed to the President or designee, must be managed, reduced, or eliminated, and the potential conflict of interest and management plan, if any, must be disclosed to the various Institutional Review Boards (IRBs) so that the appropriate IRB can decide whether the interest and its management, if any, allows the human subjects research to be approved.

Conflicts of interest of University officials and employees are addressed separately in Sections 10.090 (Curators), 330.015 (all employees), and 420.030 (“investigators” on funded or proposed NSF or PHS research or educational activities).

Institutional Conflict of Interest in Human Subjects Research, Defined --
1. The University may have a conflict of interest (“institutional COI”) in human subjects research whenever the interests of the institution might affect – or reasonably appear to affect – institutional processes for the design, conduct, reporting, review, or oversight of human subjects research.
Human Subjects Research, Defined –
1. Human subjects research for the purposes of this policy is the same as that in Section 410.010A., namely:
  1. Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains
    (1) Data through intervention or interaction with the individual, or
    (2) Identifiable private information.
  2. Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
2. Human subjects research requires review and approval by an appropriate, officially appointed, Institutional Review Board registered with the Office of Human Research Protections prior to project initiation, and without respect to the source of funding or sponsorship, as provided by Section 410.010B.
Identification of Potential Institutional Conflicts of Interest. As a general guide, the following significant financial and fiduciary interests of the University warrant formal review of potential institutional COI with respect to human subjects research, as provided in this policy:
1. Royalties: The University has the potential to receive significant milestone payments and/or royalties from the commercialization of a product based at least in part on technology that is the subject of University research.
2. Non-publicly traded equity: Through its technology licensing activities or investments related to such activities, the University has obtained an equity interest or an entitlement to equity of any value (including options or warrants) in a non-publicly traded company that is (i)the sponsor of human subjects research at the University, or (ii) the manufacturer or distributor of a product to be studied or tested in human subjects research at or under the auspices of the institution or based at least in part on technology developed at the University.
3. Publicly traded equity: Through technology licensing activities or investments related to such activities, the University has obtained a significant equity interest or an entitlement to significant equity (including options or warrants), in a publicly traded company that is (i) the sponsor of human subjects research at the institution, or (ii) the manufacturer or distributor of a product to be studied or tested in human subjects research at or under the auspices of the institution, or based at least in part on technology developed at the University.
4. Governance/Fiduciary roles: Through technology licensing activities or investments related to such activities, the University has obtained the right to appoint one or more members to the governing board of any company that is (i) the sponsor of research at the University, or (ii) the manufacturer or distributor of a product that is either studied or tested in research at or under the auspices of the University, or based at least in part on technology developed at the University.
5. Gifts from companies/sponsors. The University is offered or has received significant gifts (including, but not limited to, gifts in kind, discounts, fellowships, and unrestricted educational grants) from a person, company or a foundation established by or closely affiliated with a company that is (i) sponsoring or offering to sponsor research at the University, (ii) the manufacturer or distributor of a product that is either studied or tested in research at or under the auspices of the University, or based at least in part on technology developed at the University; or (iii) a company known to be a business competitor of companies described in (i) or (ii) above.
  The following circumstances, among others, should be evaluated in the gifting context:
  1. Whether a gift is of sufficient magnitude that even when held in the general endowment, it might affect, or reasonably appear to affect, oversight of research at the University;
  2. Whether a gift is held for the express or limited benefit of a school, department, institute or other unit where some or all of the research is conducted; or
  3. Whether any institutional official who has the authority to affect or reasonably appear to affect the design, conduct, reporting, review, or oversight of the research has also been actively involved in solicitation of the gift, or in the management of the gift once received by the University.
The goal of this policy is not to preclude or discourage the University from accepting philanthropy from individuals or entities that support research, or that own or control products whose underlying technologies are developed, studied or tested in research at the University, provided that such gifts do not limit or reasonably appear to limit the professional independence of faculty and staff engaged in the research or research related activities. This policy is intended to help the University develop means of identifying and examining such circumstances, and of managing, through disclosure, separation of responsibilities, and as otherwise appropriate, any actual or reasonably apparent conflicts of interest that may result.
Procedures
1. As part of the IRB application process, each Principal Investigator applying for IRB approval of proposed human subjects research shall identify parties with a potential financial interest in the outcome, if known.
2. Annually by January 31 and immediately whenever there is a significant change, the Vice President for Finance and Administration and the Vice President for Research and Economic Development shall report to the President any significant financial or fiduciary interests of the University relating to human subjects research, and the campus offices of research shall report information regarding sources of research funding to the University.
3. Annually by January 31 and immediately whenever there is a significant change, each General Officer of the University shall report to the President or designee any significant gift to the University or any of its parts (including, but not limited to, gifts in kind, discounts, fellowships, and unrestricted educational grants) from an individual or entity or a foundation established by or closely affiliated with an individual or entity that is (i) sponsoring or offering to sponsor research at the University, (ii) the manufacturer or distributor of a product that is either studied or tested in research at or under the auspices of the University, or based at least in part on technology developed at the University; or (iii) a company known to be a business competitor of companies described in (i) or (ii) above.
4. The President or his designee shall:
  1. Identify potential institutional conflicts of interest from the information provided by the Principal Investigators, Vice Presidents of Finance and Administration and for Research and Economic Development, General Officers, campus research offices and other sources of information.
  2. Implement an oversight process and administrative policies and procedures to address institutional conflicts of interest relating to human subjects research and to identify situations in which such conflicts may arise;
  3. Devise and implement plans to manage, reduce, or eliminate institutional conflict of interest relating to human subjects research;
  4. Inform the various IRBs on each of the campuses of the potential institutional conflict of interest relating to human subject research and any plan to manage, reduce or eliminate it for the IRB’s review of human subjects research under Section 410.020, with the IRB having the final authority to decide whether the interest and its management, if any, allows the research to be approved.

Chapter 410: Research Involving Humans

410.010 Research Involving Humans in Experiments

410.020 Institutional Conflicts of Interest in Human Subjects Research