The Missouri University of Science and Technology has a continuing affirmative duty to review all research involving the use of human subjects. This duty is imposed by Federal Regulations ( 45CFR 46.101 et seq). In order to initiate this review process, an investigator must complete and submit the Campus IRB Application Missouri S&TIRB-1 to the Campus IRB for proper review. Once submitted the Campus IRB will review the project's use of human subjects.

TO WHOM THE REGULATIONS PROTECTING HUMAN SUBJECTS APPLY:

All faculty, staff, and students who conduct research involving human subjects (see: Human Subject Regulations Decision Chart) must have their research reviewed and approved, or reviewed and granted exemption, by the Institutional Review Board.

RESEARCH DEFINED:

"Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities." ( 45 CFR 46.102(d))  This definition is sufficiently broad to include social science interviews and surveys, evaluations of non-research activities, ethnographic research, and oral histories.

REVIEW OF PROPOSALS FOR USE OF HUMAN SUBJECTS:

The Campus Institutional Review Board will review each application and determine if the project either fits into the exemption category, or should be further reviewed via expedited review or a full board review in accordance with 45CFR 46.110 of the Federal Regulations. Review will consist of review of the Missouri S&TIRB-1 and appropriate consent documentation (or a request for waiver of consent documentation), the proposal itself (including the literature review and budget), as well as any additional documentation required for special subject populations (e.g., minors, prisoners).

EXEMPTIONS:

Most interviews and other survey techniques qualify for an exemption under 45CFR 46.101(b) of the Federal Regulations and do not require further review for use of human subjects. However, if a project qualifying for exemption has a project period of one (1) year or longer, a continuing review must be conducted within 10 months from date of approval. If the Campus IRB grants an exemption, investigators may not be required to obtain written consent. Under the relevant Regulations, some research presents such a low quantum of risk that securing written consent is superfluous, would impede the research, and, in some cases, might actually create risk by providing a traceable link to subjects. The investigator will be, however, required to include a prefatory statement of the voluntary nature of the research.

EXPEDITED REVIEWS:

The Board may use an expedited review procedure for those proposals that it determines present minimal risk   and fall within one of nine (9) categories listed in 63FR 60364. (November 9, 1998) The Board may also employ the expedited review procedure for those projects previously reviewed and for which an Investigator submits a change request that, in the Board's judgment, is minor in respect to the use of human subjects.

FULL BOARD REVIEWS:

Those projects that the Campus IRB determines present greater than minimal risk   or present minimal risk but do not fall within the regulatory categories listed in 63FR 60364, (November 9, 1990) are referred to the Full Board for review.

CONSENT PROCEDURES:

All Investigators whose projects do not fit into the exemption category must submit consent forms for Campus IRB review. At a minimum, the consent forms must specifically follow the requirements of consent set forth in 45CFR 46.116(a). After review of the consent document, the Campus IRB may require the Investigator to disclose further information to the subjects.

WAIVER OF WRITTEN CONSENT:

After review of the entire project, the Board may waive the Investigator's duty to obtain written informed consent in accordance with 45CFR 46.116(d); and 45CFR 46.117(c). The Investigator may also request that the Board grant a waiver of consent; however, all waivers must be within the regulatory parameters of the Federal Regulations and the consent requirements of both the statutory and common law of the State of Missouri. Although the Federal Regulations allow IRBs to grant complete waivers, Missouri law requires that the Investigator maintain consent procedures whether oral or written.

CONSENT IN RESEARCH ON MINORS:

Under most circumstances, Investigators who undertake research on children will need to obtain parental consent   and   child assent.

CHILD ASSENT:

If the subjects are under seven years old, the Board, after approving the text for the child's assent, requires only oral consent of the child. If the subjects are older than seven years, the Board, after approval of the assent form, generally requires that the Investigator obtain written assent from the child. The assents must be written in terms understandable to the subjects. The assents may be abbreviated, as determined by the Board; however, the Investigator must include a clear statement of risk as well as the parameters of confidentiality. The Investigator must disclose to the minor child who has access to the data he/she contributes, including parental access to the results of any tests, diaries, psychological profiles, or other data. In particular, the Investigator must inform the child that if he/she chooses not to participate in the research, this decision is final and binding on the Investigator regardless of whether the child's parents have given consent for the child to participate.

PARENTAL CONSENT:

In addition to the required elements of consent, the Investigator must inform the parent of the parameters of confidentiality, including the parent's access to the data his/her child contributed to the research. The Investigator must also inform the parent that if the child chooses not to participate or to withdraw from participation, that decision overrides the parent's consent.

COOPERATING INSTITUTIONS:

Researchers (including students doing dissertation research) who plan to conduct research at another institution rather than the University of Missouri, MUST obtain written permission from the head of the institution/organization or member of the administration with sufficient rank to grant such permission. For example, a teacher friend may not give you permission to enter his/her eighth grade classroom in the Rolla Public School System to conduct research. This permission must be obtained from the Superintendent of Schools of that district, or the principal of the specific school, at a minimum.

ISSUES OF CONFIDENTIALITY:

An Investigator must fully articulate the parameters of confidentiality in the Missouri S&TIRB-1 and the consent forms. An Investigator must realistically assess any possible breaches in confidentiality, including those that may result if data is subpoenaed or if the Investigator, under Missouri statute, is required to breach confidentiality to report child or elderly abuse. Such foreseeable breaches must be disclosed to the subjects. If an Investigator is disbursing money to subjects in reimbursement for their participation, the Investigator must disclose the process of payment and whether that payment might appear on the Internet on the University of Missouri financial database. This financial citation might constitute a potential breach in confidentiality or a tracer back to the subject's identity.

The Investigator must distinguish anonymity from confidentiality. If the subjects are unknown and untraceable to everyone, including the Investigator, at all times, then the Investigator may inform the subjects that the information they contribute is anonymous, and immune to subpoena. If the Investigator uses codes, student numbers, or other tracers, the information is not anonymous and should not be represented as such to the subjects. See definitions below:

OTHER ISSUES:

The Missouri S&T IRB has adopted the UMC IRB policies on obtaining consent from minors and parents, and intervening when a psychological measure indicates depression or suicidal ideation. These policies are available on the UMC IRB Web Page at http://www.research.missouri.edu/cirb/index.htm.

CHANGE IN IRB APPROVAL:

Once an investigator has received approval for a project and needs to make a change, no matter how minor, the Campus IRB must review, approve, and document this in our files. Investigators should complete and submit the Change in IRB Approval Missouri S&TIRB-2, to the Campus IRB with all necessary documentation to explain the type of change and reason for the change.

CONTINUING REVIEW:

The Campus IRB reviews all active research, except projects fitting into the exemption category that last less than one (1) year in length, on a continuing basis as required by 45 CFR 46.109(e). Unless otherwise specified by the Campus IRB during initial review, the Campus IRB Office will request the completion and return of the Continuing Review Report Missouri S&TIRB-4 ten (10) months from the original date of approval of a project. Failure to comply with this request will result in the termination of IRB approval.

FEDERAL AGENCIES THAT HAVE ADOPTED 45 CFR 46 / "THE COMMON RULE"

Central Intelligence Agency

Consumer Product Safety Commission

U. S. Department of Agriculture

U. S. Department of Commerce

U. S. Department of Defense

U.S. Department of Education

U.S. Department of Energy Human Subjects Protection Page

U. S. Department of Health &  Human Services

U. S. Department of Housing & Urban Development

U. S. Department of Justice

U. S. Department of Transportation

U. S. Department of Veterans Affairs

U. S. Environmental Protection Agency

U. S. Agency for International Development

National Aeronautics & Space Administration

National Science Foundation

U. S. Social Security Administration