Statement of Purpose and Authority
The Rights of Subjects
The Responsibilities of Investigators
STATEMENT OF PURPOSE AND AUTHORITY
Davidson College (hereinafter "the College") affirms that human research subjects should be treated with dignity, respect, and with due regard for their welfare. To protect these values, the College establishes the Institutional Review Board (hereinafter "IRB"). The IRB shall review all research involving human subjects, performed under College auspices, for compliance with federal guidelines and with ethical standards. "Research" means a systematic investigation designed to develop or contribute to generalizable knowledge. Activities which fit this definition amount to "research" for purposes of this policy irrespective of whether they are supported or funded under a program which may or may not be considered research for other purposes. For example, some "demonstrations" may include activities that qualify as "research" under this policy.
1.0 STATEMENT OF PRINCIPLES
1.1 The Rights of Subjects
The College recognizes that the rights of research subjects include: the right to be informed regarding the nature of the research, including its methods and procedures including any aspect of the research that could reasonably influence a subject's willingness to participate, the nature of any expectable benefits for the research subject or for society, and its reasonably foreseeable risks (if any); the right to withdraw from participation in the research without penalty; and the right to have the subject's confidentiality respected.
1.2 The Responsibilities of Investigators
Faculty and student investigators must be fully informed of all pertinent federal guidelines and ethical principles.
1.2.1 Investigators must provide to the IRB formal assurance of compliance with all applicable guidelines and standards by submitting an application for approval together with a copy of the complete research protocol.
1.2.2 Research projects shall not proceed until the investigator receives written notice of approval from the IRB.
1.2.3 Student-directed research must be formally sponsored by a faculty member of the College. Faculty sponsors must provide an assurance to the IRB that student research projects comply with all applicable requirements and ethical guidelines.
1.2.4 Faculty investigators shall not require students to participate in their own research projects; nor shall faculty investigators make participation in their own research one of several options for satisfying a course "research" requirement; nor shall faculty investigators offer "extra credit" as an inducement for students to participate in their own research projects.
2.0 RESEARCH CATEGORIES
2.1 Federally Funded Research
Investigators seeking federal funding must submit an application for "Approval of Sponsored Research Involving Human Subjects." Written notice of IRB approval must be secured from the Office of Grants and Contracts prior to submission of the application for federal funding. Note: NIH does not require IRB approval at the time of application.
2.2 Research Funded by Off-Campus Sources
Investigators seeking research support from non-federal, off-campus sources must submit an application for "Approval of Sponsored Research Involving Human Subjects." Written notice of IRB approval must be secured from the Office of Grants and Contracts prior to submission of the application for funding.
2.3 Davidson College Funded Research
Investigators seeking research support from the College must submit an application for "Approval of Sponsored Research Involving Human Subjects." No funds shall be released until the IRB has reviewed and approved the research.
2.4 Non-funded Research
Investigators must submit an application for "Approval of Research Involving Human Subjects" to the IRB. Proposed research projects shall not proceed until written IRB approval has been secured.
2.5 Research Exempted from Further Review
Federal guidelines and this policy permit certain types of research to proceed without IRB approval. The determination whether any particular research project qualifies as "exempted" must be made by the Chair of the IRB usually after consultation with at least two members of the IRB. Investigators do not have discretion to make this determination. Investigators who believe their research projects should be classified as "exempted" must secure concurrence from the Chair of the IRB. The following research activities shall normally be exempt from IRB review.
2.5.1 Research conducted in established or commonly accepted educational settings involving normal educational practices.
2.5.2 Research involving the use of educational tests if the information taken from these sources is recorded in such a manner that the subjects cannot be identified either directly or indirectly.
2.5.3 Research involving the observation of public behavior or research involving survey or interview procedures except where any of the following conditions exist:
a. Data are recorded in a manner enabling identification of subjects and the subject's responses, if they were to become known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing or employability or,
b. The research deals with sensitive aspects of the subject's behavior such as illegal conduct, drug or alcohol use, sexual behavior, or,
c. The research deals with study participants who are likely to be vulnerable to coercion or undue influence, such as minors under the age of 18 (45 CFR 46 Subpart D), prisoners (45 CFR 46 Subpart C), pregnant women, human fetuses and neonates (45 CFR 46 Subpart B), persons with mental disabilities, or persons whose economic status would leave them susceptible to coercion.
NOTE: Provision 2.5.3 of the Davidson College policy is more restrictive than Federal Regulations.
2.5.4 All research involving survey or interview procedures when the respondents are elected or public officials or candidates for public office.
2.5.5 Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens if these sources are publicly available and if the information is recorded by the investigator in such a manner that subjects cannot be identified directly or indirectly.
2.5.6 Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the FDA or the EPA.
2.6 Research Reviewed Elsewhere
The Chair of the IRB may waive review requirements that ordinarily would apply to a project when the investigator has already secured approval for the particular projects from an IRB at another institution that operates according to 45 CFR 46. Investigators seeking a waiver under this provision must submit evidence of prior formal IRB review and approval to the Chair of the IRB after contacting the Office of Grants and Contracts for current procedures.
3.0 EXPEDITED REVIEW
Expedited review is not normally available. Exceptions will be made for i) those proposals which clearly fall within an exempted category or ii) protocol revisions submitted in response to a previous IRB review.
4.0 MERIT REVIEW
Ordinarily, the IRB will not review research proposals for scientific merit.
5.0 IRB COMPOSITION
The IRB shall consist of at least five members, with varying backgrounds and professional competence necessary to promote complete and adequate review of research activities commonly conducted under the auspices of the College. The Chairperson and board members shall be appointed annually by the Vice President for Academic Affairs. The Chairperson may designate another committee member to conduct necessary business in his/her absence. The IRB shall not consist entirely of men or women; at least one member shall be primarily concerned in a scientific area; and one member shall be primarily concerned in a non-scientific area; two student members shall be appointed annually by the SGA; and at least one member shall be unaffiliated in any way with the College. The IRB may invite other qualified persons with competence in special areas to assist it in the review of complex research. When necessary, or when in the best interest of the IRB, other individuals may be invited by the Chairperson to attend and participate in meetings as an invitee. Invitees shall not be eligible to vote. No member of the IRB may participate in the review of any project in which that member has a conflicting interest. The director of the Grants and Contracts Office serves ex-officio, non-voting.
(HSIRB Policy Statement - Rev. 01/07/2010)