- Compliance with Law
- Edgewood College is committed to ensuring compliance with Federal Regulations for the protection of human research participants. Any member of the Edgewood College faculty, staff, student body, or its affiliates who is involved in research with human participants must be in compliance, regardless of the project or source of project funding. “Research” is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or to contribute to generalizable knowledge.
- Submissions to IRB
- Research that is conducted by or uses Edgewood College faculty, staff, students, or its affiliates as research participants must be reviewed and approved by the IRB, including projects where the lead researcher is from another institution. Edgewood College investigators engaged in research projects that are submitted to an external agency for funding or publication must also submit a proposal for review to the IRB.
- Faculty research projects related to teaching, classroom demonstrations, and/or class assignments need review by the IRB only if the data to be collected in the classroom will be published or presented in a public forum (e.g., undergraduate research symposium). Data collected for student or faculty assessment only does not need IRB review.
- Course projects where results are to be presented only to current class members may not be subject to these Guidelines (i.e., they may not need to be reviewed by IRB). In these circumstances the instructor is responsible for ensuring that there are minimal risks , not only to the participants of the research, but also to the student researchers. However, if the instructor hopes that some student projects may produce results of high enough quality to justify public presentation (e.g., undergraduate research symposium), then all such projects are to be reviewed by the IRB. The results of research projects involving human participants may not be presented outside a classroom setting unless the research was approved by the IRB, and approval can never be given retroactively to work already done. When in doubt about whether IRB review is necessary, the appropriate course of action is to seek review.
- Faculty who assign or supervise human participant research conducted by students are responsible for ensuring that the student submits a proposal for review by the IRB, and that the student is qualified to adequately safeguard the well-being of the participants (safeguards may include the support of additional personnel, e.g., the Fitness Center staff or the counseling center).
- Documentation of Consent
- Principal investigators shall be responsible for ensuring that consent is documented by use of the consent procedures approved by the IRB. With respect to research that presents minimal risk, such as questionnaires that are distributed and returned anonymously, the return of the questionnaire may be sufficient documentation of participant implied consent, provided that the implied consent form is the first page of the survey. Research that imposes more than a minimal risk on participants typically requires documentation of informed consent, or written consent signed by the participant, or the participant’s legally authorized representative. Each participant should be provided a copy of the consent form and information sheet.
- Written, oral, or implied consent must be obtained freely and with an understanding of the consequences. Participants or representatives must be given ample time to consider their participation and may not be coerced or unduly induced into participation. In no case may the person's consent be based on an agreement, written or oral, through which the participant is made to waive, or appear to waive, any legal rights, or to release Edgewood College, its agents, or the investigator, from liability for negligence.
- Materials must be written or communicated in language that participants can understand, including simple or lay explanations for apparatus or procedures to be employed. Ordinary language should replace technical terms (e.g., upper extremities should be referred to as arms, venipuncture as taking blood from the arm with a needle, etc.).
- When the participants include individuals who are not legally or physically capable of giving documented informed consent, because of age, mental incapacity, or inability to communicate, then consent should be obtained from the participant’s legally authorized representative (i.e., parents or legal guardians of children, or the guardian of a person adjudged incompetent, or any person authorized in writing by the participant). Careful consideration must be given to whether third parties have both the legal authority and sufficient interest in and concern for the individuals to provide consent.
- When research participants are minors, in addition to obtaining written consent from parents or legal guardians, the participants also should be asked for their oral consent (assent) to participate in the research project, if they are capable of providing assent. The child should be given an explanation of the procedures to be used, at a level appropriate to the child’s age, maturity and condition, their meaning to the child in terms of discomfort and inconvenience, and the general purpose of the research. A written form should be used to document assent for children who are 12 years of age and over.
- In some research situations, full disclosure of the aims of the study before the fact may invalidate results. In these cases, the investigator should describe procedures that the participant will be asked to participate in and state the aim of the study in as clear and as accurate a manner as possible so as to maintain the integrity of the research (while still informing the participants as much as possible). In preparing the proposal for Board review, any deception in the research should be clearly identified. The rationale for deception and plans for after-the-fact debriefing of participants should be provided to the review Board.
- Compliance with IRB-Approved Investigational Plan
- Investigators must conduct the research in accordance with the IRB-approved plan. Except in the event of a life-threatening emergency, or if necessary to eliminate an immediate hazard to subjects, a research study protocol deviation requires prior IRB approval. Investigators must notify the IRB of any changes to the research study protocol no later than five (5) working days after the occurrence.
- Investigators must report promptly to the IRB any unexpected findings or problems involving risks to subjects or others, and any occurrence of serious harm to subjects or others. Investigators of approved research studies are responsible
for reporting the progress of the study in the interval prescribed by the IRB, but no less than once per year.
- A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life).