Bates College Institutional Review Board
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Resources - Informed Consent Form (Sample) - Parental Informed Consent Form (Sample) - Parental Informed Consent Form (PDF) |
The Bates College Institutional Review Board (IRB) has been established
to approve research projects involving the use of human participants.
The IRB exists both because Bates wants to ensure that research
participants are treated with the utmost respect and safety and because
federal law requires that all federally funded research involving human
participants receive IRB approval. The research projects concerned
include not only standard research but in-class research and service
learning projects as well, and extend to journals and photographs, video
and tape recordings of participants. Because it appears that few faculty
are aware of this requirement, we have prepared the following statement
to convey the gist of the regulations and expectations for the review
process. "An IRB shall review and have authority to approve, require
modifications in (to secure approval), or disapprove all research
activities covered by this policy. An IRB may require informed consent
and require documentation of informed consent. An IRB is to notify the
investigator and the institution of its approval or disapproval of a
research activity. If it disapproves, it will give its reasons and
provide an opportunity for the investigator to respond in writing or in
person. An IRB will provide periodic (usually annual) reviews of
approved, long-term research activities." (Code of Federal Regulations Title 34 -- Education. p. B15) Bates College requires that all faculty, administrative, or student research projects be reviewed by the IRB if.. 1) the research involves participants who are minors (under age 18, Bates students exempted), or 2) the research procedure poses any mental or physical risk to the participant, or 3) the anonymity/confidentiality of the participants cannot be guaranteed, or 4) deception is a part of the research design, or 5) participants cannot withdraw from participation at any time. If a research project meets any one of the above requirements, the research director should submit the research design to the Chair of the IRB for Board approval. Projects do not have to be submitted if the faculty advisor, faculty researcher, or classroom professor decides: a) The risks involved are no more strenuous than a person normally
experiences in a typical day, or
b) the research is used to evaluate educational practices and participants cannot be individually identified, or c) the research is a general survey or interview where participants cannot be individually identified, or d) the research is observation of public behavior where participants cannot be individually identified, or e) the research involves only the collection or study of documents or data that are publicly available (e.g., court documents) When in doubt about whether or not to submit, you may contact the IRB chair for advice. When to submit for approval: at least two weeks before the research begins; in exceptional circumstances, expedited review may be possible. *Please allow at least two business days for a response about your proposal.* What to submit:
a) a brief summary of the nature and intent of the project; the full
proposal is not necessary.
b) a detailed description of the procedural section of the research proposal. i. If the study includes a questionnaire or other test questions,
include at minimum a reasonable sample of the test items.
ii. Be sure to describe procedures for ensuring participants’ anonymity or confidentiality.. iii. Be sure to describe the participant debriefing process. a. Debriefing includes full disclosure of the nature and intent of the
research project.
b. If any physical or emotional discomfort may occur during or as a result of the research, the debriefing should include a listing of resources available to participants (e.g., counseling services) and, in the case of student research, the advisor’s name and telephone number. In addition, describe plans for informing the resources, such as the Health Service, about the nature of the research and when it will be conducted. c) informed consent forms to be given to participants, or an explanation
why no form is used and how informed consent will be obtained in other
ways. See Appendix A for a sample copy of an informed consent form.
d) a cover sheet with the researcher’s email address, telephone number and mail box. If the researcher is a student, be sure to include the advisor’s name, telephone number, and signature indicating his or her approval of the research design. e) a completed Checklist Form Nature of IRB review: Review will take one of the following forms. a) If the procedure is relatively clear and guidelines (described below)
have been met, the chair of the IRB may approve the project without full
board review, or
b) the chair of the IRB may consult a second member of the IRB and approve the project without further board review, or c) the chair of the IRB may circulate the proposal to the board and solicit telephonic or email approval of the project, or d) the full IRB may be convened to review the procedures and may request that the researcher attend the review to answer any questions. Review in cases (a) and (b) above may take place promptly (i.e. within a week). In cases (c) and (d) the IRB will make every effort to review the project within two weeks of receiving the request for approval. In conducting its review, the IRB will be guided by the following minimal "criteria for approval" pertinent to research at Bates College. These guidelines derive from the federal regulations. a) Risks are minimized by using the least intrusive procedures possible
and using procedures that may already be in use for the subjects..
The IRB will provide a written statement of the results of its review,
including any reasons for requested modifications or for disapproval of
the project. The Chair of the IRB has more detailed information
available upon request.b) Risks should be reasonable relative to expected benefits. c) Subjects must be selected equitably, keeping in mind the special problems of research on vulnerable populations, e.g., children, mentally disabled people or economically or educationally disadvantaged people. d) Informed consent will be sought from subjects or their legally authorized representatives; in the case of schoolchildren, the IRB prefers active rather than passive consent from parents. e) Privacy and confidentiality are to be guaranteed to the extent permitted by law, and monitored as appropriate. Questions should be directed to Professors Douglass and Kahan (adouglas@bates.edu and tkahan@bates.edu) who are available to meet with Departments to discuss the requirement and these procedures. |