THE COLLEGE xxxxxxxxxxx
INSTITUTIONAL REVIEW BOARD
APPLICATION FORM
Research activity involving human participants will be reviewed by the xxxxxxxxxxx Institutional Review Board. The Institutional Review Board policy for review and approval of proposed research is in keeping with federal policies relative to the protection of the rights and welfare of human participants (Code of Federal Regulations 45 CFR Part 46).
Principal Investigator (and co-investigators):
If student research, name of faculty member who has read and approved the IRB application for this research project:
Departmental/Program Affiliation:
Project Title:
Respond to each item below by typing in the space provided (do not attach proposals):
A brief description of the research in non-technical language. Include in your description: a) the purpose or main aim of the study; b) definitions of key terms/concepts; c) a statement justifying the need for this research; d) a statement indicating what impact the results may have on society; provide research questions and/or hypotheses if relevant; e) a statement about whether this a quality improvement project or a research study with the intent to produce generalizable knowledge; and f) a declaration of whether this project is funded, and if so, provide the funding agency.
A description of the participants, how they will be selected, and an estimate of the total number to be recruited. Indicate explicitly whether any are vulnerable participants (e.g., minors, prisoners, elderly, disabled). Include recruitment flyers or letters with this application.
A description of the procedures involving the participants. In this section, be specific when explaining all activities the participants will be asked to perform if they agree to participate in this study. This includes not only what participants will do, but when and how often; provide an estimate of the total amount time the participant will be involved in the study. Any questionnaire, survey form, interview guide, specific assessment or cover letter must be attached.
A description of the benefits of the research to the human participants in the proposed study, if any, and of the benefits to human or scientific knowledge.
A description of the risks and discomforts, if any, to the participants. Risks or discomforts may be physical, psychological, or social. Some research involves neither risks nor discomforts, but rather violations of normal expectations of daily life. Such violations, if any, should be specified.
A description of the means to be taken to minimize each risk or violation, including the means by which the participant’s personal privacy is to be protected and confidentiality of information received maintained (e.g., disposition of questionnaires, interview notes, recorded audio or video tapes, etc.)
Consent, as a process, is successful when: 1) a potential participant is provided with all the information that is needed to make an informed decision about whether to participate; 2) the information is provided such that the individual fully comprehends the research activity including details about what they will be asked to do; and 3) the individual’s decision to participate is voluntary.
A copy of the consent form that is to be used with the participants must be attached. This may be an adult consent form, parental permission form, children’s assent form, or some combination. The College of St. Scholastica should appear as a heading on the form; include the project title at the top of the form. Include a description of the study procedures in nontechnical language. It should also include statements about benefits and risks; if risks are present, describe steps that will be taken to minimize those risks. Also, provide a statement informing the participant that they may withdraw their participation without consequences at any time. Note also the steps taken to protect participant’s personal identity and treat collected information with confidentiality. For research involving physical and emotional risks, a statement as to the availability or non-availability of treatment for injuries, infections, illness resulting from the research must be provided. Consent forms and data must be retained securely for a minimum of three years. See the required list of basic elements of all consent forms below.
Copies of letters of affiliation or permission. The most common letter of affiliation is that obtained from an authority figure at the site (e.g. hospital administrator or school principal) who is capable of granting permission to conduct research at their institution. This form is required when research activity (data collection) occurs away from The College of St. Scholastica campus. This form must be signed and turned in prior to receiving IRB approval.
If deception of participants is viewed as necessary, a justification for such deception must be provided. Debriefing must also be included in the methodology.
Provide the name of any professional document(s) that will guide your ethical responsibilities to protect participants in this research project.
Informed Consent
Your consent form should provide the information needed to help a potential participant make an informed decision about whether to participate. Information should be presented in sufficient detail and organized and presented in a way that facilitates a subject’s understanding of why one might or might not want to participate. Avoid using technical terms.
Consent forms should include the following basic elements:
The College name should appear at the top of the form;
Provide the title of the project;
Indication of investigator’s status, i.e., faculty, graduate student, undergraduate student; if a student, provide the name of your mentor;
Description of the purpose of study in nontechnical terms;
Description of all tasks the participant will be asked to perform; include an accurate estimate of the length of time needed to participate;
Information about risks and steps taken to minimize those risks;
Information about potential benefits to the participant;
Alternatives to participating in the study;
Statement clearly indicating that participation is voluntary and the subject’s right to withdraw at any time;
Notification of steps taken to protect personal identity of participants and confidentiality of data;
Include contact information (name, title, phone) for the current Dean of the School and Department Chair affiliated with the research; provide the name and contact information for the Chair of the Institutional Review Board;
Lines for participant’s and researcher’s name, signature, and date (except electronic surveys);
A statement indicating that a copy of the consent form will be provided to the participant;
For research involving physical risks, a statement as to availability or non-availability of treatment for illness or injuries resulting from the research must be provided.
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