(2) identifiable private information. Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the participant or the participant’s environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and participant. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the participant is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human participants
(a) In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied:
(1) Risks to subjects are minimized: (i) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
(2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
(3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
(4) Informed consent will be sought from each prospective subject or the subject’s legally authorized representative, in accordance with, and to the extent required by §46.116.
(5) Informed consent will be appropriately documented, in accordance with, and to the extent required by §46.117.
(6) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
(7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
(b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.
• You will be using the data in your dissertation or thesis.
• The data will be published (including at Lamson library).
• The data will be used to create a presentation that will be given at a peer-reviewed or professional conference.
• Your research poses more than minimal risk to participants.
• You wish to have your research reviewed by IRB for grant review.
The answer is no, if:
• You will be collecting the data only to better your teaching skills.
• The data will be shared only on a casual basis with other teachers close to you.
• You will share the data only within the school.
• You will present the data only to the principal.
• You will be presenting the data only to your teacher, class members, and other Plymouth State University students and faculty (not for a thesis or dissertation).
• Your research does not involve vulnerable populations (children, prisoners, pregnant women, or handicapped or mentally disabled persons).
• Your research poses minimal risk to the participants, meaning the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
• Your research is the analysis of de-identified, publicly available data.
• If the investigator or members of the investigator’s family have significant financial interest in the study, sponsor of the study or the subjects, technology, site, etc. being investigated
• If you have an immediate family member including a spouse, domestic partner, dependents, and all members of the employee’s household listed as an investigator
• If you have any conflict that might be perceived to inhibit a fair and unbiased review of the research
• If you have any interests that may adversely effect the rights and welfare of the subjects
• IRB Application
• Consent and/or assent form(s)
• IRB’s response or request for additional information or revisions
• Responses to the IRB’s requests for additional information or revisions
• Notice of final approval
• Correspondence between the investigator and the IRB
• Continuing review forms and attachments (if applicable)
• Renewal of Approval, (if applicable)
• Amendment forms and attachments (if applicable)
• Amendment approval (if applicable)
• Original letters of collaboration from other institutions
• All approved research study materials, including IRB validated copies, if applicable (e.g., consent forms, recruitment materials, data collection instruments or forms, etc.)