What qualifies as research requiring an IRB review?
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalize knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
What is the definition of human participant?
Human participant means a living individual about whom an investigator (whether professional or student) conducting research obtains(1) data through intervention or interaction with the individual, or
(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
(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
What about research conducted as part of a class project?
Often students at all levels are required to conduct “research” as part of class responsibilities or activities. Most of this research does not qualify for IRB review. These are the essential questions to be answered: Will this research be published? If yes, the research is required to be reviewed prior to implementation. What will be done with the data / information? If the information is identifiable to an individual or may be used or published in the future, the research may require IRB review prior to being implemented. If you have any questions about this area please check with IRB before conducting or planning “class project” research
How long does an IRB review take?
The short answer is that it depends on the nature of the proposed study. Studies involving more than minimal risk to participants and/or protected populations generally take longer than other proposals. Applications that require full Committee review may take as long as two months for Committee review depending on when the application is received and the Committee availability. Exempt or expedited reviews will generally take about 7 to 14 days if all required information and documents are provided and there are no revisions or additional information requested
Do I need to have training before being eligible to conduct human participant research?
Currently Plymouth State University requires training on human participant research to be eligible to submit a proposal for research. Some federal agencies also require this training and applicants should check with any funding agency for their requirements. We do strongly recommend, where appropriate, University courses include human participant training within their curriculum.Documentation certifying the completion of this training is required to submit a proposal for IRB review. Training must have taken place within the last 3 years.
What do I need to do if I want to change something in my research?
Approval to conduct proposed research is given only on the application and protocol as presented or amended at the time of approval. If there are any changes to the research protocol after this approval has been granted these proposed changes must also be reviewed by the Committee before being implemented. This includes, but is not limited to, any changes in the selection of participants, additional questions or additional survey items, changes in the approved protocol or any deletions or additions in the approved consent forms. This applies to research approved by full Committee review, expedited review, or exempt approval. To notify the Committee of an amendment to a protocol, use the status report form (pdf|doc). If the protocol was originally approved as exempt, you may notify the Committee of changes using a letter detailing the changes, rather than with the status report form. Bear in mind, if the amendment to an exempt project is sufficient to alter its exempt status, an expedited or full review may be required. If you have any additional questions about this, please contact IRB staff prior to any changes in your research
Is there someone I can call if I need assistance or have questions?
Yes. Please do not hesitate to contact IRB if you have questions about any aspects of the application requirements, required forms, or eligibility criteria.
What is the criteria used by the IRB when they make their decision to approve human subjects research?
The PSU IRB Committee uses the US Department of Health and Human Services criteria for IRB approval which states:
(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.
(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.
What are the deadlines for submitting new IRB applications for human research?
The PSU IRB does not have a cut-off date for material submission. The IRB accepts applications on a regular basis for review.
Does my teaching study require IRB approval?
The answer is yes, if:
• 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.
• 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.
When can I begin my research?
Research can only begin once an approval letter is received from the IRB. Therefore, subjects should not be contacted or recruited before the approval letter is obtained.
What about secondary data with or without identifiers?
Studies that involve secondary analysis of data are generally not considered human subjects research.
What about research at a pilot or feasibility stage?
Pilot studies and feasibility studies, including those involving only one human subject, require the same scrutiny as full-scale research projects. Pilot studies should be identified as such in applications to the IRB. Ordinarily, the data collected from subjects in a pilot/feasibility study are not used for study findings. It must be explained to subjects during the consent process that the study is a pilot. When the pilot study becomes a full study, the PI will need to apply for IRB approval again.
How do I determine if I have Conflict of Interest (COI) in my study?
• 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
Documents researchers should have on file include but are not limited to the following:
• 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.)