IRB Review Timeframe
The Edgewood College Human Participant Review Board accepts research proposal applications anytime during the academic school year. Properly completed proposals generally take at least 2 weeks to approve if exempt, 3-4 weeks to approve if expedited, or 4-5 weeks to approve if full board review is necessary. It is researchers’ responsibility to plan their projects with these timeframes in mind. Be aware that the IRB Administrator makes the final determination regarding what the appropriate review process should be (exempt, expedited, or full review). Once your proposal is signed by all investigators and advisors and submitted through IRBnet, the IRB Administrator will conduct an initial review, this will include evaluating the proposal for completeness and readiness for committee review. If the proposal is incomplete or needs major clarifications to be ready for committee review, this will delay the process. If the proposal is ready for committee review, it will be sent out to committee members for their feedback. Once their reviews are submitted, the IRB Administrator will send the researcher the decision of the committee via the IRBnet system.
Please note that almost all IRB Administrators, Chairs, and Committee Members are also full-time faculty members at Edgewood College. Thus during especially busy times of the semester such as the last week of classes and finals week, these timeframes may be longer. Summer and Winter Break reviews will be completed using similar timeframes, but can also take longer depending on the summer and break schedules of committee members.
Research involving human subjects conducted at Edgewood College is to be guided by ethical principles and applicable law. The primary purpose of the IRB review process is to protect human participants and to assure that the use of human participants in research projects conducted at Edgewood College or by Edgewood College faculty, staff, students and its affiliates is in compliance with federal rules for the protection of human research participants, as well as the National Commission for the Protection of Human Participants of Biomedical and Behavioral Research’s Ethical Principles and Guidelines for the Protection of Human Participants of Research (the Belmont Report). Copies of the Belmont Report may be obtained on-line at http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html. To facilitate review, investigators must submit a description of the research to be conducted, complete the Human Participants Review Proposal form, and provide copies of all materials that will be presented to participants in some way (e.g., consent form, recruitment materials, questionnaires, interview questions, etc.).
- Research Activities Exempt from Review
Determination of exemption may be made by the IRB Administrator or an IRB member designated by the Administrator. If it is determined that the study is not eligible for exempt status, the study may be eligible for expedited review or sent to the full IRB for review. Exempt status does not mean exempt from submission, but simply a designation of the category of project.
Unless otherwise required by Department of Health and Human Services (DHHS), DHHS-regulated studies in which the involvement of human participants is confined to one or more of the following categories are exempt from IRB review:
- Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (a) research on regular and special education instructional strategies; or (b) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, unless: (a) information taken from these sources is recorded in such a manner that participants can be identified, either directly or through identifiers linked to the participants; or (b) any disclosure of the responses outside the research could reasonably place the participant at risk of criminal or civil liability or be damaging to the participant’s financial standing, employability, or reputation.
- Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the legally available information is recorded by the investigator in such a manner that participants cannot be identified, directly or through identifiers linked to the participants.
- Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
- Research Eligible for Expedited Review
Determination that a study is eligible for expedited review may be made by the IRB Administrator or an IRB member designated by the Administrator. If expedited review criteria are met, the review of the research study may be carried out by the IRB Administrator or designee. The Administrator or designee shall have all of the authority of the IRB, except that the Administrator or designee may not disapprove a research study through the expedited review process.
Research activities involving no more than minimal risk and in which the only involvement of human participants will be in one or more of the following categories may be reviewed by the Human Participants Review Board through the expedited review procedure authorized in sec. 46.110 of 45 C.F.R. Part 46 of the DHS policy for the protection of human research participants, as described in paragraph 2, below:
- Prospective collection of biological specimens for research purposes by noninvasive means. Examples: Collection of hair and nail clippings, in a non-disfiguring manner; deciduous teeth and permanent teeth if patient care indicates a need for extraction; excreta and external secretions (including sweat); uncannulated saliva; placenta removed at delivery; amniotic fluid at the time of rupture of the membrane prior to or during labor; and supra-and subgingival dental plaque and calculus, provided the procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques.
- Collection of data from participants 18 years of age or older using noninvasive procedures routinely employed in clinical practice. This includes the use of physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the participant or an invasion of the participant’s privacy. It also includes procedures such as weighing or testing sensory acuity, and electrocardiography and moderate exercise by healthy volunteers. It does not include exposure to electromagnetic radiation outside the visible range (e.g., x-rays and microwaves).
- Collection of blood samples by venipuncture, in certain circumstances.
- Collection of data from voice, video, digital or image recordings made for research purposes.
- Research involving materials (data, documents, records, specimens) that have been collected or will be collected solely for nonresearch purposes.
- Research on individual or group characteristics or behavior, such as studies of perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior, and research employing survey, interview, oral history, focus group, program evaluation or quality assurance methodologies.
- Research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required.
- Research Requiring Board Full Review
A. The full IRB must review research that does not fit into Categories A or B above.
B. When research requires Full Board Review, such review will occur at a duly convened meeting at which a quorum is present (either in person or by telephone). A quorum shall exist if a majority of the total number of voting members, including at least one member whose primary concerns are in a nonscientific area, are present.
C. The full IRB has the authority to approve, require modifications in, table, or disapprove any research study that falls within its jurisdiction. Following IRB review, the principal investigator will be notified by the IRB chairperson in writing as to the outcome of the review. Notification will include the IRB ruling as well as recommendations, suggestions, and/or need for subsequent submissions.
D. In order for a research study to be approved, it must receive the approval of a majority of those voting members present at the meeting. Approval criteria include the following:
- Risks to subjects are minimized.
- Risks to subjects are reasonable in relation to anticipated benefits, if any, and the importance of the knowledge that may be expected to result;
- Selection of subjects is equitable;
- The informed consent form and process complies with applicable law and utilizes the appropriate consent template;
- Where appropriate, there are adequate provisions to protect the privacy of subjects and maintain the confidentiality of data;
- Appropriate additional safeguards are included to protect the rights and welfare of subjects who are likely to be vulnerable to coercion or undue influence.
- Continuing Review
The IRB will conduct continuing review of approved research studies in intervals appropriate to the degree of risk involved but not less than once per year. Investigators will be responsible for submitting an annual report or progress report (as appropriate) prior to the expiration date of the IRB’s approval of the study, using the Continuing Review form. Continuing reviews may be conducted on an expedited basis if the protocol initially was reviewed using the expedited review procedures.