Institutional Review Board
Institutional Review Board (IRB)
The mission of the Edgewood College Institutional Review Board (IRB) is to assure the highest quality of research involving human participants conducted under the auspices of the college. Edgewood College is committed to following Federal Regulations for the protection of human research participants. The IRB’s primary function is to ensure protection of human subjects through the review, approval, modification, or disapproval of research applications submitted by faculty, staff, and students. Any member of the Edgewood College community who is involved in research with human participants must be in compliance, regardless of the project or source of project funding.
Proposals
IRB Proposal Submission Process
Proposals are reviewed on a rolling basis, in the order that they are received. The Edgewood College IRB utilizes an initial pre-review screening process, during which the IRB Administrator reviews each submission for completeness and compliance. The administrator may ask the investigator to make changes to the submission before being formally reviewed by the IRB.
Once formal review begins, exempt studies, posing minimal risk to human subjects, take approximately 2 weeks to be processed. Expedited studies take approximately 2-3 weeks to be processed. Studies needing full board review can take up to 4 weeks to be processed. These processing timelines do not include the initial pre-review screening process. These timelines relate to when the IRB is able to initiate formal review of the proposal. The administrator will provide feedback to the PIs regarding any modifications that will be required in preparing the study for IRB approval.
It is the investigator’s responsibility to plan in advance and allow a sufficient amount of time for submission, review, and approval of the study. The review timeline for IRB proposal approvals can be impacted by many variables and may vary throughout the year. As stated above, proposals that are incomplete or lack details will be returned to the Principal Investigator (PI), further delaying the review and approval process. Proposals of greater complexity or risk will take more time to review. The turnaround time may depend on the volume of submissions received by the IRB office. Additionally, as all IRB reviewers are faculty at Edgewood College, review of proposals submitted during midterms, finals, or during breaks in the academic calendar may be delayed.
Please review all of the IRB Resources provided to the left to assess the readiness of your study documents for review. Edgewood College’s IRB processes research proposals through IRBNet, an online submission tool. To the left you will find a link to IRBNet and all of the resources (training documents to lead you through the process) you will need to submit your proposal. If you are having trouble with the system or would like to schedule a time to meet with an IRB representative to receive training for IRBNet, please email lambert@edgewood.edu or ashleyholland@edgewood.edu.
The proposal form and a document with instructions for completing the proposal are provided to the left. We have also provided consent form templates (formal, implied, assent) that we would like all researchers to utilize to help standardize the consent process at Edgewood College.
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.).
1. 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:
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- 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.
2. 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:
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- 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.
3. 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:
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- 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.
4. 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.
Investigator Responsibilities
- Edgewood College is committed to ensuring compliance with Federal Regulations for the protection of human research participants. Any member of the Edgewood College faculty, staff, student body, or its affiliates who is involved in research with human participants must be in compliance, regardless of the project or source of project funding. “Research” is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or to contribute to generalizable knowledge.
- Research that is conducted by or uses Edgewood College faculty, staff, students, or its affiliates as research participants must be reviewed and approved by the IRB, including projects where the lead researcher is from another institution. Edgewood College investigators engaged in research projects that are submitted to an external agency for funding or publication must also submit a proposal for review to the IRB.
- Faculty research projects related to teaching, classroom demonstrations, and/or class assignments need review by the IRB only if the data to be collected in the classroom will be published or presented in a public forum (e.g., undergraduate research symposium). Data collected for student or faculty assessment only does not need IRB review.
- Course projects where results are to be presented only to current class members may not be subject to these Guidelines (i.e., they may not need to be reviewed by IRB). In these circumstances the instructor is responsible for ensuring that there are minimal risks [1], not only to the participants of the research, but also to the student researchers. However, if the instructor hopes that some student projects may produce results of high enough quality to justify public presentation (e.g., undergraduate research symposium), then all such projects are to be reviewed by the IRB. The results of research projects involving human participants may not be presented outside a classroom setting unless the research was approved by the IRB, and approval can never be given retroactively to work already done. When in doubt about whether IRB review is necessary, the appropriate course of action is to seek review.
- Faculty who assign or supervise human participant research conducted by students are responsible for ensuring that the student submits a proposal for review by the IRB, and that the student is qualified to adequately safeguard the well-being of the participants (safeguards may include the support of additional personnel, e.g., the Fitness Center staff or the counseling center).
- Principal investigators shall be responsible for ensuring that consent is documented by use of the consent procedures approved by the IRB. With respect to research that presents minimal risk, such as questionnaires that are distributed and returned anonymously, the return of the questionnaire may be sufficient documentation of participant implied consent, provided that the implied consent form is the first page of the survey. Research that imposes more than a minimal risk on participants typically requires documentation of informed consent, or written consent signed by the participant, or the participant’s legally authorized representative. Each participant should be provided a copy of the consent form and information sheet.
- Written, oral, or implied consent must be obtained freely and with an understanding of the consequences. Participants or representatives must be given ample time to consider their participation and may not be coerced or unduly induced into participation. In no case may the person’s consent be based on an agreement, written or oral, through which the participant is made to waive, or appear to waive, any legal rights, or to release Edgewood College, its agents, or the investigator, from liability for negligence.
- Materials must be written or communicated in language that participants can understand, including simple or lay explanations for apparatus or procedures to be employed. Ordinary language should replace technical terms (e.g., upper extremities should be referred to as arms, venipuncture as taking blood from the arm with a needle, etc.).
- When the participants include individuals who are not legally or physically capable of giving documented informed consent, because of age, mental incapacity, or inability to communicate, then consent should be obtained from the participant’s legally authorized representative (i.e., parents or legal guardians of children, or the guardian of a person adjudged incompetent, or any person authorized in writing by the participant). Careful consideration must be given to whether third parties have both the legal authority and sufficient interest in and concern for the individuals to provide consent.
- When research participants are minors, in addition to obtaining written consent from parents or legal guardians, the participants also should be asked for their oral consent (assent) to participate in the research project, if they are capable of providing assent. The child should be given an explanation of the procedures to be used, at a level appropriate to the child’s age, maturity and condition, their meaning to the child in terms of discomfort and inconvenience, and the general purpose of the research. A written form should be used to document assent for children who are 12 years of age and over.
- In some research situations, full disclosure of the aims of the study before the fact may invalidate results. In these cases, the investigator should describe procedures that the participant will be asked to participate in and state the aim of the study in as clear and as accurate a manner as possible so as to maintain the integrity of the research (while still informing the participants as much as possible). In preparing the proposal for Board review, any deception in the research should be clearly identified. The rationale for deception and plans for after-the-fact debriefing of participants should be provided to the review Board.
4. Compliance with IRB-Approved Investigational Plan
- Investigators must conduct the research in accordance with the IRB-approved plan. Except in the event of a life-threatening emergency, or if necessary to eliminate an immediate hazard to subjects, a research study protocol deviation requires prior IRB approval. Investigators must notify the IRB of any changes to the research study protocol no later than five (5) working days after the occurrence.
- Investigators must report promptly to the IRB any unexpected findings or problems involving risks to subjects or others, and any occurrence of serious harm to subjects or others. Investigators of approved research studies are responsible for reporting the progress of the study in the interval prescribed by the IRB, but no less than once per year.
- A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life).
Instructions for Obtaining Consent
In general, researchers should insure that their research participants are voluntary participants. Consent refers to a person’s freely given choice to participate in a research project based on full knowledge and understanding of the project and its implications for the participants’ welfare. In some cases this requires the use of written consent forms signed by the research participants. In other cases, it is sufficient to inform the participants of the nature of the research and that their participation is voluntary. In these cases the completion of the survey is an indication of consent.
Research Not Requiring Written Consent
- A statement of the nature, purposes, and expected duration of the research (the participants must know that they are involved in research).
- The names of those who are conducting the survey and any sponsoring organizations.
- The uses that will be made of the research information.
- A statement that participation is voluntary and that the participant may refuse to participate or discontinue participation at any time without penalty.
- An explanation of whether the survey is anonymous or merely confidential. When participants can be identified from demographic data the survey is not anonymous even if the participant’s identity is kept confidential. In this case a statement must be included describing how confidentiality of records will be maintained and who will have access to such records.
- A statement of implied consent, such as “Your willingness to return the completed questionnaire indicates your consent to participate in this study.”
- An explanation of whom to contact regarding concerns about the research (this should include the telephone number or e-mail address of the person conducting the research)
Research Requiring Informed Consent Forms
- A statement of the nature, purposes, and expected duration of the research (the participants must know that they are involved in research).
- A description of the procedures to be followed, including reference to any uses of audio or visual recordings, and identification of any procedures used that are experimental.
- A description of any reasonably foreseeable discomforts or risks to the participants, as well as a description of any benefits to the participants (including any compensation if provided).
- A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained and the individuals who may have access to such records.
- An explanation as to whether any compensation or medical treatments are available if injury occurs, and, if so, what they consist of, where they may be obtained, and where additional information may be obtained.
- A statement that participation is voluntary and that the participant may refuse to participate or discontinue participation at any time without penalty.
- The uses that will be made of the research information.
- An explanation of whom to contact regarding concerns about the research and research participants’ rights (this should include the telephone number or e-mail address of the person conducting the research).
Definitions for Research Involving Human Participants
“Anonymous” means that the name or other identifying characteristics of participants will not be disclosed. Data are considered anonymous if there are no identifying names, numbers or symbols through which anyone, including the investigator, could connect individual responses with a specific participant. Video or photographic records are not anonymous.
“Confidentiality” means that the identity of the individual providing information to the researcher will not be revealed and will remain secret, unless otherwise required or permitted by law.
“Conflict of Interest” means a situation in which the interests of an individual affiliated with Edgewood College, acting within his or her authority on behalf of the College, a) might affect or reasonably appear to affect institutional processes for the conduct, review or oversight of human subjects research; or b) might compromise or have the appearance of compromising the individual’s professional judgment in conducting or reporting research (e.g., simultaneously being a project advisor or principal investigator for a proposal and serving on the HPRB).
“IRB Approval” means the determination of the IRB, following its review of research; the research may be conducted at Edgewood College within the constraints set forth by institutional and federal requirements. The IRB shall have the authority to suspend research that is not being conducted in accordance with the IRB’s requirements.
“Human Participant” means a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information.
“Informed Consent” refers to a person’s freely given choice to participate in a research project based on full knowledge and understanding of relevant aspects of the project and its implications for the participants’ welfare.
“Intervention” means manipulations of the participant or participant’s environment that are conducted for research purposes including any physical procedures for which data are collected.
Legally Authorized Representative
“Legally Authorized Representative” means an individual authorized under applicable law to consent on behalf of a prospective research subject to the subject’s participation in procedure(s) involved in a research study.
“Minimal Risk” means that the probability and magnitude of harm or discomfort anticipated in the research is not greater in and of itself than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
“Professional Competence” means a person who has been a principal investigator conducting research projects either qualitative and/or quantitative in nature.
“Research” means a systematic investigation, including design, data collection, analysis and dissemination of findings, intended to develop or contribute to generalizable knowledge.
“Vulnerable Populations” refer to participants of a study who are likely to be vulnerable to coercion or undue influence, for example: children (including disabled children), prisoners, pregnant women, mentally disabled persons, or others. In these circumstances, additional safeguards must be included in the study to protect the rights and welfare of these participants.
For additional information please see: Vogt, Paul W. Dictionary of Statistics and Methodology. Sage Publications.
IRB Policies
This document is to serve as a guide for Edgewood College faculty, staff, and students engaged in research projects involving human participants. These guidelines have been prepared with the requirements set forth in Title 45, Part 46 of the Code of Federal Regulations (45 CFR Part 46), known as the “Common Rule,” as a guide. These guidelines provide for and direct the activities of the Edgewood College Institutional Review Board (IRB). The guidelines are housed in the Edgewood College Oscar Rennebohm Library, can be obtained from the IRB Chairperson, or can be found here.
The Edgewood College Institutional Review Board (IRB) will be responsible for reviewing all Edgewood College research proposals involving the use of human participants. The IRB shall review, approve or disapprove, and/or request changes in submitted projects brought before it based on the policies stated herein.
1. The Human Participants Review Board (HPRB)
A. Members
The Edgewood College IRB shall be composed of individuals that will credibly represent the varying perspectives of participants, investigators, and society at large. The Human Participants Review Board shall strive to include diverse membership. The Edgewood College IRB will be composed of at least 6 members (5 active and 1 alternate [1]; including the IRB Chair and IRB Administrator) who have exhibited the professional competencies necessary to review human research proposals. The IRB Chair and IRB Administrator will be appointed by the Vice President for Academic Affairs and will have expertise in research methods and ethical guidelines. Members will have demonstrated knowledge, expertise and competency in quantitative and/or qualitative methodologies, disciplines and perspectives. The IRB members will include, but not be limited to: one faculty member teaching in a graduate program, one faculty member teaching in an undergraduate program, one member external to the Edgewood College community [2], one member whose main concerns are nonscientific areas, one member who is a Edgewood College student, and two members at large from the Edgewood College community.
The non-affiliated member(s) of the IRB will be drawn from the local community-at-large. The person(s) selected should be knowledgeable about their own local community and be willing to discuss issues and research from that perspective. Consideration will be given to the type of community from which the institution will draw its research participants. Ad hoc members with expertise in special populations (e.g., the incarcerated, the elderly, the mentally ill, pregnant women, and children) may also be appointed and consulted as needed.
Affiliated IRB committee members will meet the rules set forth in The Common Rule (45 CFR Part 46) and serve staggered two or three year terms as appointed by the VPAA.
IRB members will complete or have completed appropriate training in the legal and ethical standards for the conduct of human subject research.
B. Responsibilities
The Edgewood College IRB will review, approve or disapprove, and/or recommend changes in submitted protocols based on the criteria outlined in these “Guidelines For Research Involving Human Participants,” their experience and expertise, and in accordance with all applicable laws, regulations, and institutional policies. Research involving human participants must come before the IRB in accordance with the policies stated herein. In addition, the IRB has the authority to conduct audits, investigate complaints about, place restrictions on, suspend or terminate approval of a research study that is not being conducted in accordance with applicable law or institutional policies or that has been associated with unexpected serious harm to subjects.
C. Records/Reports
- The IRB will keep the following records for at least three (3) years after closure of the research study:
- Copies of research study proposals, informed consent documents, and progress reports;
- Copies of correspondence between the IRB and principal investigators;
- Adverse reaction reports.
- IRB will permanently maintain IRB membership records, IRB policies and procedures, and minutes of IRB meetings.
- The work of the Board and appropriate supporting documents will be submitted to the Vice President of Academic Affairs at the end of each semester.
- The IRB Chair will promptly provide written notice of suspension or early termination of the IRB’s approval of a research study to the investigator, the Vice President of Academic Affairs and, if appropriate, the Department of Health and Human Services (DHHS), the head of any supporting federal agency and the Office of Human Research Protections (OHRP).
- If the IRB becomes aware of any unanticipated problems involving risks to participants or any serious or continuing noncompliance with the federal regulations governing research, the IRB Chair will notify the head of the appropriate supporting federal agency and, if appropriate, OHRP. A copy of the report will be simultaneously delivered to the Vice President of Academic Affairs and to the investigator.
- The IRB Chair will report to the Office for Research Integrity any occurrence of scientific misconduct in a Public Health Service-sponsored research study that involves fabrication, plagiarism or other practices that are not accepted within the scientific community for proposing, conducting or reporting research.
[1] Any IRB member who has a conflicting interest with a specific proposal must recuse him/herself from the Board during deliberation of the specific proposal. The alternate will attend all meetings but will not vote unless a permanent member recuses him/herself.
[2] The IRB member from the community will not be affiliated with Edgewood College and must be qualified to review proposals and be knowledgeable regarding the context of the community.