The membership of the Institutional Review Board is appointed by the Provost and Vice President for Academic Affairs in consultation with the deans of the colleges and schools. The IRB is comprised of members from diverse backgrounds to promote complete and adequate review of research activities, and has the professional competence necessary to review the specific research activities which are assigned to it. The board is sufficiently qualified through the experience and expertise of its members, and the diversity of the members’ backgrounds including consideration of the racial and cultural backgrounds of members and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of volunteers.
When research is reviewed involving a category of vulnerable volunteers (e.g., subjects vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision making capacity, or economically or educationally disadvantaged persons) , the IRB shall include in its reviewing body one or more individuals who have as a primary concern the welfare of these volunteers. The board includes both male and female members as well as individuals representing a variety of professions. The Detroit Mercy IRB also includes at least one member who is not otherwise affiliated with the institution and who is not a part of the immediate family of persons who are affiliated with the institution.
If you have questions, please contact the IRB Chair at IRB@udmercy.edu
The purpose of the review is to protect the rights and welfare of volunteers in research projects as required by federal regulations. The IRB has the authority to approve, require modifications in (to secure approval), or disapprove research based on its review. In conducting the review the IRB assures that:
To make these determinations, the IRB weighs the following:
Only when the IRB has decided that the answers to the above are adequate for the protection of the volunteer, does it approve the project. Further information and procedures related to each of these areas may be obtained from the IRB Chair.
Research investigators, department heads, and thesis/dissertation or faculty advisors are responsible for insuring that ALL research involving human subjects is submitted to the IRB for review. Definitions from the federal rules for human subject research 45 CFR 46.102:
Human subject means a living individual about whom an investigator (whether professional or student) conducting research:
Research: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalize knowledge
The following activities are deemed not to be research:
All research involving human subjects will be reviewed if:
In contrast to research, projects that entail quality improvement or program evaluation may not need IRB review. These studies focus on a particular group or setting and are not intended to result in generalizable findings. In these cases, investigators should request a determination memo from their study site and attach it to their Cayuse IRB submission. A Cayuse submission is still needed, in order to receive the determination letter. Please contact the IRB for more instructions.
Most projects with minimal risk will be reviewed by the chair alone, and whether or not a full board review will be necessary can usually be ascertained by contacting the IRB chair at IRB@udmercy.edu.
What needs to be submitted throughout your study?
If you have significant changes in your research protocol, please submit a Modification submission in Cayuse IRB to amend your application. Please report any adverse events immediately using the Incident submission in Cayuse.If you have significant changes in your research protocol, please submit a Modification submission in Cayuse IRB to amend your application. Please report any adverse events immediately using the Incident submission in Cayuse.
RESEARCH ACTIVITIES THAT MAY BE EXEMPT FROM REVIEW
The IRB reviews all research involving volunteers regardless of whether the research is funded by a federal agency or not.
The information which follows is meant to help clarify those instances when there is uncertainty as to whether there is a need for an IRB review. However, under
no circumstances may investigators exempt themselves, nor may investigators be exempted by department heads or dissertation advisors; all exemptions require concurrence by the IRB. Neither can exemptions be requested orally, in person or by telephone.
EXEMPTION CATEGORIES
According to Federal regulations (45 CFR 46.104(d)), unless otherwise required
by department or agency heads, research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from this policy:
RESEARCH ACTIVITIES THAT MAY BE REVIEWED THROUGH EXPEDITED PROCEDURES
The IRB reviews all research involving volunteers regardless of whether the research is funded by a federal agency or not.
The information which follows is meant to help clarify those instances when there is uncertainty as to whether there is a need for a full IRB review. However, under no circumstances may investigators expedite reviews themselves, nor may reviews be expedited by department heads or dissertation advisors; all expedited reviews
require concurrence by the IRB. Neither can expedited reviews be requested orally, in person or by telephone.
Federal regulations 45 CFR 46.110, unless otherwise required by department or agency heads, state the following about research that may be reviewed through an expedited process:
Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) through an Expedited Review Procedure1
Applicability
(A) Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.
(B) The categories in this list apply regardless of the age of subjects, except as noted.
(C) The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects= financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate
protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
(D) The expedited review procedure may not be used for classified research involving human subjects.
(E) IRBs are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review–expedited or convened–utilized by the IRB.
(F) Categories one (1) through seven (7) pertain to both initial and continuing IRB review.
Research Categories
(1) Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
(a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required.
(Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the
risks associated with the use of the product is not eligible for expedited review.)
(b) Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812)
is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used
in accordance with its cleared/approved labeling.
(2) Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
(a) from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or
(b) from other adults and children2, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and
collection may not occur more frequently than 2 times per week.
(3) Prospective collection of biological specimens for research purposes by noninvasive means.
Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance
with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.
(4) Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are
employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.)
Examples: (a) 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 subject or an invasion of the subject=s privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
(5) Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR
46.101(b)(4). This listing refers only to research that is not exempt.)
(6) Collection of data from voice, video, digital, or image recordings made for research purposes.
(7) Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers
only to research that is not exempt.)
(8) Continuing review of research previously approved by the convened IRB as follows:
(a) where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or
(b) where no subjects have been enrolled and no additional risks have been identified; or
(c) where the remaining research activities are limited to data analysis.
(9) Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.
_______________________
1 An expedited review procedure consists of a review of research involving human subjects by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB in accordance with the requirements set forth in 45 CFR 46.110.
2 Children are defined in the HHS regulations as “persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.” 45 CFR 46.402(a).
Source: 63 FR 60364-60367, November 9, 1998.
The Institutional Review Board generally meets on a regular basis six times a year. Documents to be reviewed by the IRB must be submitted to the chair, IRB, at least three weeks prior to the next regularly scheduled board meeting. Location of the meetings is in a Student Union conference room or by online videoconference.
Meeting Schedule
SUBMISSION DEADLINES | MEETING DATES |
Monday, August 26, 2024 | Monday, September 16, 2024 |
Monday, October 28, 2024 | Monday, November 18, 2024 |
Monday, January 6, 2025 | Monday, January 27, 2025 |
Monday, February 24, 2025 | Monday, March 17, 2025 |
Monday, April 28, 2025 | Monday, May 19, 2025 |
Monday, June 30, 2025 | Monday, July 21, 2025 |
Researchers who are certain that they will need to have their protocols reviewed by the full board must submit the application at least three weeks ahead of the meeting date and also contact the IRB Chair at IRB@udmercy.edu
Revised 08/2024
The Institutional Review Board (IRB) constitutes a quorum that must include at least one member whose primary concerns are in nonscientific areas. A quorum is required in order to convene a meeting for the review of project protocols. When the IRB reviews an investigational new drug (IND) study, the FDA expects at least one physician member to be present at the meeting. This regulation also requires a majority vote of those present. Meeting dates may be confirmed, and placement on the IRB agenda may be accomplished by contacting the chair.
The chair must receive a project proposal three weeks before a scheduled meeting.
Board members
James Tubbs, Jr., PhD
Harold Greene, PhD
Julia Stocker Schneider, PhD, RN, CNL
Cristine Smoczer, MD, PhD
Curtis Smith, MURP
James Windell, MA
Elizabeth Hill, PhD (Co-Chair)
Linda Slowik, PhD (Co-Chair)
Revised 08/2024
The University of Detroit Mercy has implemented a cloud-based software called Cayuse IRB. With Cayuse IRB, we are able to streamline IRB submission processes and provide greater access to your IRB records. All IRB applications must be submitted via Cayuse IRB, unless they began prior to July 1, 2019 and are simply seeking renewal or modification.
Before you are able to access the system, you will need an account created or IRB permissions added. Please email the IRB at IRB@udmercy.edu for current instructions.
After accounts are created, access href=”https://udmercy.app.cayuse.com/” target=”_blank” rel=”noopener”>Cayusewith your udmercy.edu email username and password. If you already have email open, simply click this link or copy it into your browser. The first page is “Tasks.” To access “Human Ethics,” go to the top right corner and click “Products.” Select “Human Ethics.”
If you have not used Cayuse IRB previously, or you have questions, please contact the IRB via email (IRB@udmercy.edu).
IRB approval letters will state whether a continuing annual review is needed. Only projects which received an initial approval via expedited review may be granted a continuation via expedited review. If an expedited project requires annual Continuing Review, a Renewal Submission should be submitted in Cayuse at least 10 days prior to the expiration date. If the project required full board review, the Renewal Submission should be submitted to Cayuse three weeks prior to the next regularly scheduled full board meeting closest to the expiration of the project.
When changes are desired, the Renewal Submission should include descriptions of revisions to procedures in the protocol along with updated forms. While Cayuse IRB will notify the investigator when a study is due for renewal, the investigator is still responsible for ensuring that the study is not conducted after IRB approval has expired. The investigator need not attend the meeting for a routine continuation application, as long as there were no unexpected adverse effects or significant changes to the consent form or project protocol. The IRB will notify the investigator in writing of its decision.
If it becomes necessary to revise an approved project protocol or consent form, it is the responsibility of the investigator to submit a Modification submission in Cayuse IRB. This application includes the following information:
Changes in research during the period for which IRB approval has already been given may not be initiated by research investigators without IRB review and approval, except where necessary to eliminate apparent immediate hazards to the volunteers. Research investigators, department heads, and thesis/dissertation or faculty advisors are responsible for complying with all IRB decisions, conditions and requirements.
Advertisements used to recruit volunteers should be prepared according to ethical principles. Solicitations to recruit volunteers should be limited to:
Advertising copy must be submitted to the IRB for review and approval.
At the conclusion of research activity, please complete a Closure submission in Cayuse IRB. This step is especially important if your project requires annual review. Do not close the study if you are continuing with data analysis, however.
Investigators are required to submit an Incident Report in Cayuse within 48 hours of the occurrence of such incident. This is in addition to the requirement that such incidents must be reported to the sponsoring agency and OHRP and/or FDA.
The exemption or expedited approval of research on volunteers is a privilege, not an entitlement. An investigator who thinks a project qualifies for exemption (SeeResearch Activities Which May Be Exempt From Review or expedited review (See Research Activities Which May Be Reviewed Through Expedited Procedures) and approval should submit a regular Cayuse application with full details. Under no circumstances may investigators exempt themselves, nor may investigators be exempted by department heads or thesis/dissertation advisors; all exemptions require concurrence by the IRB. Exemptions may not be requested through other channels than Cayuse IRB.
Research with vulnerable groups will be reviewed by the Chair or by the full-board, depending upon federal regulations and the level of risk. The Chair reviews applications in the exempt or expedited categories. Projects will always go to the full board if they involve pregnant women or prisoners. Research with children may be reviewed by the chair following federal guidelines (e.g., minimal-risk studies such as those in education). Research with groups that are educationally or economically disadvantaged or decisionally-impaired may be reviewed as exempt or expedited if the risk is minimal and potential issues with informed consent have been adequately addressed. If the risk level is unclear, the application will be circulated to the committee for input on the need for full-board review.
Investigators who believe their project qualifies for either exemption or expedited review must submit an application to Cayuse IRB, including an informed consent for, and description of the project. The submission will be reviewed by the chair, who will determine if it is qualified for either exemption or expedited review. During such review, the chair will determine whether or not the use of the consent form will be required, or if a Research Information Sheet is sufficient. If the project is of such a nature that a determination cannot be made by the chair alone, other members of the IRB may be asked to assist with the review. Investigators will be notified in most cases within 10 working days as to the disposition of their requests. The IRB will be notified in writing by the chair at each regularly scheduled meeting of all projects approved via expedited review in the interim between such meetings.
The Department of Health and Human Services (HHS) requires that research investigators provide the following information to each participant:
When required by the IRB, the research investigator shall provide one or more of the following additional elements of information to each participant:
A statement describing the extent of confidentiality of records. On drug studies, this should include a statement that the records may be reviewed by the FDA.
A statement that informs the volunteer that he or she will receive a signed copy of the consent form.
In most cases, the IRB requires the informed consent be documented in writing. Language of the form should be aimed no higher than the eighth-grade reading level. Under certain circumstances, alteration or waiver of the standard written informed consent is granted by the IRB. Options that may be acceptable include oral consent (for telephone surveys), a short form consent for participants who do not speak English, and an information sheet in lieu of written consent. Federal regulations govern the use of these options. If you are seeking a waiver of documentation of informed consent, investigators must describe how the project qualifies for the following criteria: 1) The research is no more than minimal risk of harm to subjects, 2) The research could not practicably be carried out without the waiver, 3) Research participants belong to distinct cultural groups or communities in which signing forms is not the norm, and 4) There is an appropriate alternative mechanism for documenting that informed consent was obtained.
Revised 8/2024
IRB Chair,
Linda Slowik
IRB@udmercy.edu
Please welcome Linda Slowik as incoming IRB chair. For a smooth transition during this fall semester, she & Elizabeth Hill will be co-chairs.
Required Forms/Templates
Working with OSPRA from project concept through award has significantly increased my awareness and understanding of the processes and UDM policies.
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