The Institutional Review Board - Human Subjects Research聽(IRB) is responsible for ensuring that all research at 村花论坛 involving human subjects is appropriately documented in accordance with pertinent legal and ethical requirements. Researchers who receive the Committee's approval for their projects are responsible for conducting the research as approved, without changes pertaining to the treatment of subjects, and are responsible for maintaining ethical standards while conducting research.
This page provides faculty and students with the necessary information to conduct, report and seek approval of research in the most appropriate and efficient manner.
Before submitting proposals, researchers must consult the 村花论坛聽,聽including its description of criteria for聽Exempt, Expedited and Full Review Proposals, and required聽elements of informed consent.
Submission Instructions
All requests for review of proposals should be submitted through 聽according to the following instructions:
- Login to the website using your 村花论坛 credentials and click on the "IRB" icon or select聽"IRB"聽from the dropdown menu.听
- Select the "My Protocols" tab from the left menu bar and click on "Create New Protocol" at the top of the page.听
- Complete the "IRB Pre-Protocol Survey" to determine the appropriate level of review for your study and confirm that the project meets the definition of Human Subjects Research.
- Create the initial study protocol by answering basic questions about the research study.
- Next, click on the "Application Sections" link to complete each required section of the protocol. You can also use the "Upload Docs" button to upload additional study-related documents if necessary.
- Pay attention to the blue tool tip icons
that provide聽additional information and suggested language for many of the required application questions. The information in these tool tips can save researchers聽time during the review process!
- Pay attention to the blue tool tip icons
- Each member of the research team will need to sign off on the protocol before it can be submitted, and all required application section questions must be completed before researchers can sign the protocol.
- If the project involves student researcher(s), the protocol must be fully reviewed, edited, and approved by the 村花论坛 faculty member supervising the project.
- Each investigator聽on the project (including students and faculty) will also need to provide current evidence of ethics training for research with human subjects before any submitted protocols can be reviewed. The 村花论坛 IRB requires investigators to complete the Collaborative Institutional Training Initiative (CITI) research ethics聽course and to submit CITI completion certificates聽before the review process can begin. This training can be accessed on the .听
- Complete the CITI course entitled "村花论坛 Human Subjects Training for Researchers". Be sure you are completing the correct course. If you do not see this course, you will need to select "Add a Course" at the bottom of the "My Courses" tab on the CITI website.
- Please refer to the CITI Instructions below (under FAQs) for more detailed information on completion requirements and聽accessing the CITI website.
- Upload CITI completion reports to Mentor from the "Training Certification" tab on the left menu bar.
- Please note that if you've recently uploaded a CITI certification in Mentor, it may read "No CITI" on your application until the CITI certification is reviewed and approved by IRB staff. You may proceed with聽your protocol submission while your CITI is being reviewed.听
For more detailed information about Mentor and how to submit and revise protocols, see the Mentor training videos below.
Timelines
Proposals for Exempt and Expedited review are accepted and reviewed on a rolling basis (ie. no deadlines) and may be submitted at any time without regard to meeting schedule. For your research timeline, please聽plan on 2 - 3 weeks turnaround time for review of applications for Certification of Exemption, and 3 - 4 weeks turnaround time for review of applications for Expedited review or for Certification of Exemption with limited review.听Protocols that are incomplete or lack sufficient detail will likely extend the timeline for review and approval.听
Proposals for Full Committee review must be received 10 business days prior to the scheduled meeting date (see below), or review of the proposal may be tabled for the following meeting.
*Please note: regardless of the type of review being submitted, please plan your timeline accordingly, and allow聽for the potential of multiple rounds of revisions. The average new protocol takes 2-3 rounds of revisions before it is approved.
Academic Year 2024 - 2025 IRB聽Meeting Dates
Meetings to discuss full-review protocol submissions are usually held once per month聽on a Thursday via Zoom from聽11:30 a.m. to 12:45 p.m. during the academic year. (Please note that the IRB does not typically meet to review full-review protocols during the summer - please plan accordingly).听
Fall 2024
- September 12th
- October 17th聽
- November 7th
- December 12th
Spring 2025
- February 6th
- March 6th
- April 3rd
- May 8th
General IRB and Protocol Information
村花论坛, 4380 Main Street, Amherst, NY 14226
Web Address:聽/academics/research/IRB
Email: irb@daemen.edu
IRB Administrator Phone: 716-839-8477
Shannon聽Lupien鈥嬧, Chair
Melissa Peterson, Administrator
Erin Carman*
Laura Edsberg
Janice Hobba-Glose
Theresa Kolodziej鈥
Helen McCabe
Paulette Niewczyk
鈥婦eborah Merriam
Heather Pane*
惭颈肠丑补别濒听搁辞蝉蝉
闯别苍苍颈蹿别谤听厂肠丑别颈诲
Sandra Sheppard, Community Member
*IRB Alternate Members
Mentor Tutorials for Researchers
- This video tutorial provides an overview of the Mentor system.听
- This video tutorial walks researchers through the submission process from initial protocol creation to submission to the IRB.听
- This video tutorial walks researchers through the revision process and explains how to address requested revisions from the IRB.听
Mentor Tutorials for IRB Reviewers
- This video tutorial walks IRB Reviewers through the process of reviewing a submitted IRB protocol.
Once a research study protocol has been approved by the IRB, the principle investigator must conduct the study exactly as approved.
No changes in approved research should be initiated without prior IRB review and approval, except where necessary to eliminate apparent immediate hazards to participants (and then a modification should be submitted immediately thereafter). This includes, but is not limited to, changes to approved documents, (e.g., consent forms), personnel, recruitment materials,聽approved instruments to be used in the study, and approved procedures (e.g., procedures for maintaining privacy and confidentiality, recruitment procedures, etc.). Updated documents, instruments, or procedures may NOT be implemented until the new versions are approved by the IRB.
Modification requests can be submitted through .听To submit a modification, click on the relevant protocol from the "My Protocols" tab. From the "View Protocol" page, click on the "Modifications" tab at the bottom where you can create the modification. You will need to include a summary of the changes and upload any modified protocol documents (e.g., Informed Consent) as both a clean copy and with changes tracked in MS Word.听
All Expedited or Full Board approved protocols are required to submit either an annual continuing review report or a protocol termination. Exempt protocols are not required to submit a continuing review, but instead must submit either an annual check-in or a protocol termination. Mentor will automatically notify researchers of an impending report due date.
Annual reports should be submitted through . To submit the report, click on the relevant protocol from the "My Protocols" tab. From the "View Protocol" page, click on the "Annual Report" tab at the bottom. Click on the Context Menu and select "Edit" and complete the resulting menu.
If a 村花论坛-affiliated researcher has IRB approval from an institution with whom they are conducting collaborative research, a Reliance Agreement may be implemented such that the 村花论坛 IRB would rely upon the IRB of the collaborative institution to review and approve the research. To request a reliance agreement, the approved IRB protocol, along with all study-related documents, must be submitted to through the regular submission process.听
Please note that the 村花论坛 IRB may still request revisions to the approved protocol before granting the reliance agreement and before the research protocol can be initiated with any 村花论坛-affiliated research subjects.
村花论坛 should serve as the IRB of record for collaborative research if the majority of the research takes place at 村花论坛 or if the majority of the research subjects are 村花论坛-affiliates.听
In the event that a human subject makes a complaint or is harmed as a result of participation in your study, it is necessary that you immediately inform the 村花论坛 IRB.听
Adverse events should be submitted through . To submit an adverse event, click on the relevant protocol from the "My Protocols" tab. From the "View Protocol" page, click on the "Adverse Events" tab at the bottom. You will need to upload a description of the event indicating your judgment of whether the harm to the subject was a result of their participation in the project or incidental to it. You should also indicate if you think that the event warrants any changes to your protocol or consent form. If so, you should then submit a protocol modification. It is best to talk with the IRB chair before submitting any modifications related to adverse events.
Although it is important and required that investigators follow the protocol exactly as approved by the 村花论坛 IRB, in the event that the investigators have deviated from the approved protocol, the IRB must be notified immediately.听
Protocol deviations should be submitted through . To submit a deviation, click on the relevant protocol from the "My Protocols" tab. From the "View Protocol" page, click on the "Protocol Deviations" tab at the bottom. You will need to upload a description of the event indicating your judgment of whether any harm to subjects occurred as a result of the deviation You should also indicate if you think that the event warrants any changes to your protocol or consent form. If so, you should then submit a protocol modification. It is best to talk with the IRB chair before submitting any modifications related to protocol deviations.
Frequently Asked Questions
Yes! We welcome you to reach out for individual, group, or class assistance with IRB educational programs/lectures, application preparation, and questions. Please email irb@daemen.edu聽for inquiries.
Please use the following decision tree to assist you in determining what approval you are seeking from the 村花论坛 IRB:
1. Will you be conducting the proposed study as a 村花论坛聽University affiliate聽(e.g., a 村花论坛 student or faculty member)?聽
- YES 鈬 Proceed to Item 2
- NO, I am not affiliated with 村花论坛 but would like to recruit participants from 村花论坛 鈬 The proposed study would need to be submitted using the guidelines listed under Recruitment Request By Investigators not affiliated with 村花论坛.
2. Will you be conducting the proposed study in collaboration with another institution who is serving as the IRB of record (i.e., another institution's IRB has reviewed the study and granted their approval)?聽
- YES聽鈬 A Reliance Agreement may be submitted to along with聽evidence of IRB approval聽and all related study documents.听
- 狈翱听鈬 Proceed to Item 3
3. Will the proposed study fit the definition of 鈥榬esearch鈥 involving human subjects?聽Research,聽according to the U.S. department of Health and Human Services (USDHHS) and for the purposes of the IRB, is聽defined as "a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge" [搂46.102(l)]聽- See for additional guidance.
- YES 鈬捖Proceed to Item 4
- NO 鈬 The proposed study聽would聽not be considered research according to the USDHHS definition and does not require IRB review and approval. Other ethical and safety guidelines may still apply.銆
4. Would you like to make modifications to a study that has already been approved by the 村花论坛 IRB (or to extend the duration of an active study or reopen/renew a closed/expired study)?
- YES 鈬捖This聽would require聽a modification request. Please submit a modification to the protocol through .
- NO 鈬 Proceed to Item 5
5. Will the proposed study fall under one of the following eight聽exempt categories listed in the federal regulations [搂46.104(d)]聽- See 聽for additional guidance.
- Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods (see ).
- Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met: (i) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;聽(ii) Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or聽(iii) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by 搂46.111(a)(7). See .
- (i) Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:聽(A) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; (B) Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or聽(C) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by 搂46.111(a)(7). 聽(ii) For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing (See ). Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else. 聽(iii) If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research (see ).
- Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:聽(i) The identifiable private information or identifiable biospecimens are publicly available;聽(ii) Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects;聽(iii) The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of 鈥渉ealth care operations鈥 or 鈥渞esearch鈥 as those terms are defined at 45 CFR 164.501 or for 鈥減ublic health activities and purposes鈥 as described under 45 CFR 164.512(b); or聽(iv) The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501聽et seq. See .
- Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.听(i) Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects. See .
- Taste and food quality evaluation and consumer acceptance studies:聽(i) If wholesome foods without additives are consumed, or聽(ii) If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture (see ).
- Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by 搂46.111(a)(8). See .
- Secondary research for which broad consent is required: Research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met:聽(i) Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with 搂46.116(a)(1) through (4), (a)(6), and (d);聽(ii) Documentation of informed consent or waiver of documentation of consent was obtained in accordance with 搂46.117;聽(iii) An IRB conducts a limited IRB review and makes the determination required by 搂46.111(a)(7) and makes the determination that the research to be conducted is within the scope of the broad consent referenced in paragraph (d)(8)(i) of this section; and (iv) The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results (see )
- YES 鈬 The proposed study聽would qualify for a certification of exemption.听Please submit a protocol under Exempt IRB Review through .
- NO or UNSURE 鈬 Proceed to item 6.
6. Will the proposed study be ineligible for the exemption categories above but involve no greater than minimal risk? Minimal risk, according to the聽USDHHS聽and for the purposes of the IRB, is聽defined as "the probability and magnitude of harm or discomfort anticipated in the research is 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"聽[搂46.102(j)]聽
- YES 鈬 The proposed study would聽qualify聽for for expedited review.听Please submit a protocol under Expedited聽IRB Review through .
- 狈翱听鈬 The proposed study would聽qualify聽for for full review.听Please submit a protocol under Full IRB Review through .
'Informed consent' is more聽than just a聽document or act of documentation. It is a聽process聽to ensure that a potential participant is fully informed of his/her rights before deciding whether or not to participate in a research study. This process includes providing necessary information to potential participants and making sure that they聽fully understand聽this information. It is the researcher's job to聽ensure聽understanding of all aspects of informed consent with all potential participants. Additionally, it is important to clearly delineate this聽informed consent聽process聽in the research protocol (e.g., using clear and simple language (i.e., at the 8th grade reading level for adults) that is free of jargon, and all abbreviations or acronyms spelled out and explained, giving sufficient time for the participants to read the consent form or for the form to be read aloud to them, reiterating important consent elements, such as聽the study procedures, what participation entails, risks, benefits, etc., asking the potential participant to explain in their own words what the study entails, and asking for and answering any questions potential participants may have about the study).听The person conducting the informed consent process should be clearly indicated in the study protocol and should not hold any authority over potential participants.听
Participants'聽informed consent is typically documented using written or electronic signatures. However, the聽IRB may waive the requirement for signed consent under certain circumstances, such as when the research presents no more than minimal risk, and there are no procedures for which written consent is normally required outside of the research context, or when the signed consent is the only record linking the participant to the research, and the principal risk would be potential harm resulting from breach of confidentiality - See 聽for additional guidance. In these聽cases, all elements of consent should still be provided and consent otherwise indicated or documented (e.g., individuals interested in a study can click on the study URL,聽view consent information聽prior to deciding to begin聽the survey, and then can click an "I Agree" option to indicate their consent).
Additionally, the informed consent process itself can be waived or altered under certain (rare) circumstances (e.g., the study involves no more than minimal risk, the research could not practicably be carried out without the waiver or alteration, and the waiver or alteration will not adversely affect the rights and welfare of the participants) -聽See 聽for additional guidance.听聽
During the informed consent process (signed or otherwise), key information should be included that will assist potential participants in understanding the reasons why they may (or may not) wish to participate in the research. This key information includes:
1. that consent is being sought for research and an explanation of the purpose聽of the research
2. expected duration of participation and an explanation of specific procedures that will be followed (in sufficient detail to facilitate full understanding of what participants will be asked to do 鈥 e.g.,聽step by step tasks, sample questions, etc.)
3. a statement of any reasonably foreseeable risks or discomforts and any direct benefits to the participant or to others that may reasonably result from the research
4. a statement of how confidentiality will be maintained for any records (directly or indirectly) identifying participants
5. an explanation of whom to contact for answers to pertinent questions about the study procedures or聽participant rights, or in the event of a research-related injury, complaint, or concern
6. a statement that participation is voluntary and that deciding not to participate, withdrawing from the study at any time, or skipping a part of the study,聽will involve no penalty or loss of services to which participants would otherwise be entitled
And if applicable:
7. disclosure of any alternative procedures or courses of treatment that might be available and beneficial to the participant
8. an explanation of whether any medical treatments are available if injury occurs, what they consist of, and where to obtain further information
Note: The following statement should be included where relevant: "Routinely, 村花论坛, its agents, or its employees do not compensate for or provide free medical care for human subjects/participants in the event that any injury results from participation in a human research project. In the unlikely event that you become ill or injured as a direct result of participating in the study, you may receive medical care, but it will not be free of charge even if the injury is a direct result of your participation."
9. a statement that if private identifiable information or biospecimens are collected that (1) identifiers may be removed and used for further research without additional consent, or (2) the information (even if identifiers are removed) will not be used for further research
Informed Consent information should be prepared according to the Informed Consent Template, and included with protocol submissions. You may use the Informed Consent Checklist to ensure you've included all pertinent information.
Given that the utmost responsibility of the IRB is to protect human subjects, it is essential to demonstrate in a study proposal that participants are fully aware of the research they are choosing to participate in聽and that they are not coerced聽and do not experience undue influence.听 This is particularly true when designing recruitment strategies.听 This means that health care providers should not be involved in directly recruiting their patients for their own studies, employers should not be involved in recruiting their employees for their own studies, and instructors should not be involved in directly recruiting their students聽for their own studies. Furthermore, if subjects do聽decide to participate, they聽must also feel free to skip any questions they may wish and/or discontinue their participation at any time without penalty.
It is often the case that researchers don't even realize that they are being coercive.听 For example, below is a list of common phrases used by researchers that could be considered coercive, accompanied by suggestions to correct them.
Coercive/Creating Undue Influence |
Explanation |
Suggestion |
"Dear Participants," | Assumes they will agree to participate | "Dear potential participant," or "Hello," |
"We request that you complete this survey." | May lead to feelings of being pressured to comply with the request | "You are invited to participate..." |
"After agreeing to participate..." | Assumes that they will agree to participate | "If you agree to participate..." |
"Please answer all the questions honestly." | May pressure participants to answer questions they do not wish to | "Please answer the questions honestly. Remember that you are able to skip any questions that you wish." |
"Once you complete the questionnaire..." | Assumes they will decide to fully complete it | "After the questionnaire..."聽 |
鈥嬄
Yes. You need to show that you have permission from all site(s) in which you plan to recruit (or explain why permission is not needed).听This includes, but is not limited to, physical sites, virtual sites, and other on-line mechanisms. It should be clear who the person giving permission is (in relation to his/her authority at the site to ensure that the person has proper authority to grant permission) and that he/she has a general understanding of what the researcher plans to do. Agreement letters should indicate that the official has an understanding of the study title, purpose, topic, and methodology. This letter should be聽on official organizational/institutional letterhead from the recruitment site and signed by the authority granting permission (See Site Agreement Letter Template).听
No,聽the 村花论坛 IRB does not allow researchers to actually collect data from a potential participant prior to conducting the informed consent process and obtaining consent.听Post-consent screening might include a formal screening process during which time the researcher can collect information about the participant to ascertain that they meet inclusion criteria.听Additionally, it聽must be clearly stated in the protocol how participants will be screened for inclusion criteria.听Generally, it is easiest to have participants self-screen based on what is listed in the recruitment documents, after which the researcher can reiterate the inclusion criteria prior to obtaining informed consent and give the participant the opportunity to decline study participation if he/she feels she does not meet inclusion criteria.听This helps prevent potentially wasting聽individuals鈥 time if they do not meet inclusion criteria.听 聽聽
In an effort to provide聽"high quality, peer reviewed, web based research education materials to enhance the integrity and professionalism of investigators and staff conducting research" to 村花论坛 researchers, 村花论坛 subscribes to the program, which provides researchers with a training certificate after successfully completing all required training modules.听Researchers are required to upload their聽certificates to before any research protocols can be reviewed.听
If you are new to the CITI program, follow the instructions below to get started:
- Navigate to the
- Click the 'Register' link above the username and password fields.听
- Follow the prompts and be sure to use your 村花论坛 email address when asked.
- When asked to provide a role, select either Co-Investigator (students) or Principle Investigator (faculty) unless another role is more appropriate.
- You will be asked which courses you would like to enroll in. Be sure to select 鈥淗uman Subjects Research鈥 (You may select others as well, and you can always change or add to your selection by clicking on "View Courses鈥 and selecting 鈥淎dd a Course鈥 from the link at the bottom of the page).
- Be sure to complete the correct CITI course. The course that the 村花论坛 IRB requires is entitled聽"村花论坛 Human Subjects Training for Researchers"Course. Note, this may take聽several hours over several days to complete. Please plan accordingly.
- Upon course completion, click on the "View - Print - Share Record" option to download your completion report. (Note, this is different than a completion certificate. It is important to submit your full report that lists all modules completed along with their accompanying scores.)
- Upload your completion report to 聽using the "Training Certification" link under the main "IRB" tab.
If you have already registered with CITI, you can login to download your completion report or to renew your certification:
- Navigate to the
- Click the 'Login' link above the username and password fields.
- Click on 'View Courses' next to '村花论坛'
- To renew your certification, complete all required modules in the "村花论坛 Human Subjects Training for Researchers" Course. Note, this may be a different course than you've taken previously. Be sure that you complete the correct course. If you don't see the course listed above, you can find the course by聽clicking on "View Courses鈥 and selecting 鈥淎dd a Course鈥 from the link at the bottom of the page. Additionally please note that the course may take聽several hours over several days to complete. Please plan accordingly.
- Upon course completion, click on the "View - Print - Share Record" option to download your completion report.听(Note, this is different than a completion certificate. It is important to submit your full report that lists all modules completed along with their accompanying scores.)
- Upload your completion report to 聽using the "Training Certification" link under the main "IRB" tab.
Please contact irb@daemen.edu if you have any questions.
村花论坛 researchers may recruit 村花论坛 affiliates (i.e., students, faculty, employees, and alumni) though use of research designated mailing lists. IRB review and approval聽are necessary prior to posting recruitment for a study to the listserv, and requests must be sent from the faculty supervisor if the study involves student researchers.听Please see an and IRB instructions for use.
村花论坛 IRB does not commonly approve requests for researchers unaffiliated with 村花论坛 to recruit from the 村花论坛 community (i.e., on the 村花论坛 main campus or any of its satellite campuses). However, researchers may request to recruit 村花论坛 subjects by providing a copy of an approved IRB protocol to the 村花论坛 IRB for review. Permission must be granted by the 村花论坛 IRB before any recruitment may take place. If approved, recruitment may take place via flyer or poster only (e.g., no in-person solicitation or use of the 村花论坛 research listservs will be granted).
If you would like to inquire about approval to recruit聽村花论坛-affiliated subjects, please submit a copy of the approved IRB and all study-related materials to聽irb@daemen.edu.听
The IRB chairperson or his/her designee will review any requests, and may deny at will, or require changes/revisions before approval is granted. Approved requests will be acknowledged by a letter of approval and permission to recruit on campus. Recruitment cannot occur until/unless this official approval is granted.
IRB Templates and Samples
It is best practice to obtain the informed consent from research subjects whenever possible. Using the relevant templates below will likely speed up the protocol approval timeline.
Informed Consent Sample 1 (Exempt, Online Study)
Informed Consent Sample 2 (Exempt, In-Person Study)
Legally Authorized Representative Consent and Assent Template聽(e.g., for parental/guardian consent and child assent OR for LAR consent and assent of an individual with impaired decision-making capabilities)
View the sample protocol below to see what a completed protocol submitted through looks like. The protocol contains the initial protocol face sheet, all application sections and related questions, and all relevant study materials.听
Each protocol may look slightly different as the required application sections and related questions are tailored for each individual protocol.
Please use the template below when聽working with an outside group, agency, or institution (i.e., outside of 村花论坛) to recruit subjects.听
Please use the template below if your study procedures involve audio/video recording research subjects and you are employing the use of a transcription service to transcribe the recordings (or for any other methodology for which a transcription service would be used).
Debriefing is mandatory when the research procedures involve deception聽and should occur immediately after each subject participates in the study. Additionally, even if a research study does not involve the use of deception, debriefing can be used as an educational tool.听
If you plan to debrief research subjects (or are required to because of study procedures that involve deception), please use the relevant template below to ensure that you've included all the important elements of debriefing.
IRB Checklists for Important Protocol Sections
Use the checklists below as you complete your protocol for review to ensure that you are including all relevant information. Using these checklists will likely speed up the protocol approval timeline.
It is best practice to obtain the informed consent from research subjects whenever possible. Using the relevant checklists below will help to ensure that you've included all required components and will likely speed up the protocol approval timeline.
General Informed Consent Checklist
Special considerations must be made when recruiting subjects who are children or who have impaired decision-making ability. Please use the checklists below to ensure that you've met all the qualifications for being able to recruit such subjects.
Debriefing is mandatory when the research procedures involve deception聽and should occur immediately after each subject participates in the study. Please use the checklist below to ensure that you've included all required elements of debriefing if your study procedures involve deception.