Daemen University, 4380 Main Street, Amherst, NY 14226

Web Address: https://www.daemen.edu/academics/research/IRB

Email: irb@daemen.edu

IRB Administrator Phone: 716-839-8477

Shannon Lupien​​, Chair

Melissa Peterson, Administrator

Erin Carman*

Laura Edsberg

Janice Hobba-Glose

Theresa Kolodziej​

Helen McCabe

Paulette Niewczyk

​Deborah Merriam

Heather Pane*

Michael Ross

Jennifer Scheid

Sandra Sheppard, Community Member

*IRB Alternate Members

Mentor Tutorials for Researchers

Mentor Overview

• This video tutorial provides an overview of the Mentor system. 

Creating an IRB Protocol

• This video tutorial walks researchers through the submission process from initial protocol creation to submission to the IRB. 

Addressing Requested Revisions for an IRB Protocol

• This video tutorial walks researchers through the revision process and explains how to address requested revisions from the IRB. 

Mentor Tutorials for IRB Reviewers

Reviewing a Protocol

• 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, 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 Mentor. 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. 

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 Mentor. 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 Daemen-affiliated researcher has IRB approval from an institution with whom they are conducting collaborative research, a Reliance Agreement may be implemented such that the Daemen 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 Mentor through the regular submission process. 

Please note that the Daemen University IRB may still request revisions to the approved protocol before granting the reliance agreement and before the research protocol can be initiated with any Daemen-affiliated research subjects.

Daemen University should serve as the IRB of record for collaborative research if the majority of the research takes place at Daemen University or if the majority of the research subjects are Daemen-affiliates. 

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 Daemen University IRB. 

Adverse events should be submitted through Mentor. 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 Daemen University IRB, in the event that the investigators have deviated from the approved protocol, the IRB must be notified immediately. 

Protocol deviations should be submitted through Mentor. 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.

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 for inquiries.

Please use the following decision tree to assist you in determining what approval you are seeking from the Daemen IRB:

1. Will you be conducting the proposed study as a Daemen University affiliate (e.g., a Daemen student or faculty member)? 

• YES ⇒ Proceed to Item 2
• NO, I am not affiliated with Daemen University but would like to recruit participants from Daemen University ⇒ The proposed study would need to be submitted using the guidelines listed under Recruitment Request By Investigators not affiliated with Daemen University.

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)? 

• YES ⇒ A Reliance Agreement may be submitted to Mentor along with evidence of IRB approval and all related study documents. 
• NO ⇒ Proceed to Item 3

3. Will the proposed study fit the definition of ‘research’ involving human subjects? Research, according to the U.S. department of Health and Human Services (USDHHS) and for the purposes of the IRB, is defined as "a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge" [§46.102(l)] - See USDHHS flow chart 1 for additional guidance.

• YES ⇒ Proceed to Item 4
• NO ⇒ The proposed study would 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.　

4. Would you like to make modifications to a study that has already been approved by the Daemen University IRB (or to extend the duration of an active study or reopen/renew a closed/expired study)?

• YES ⇒ This would require a modification request. Please submit a modification to the protocol through Mentor.
• NO ⇒ Proceed to Item 5

5. Will the proposed study fall under one of the following eight exempt categories listed in the federal regulations [§46.104(d)] - See USDHHS flow chart 2 for additional guidance.

1. 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 USDHHS flow chart 3).
2. 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; (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 (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 §46.111(a)(7). See USDHHS flow chart 4.
3. (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: (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 (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 §46.111(a)(7).  (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 USDHHS guidance on benign behavioral interventions). 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.  (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 USDHHS flow chart 5).
4. 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: (i) The identifiable private information or identifiable biospecimens are publicly available; (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; (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 “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b); or (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 et seq. See USDHHS flow chart 6.
5. 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. (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 USDHHS flow chart 7.
6. Taste and food quality evaluation and consumer acceptance studies: (i) If wholesome foods without additives are consumed, or (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 USDHHS flow chart 8).
7. 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 §46.111(a)(8). See USDHHS flow chart 9.
8. 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: (i) Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with §46.116(a)(1) through (4), (a)(6), and (d); (ii) Documentation of informed consent or waiver of documentation of consent was obtained in accordance with §46.117; (iii) An IRB conducts a limited IRB review and makes the determination required by §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 USDHHS flow chart 10)

• YES ⇒ The proposed study would qualify for a certification of exemption. Please submit a protocol under Exempt IRB Review through Mentor.
• NO or UNSURE ⇒ 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 USDHHS and for the purposes of the IRB, is 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" [§46.102(j)] 

• YES ⇒ The proposed study would qualify for for expedited review. Please submit a protocol under Expedited IRB Review through Mentor.
• NO ⇒ The proposed study would qualify for for full review. Please submit a protocol under Full IRB Review through Mentor.

'Informed consent' is more than just a document or act of documentation. It is a process 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 fully understand this information. It is the researcher's job to ensure understanding of all aspects of informed consent with all potential participants. Additionally, it is important to clearly delineate this informed consent process 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 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). The person conducting the informed consent process should be clearly indicated in the study protocol and should not hold any authority over potential participants. 

Participants' informed consent is typically documented using written or electronic signatures. However, the 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 USDHHS flow chart 14 for additional guidance. In these 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, view consent information prior to deciding to begin 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) - See USDHHS flow chart 13 for additional guidance.  

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 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 — e.g., 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 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, 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, Daemen University, 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 and that they are not coerced and do not experience undue influence.  This is particularly true when designing recruitment strategies.  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 for their own studies. Furthermore, if subjects do decide to participate, they 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.  For example, below is a list of common phrases used by researchers that could be considered coercive, accompanied by suggestions to correct them.

​ 

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). 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 on official organizational/institutional letterhead from the recruitment site and signed by the authority granting permission (See Site Agreement Letter Template). 

No, the Daemen University IRB does not allow researchers to actually collect data from a potential participant prior to conducting the informed consent process and obtaining consent. 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. Additionally, it must be clearly stated in the protocol how participants will be screened for inclusion criteria. 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. This helps prevent potentially wasting individuals’ time if they do not meet inclusion criteria.    

In an effort to provide "high quality, peer reviewed, web based research education materials to enhance the integrity and professionalism of investigators and staff conducting research" to Daemen researchers, Daemen subscribes to the Collaborative Institutional Training Initiative (CITI) program, which provides researchers with a training certificate after successfully completing all required training modules. Researchers are required to upload their certificates to Mentor before any research protocols can be reviewed. 

If you are new to the CITI program, follow the instructions below to get started:

1. Navigate to the CITI Home page
2. Click the 'Register' link above the username and password fields. 
3. Follow the prompts and be sure to use your Daemen email address when asked.
4. When asked to provide a role, select either Co-Investigator (students) or Principle Investigator (faculty) unless another role is more appropriate.
5. You will be asked which courses you would like to enroll in. Be sure to select “Human Subjects Research” (You may select others as well, and you can always change or add to your selection by clicking on "View Courses” and selecting “Add a Course” from the link at the bottom of the page).
6. Be sure to complete the correct CITI course. The course that the Daemen IRB requires is entitled "Daemen University Human Subjects Training for Researchers"Course. Note, this may take several hours over several days to complete. Please plan accordingly.
7. 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.)
8. Upload your completion report to Mentor 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:

1. Navigate to the CITI Home page
2. Click the 'Login' link above the username and password fields.
3. Click on 'View Courses' next to 'Daemen University'
4. To renew your certification, complete all required modules in the "Daemen University 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 clicking on "View Courses” and selecting “Add a Course” from the link at the bottom of the page. Additionally please note that the course may take several hours over several days to complete. Please plan accordingly.
5. 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.)
6. Upload your completion report to Mentor using the "Training Certification" link under the main "IRB" tab.

Please contact irb@daemen.edu if you have any questions.

Daemen University researchers may recruit Daemen affiliates (i.e., students, faculty, employees, and alumni) though use of research designated mailing lists. IRB review and approval 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. Please see an explanation of the mailing lists and IRB instructions for use.

Daemen University IRB does not commonly approve requests for researchers unaffiliated with Daemen to recruit from the Daemen community (i.e., on the Daemen University main campus or any of its satellite campuses). However, researchers may request to recruit Daemen subjects by providing a copy of an approved IRB protocol to the Daemen University IRB for review. Permission must be granted by the Daemen University 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 Daemen research listservs will be granted).

If you would like to inquire about approval to recruit Daemen-affiliated subjects, please submit a copy of the approved IRB and all study-related materials to irb@daemen.edu. 

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.

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 Template

Informed Consent Sample 1 (Exempt, Online Study)

Informed Consent Sample 2 (Exempt, In-Person Study)

Legally Authorized Representative Consent and Assent Template (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 Mentor looks like. The protocol contains the initial protocol face sheet, all application sections and related questions, and all relevant study materials. 

Each protocol may look slightly different as the required application sections and related questions are tailored for each individual protocol.

Sample Protocol: Exempt Review, Category 2

Please use the template below when working with an outside group, agency, or institution (i.e., outside of Daemen University) to recruit subjects. 

Site Agreement Letter Template

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).

Transcription Confidentiality Agreement Template

Debriefing is mandatory when the research procedures involve deception 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. 
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.

Deception-Related Debriefing Template

Educational Debriefing Template

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

Waiver or Alteration of Consent Checklist

Waiver of Documentation of Signed 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.

Research with Children Checklist

Research with Adults with Impaired Decision-Making Ability

Debriefing is mandatory when the research procedures involve deception 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.

Debriefing Checklist