Daemen University, 4380 Main Street, Amherst, NY 14226

Web Address: https://www.daemen.edu/academics/research/institutional-review-board-human-subjects-research

Email: irb@daemen.edu

IRB Administrator Phone: 716-839-8477

Shannon Lupien​​, Chair

Melissa Peterson, Administrator

Diane Bessel

Laura Edsberg

Janice Hobba-Glose

Theresa Kolodziej​

Helen McCabe*

Deborah Napolitano*

Paulette Niewczyk

​Deborah Merriam

Michael Ross

Jennifer Scheid

Sandra Sheppard, Community Member

*IRB Alternate Members

If the researcher(s) determine that the proposal is appropriate for expedited review because of the relative lack of apparent risk to research participants, and it falls into one of the eight federally designated exempt categories (see FRQs 'How do I know which IRB review to apply for' below), please download and complete the Application for Certificate of Exemption. Researchers are required to receive an official certification of exemption from the IRB prior to commencing recruitment for the study.   

Proposals submitted for Certification of Exemption 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 planning, please expect 2 - 3 weeks turnaround time for review of applications for Certification of Exemption. Please plan your timeline accordingly, and allow for the potential of multiple rounds of revisions​. Proposals that are incomplete or inaccurately submitted will likely extend your timeline.

If the researcher(s) determine that the proposal requires an expedited or full review, please download and complete the Application for Expedited or Full Review.

Proposals for 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 planning, please expect 3 - 4 weeks turnaround time for review of applications for Expedited review.

Proposals for Full Committee review must be received 10 business days prior to the scheduled meeting date (see meeting dates listed above) or review of the proposal may be tabled for the following meeting date. Researchers are invited and encouraged to attend the IRB meeting during which their proposals will be reviewed.

Please plan your timeline accordingly, and allow for the potential of multiple rounds of revisions.  Proposals that are incomplete or inaccurately submitted will likely extend your timeline.

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 application should be filed 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.

To modify an approved study protocol, to request an extension of an active study protocol, or to reopen/renew an expired/closed study protocol, please complete the Application for Modification and append the most recently approved version of the protocol the end of the application. The application should be sent by the faculty member as a single Word doc. attachment to irb@daemen.edu, with all associate investigators on the project cc'd using only daemen.edu e-mail addresses where applicable. 

If a Daemen-affiliated researcher has IRB approval from a parent institution with whom they are conducting collaborative research, a Collaborative Research Authorization Agreement may be implemented in place of a Daemen IRB application. Researchers must submit a completed application for a Collaborative Research Authorization Agreement, evidence of approval from the parent institution's IRB, and the official protocol that was approved, with all supporting materials and appendices to irb@daemen.edu. Please note that the Daemen University IRB may still request revisions to a protocol approved by an IRB at parent institution before granting the authorization agreement, and before the research protocol can be initiated with any Daemen-affiliated participants.

Daemen University should serve as the parent institution for collaborative research if the majority of the research takes place at Daemen University or if the majority of the participants are Daemen-affiliates. 

Researchers who are unaffiliated with Daemen University but who wish to recruit participants on the Daemen University main campus or any of its satellite campuses must submit an application and obtain permission from the IRB before any recruitment may take place. Approved recruitment may take place via approved flyer or poster only (i.e., no in-person solicitation or use of the research listservs will be granted).

Requests to recruit Daemen participants by those unaffiliated with Daemen are not commonly granted, but if you would like to seek approval to recruit on the campus, please submit a copy of the materials (either a complete the appropriate application for review or exemption, or an authorization agreement application and all supporting documents if already approved by another IRB - see section above) 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 this official approval is granted.

Yes! We welcome you to reach out for individual, group, or class assistance with IRB educational programs/lectures, application preparation, and questions. 

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

1. Are you conducting the work as a Daemen University affiliate (i.e., 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 ⇒ This work qualifies as a Recruitment Request By Investigators not affiliated with Daemen University.

2. Are you conducting the work in collaboration with another institution who is serving as the parent institution (i.e., the parent institution has reviewed the work and granted their IRB approval)? 

• YES ⇒ This work can be submitted using a completed application for a Collaborative Research Authorization Agreement with evidence of approval and the approved protocol included. 
• NO ⇒ Proceed to Item 3

3. Is the work considered ‘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 ⇒ This work is not considered research according to the USDHHS definition and does not require IRB review and approval. Other ethical and safety guidelines may still apply.　

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

• YES ⇒ This work qualifies for a request for a modification to an approved study; please complete the Application for Study Modification.
• NO ⇒ Proceed to Item 5

5. Does the research 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.
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).
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.
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.
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.
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.
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).
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.

• YES ⇒ This research qualifies for a certification of exemption. Please complete the application form for a protocol qualifying for a Certification of Exemption.
• NO or UNSURE ⇒ Proceed to item 6.

6. Does the said research involve no more than minimal risk? Minimal risk, according to the USDHHS and for the purposes of the IRB, is defined such that "the probability and magnitude of harm or discomfort anticipated in the research are 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 ⇒ This research qualifies for Expedited Review.
• NO or UNSURE ⇒ This research requires Full Review.

'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 should be documented using written or electronic signatures. In some cases 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 appended to your protocol application.

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 researcher cannot 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" (CITI Program Mission Statement) to Daemen researchers, Daemen subscribes to the Collaborative Institutional Training Initiative (CITI) program, which provides researchers with a program completion report after successfully completing all required modules. Researchers are required to submit their completion reports when submitting proposals for review. 

If you do not have a CITI certificate, please follow these instructions for getting started.  First, navigate on-line to the CITI Home page and create an account by registering (Click on 'Register' in the box at the top right of the page). Then, select 'Daemen University' as your organization affiliation, agree to the terms and affirm your affiliation, then click 'Continue To Create Your CITI Program Username/Password'. Complete the various information about yourself in the following steps. 

If you have already registered with CITI, you can log in by clicking on 'Log In' and entering your 'Username' and 'Password'. At the next screen, click on 'View Courses' next to 'Daemen University' and proceed with completing the required 'Daemen University CITI Certification' basic course modules and associated quizzes. When you successfully complete all required modules, you should save/print your completion report through the 'View - Print - Share Record' option under 'Completed Courses'. This is the completion report that should accompany your protocol submission to the IRB.  

Additional CITI training to understand the revisions to the Common Rule.

All faculty supervising research must complete an additional certification with CITI called "Revised Common Rule" unless you completed or renewed your CITI training after January 21 2019, as the new information is now integrated into the regular CITI training.  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.

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 Consent and Child Assent)

Certification of Exemption Protocol - Sample 1

Certification of Exemption Protocol - Sample 2

Expedited Review Protocol Sample

Sample Safety Plan

Site Agreement Letter Template

Transcription Confidentiality Agreement Template