The Human Subjects Research Review Committee
The Human Subjects Research Review Committee (HSRRC) is responsible for ensuring that all research at Daemen College 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 Daemen College Research Review Policy, including its description of criteria for Exempt, Expedited and Full Review Proposals, and required elements of informed consent.
All requests for review of proposals should be submitted to email@example.com according to the following instructions. Please note that the review process will be delayed if applications are not submitted according to the following instructions.
- Complete an application for review of your protocol using the most current form that is available (posted in the sidebar).
- Send the application as a single Word doc. attachment (with all relevant appendices included at the end of the protocol application) to firstname.lastname@example.org. The file name of your main application should be in the following format: Last Name First Initial - HSRR - Date [e.g., Smith K HSRR 10-18-16.doc].
- Include a meaningful subject line in your e-mail (e.g., HSRR Expedited Review Request: K. Smith) and a brief message in your e-mail indicating the level of review you are requesting.
- If the project involves student researcher(s), the application must be fully vetted and sent by the Daemen faculty member supervising the project. Submissions will be returned and NOT reviewed if submitted by anyone other than supervising faculty.
- Send the application from your daemen.edu e-mail address, and cc all associated investigators on the email submission. (Copy the submission e-mail to all Daemen-affiliated associate investigators' daemen.edu e-mail addresses and to all non-Daemen-affiliated associate investigators' professional e-mail addresses.)
- Current verification (completion reports) of CITI training from ALL investigators (including all student researchers and faculty sponsors) must accompany the application (either as a separate attachment or within the protocol application document). Daemen researchers needing CITI training should access the CITI Program website. Please refer to CITI Instructions below (under FAQs) for further information and more detailed instructions about accessing the CITI site and completion requirements.
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 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. Proposals that are incomplete or inaccurately submitted will likely extend your timeline.
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 for the potential of multiple rounds of revisions.
*Academic Year 2019 - 2020 HSRRC Meeting Dates
Meetings are usually held on the second or third Thursday of each month during the academic year (as specified below) in the RIC from 11:30 a.m. to 12:45 pm.
- September 19th - RIC 101
- October 17th - RIC 213
- November 21st - RIC 213
- December 12th - RIC 213
Daemen College, 4380 Main Street, Amherst, NY 14226
HSRRC Administrator Phone: 716-839-8477
Shannon Lupien, Chair
Melissa Peterson, Administrator
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 HSRRC 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 HSRRC 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 Investigation Involving Human Subjects.
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 HSRRC 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 has been approved by the HSRRC, the principle investigator must conduct the study exactly as approved. No changes in approved research should be initiated without prior HSRRC 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 changes to approved documents, such as consent forms, personnel, recruitment materials, approved instruments to be used in the study, and approved procedures, such as those outlined for maintaining privacy and confidentiality or recruitment methods. Updated documents, instruments, or procedures may NOT be used until the new versions are approved by the HSRRC.
To modify the approved study and/or documents, or to request a continuation of a previously approved protocol, please complete the Application for Modification to an Approved Proposal and append supporting materials to the end of the application. The application should be sent by the faculty member as a single Word doc. attachment to email@example.com, 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, an IRB authorization agreement form may be implemented in place of a Daemen HSRRC application. Researchers must submit a completed IRB Authorization Agreement form, evidence of approval from the parent institution's IRB, and the official protocol that was approved to firstname.lastname@example.org. Please note that Daemen College should serve as the parent institution for collaborative research if the majority of the research takes place at Daemen College or if the majority of the participants are Daemen-affiliates.
Researchers who are unaffiliated with the College but who wish to recruit participants on the Daemen College main campus or any of its satellite campuses must request and obtain permission from the Human Subjects Research Review Committee before any recruitment may take place. Recruitment may take place via approved flyer or poster only.
If you would like to recruit on the campus, please submit one copy of the materials (application and all supporting documents) that were submitted to your home institution IRB, along with the letter of IRB approval to email@example.com. The HSRRC chairperson or his/her designee will review the request. Approved requests will be acknowledged by a letter of permission to recruit on campus. On occasion, the HSRRC chairperson may decide that requests for permission to recruit on campus go to the full HSRR committee for review and/or approval.
Please note that the HSRRC may choose deny, at will, any requests to recruit Daemen participants from researchers not affiliated with Daemen College.
Frequently Asked Questions
Yes! We welcome you to reach out for individual, group, or class assistance with HSRRC 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 HSRRC:
1. Are you conducting the work as a Daemen College affiliate (i.e., a Daemen student or faculty member)?
- YES ⇒ Proceed to Item 2
- NO, I am not affiliated with Daemen College but would like to recruit participants from Daemen College ⇒ This work qualifies as a Recruitment Request By Investigators not affiliated with Daemen College.
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), and you are using participants who are not Daemen-affiliated?
- YES ⇒ This work can be submitted using a completed IRB Authorization Agreement form 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 and for the purposes of the HSRRC, is defined as "a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge" (45CFR46.102[l])
- YES ⇒ Proceed to Item 4
- NO ⇒ This work is not considered research according to the USDHHS definition and does not require HSRRC review and approval.
4. Are you applying for approval to make modifications to a study that has already been approved by Daemen College HSRRC?
- YES ⇒ This work qualifies for a request for a modification to an approved study; please complete the application form for modification requests.
- NO ⇒ Proceed to Item 5
5. Does the research fall under one of the following eight exempt categories listed in the federal regulations (45 CFR 46.101(b)):
- 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.
- 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).
- (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. 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.
- 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.
- 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.
- 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.
- 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).
- 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 Exempt Review; please complete the application form for a proposal qualifying for exempt review.
- NO or UNSURE ⇒ Proceed to item 6.
6. Does the said research involve no more than minimal risk?
- 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), 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 HSRRC 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. In these cases, all elements of consent should still be provided and consent indicated through action. For example, participants might receive a recruitment letter (containing informed consent information) that contains a URL link to a survey. If interested, they can navigate to the survey and view consent information prior to deciding to begin the survey. They can click an "I Agree" option to indicate their consent. Additionally, the informed consent process itself can be waived or altered under certain circumstances (e.g., research that is considered exempt under 45 CFR 46.101(b), or when 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).
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 College, 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 Consent Form Template, and appended to your protocol application.
Given that the utmost responsibility of the HSRRC 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 they are not at all coerced to do so. 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.
|"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..."|
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) 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.
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 program (https://www.citiprogram.org/index.cfm?pageID=22) 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 at https://www.citiprogram.org/index.cfm?pageID=22 and 'Create an account' by registering (Click on 'Register' in the blue box that is third from the top). Then, select 'Daemen College' as your organization affiliation and click 'Continue to Step 2'. Complete the various information about yourself in the following steps.
If you have already registered with CITI, you can log in by entering your 'Username' and 'Password' and clicking on 'Log In'. At the next screen, click on 'Daemen College Courses' and proceed with completing the required modules and associated quizzes. When you successfully complete all required modules, you should save/print your completion report through the 'Print Report' link or 'Previously Completed Coursework' page. This is the completion report that should accompany your proposal submission to HSRRC.
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". If you complete or update your CITI training after January 21 2019 then you will not need to complete the Revised Common Rule certification since the new information will be integrated into your regular CITI training. Please contact firstname.lastname@example.org if you have any questions.
NOTE: Some of these examples are older, but still have some utility. The HSRRC is in the process of creating new examples.
Exempt application (Category 3): /sites/default/files/documents/HSRRC-Exempt-example.pdf
Facility Access/Permission letter: /sites/default/files/documents/Permission-to-access-facility-letter.docx
Sample template for informed consent/information form document: /sites/default/files/documents/SAMPLE-INFORMED-CONSENT-DOCUMENT%209.2017.docx
Exempt application (Category 4): /sites/default/files/HSRRC-Exempt-example-Category4.pdf
Daemen College researchers may recruit Daemen affiliates (i.e., students, faculty, employees, and alumni) though use of research designated mailing lists. HSRRC 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 a description of the appropriate use of mailing lists on the Daemen website: http://www.daemen.edu/student-life/student-services/technology-services/it-services-best-practices/mailing-lists