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 word doc attachment 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 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. Copy the submission e-mail 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 application document). Daemen researchers needing CITI training may access this process on 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 planning, please expect 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. Please note these guidelines are ONLY for proposals that are accurately and completely submitted.
Proposals for Full Committee review must be received 10 business days prior to the scheduled meeting date (or review of the proposal may be tabled for the following meeting date)*.
Meetings are usually held on the third Thursday of each month during the academic year (as specified below) in RIC 212 at 11:30 a.m. to 12:45 pm.
- DATES TBD
Daemen College, 4380 Main Street, Amherst, NY 14226
HSRRC Administrator Phone: 716-839-8477
Shannon Lupien, Chair
Melissa Peterson, Administrator
Please use this form if you think that an Application for Certificate of Exemption is appropriate for your study because of the relative lack of apparent risk to research participants and it falls into one of the 6 federally designated exempt categories. 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 note these guidelines are ONLY for proposals that are accurately and completely submitted.
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 note these guidelines are ONLY for proposals that are accurately and completely submitted.
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 the amendment should be filed immediately thereafter). This includes changes to approved documents, such as consent forms, personnel, recruitment materials, or instruments to be used in the study. Updated documents 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.
Once this form is completed, the faculty member (including those who are supervising student projects) should submit an electronic version in MS Word format to email@example.com, with a carbon copy to all associate investigators on the project to daemen.edu e-mail addresses only. Hard copies are not needed unless one or more of the associate investigators are not affiliated with Daemen College. In this case, a hard copy of the application with all signatures is needed.
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 firstname.lastname@example.org. 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.
If a researcher has IRB approval from a parent institution, an IRB authorization agreement form may be implemented in place of a full HSRRC application. Researchers must submit a completed IRB Authorization Agreement form, evidence of approval from the parent institution's IRB, and the protocol that was approved to email@example.com.
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 Research Affiliate such as Daemen student or faculty (ie. Daemen is the parent institution for which the work is being conducted)?
- YES ⇒ Proceed to Item 2
- NO, I am just recruiting from Daemen College ⇒ This work qualifies as a Recruitment Request By Investigators not affiliated with Daemen College.
2. Is the work considered ‘generalizable research’ involving human subjects, defined as "a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge" (45CFR46.102[d])
- YES ⇒ Proceed to Item 3
- NO ⇒ This work is not considered research according to the USDHHS Common Rule and does not require HSRRC review and approval.
3. 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 4
4. Does the research fall under one of the following eight exempt categories listed in the federal regulations (45 CFR 46.104[d]):
- 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 5.
5. 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 a document or act of documentation. It is a process that includes a document regarding the various parts of informed consent that is given to participants. It is the researcher’s responsibility to ensure that the participant is fully informed of his/her rights. The person conducting the informed consent process and obtaining the documented signature should be clearly indicated in the study proposal and should not hold any authority over the potential participant (such as being the student, patient, or employee). HSRRC reviewers are looking to see that the informed consent process (answering questions, and giving sufficient time for explaining the the study, procedures, what participation entails, and answering questions) is clearly delineated in the study proposal. This includes review and assurance of understanding of all aspects of informed consent with the interested potential participant.
In anonymous studies, it increases risk to the participant to collect a signed informed document since this would be the only means of linking of the participant to the study. In such cases, it is recommended that participants instead be given all of the informed consent information in an information sheet (or incorporated into the cover or recruitment letter) that clearly explains that return of the anonymous survey implies consent to participate in the study. The information sheet is a document that includes all of the same aspects of the informed consent document but without the signature line. Depending on study design, consider incorporating the informed consent aspects into both the recruitment and survey cover letter. For example, you might send a recruitment letter (inclusive of informed consent aspects) to a pool of candidates who are to click on a URL link to your survey pending participation interest; upon navigating to the survey link, the participant could be shown the informational sheet prior to completing the survey.
There are specific elements that need to be included in an informed consent document (or information sheet). An example of a template for an informed consent document (or information sheet) with the required elements to be included in the document is attached here:
Informed Consent forms should be prepared according to the Consent Form Template, and appended to your 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 signing up for, and 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 own patients for their own studies, employers should not be involved in recruiting their own employees for their own studies, and instructors should not be involved in directly recruiting their own students, especially just for the ease of sampling.
It is often the case that researchers don't even realize that they are being coercive. For example, even stating that "We request that you complete this survey" is considered coercive. Instead, when recruiting for research, potential participants should be "invited to participate" and reassured that participation in the study is completely voluntary.
Yes. You need to show that you have permission from all site(s) in which you plan to recruit. 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; the letter should indicate that the official has an understanding of the study title, purpose, topic, and methodology. This letter should be printed on official organizational/institutional letterhead from the recruitment site and signed by the authority granting permission.
No. First, you must clearly state in the protocol how you will screen for inclusion criteria. Generally, it is easiest to have participants self-screen themselves based on what is listed in the recruitment documents and 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), but the researcher cannot actually collect data from the potential participant prior to conducting and obtaining the signed informed consent process. Generally, it is best not to waste potential participants’ time if they do not meet inclusion criteria. 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. Remember, the person is not a participant (and thus you cannot collect his or her information) until he/she is fully informed about the study and provides consent to participate.
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 though use of research designated mailing lists. HSRRC review and approval are necessary prior to posting recruitment for a study to the listserv. 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