Instructions for Research Involving Human Subjects
Nazareth College of Rochester (the College) values and encourages research involving human subjects and strives to provide opportunities for faculty, staff, and students to engage in this activity. In doing so, the College accepts the legal and ethical responsibilities for safeguarding the rights and welfare of human subjects involved in this research and operates in compliance with the Federal Wide Assurance required for federal funding of research.
Policies and Procedures Governing Human Subjects Research
The College requires that all research projects that use human subjects be approved and periodically reviewed by the Human Subjects Research Committee (HSRC). The HSRC operates under Section 474(a) of the Public Health Service Act (P.L. 93-348) as implemented by Department of Health and Human Services regulation Title 45, Part 46 of the Code of Federal Regulations (45 CFR 46) which details procedures to safeguard human subjects in research.
As defined in CFR Title 45, Part 46, "research" is a "systematic investigation designed to develop or contribute to generalizable knowledge," and a "human subject" is "a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information." Since class work assignments are usually not intended to or likely to lead to generalizable results, the Human Subjects Research Committee does not normally include these projects under its operational definition of research. However, if the intent of a project is to conduct research (e.g. honors or master’s thesis) versus learning about conducting research, the project should be submitted to the HSRC for review. If a project involves in any way the use of human subjects it must be conducted so as to safeguard human subjects in research, including consideration of risks and use of informed consent. See document on student research.
The HSRC functions as the Institutional Review Board (IRB) at the College regardless of the source of funding. The HSRC shall be composed of at least five members pursuant to section 107 of 45 C.F.R. 46. Members shall have varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The HSRC shall be sufficiently qualified through the experience and expertise of its members, and the diversity of its members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes and religious beliefs. If research involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or persons with disabilities, consideration shall be given to the special appointment of one or more individuals who are knowledgeable about and experienced in working with these subjects. The members of the HSRC are full-time faculty members elected by the faculty except for one member who is a community representative (someone not employed by the College) appointed by the Committee. The Chair of the HSRC shall be one of the faculty members of the Committee. Members will serve a three-year term and may be re-elected for one additional three-year term.
These policies and procedures apply to all research which is either (a) conducted on the premises of the College; or (b) funded through the College; or (c) conducted by faculty, staff, or students of the College who are acting in connection with their responsibilities or relationships to the College or who intend to use the name of the College in any report of the activity; or (d) conducted through the use of the College’s records.
The Application Process
Before starting the application process, please use the flowchart, which can be found on the HSRC website to help determine if there is a need for submitting an application to HSRC.
- Prior to submitting an application to HSRC, a researcher must demonstrate his or her awareness of issues involving protection of human subjects by completing a set of training modules available online at www.citiprogram.org (see Training Module Instructions). A certificate of completion provided by the CITI website should be sent to the HSRC as part of the application procedure for category II and III research. While a CITI certificate is not required for Category I (Exempt research), completing the CITI training is highly recommended especially for students.
For Category I or Exempt research, please complete the Exempt Research form only and submit the form to HSRC@naz.edu. Please note that HSRC has the final authority in determining if the research proposal qualifies for the Exempt category.
- For category II (Expedited) and III (Full Review) research, please complete an Application form and submit electronically to HSRC@naz.edu. A copy of the Application can be obtained from the HSRC website. Click on “Read Only” to open the form.
Send proposals as Word documents using the following naming convention:
“NAME.HSRC_Proposal.doc” Use the PI’s last name. When necessary, a letter to a prospective funding agency may be issued stating that the proposed research protocol is under review.
- The HSRC accepts applications using a rolling submission process. Proposals that are complete and conform to application guidelines will be reviewed within one month of submission with two exceptions:
• applications submitted after November 15 will have a review deadline of February 1
• applications submitted after April 15 will have a review deadline of August 25
The HSRC chair will inform an applicant within one month of the submission date regarding the status of the proposal (for category I and II research). The applicant should be mindful of the HSRC’s review schedule as he or she is considering the length of time needed to complete the research. Faculty and students who may need to receive HSRC approval for their research as stipulated by external granting agencies should be especially attentive of the HSRC review schedule.
Below is a brief description of each research category.
- Category I Research (Exempt) is usually the case for anonymous, mailed surveys on innocuous topics, or anonymous, noninteractive observation of public behavior (e.g., shoppers at a mall). Some typical examples include:
(1) Research conducted as part of academic coursework involving instructional strategies, techniques, curricula, or classroom management methods; (2) research involving the use of educational tests; (3) research involving survey procedures; (4) research involving observation of public behavior; or (5) research involving the collection of existing data, documents, or records. Please refer to the Exempt categories document which can be found on the HSRC website for detailed descriptions of each exempt category.
Each exemption specifies that no human subjects may (1) be identified directly or through identifiers linked to the subjects; (2) be identified in such a way that subjects could be reasonably placed at risk of criminal or civil liability or incur damage to their financial standing or employability; or (3) be identified in such a way which deals with sensitive aspects of the subject's own behavior such as illegal conduct, drug use, sexual behavior, or use of alcohol.
- Category II Research (Expedited) is research carrying minimal risk to the subjects but which does not qualify as Category I research. Category II research includes methods such as interviews or self-report measures or any data collected either one-on-one or in groups in which there is no psychological intervention or deception. Category II proposals require the use of written informed consent forms.
Category II Research qualifies for expedited review. In this situation, an application will be reviewed by two members of the HSRC. If these reviewers deem that the risk may exceed minimal, the application will be reviewed by the entire committee. This may extend the review process beyond a month.
- Category III Research (Full review) is research that involves risk to subjects. Category III research is usually applied to studies involving invasive measurements (such as blood draws), interventions (such as those involving exercise and physical exertion by volunteers), asking about sensitive topics (e.g., sexuality, drug use), experiments involving deception, or use of “special” populations such as minors or prisoners. Category III proposals require the use of written informed consent forms. Proposals given this designation require a review by the entire HSRC. This may extend the review process beyond a month. The HSRC or the Principal Investigator can also request for a meeting to discuss and clarify concerns of the project.
Below is the review process for application. The HSRC Chair, in consultation with other members when necessary, reviews the application to determine the appropriate designation.
- After reviewing an application, the HSRC chair will notify the
principle investigator of one of four decisions: (a) approval; (b)
approval pending revisions; (c) deferral of judgment pending further
consideration; or (d) disapproval. If revisions are required, the
stipulations will be specified in writing to the Principal Investigator
and must be addressed before the project can be approved.
a. If approved, the project may proceed as described in the application.
b. The designation “Approval Pending Revisions” means that the HSRC approves the project on the condition that the investigator agrees to specific minor changes. The HSRC Chair communicates this finding to the Investigator and requests that the HSRC receives an appropriately revised application within three weeks. The revised proposal will be reviewed within two weeks. All revisions must be approved before the research proceeds.
c. The designation “Deferral of Judgment Pending Further Consideration” is used on occasions when the application is incomplete or the HRSC requires further information from the Principal Investigator before ruling on the application.
d. The designation “Disapproval” means that research may not proceed. The HSRC Chair communicates this finding and the HSRC's rationale to the Principal Investigator.
- If required, a letter describing the decision of the HSRC will be addressed to the funding agency. Normally, the Principal Investigator will forward the letter to the agency.
Responsibility of the Researcher
Some research involving human subjects must be sponsored by an approved investigator. Investigators whose appointments carry the approved rank codes do not require sponsorship. See the end of this section for a list of approved rank codes. All other investigators, including students, research associates, postdoctoral fellows, non-salaried clinical rank appointees, non-tenure track faculty and librarians, and part-time appointees must be sponsored by one or more full-time Nazareth faculty, librarian, salaried clinical rank, or research rank appointee whose primary appointment carries one of the below-listed ranks.
Sponsorship is more than simply a signature, and carries two responsibilities: (1) assistance in preparing the application for Human Subjects Research Committee approval, and (2) supervision of the research project. While the Committee is able to offer assistance in how to complete the HSRC applications, it cannot take the place of the sponsor.
When a student is working on a project that already has HSRC approval and that student will use some of that data to fulfill a course or degree requirement--such as honor's thesis, first-year project, or master's degree--the original principal investigator must submit an amendment to the HSRC requesting the student to be added as a co-investigator on his/her project for the stated purpose. Any student working in the same capacity but who wishes to use the data for his/her dissertation must submit a separate application to the HSRC describing the project and the data to be used. In all other situations, student-initiated research must be submitted as an independent project, NOT as an amendment to an already approved protocol. All student projects must be sponsored by one or more full-time Nazareth faculty, librarian, salaried clinical rank, or research rank appointee. If the sponsor's appointment is at another campus, the review must take place on that campus. Full-time persons with the following ranks are approved to submit, or sponsor, an application to use human subjects in a research project:
- Associate Professor
- Associate Dean
- Assistant Professor
- Vice President
- Assistant Dean
- Clinical Professor
- Assistant Vice President
- Clinical Associate Professor
- Associate Vice President
- Clinical Assistant Professor
About Informed Consent
In addition to concerning itself with risk, the HSRC must consider the subject's consent to participate in the research project. An underlying ethical principle of the Federal regulations is that human subjects enter into research voluntarily and with adequate information. (See “Ethical Principles and Guidelines for the Protection of Human Subjects of Research,” (1979), known as The Belmont Report. <http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html>) Thus, consent must be informed and voluntarily given. A subject's consent is "informed" if he/she has a reasonable comprehension of that to which he/she is consenting. The investigator must use language appropriate to the subject's ability to comprehend. Generally, the consent form should be written at the 7th grade reading level. Nondisclosure of information to subjects must not be used simply to assure their participation in the research. It is desirable, but not mandatory, that the investigator, rather than an assistant, obtain the consent.
To ensure that subjects' consent is voluntary, the HSRC considers whether any undue pressures will be brought to bear on potential subjects. Such pressure may be subtle as, for example, when a teacher asks his or her own students to become subjects of his or her research. Excessive compensation or no payment for withdrawals is viewed by the HSRC as pressure.
In order to obtain informed consent the investigator must provide a statement that includes the information listed on the Informed Consent Statement Checklist. A checklist for the informed consent statement is included below in order to assist investigators in the preparation of their consent form. This checklist reflects both requirements of the Federal regulations and customary language adopted by the HSRC. Use of the checklist will facilitate HSRC review. Each participant shall sign two copies of the Informed Consent form. One copy will be filed by the PI and the other retained by the participant.
Who is to give consent? Any legally competent adult can give consent; but said adult cannot give valid consent if he/she is under the influence of alcohol or drugs, or if the consent is obtained under duress. This latter point is important in academic circumstances since students are often asked to volunteer as subjects. If possible, investigators should not use their current students. If current students must be used, it must be made clear to the subjects that the decision to participate will have no effect upon their grades.
The consent process for studies conducted in foreign countries, or with illiterate populations, may be altered so that consent may be given orally and documented on tape. Such tapes must be treated in the same manner as paper consent forms. Any other alteration to the consent process must be reviewed by the full committee.
To prepare your informed consent form, please review the Informed Consent Checklist found at the end of this document or Sample Consent forms for Nazareth College which can be found on the HSRC website.
Research with Minors
Minors require special consideration. Persons aged 18 and older may consent to participating in research and parental permission is not required. For subjects aged 17 and under, however, the consent of at least one parent or guardian is required. If a child is age 7 or older, the aims and general nature of the project must be described in language the child can comprehend, and the child's assent must be obtained. Children under age 7 need not be asked to assent; parental or guardian consent is sufficient. If biomedical research on infants is planned, the drugs or procedures must first have been tried on animals, adults, and older children. In certain cases where there is no risk and where it would be unreasonable to require parental permission, the HSRC may waive the requirement. Research on minors that involves more than minimal risk will be approved only if it is (i) of direct benefit to the subject or (ii) yields useful knowledge about a subject's problem or disorder. In the latter case, both parents must give consent. If a child is a ward of the state, the HSRC must require that there be an advocate appointed to function as a guardian in the child's behalf.
To prepare your assent form, please review the Assent Checklist found at the end of this document or Sample Assent forms for Nazareth College which can be found on the HSRC website.
Research with Persons with Mental Disabilities
Persons with mental disabilities also require special consideration. They may or may not be able to give consent depending upon the severity of their disabilities. If a person is capable of understanding the nature of the project, consent should be obtained from both the subject and a parent or guardian. In instances where the person is not competent to consent, parental or guardian consent alone is sufficient.
A letter of assent should also be used with persons with mental or other disabilities that require a separate letter of consent.
Informed Consent Checklist
- Header that includes Nazareth College of Rochester, the Department, title of research study, and Researcher’s name and contact information. Information of faculty advisor is mandatory for student applicants.
- Written in the first person (e.g., I, me, my).
- Language at a level appropriate for the participant (remembering that the mean reading level in the U.S. is 7th grade).
- The nature, purpose, duration of the study.
- Procedures to be employed in the experiment (i.e., exactly what the participants are expected to do).
- Risks (hazards, inconveniences, discomforts) the subject may experience, as far as they are known and how any risks will be minimized.
- The following statement: "As in all research, there may be unforeseen risks to the participant. If an accidental injury occurs, appropriate emergency measures will be taken."
- Benefits to the subject; state none if none; if general benefits expected, state those.
- If experiment is therapeutically related, disclosure of alternate procedures the subject might choose.
- Conditions of participation such as age, health status, etc.
- How confidentiality will be maintained and any limits to confidentiality.
- That the participant can withdraw her/his consent to the research or discontinue participation in the research at any time without prejudice or penalty.
- Circumstances under which the PI may terminate subject participation without subject consent.
- Contact person(s). Include the researchers' name and telephone numbers (students must include faculty advisor's name and telephone number) as well as the following statement: "The participant may also contact the Chair, Human Subjects Research Committee, Nazareth College, if questions or problems arise during the course of the study." (Please include the name and phone number of HSRC Chair)
- Place for date and signature of the participant; witness line should be included ONLY if required.
- No language that would absolve the researcher of negligence.
- If appropriate, that any significant new findings affecting risks will be reported to the participant.
- If appropriate, debriefing procedures.
- A letter of assent is required for research with children ages 7-17 and for research with adults not legally able to give informed consent for themselves.
- Verbal assent is required for children under the age of 7.
- Assent form MUST be included with an informed consent form for the parent or guardian to sign that meets all the requirements on the informed consent checklist.
- Assent form should have a simple format with brief statements.
- Written in the first person (e.g., I, me, my, we,) from the perspective of the person signing.
- Language at a level appropriate for child participants (e.g. written at a 2-3rd grade comprehension level).
- What will happen in the research (procedures)
- How long will the research take (duration)
- If applicable, risks to the participant or other things that the participant should know
- Being in the research is the participant’s choice (voluntary), even after a parent/guardian has given permission for participation in the research This MUST be clearly stated in the letter of consent.
- Place for date and signature of the participant; parent signature line should be included as well.
Updated August 1, 2013