Getting Started on the Process of Human Research Ethics Review
Congratulations! You are about to embark on an exciting journey to answer your study questions! But,
first, you (and we!) have to ensure that your study participants will be treated ethically, as per laws and
guidelines established by the federal government, New York State, and SUNY New Paltz. That means
that you have to determine what kind of research you will be doing. Then, fill out the appropriate forms
and follow the procedures established by the SUNY New Paltz Human Research Ethics Board (HREB) to
gain approval for your study.
Below is a definition of HUMAN SUBJECTS RESEARCH and three categories of review—these
categories determine how closely we review the project. Read through all of them and try to narrow down
as best as you can which category your study falls into. Once you have made that decision, click on the
links to the appropriate forms and follow the directions to get the HREB review process started. Note that
we make every effort to review your proposals in 2-3 weeks. Once we have reviewed the proposals, we
will send you a notice, either asking for revisions to ensure compliance with federal laws (we use a
review form that aligns with your proposal), or informing you that your proposal is acceptable and you
can begin research once you receive an official, hard copy of acceptance. If you need to make revisions,
follow the suggestions given in the review form, and then return your revised proposal to your reviewer.
Also, depending on the type of research you are conducting, you will most likely need to complete
training in ethical research practices. See Human Subject Education Requirements for Investigators and
Study Teams [http://www.newpaltz.edu/sponsored_programs/Human-Subject-Education-RequirementsInvestigators-and-Project-Team.pdf] for more information.
HUMAN SUBJECTS RESEARCH
The definition of human subjects research is based on federal law, 45 CFR 46, Section 102. To qualify as
human research, a study has to fulfill two main criteria. One, it should be “research,” defined as “a
systematic investigation, including research development, testing and evaluation, designed to develop or
contribute to generalizable knowledge.” Two, it must involve human subjects, defined as “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.”
(defined further on page 3 of Determining the Need for IRB Review from Definitions and Scenarios
http://www.newpaltz.edu/sponsored_programs/determiningneed.pdf).
Examples: Here are examples of Human Subjects Research:
 Internet survey measuring attitudes about magazine ads
 Anonymous interviews with teenagers about their views on sexuality
 Analysis of music therapy sessions conducted with Alzheimer’s patients
 Observations of parental interactions with children in a school.
If you feel that your research project does not involve “Human Subjects Research” as defined above, you
must apply for a “Not Human Subjects Research Determination.” As long as your study is not a
systematic investigation that involves interaction or intervention with individuals or identifiable private
information, you can ask for this type of determination.
Examples: Here are examples of Not-Human Subjects Research:
 Analysis of data that has no identifying information (e.g., a meta-analysis that analyzes only
group level data)
 Analysis of gender stereotyping in television commercials or magazines
Revised 10/25/13
1

Survey that asks what type of heating system people use (but not about attitudes, opinions,
beliefs, or characteristics of the individuals themselves).
Forms: Here is the Determination of Not-Human Subjects Research procedure you should use to request
a determination:
http://www.newpaltz.edu/sponsored_programs/Determination%20of%20not%20human%20subject%20re
search%206.10rev.pdf
For all Human Subjects Research, you will need to complete an application for proposal review. Three
categories of reviews are described below: 1) Exempt, 2) Expedited, and 3) Full-Board. Read through the
descriptions below to identify the correct type of review and to identify the necessary forms you should
complete.
REVIEW CATEGORIES
1. Exempt Research: To qualify for exempt review procedures, research involving “human subject
involvement may not exceed minimal risk (physical, psychological, social, undue stress and/or invasion
of privacy)” and must fall within one of the specific categories outlined in 45 CFR 46. The Exempt
Category Descriptions [http://www.newpaltz.edu/sponsored_programs/exemptresearchcategories.pdf]
explains the types of data collection that may count as exempt research. Generally, this type of research
focuses on innocuous questions (no chance of harm to reputation, financial/legal standing, or
employment) or is completely anonymous. If your study participants are identifiable (including linking
individual data with codes), and there may be a slight chance of harm if confidentiality is not maintained,
your study would fall into the “expedited” review category (next).
Please note: “No exemption categories apply to research involving prisoners, fetuses, pregnant women or
human in vitro fertilization. Only certain exemptions pertain to children.”
Examples: Here are examples of Exempt Research:
 Customer satisfaction surveys, in which data is completely anonymous
 Non-audio or videotaped interviews with adults who are capable of giving consent and whose
answers, if identifiable, would cause no harm to them
 Analysis of materials (eg, field notes) that were not initially collected for research purposes and
which will not include any individually identifiable information
 Oral history on veterans’ memories of the Vietnam War.
Forms: There are several forms for exempt research, depending on the exemption category you are
seeking: Application for Existing Data Exemption (category 4); Application for Interview Research
Exemption (category 2);Application for Survey Research Exemption (category 2).
2. Expedited Research: If you believe your study qualifies as human subjects research, but not in one of
the Exempt categories, it may fall into the categories of “expedited research,” and therefore may qualify
to follow a quicker review process than research requiring Full-Board Review. To qualify as expedited
research, your study must: A) “present no more than minimal risk to human subjects”; B) ensure that the
privacy of participants and the confidentiality of their data will be maintained, and C) fall into one or
more of these specified categories (see
http://www.newpaltz.edu/sponsored_programs/expeditedresearchcategories.pdf): Categories 1-4 apply to
medical research; (5) “Research involving materials (data, documents, records, or specimens) that have
been collected or will be collected solely for non-research purposes (such as medical treatment or
Revised 10/25/13
2
diagnosis)”; (6) “Collection of data from voice, video, digital, or image recordings made for research
purposes”; (7) “Research on individual or group characteristics or behavior (including, but not limited to,
research on perception, cognition, motivation, identity, language, communication, cultural beliefs or
practices, and social behavior) or research employing survey, interview, oral history, focus group,
program evaluation, human factors evaluation, or quality assurance methodologies.”
Examples: Here are examples of Expedited Research:
 A survey study that involves multiple surveys collected over time where the data are linked by a
code that identifies the participants
 A study on language perception where the participants view stimuli on the computer and their
reaction time is measured
 An interview study where the interviews are video taped and later coded.
Forms: If you believe your research falls into one of the Expedited categories, you will fill out the
Research Proposal Review Form, and check the box “expedited category” at the top of the page. In
Category H on the form, you will be asked to justify why you think the research is expedited. Draw from
the Expedited Research Categories [hyperlink] to explain your choice.
3. Full Board Review: If your study does not fit in any of the Exempt or Expedited categories, you will
need to go through Full-Board review. Full-Board review will also be necessary if your study involves
more than minimal risk to the participant (risk to reputation, employment, financial standing, or legal
status). Generally, studies involving “vulnerable populations” such as prisoners, pregnant women, and
disabled or mentally impaired people may also require Full-Board review.
Examples: Here are examples of studies that require Full Board Review:
 Survey that involves multiple measurement where participants will be identified through a code
and asked questions that may put participants at risk (e.g., underage alcohol use, drug use, illegal
gambling)
 A study using a mentally impaired population (like Alzheimer’s patients) where the individuals
cannot provide consent and there is no legal guardian to provide consent for them.
Forms: For research that will be reviewed using Full Board procedures, you will need to fill out the
Application for Research Proposal Review form [hyperlink].
INFORMED CONSENT
For most types of human subject research, you will have to follow a process of informed consent. This
means that you need to establish a process for explaining your research study to study participants and
asking for their consent to participate in it. It is important that individuals know what will be involved in
the research project before they agree to participate. For studies that fall under the “Exempt” research
category, you should include a brief statement about the purpose of your study prior to participants
beginning your survey, interview, or other procedure. For research that falls under the Expedited and
Full-board review categories described above, you will need to create an Informed Consent document that
will require the participant’s signature. The Informed Consent [hyperlink] document explains this process
and indicates what information needs to be included in the form. You can use the HREB Consent Form
Checklist [hyperlink] to make sure that your Consent form has all of the necessary elements. In some
cases, you might need to get consent from a guardian and assent from the study participant. You can
follow this sample Assent Form. In other cases, you may be videotaping participants and want to use
clips of the video tape in your presentations and publications, you will probably want to use a Video
Documentary Interview Release Form.
Revised 10/25/13
3
SOME ADDITIONAL CONSIDERATIONS
Student Research Exercises: These are projects typically completed in courses that focus on student work
in supervised practical applications of theories, research methods and professional research writing styles.
These projects may involve the collection and analysis of data and all are closely supervised by the course
instructor. The instructor is responsible for the safe and ethical conduct of these research exercises. The
results and outcomes of these exercises can ONLY be presented within the classroom context and
CANNOT be published or presented outside of the classroom. This includes oral presentations, posters or
other written descriptions of the research & no public display of research findings can be hung on the wall
or anywhere (e.g., posters hung in hallways, they cannot be presented at the Student Research
Symposium, etc.). ALL data from these exercises must be destroyed at the end of the semester.
Guidelines for Student Research Exercises can be found here:
http://www.newpaltz.edu/sponsored_programs/student_research_guidelines.pdf
International Research: If you are conducting a study abroad, we must ensure that you are adhering to the
ethical standards of that country as well as those of the United States. You will need to complete the
appropriate application for the type of research you are conducting. You may also need to complete the
International Research Addendum. (See the SUNY New Paltz International Research Policy:
www.newpaltz.edu/sponsored_programs/internationalresearchpolicy.doc .) The Office of Human
Research Protections has compiled a list of ethical standards from other countries that you will need to
consult (www.hhs.gov/ohrp/international/index.html). We will also ask you to provide the name of a
Cultural Consultant who can ensure the accuracy of your translations and assist us in managing any
potential ethical issues.
Examples: Here are examples of International Research:
 Tape recorded interviews on the political views of adults living in an oppressive regime
conducted in Southeast Asia
 Implementation of behavior management strategies with parents and children in their homes
conducted in China
 Surveys of individuals on family dietary practices conducted in Canada.
Forms: You should determine what kind of research you are conducting based on the 3 categories of
review (listed above) and then fill out the relevant forms. In addition, you will fill out the International
Research Addendum.
CONTACT US
If you would like further assistance in making your determination, please contact our secretary, Roseann
Merrill, at hrebsecretary@newpaltz.edu, or the Chair of HREB, Maryalice Citera, at
hrebchair@newpaltz.edu.
Last modified on 10/25/2013
Revised 10/25/13
4