*This website represents the official source of record for the Human Research and Ethics Board's policies and procedures
SUNY New Paltz abides by the ethical principles and guidelines for the protection of human subjects as stated in the Belmont Report. When SUNY New Paltz becomes engaged in human subjects research, the Institution and the Human Research Ethics Board, the institutional review board upon which it relies for review of such research, complies with federal regulations 45 CFR 46 regardless of funding source.
HREB Location & Contact Information:
Phone: (845) 257-3476
HREB Secretary: Roseann Merrill
Sponsored Programs & Research Compliance
Old Main B120
Phone: (845) 257-3282
The HREB Chair emailed the SUNY New Paltz community on September 16, 2019 announcing the implementation of the New Revised Common Rule.
Human Subjects Research Guidelines have changed. The Office of Human Research Protections has implemented the revised common rule. This can be found on the HREB website and in the PACS library. The rule provides more flexibility in some areas, but calls for greater protections in others.
The quick highlights include: 1) new requirements for informed consent, 2) major changes to the Exempt review categories, 3) greater specification of what is and is not considered human subjects research, 4) for Expedited research, continued approval will only be required in a limited number of cases, and 5) specifications about the secondary use of data for research and greater protections for personally identifiable information and biospecimens.
We have adapted our procedures and forms and the revised documents are available on the Human Research Ethics Board (HREB) website https://www.newpaltz.edu/sponsored_programs/humansubs.html and in the PACS library. Please be sure to use the new forms and follow these new guidelines.
If you have any questions or would like to discuss how these changes might influence your research and HREB submissions, please do not hesitate to contact me at HREBchair@newpaltz.edu or give me a call at 845-257-3476. You may also contact Roseann Merrill at HREBsecretary@newpaltz.edu or by phone at 257-3282.
Maryalice Citera, Chair, Human Research Ethics Board
The HREB Chair emailed the SUNY New Paltz community on October 8, 2019 with HREB Updates containing information on NEW Exempt Categories.
The Exempt categories have changed. To be clear, Exempt does not mean exempt from review. It means that there are certain guidelines to which the researcher does not have to strictly adhere. Attached is a list of the new Exempt categories. Revised forms, called templates, for: 1) Survey/Interview Exemption, 2) Educational Exemption, 3) Existing Data Exemption, and 4) the Benign Behavioral Intervention Exemption (this is new see the description below) can be found on the HREB website https://www.newpaltz.edu/sponsored_programs/humansubs.html and in the PACS library.
Below is a brief list of the changes:
There are now 8 Exempt categories. Attached is a list of the new Exempt categories. Below are some key changes to these categories:
· The Survey/Interview exemption allows for the collection of personally identifiable data. Now you can use the short Exempt form even if you are collecting identifiers. The new form now contains questions about data security and data storage that must be answered. Note this form cannot be used if you are surveying individuals under 18.
· There is a new category called “Benign Behavioral Interventions.” Research that involves manipulation of variables that 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.” This exemption is not applicable for research involving deception “unless the subject authorizes the deception through a prospective agreement to participate in research and the subject is informed that they will be unaware of or they will be misled regarding the nature or purposes of the research.” This exemption can only be used for the collection of information from adult participants through verbal written responses (including data entry) or audiovisual recording. If you are collecting biological data such as heart rate, EEG, or data from a fitness tracker like a Fitbit, this exemption does not apply. This exemption also does not apply to children.
· The existing data exemption has been changed. Existing data is now called secondary research. There are additional qualifications about what can be considered exempt or not.
· Research collecting biospecimens have additional requirements that must be met.
· There are broad consent requirements for storage, maintenance, and secondary research use of personally identifiable data and biospecimens.
· There are restrictions on the storage and maintenance of biospecimen data and personally identifiable data for secondary research.
· Former Exempt category 3 that applied to research with public and elected officials has been removed.
If you have any questions, please do not hesitate to contact me at HREBchair@newpaltz.edu or give me a call at 845-257-3476. You may also contact Roseann Merrill at HREBsecretary@newpaltz.edu or by phone at 257-3282.
Maryalice Citera, Chair, Human Research Ethics Board
Human Research Ethics Board (HREB) Information:
As of October 11, 2017, all HREB proposals must be submitted through the SUNY Pre-Award and Compliance System (PACS). Please see PACS webpage at this link for training and information: http://www.newpaltz.edu/sponsored_programs/pacs.html
Fall 2019 HREB Meeting Schedule:
Policies, Procedures and Principles
- Belmont Report - Ethical principles and guidelines for the protection of human subjects in research
- Protection of Human Subjects - Title 45 CFR 46 - Applicable through January 20, 2019
- Protection of Human Subject - 45 CFR 46 - Applicable as of January 21, 2019
Standard Operating Procedures
- NP SOP 2019 Definitions
- NP SOP 2019 Exempt Categories
- NP SOP 2019 Exemption Categories
- NP SOP 2019 Expedited Categories
- NP SOP 2019 Research Subject To Human Subjects Regulations
- NP SOP 2019 Student Research Exercises and Not Human Subjects Research
- NP SOP 2019 Exempt Review by Instructor
- NP SOP 2019 External Site approval policy
- NP SOP 2019 External Researcher Policy
- NP SOP 2019 Informed Consent Guidelines 2019
- NP SOP 2019 International Research
- NP SOP 2019 IRB Considerations for Privacy and Confidentiality Safeguards
- NP SOP 2019 IRB Agreement Authorization
- NP SOP 2019 Prisoner Research Guidelines
- NP SOP 2019 Engagement in Research
- NP SOP 2019 Study Completion Reporting Policy
- NP SOP 2019 Email Lists Student Research
- NP SOP 2019 Use of Surrogates Policy
- NP SOP 2019 Adjunct Faculty Policy for Human Subjects Research
- NP SOP 2019 Student Policy For Human Subjects Research
- NP Template 2019 Exempt Benign Behavioral Intervention
- NP Template 2019 Exempt Education
- NP Template 2019 Exempt Existing Data
- NP Template 2019 Exempt Survey-Interview
- NP Template 2019 Research Protocol Application-long-form
- NP Template 2019 Informed Consent
- NP Template 2019 International Addendum
- NP Template 2019 Prompt Reporting Form
- NP Template 2019 Modification Application
- NP Template 2019 Continued Approval Application
Collaborative IRB Training Initiative (CITI)