SUNY New Paltz | Sponsored Programs & Research Compliance - WORKING

*This website represents the official source of record for the Human Research and Ethics Board's policies and procedures

All human subjects research, regardless of funding, conducted by members of the SUNY New Paltz community is reviewed by the Human Research Ethics Board (HREB) following the federal regulations in 45 CFR 46 and the policies and guidance of the Office of Human Research Protections (OHRP) and other federal agencies as needed.

SUNY New Paltz abides by the ethical principles and guidelines for the protection of human subjects as stated in the Belmont Report.

HREB Location & Contact Information

HREB Chair: Dr. Maryalice Citera

Psychology Department

WH 353
Phone: (845) 257-3476
E-mail: hrebchair@newpaltz.edu

HREB Coordinator: Roseann Merrill
Sponsored Programs & Research Compliance
Old Main B120
Phone: (845) 257-3282
E-mail: hrebsecretary@newpaltz.edu

The amount of time your review will take will depend upon the number of proposals to be reviewed. The review time may vary; however, the HREB strives to conduct reviews as expeditiously as possible. Our goal is to review proposals within two weeks of receipt by members but it may take longer. Please be aware, however, that there are certain periods of the year, e.g., mid-terms, finals, and holidays, in which proposals cannot be reviewed within two weeks.

Announcements

The HREB Chair emailed the SUNY New Paltz community on September 16, 2019 announcing the implementation of the New Revised Common Rule.

Dear Researcher,

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.

Dear Researcher,

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

The HREB Chair emailed the SUNY New Paltz community on November 4, 2019 with HREB Updates containing information on Changes to Informed Consent.

Dear Researcher,

With the new revisions to the Common Rule that went into effect in January 2019, the informed consent guidelines have changed and there are additional requirements that must be met.

First, you must begin your informed consent form with a brief summary that conveys key information that is most likely to assist a prospective participant or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. The summary must contain the following information:

The fact that consent is being sought for research and that participation is voluntary
The purposes of the research, the expected duration of the prospective subject’s participation, and the procedures to be followed in the research
The reasonably foreseeable risks or discomforts to the prospective subject
The benefits to the prospective subject or to others that may reasonably be expected from the research
Appropriate alternative procedures or courses of treatments, if any that might be advantageous to the prospective subject.

Second, if you are collecting personally identifiable private information or biospecimens you must include one of the following statements:

(i) A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or

(ii) A statement that the subject's information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.

Third, you must get broad consent for the storage, maintenance, and secondary research use of personally identifiable private information or biospecimens. Broad consent will provide participants with a choice to say no to storage, maintenance, and secondary research. If an individual was asked to provide broad consent and refused to consent, the HREB cannot waive consent for the use of identifiable private information or identifiable biospecimens in the future. In addition to the requirements for informed consent, the requirements for broad consent include:

A general description of the types of research that may be conducted with the identifiable private information or identifiable biospecimens. This description must include sufficient information such that a reasonable person would expect that the broad consent would permit the types of research conducted;
A description of the identifiable private information or identifiable biospecimens that might be used in research, whether sharing of identifiable private information or identifiable biospecimens might occur, and the types of institutions or researchers that might conduct research with the identifiable private information or identifiable biospecimens;
A description of the period of time that the identifiable private information or identifiable biospecimens may be stored and maintained (which period of time could be indefinite), and a description of the period of time that the identifiable private information or identifiable biospecimens may be used for research purposes (which period of time could be indefinite);
Unless the subject or legally authorized representative will be provided details about specific research studies, a statement that they will not be informed of the details of any specific research studies that might be conducted using the subject's identifiable private information or identifiable biospecimens, including the purposes of the research, and that they might have chosen not to consent to some of those specific research studies;
Unless it is known that clinically relevant research results, including individual research results, will be disclosed to the subject in all circumstances, a statement that such results may not be disclosed to the subject; and
An explanation of whom to contact for answers to questions about the subject's rights and about storage and use of the subject's identifiable private information or identifiable biospecimens, and whom to contact in the event of a research-related harm.

Maryalice Citera, Ph.D., 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 2020 HREB Meeting Schedule:

November 18th

December 2nd

Spring 2021 HREB Meeting Schedule:

January 20th

February 3rd

February 17th

March 3rd

March 17th

March 31st

April 14th

April 28th