NEW -  Important Information for Investigators with International Collaborations

Jan 15

December 14, 2018

As we are getting closer to the implementation of changes to the Common Rule we would like to begin communicating these changes to the research community. One major change is to the informed consent form. The new requirement is to include “key information” and that the “key information” must appear at the beginning of the informed consent form. The rationale behind this change is that the inclusion of “key information” will help the potential participant better understand the research.

What comprises “key information”? There are five factors that encompass “key information”. The five factors include the following:
1. Consent is being sought for research purposes and that participation is voluntary
2. Purpose of the research, expected duration of participation and procedures that would need to be followed
3. Any reasonably foreseeable risks/discomforts to the participant
4. Any reasonably expected benefits to the participant or others
5. Any alternative procedures that might be advantageous to the prospective participant

Additionally, investigators need to present the information in the informed consent form in enough detail and in a way that a prospective participant can comprehend the information.

The Office of Research Compliance is reformatting the consent template to include this “key information”. The template will be available by December in the IRBNet Forms and Templates Library. All applications submitted after December 21, 2018 will require the use of the new template which includes a “key information” section as well as other required changes.

Jan 15

January 3, 2019

As we are getting closer to the implementation of changes to the Common Rule we would like to continue communicating these changes to the research community. Another major change to the Common Rule is the elimination of the requirement of continuing review for all minimal risk research submitted on or after January 21st, 2019**. Reviewers will still have the option to require continuing review to enhance the protection of human subjects for particular studies on a case-by-case basis.

There will be a requirement to submit a “status update” every two years. The update method (continuing review or “status update”) will be specified in the initial approval letter. We are asking that the following be included in the “status update”:

Status of the study (actively recruiting, closed to enrollment, etc.)
Training of study personnel
Change in personnel (if applicable)
Conflict of Interest information (if applicable)
Redacted consent (for QA/QI purposes
Unanticipated problems/serious adverse events (if applicable
Changes to the study including changes to the consent form (if applicable)
Funding (if applicable)

You can find the “Research Status Report form” located in IRBnet library.

Although the renewal requirements have changed with the Common Rule, the amendment process remains the same. All changes to a study must be submitted and approved before they can be implemented. Additionally, the consent form will no longer have an expiration date. You will still continue to see an expiration date on the study, as a status report would be due every 2 years.

Continuing review requirements still apply to research reviewed by the IRB that is greater than minimal risk research unless the research involves one or both of the following:
Data analysis, including analysis of identifiable private information or identifiable biospecimens;
Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care

**Please Note: Any studies approved prior to January 21, 2019 will fall under the current common rule guidelines and are required to undergo continuing review annually

Jan 15

As we are getting closer to the implementation of changes to the Common Rule we would like to continue communicating upcoming changes to the research community. Another major change to the Common Rule is the increased ability to use the exempt category. There are more types of research that now qualify for these expanded exempt categories than in the past. These include the following:

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 the following criteria is met:
-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.
-For these types of studies, the IRB would conduct a “limited IRB review” to determine that there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of the data.

Research involving what is called “benign behavioral interventions”** (see below for definition) 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:
-Identity of subject cannot readily be ascertained.
-A disclosure of subject responses outside the research would not place the subject at risk. In this type of research, and the identity of subjects cannot readily be ascertained.
-The information obtained is recorded in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects.

For studies meeting this last criteria, the IRB would conduct a “limited IRB review” to ensure that there are adequate protections to protect privacy of subjects and confidentiality of the data

Research in this category can also receive an exemption if the research involves deceiving the subjects regarding the nature or purposes of the research. However, an 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.

**A benign behavioral intervention is an intervention that is 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 subject play an online game, having the subject solve puzzles under various noise conditions, or having the subject decide how to allocate a nominal amount of received cash between themselves and someone else.

Apr 05

February 9, 2018

See the federal register here:, and note: “Federal departments and agencies listed in the Interim Final Rule are also in the process of developing a notice of proposed rulemaking (NPRM) seeking public comment on a proposal for further delay in the required implementation of the revised Common Rule (for example, until January 21, 2019).” We will continue to monitor the situation, while concurrently working toward an easy transition for implementation of the new rule requirements when compliance with the final rule becomes required.

Apr 05

As we have been advising you for some time now, this sIRB Policy affects multi-site studies involving non-exempt human subjects research funded by NIH, and applies to grant applications with due dates on or after January 25, 2018 and R&D contracts in response to solicitations issued on or after January 25, 2018.

A new Special Topics Section to our updated Standard Operating Procedures (SOPs)  has been added that addresses the process for IRB Reliances and NIH sIRB here at SBU.

If you have any questions about relying on an external IRB, or about having SBU be the IRB of record, for multi-site studies, please contact Ms. Lu-Ann Kozlowski in this office:, 631-632-9036.

For more information and resources directly from NIH, please go to:

Apr 05

IRB approval is just one aspect of complying with institutional requirements for the conduct of human research. Ancillary reviews and approvals are required before the commencement of studies using the facilities and patients of University Hospital, involving reviewers responsible for sign-off in the following areas:

· Pathology

· Research Pharmacy

· Radiology

· Privacy/Security (HIPAA)

· Hospital Finance/Billing

· Chair of PI’s department

· Use of research-related radiation

· Use of surgical pathology or cytology specimens

Apr 05

For the past year, we have been preparing for our second re-accreditation with the Association for the Accreditation of Human Research Protection Programs (AAHRPP), and as a result, our SOPs have been extensively reviewed and updated.

We have posted them at this time as a single pdf here: Human Subjects Standard Operating Procedures but will create a more user-friendly format to allow for easy navigating in the near future. Please refer to these SOPs often to ensure the compliant conduct of your research activities.

Some of the more substantive changes you will notice:

1. Revisions to reflect the changes in FDA and NIH regulations over the past few years (and sent to you via this mailing and/or in Research News) including, e.g., the NIH GCP training requirement, allowance of FDA waiver of consent for minimal risk research, NIH single IRB requirement, etc.)

2. Revisions to reflect the (impending) move from IRBNet to Click as our IRB electronic management system.

3. Detailed SOPs on IRB reliance arrangements in Multi-site Research (see, in particular, Section 17.16)

4. Section (‘Recruitment of Subjects’) identifies that SBU participates in ResearchMatch (see new section 17.13) and confirms that, when recruiting patients as potential subjects, first contact must be made by someone who has a relationship (e.g., treatment etc.) with the patient; This policy protects the patient’s right to privacy.

5. Section 5.2 (‘Definitions’ within the ‘Obtaining Informed Consent’ section) provides greater detail, per the NYS Family Health Care Decisions Act, regarding the definition of a legally authorized representative who can give permission as a surrogate (in instances where an adult cannot consent for themselves).

6. Section 5.7 (‘Documentation of Informed Consent’) adds that, when using the short form procedure: In addition to receiving a copy of the (English) summary and a copy of the short form at the time of consenting, the subject must receive a copy of the summary, translated into their native language, as soon as possible after their enrollment into the study.

7. Extensive revision to Section 7.5 (‘Responsibilities for FDA-regulated Research’) to be clear regarding responsibilities of FDA regulated Clinical Investigators as well as responsibilities of those investigators who are also sponsors of INDs and IDE’s: see in particular Section (‘Additional Responsibilities When the Clinical Investigator is also the Sponsor of the IND or IDE [“Sponsor-Investigator”]’) and support services now available for Sponsor-Investigators (Section

8. Section 14 (Conflicts of Interest in Research) was revised to reflect the new annual disclosure process utilizing the electronic myResearch program.

9. Section 17.4 (‘Registration of Clinical Trials’) clarifies which research activities are subject to the registration requirement.

10. New Special Topics for:

a. Genomic Data Sharing (GDS) for NIH Grant Submissions (Section 17.12);

b. ResearchMatch as a Recruitment Tool (Section 17.13);

c. Conducting Research in a Clinical Setting (e.g., University Hospital): Special Considerations (Section 17.14);

d. Additional Requirements for Studies Funded by the Department of Defense (Section 17.15);

e. IRB Reliance/Single IRB (sIRB) Review (Section 17.16)

Feb 27

When the Advanced Energy Research and Technology Center (AERTC), a New York State-designated Center of Excellence, was founded several years ago at Stony Brook University, its goal was to foster collaboration between the brightest minds in academia and industry leaders in energy.

Launching the Institute of Gas Innovation and Technology are, from left, Devinder Mahajan, PhD; Stony Brook University President Samuel L. Stanley Jr.; SUNY Chancellor Kristina M. Johnson: Ken Daly, President of National Grid New York; and Robert Catell, Chairman of the Advanced Energy Center.

Its interdisciplinary research program and state-of-the-art laboratories have since kept the University at the leading edge of discovery, resulting in new technologies that impact residential and commercial energy use worldwide.

Stony Brook recently took another step in its commitment to a future that protects the environment with efficient, sustainable energy management. The University announced on Friday, Feb. 16, the formation of a new Institute of Gas Innovation and Technology (I-GIT), a consortium of industry and academic leaders focused on the development of new energy technologies designed to promote sustainability and save the environment.

University President Samuel L. Stanley Jr. joined State University of New York Chancellor Kristina M. Johnson, other University leaders, and representatives from National Grid New York for a ribbon-cutting ceremony Feb.16 at the Institute’s new offices, at AERTC in Stony Brook’s Research and Development Park. The ceremony marks Chancellor Johnson’s first visit to Stony Brook following her appointment in September 2017.

Devinder Mahajan, PhD, a professor of chemical engineering, graduate program director in the Materials Science and Chemical Engineering Department, and expert and accomplished researcher in advanced clean energy technologies, with will serve as Director of the Institute.

“I-GIT embodies three of the four themes I spoke of at my first State of the University System address: innovation, sustainability and partnership,” Chancellor Johnson said. “This institute is a strategic partnership between Stony Brook University and National Grid for research and development of sustainable energy usage innovation, but the Institute doesn’t stop there. All parties are coming to this venture with an open mind to what can be accomplished for the communities we serve, the researchers, faculty and students who will come through these doors, and future partnerships. Congratulations to Stony Brook and the community. We couldn’t be prouder to be a part of this exciting opportunity.”  

During the ribbon-cutting ceremony, President Stanley thanked Chancellor Johnson for her continued support.

“Stony Brook’s outstanding faculty is happy to collaborate with partners at SUNY and not only work with the energy center, but work across the campus to bring other disciplines involved to address key issues in gas research,” President Stanley said. “Thank you, Chancellor Johnson, for your leadership. We look forward to working with you and watching the consortium grow.”

The University has partnered with National Grid, one of the largest investor-owned energy companies in the world, to launch I-GIT. National Grid serves communities in Massachusetts, New York, Rhode Island and the United Kingdom, and it boasts robust policies and programs focused on environmental protection. Sustainability plays a key role in the company’s values and decision making.

“As a leading clean energy company, National Grid is proud to be a founding partner of the Institute, which will support clean gas technology development and deployment for homes and businesses through academic-industry collaboration,” said Ken Daly, President of National Grid New York. “The consortium’s innovative approach will help provide our customers and the local communities that we proudly serve with a 21st century clean energy economy.”

National Grid is sponsoring a research project to be developed by the consortium that includes a review of energy usage data. The data will be used to identify new methods to improve gas energy efficiency and safety.

I-GIT is focused on finding clean, affordable energy solutions to meet the nation’s growing energy demands and challenges. It will also serve as an independent source of information and analysis on gas technology and related policies, and support advanced concepts in gas technology development and deployment for homes and businesses.

The Institute is overseen by an advisory board of University researchers and leaders from founding organizations, including National Grid. Devinder Mahajan, a professor of chemical engineering and graduate program director in the Materials Science and Chemical Engineering Department in Stony Brook’s College of Engineering and Applied Sciences, and an expert in natural gas technology, will serve as director of the Institute.

“The establishment of the Institute comes at a crucial time as global gas supplies are now projected to last over 200 years at the present rate of consumption,” Mahajan said. “Natural gas burns cleanly because its principal component, methane, contains 25 percent hydrogen by weight. This large amount of hydrogen contributes greatly to the hydrogen economy. By adding renewable gas or other technologies to the mix, the hydrogen content will further increase, which is central to the Institute’s commitment to promoting ‘decarbonizing’ fuels.”

The formation of I-GIT comes on the heels of SUNY’s participation in the newly formed University Climate Change Coalition (UC3), announced Feb. 6 during a higher education summit on climate change, at which President Stanley was a featured speaker representing the SUNY system. Stony Brook University represents the 64 institutions of SUNY in the UC3, which comprises 13 leading research universities in the U.S., Canada and Mexico.

“[SUNY] has some of the largest energy demands of any system in the country, and so we’re very interested in being a part of this coalition. We believe that research universities are the place that can tackle these kinds of issues,” President Stanley said during remarks at the summit. “We have the diversity and multidisciplinary approaches to help us find those technical solutions. The partners that have been brought together as part of this coalition have both the innovative approaches and the scope and scale needed to really make a difference in our world.”

The goal of the coalition is to aid local communities in the transition to a low-carbon, eco-friendly lifestyle. To achieve this, each participating institution will hold a climate change forum, and the findings from each will be compiled to create a cohesive, international plan of action. The member institutions have already committed to lessening the carbon footprint of their campuses.

These initiatives are a continuation of the sustainability efforts already taking place at Stony Brook.

The University is in the process of improving its energy efficiency performance by 20 percent and reducing its greenhouse gas emissions by 30 percent. Over the past three years, the University has replaced all of its oil-fired boilers with more efficient gas-fired units not only to improve efficiency but also to reduce hazardous air pollutants. Stony Brook is also working toward sub-metering all of the buildings on campus, allowing for more precise energy use data. Similarly, I-GIT plans to focus on more advanced, safer methods of gas metering.

In addition, Stony Brook is a major sponsor participant in the 10th Advanced Energy Conference being held March 26–28 in Manhattan. This year’s theme, “The Future of Energy is Here,” will celebrate the ways that research and development in renewables, batteries and other technologies have become a vibrant part of our economy.

Stony Brook’s ongoing sustainability research, coupled with the achievements of AERTC, make the University a natural fit for the Institute, President Stanley said.

— By Melissa Arnold

Oct 20

This is an oldie that I sent to you before (effective date was 1/1/17), but it bears repeating:

All NIH-funded clinical investigators and clinical trial staff who are involved in the design, conduct, oversight, or management of clinical trials must be trained in Good Clinical Practice (GCP).

Reminder as to NIH's definition: A clinical trial is defined by NIH as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

The great news is that our CITI GCP course satisfies this requirement, with a refresher needed every 3 years.

Oct 20

NEW: NIH's Policy on Certificates of Confidentiality (CoC) has been revised ​​

OK, this one became effective on 10/1/17 (Sunday) but actually applies to all research that commenced or was ongoing on or after December 13, 2016. ​

In a nutshell:

· CoCs are issued automatically when research is conducted or supported by NIH and falls within the scope of the NIH policy.

· Research that is not funded by NIH (non-NIH research) may still have the protections afforded by CoCs through successful application ​ (as before) to the NIH, FDA, or other authorized Federal agencies or departments. ​

When CoC's are issued (automatically or by application) the person(s) engaged in the research must not disclose or provide the name of a subject or any information, document, or biospecimen that contains identifiable, sensitive information about the subject and that was compiled for the purposes of the research:

1. In any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding, unless the disclosure is made with the consent of the individual to whom the information, document, or biospecimen pertains; or

2. To any other person not connected with the research, unless:

          a. Required by Federal, State, or local laws (e.g., adverse event reporting to the FDA, transmissible disease reporting required under State law), but excluding proceedings as described in “1” above;

          b. Necessary for the medical treatment of the subject to whom the information, document, or biospecimen pertains and made with the consent of the subject;

          c. Made with the consent of the individual to whom the information, document, or biospecimens pertains; or

          d. Made for the purposes of other scientific research that is in compliance with applicable Federal regulations governing the protection of human subjects in research.

​But, what exactly is identifiable, sensitive, information? Those of you who have CoC's know that it USED to protect to information obtained from subjects that could get them in legal etc. trouble (drug use etc.). NOW, the definition is: ​"information that is about an individual and that is gathered or used during the course of biomedical, behavioral, clinical, or other research and

1. Through which an individual is identified; or

2. For which there is at least a very small risk, as determined by current scientific practices or statistical methods, that some combination of the information, a request for the information, and other available data sources could be used to deduce the identity of an individual.​"​​

​Yes, it's true. ​We are going to need some guidance from NIH on a lot of what I just told you, and we will keep you informed accordingly. Here's the notice of changes from NIH:​.


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