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Certificate of Confidentiality (CoC)

Notice/Policy:  https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-109.html

Summary: Effective October 1, 2017 CoCs will be issued automatically for any NIH-funded project using identifiable, sensitive information that was on-going on/after December 13, 2016

  • The CoC will be issued as a term and condition of award
  • There will be no physical certificate issued

To determine if this Policy applies to research conducted or supported by NIH, investigators will need to ask, and answer the following question:

  • Is the activity biomedical, behavioral, clinical, or other research?

If the answer to this question is no, then the activity is not issued a Certificate. If the answer is yes, then investigators will need to answer the following questions:

  • Does the research involve Human Subjects as defined by 45 CFR Part 46?
  • Are you collecting or using biospecimens that are identifiable to an individual as part of the research?
  • If collecting or using biospecimens as part of the research, is there a small risk that some combination of the biospecimen, a request for the biospecimen, and other available data sources could be used to deduce the identity of an individual?
  • Does the research involve the generation of individual level, human genomic data?

If the answer to any one of these questions is yes, then this Policy will apply to the research

Certificate of Confidentiality Assurance Template (required as a part of the CoC application)

https://humansubjects.nih.gov/coc/assurance-template

Suggested Language regarding CoC for Consent Document: (https://humansubjects.nih.gov/coc/suggested-consent-language )

Suggested consent language:

This research is covered by a Certificate of Confidentiality from the National Institutes of Health. The researchers with this Certificate may not disclose or use information, documents, or biospecimens that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other action, suit, or proceeding, or be used as evidence, for example, if there is a court subpoena, unless you have consented for this use. Information, documents, or biospecimens protected by this Certificate cannot be disclosed to anyone else who is not connected with the research except, if there is a federal, state, or local law that requires disclosure (such as to report child abuse or communicable diseases but not for federal, state, or local civil, criminal, administrative, legislative, or other proceedings, see below); if you have consented to the disclosure, including for your medical treatment; or if it is used for other scientific research, as allowed by federal regulations protecting research subjects. 

[Use the following language as applicable] The Certificate cannot be used to refuse a request for information from personnel of the United States federal or state government agency sponsoring the project that is needed for auditing or program evaluation by [THE AGENCY] which is funding this project or for information that must be disclosed in order to meet the requirements of the federal Food and Drug Administration (FDA).  You should understand that a Certificate of Confidentiality does not prevent you from voluntarily releasing information about yourself or your involvement in this research. If you want your research information released to an insurer, medical care provider, or any other person not connected with the research, you must provide consent to allow the researchers to release it.

[language such as the following should be included if researcher intends to disclose  information covered by a Certificate, such as potential child abuse, or intent to hurt self or others in response to specific federal, state, or local laws.] The Certificate of Confidentiality will not be used to prevent disclosure as required by federal, state, or local law of [list what will be reported, such as child abuse and neglect, or harm to self or others]. 

[language such as the following should be included if researcher intends to disclose information covered by a Certificate, with the consent of research participants.] The Certificate of Confidentiality will not be used to prevent disclosure for any purpose you have consented to in this informed consent document [restate what will be disclosed, such as including research data in the medical record].

** Please note that information listed here is subject to change based on additional guidance by NIH. Please continue to monitor this page for additional/updated guidance from NIH.**

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Single IRB (sIRB) Policy for Multi-site Research

Single IRB Policy: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-094.html

Frequently Asked Questions on Use of a Single IRB for Multi-Site Research Costs: https://osp.od.nih.gov/clinical-research/nih-policy-on-the-use-of-a-single-irb-for-multi-site-research-faqs-on-costs/

Frequently Asked Questions on Implementation of the Single IRB Policy: https://osp.od.nih.gov/clinical-research/implementation-of-the-sirb-policy/

For applications with due dates on or after January 25, 2018, and contract solicitations published on or after January 25, 2018, NIH expects that all sites participating in multi-site studies, which involve non-exempt human subjects research funded by the NIH, will use a single Institutional Review Board (sIRB) to conduct the ethical review required for the protection of human subjects.

This policy applies to the domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research. It does not apply to career development, research training or fellowship awards. Implementation of the NIH sIRB policy is expected to reduce unnecessary administrative burdens and systemic inefficiencies while maintaining appropriate human subjects protections.

Applicants will be expected to include a plan for the use of a sIRB in the grant applications and contract proposals they submit to the NIH (for due dates on or after January 25, 2018).

The NIH single IRB policy applies to the domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program.

The NIH single IRB policy does not apply to studies conducted under career development, research training or fellowship awards. Under the policy, “multi-site” is defined as two or more sites. Foreign sites participating in NIH- funded, multi-site studies will not be expected to follow this policy.

The NIH single IRB policy applies to multi-site human subjects research regardless of the funding mechanism (e.g., grants, cooperative agreements, contracts or other mechanisms such as Cooperative Research and Development Agreements (CRADAs), and Interagency Agreements (IAA)). The policy applies whether the sites are subawards to a primary award recipient or separate awards are made for participating sites. The NIH Single IRB policy does not apply to Other Transaction Agreements (OTAs).

** Please note that information listed here is subject to change based on additional guidance by NIH. Please continue to monitor this page for additional/updated guidance from NIH.**

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Please remember to download the expanded guidance document linked on the right side of this webpage. The expanded guidance document outlines the following items:

NIH Revisions to the Policies on Definition of a Clinical Trial 

  1. Revised NIH Definition of Clinical Trial
  2. Determination If Your Human Subject’s Research Study Meets the Revised NIH Definition of a Clinical Trial?
  3. Good Clinical Practice (GCP) Training
  4. Data and Safety Monitoring of Clinical Trials
  5. Dissemination of NIH-Funded Clinical Trial Information

** Please note that information listed here is subject to change based on additional guidance by NIH. Please continue to monitor this page for additional/updated guidance from NIH.**

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Policy on requests for letters of support to the Chancellor, Provost, and Vice Chancellor for Research and Engagement

RE: Policy on requests for letters of support to the Chancellor, Provost, and Vice Chancellor for Research and Engagement

This memo outlines a new policy for faculty requesting letters of support on proposals that do not involve formal resource commitments or cost sharing (If resource commitments are required, please refer to our cost sharing policies here or write to vcre@umass.edu for more information).

For letters of support for fellowships and sponsored research grants, please submit requests with a draft letter at least 5 business days prior to the day it is due to our Office of Grants & Contracts for their review.  This will allow the necessary time needed to evaluate, ask for additional information, edit, and return the signed letter. All requests should include a scope of work and endorsement of the unit’s Associate Dean for Research or equivalent. We will not be able to sign support letters if the above criteria are not met.

Please send all requests for the Chancellor and VCRE to vcre@umass.edu. All requests to the Provost should be sent to provost@provost.umass.edu.

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