Compliance

Certificates of Confidentiality

The National Institutes of Health (NIH) and other Department of Health and Human Service (DHHS) agencies, including the Food and Drug Administration (FDA), issue Certificates of Confidentiality. A Certificate of Confidentiality allows an investigator and others who have access to research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level. Whether or not a Certificate of Confidentiality is necessary depends on the sensitivity of the research data and the potential impact it may have on participants should it be disclosed (e.g., potential damage to their financial standing, employability, insurability, or reputation).

  • Contact the IRB Office at IRB@creighton.edu if you have any questions or issues regarding Certificates of Confidentiality.

    Instructions for Certificate of Confidentiality Applications of Non-NIH Funded Research

    When your study needs a Certificate of Confidentiality and is not funded by the NIH, investigators must complete an online application process to obtain that Certificate of Confidentiality. Start by visiting the NIH Certificate of Confidentiality website and clicking on the appropriate selection from the "Select Your Funder" dropdown. From there, the NIH site will walk you through the application process.

    Application Information

    Please use the below information when completing the Certificate of Confidentiality application.

    • Creighton University Federalwide Assurance number is #00001078:
      • Biomedical Board: #IRB00000155
      • Social/Behavioral Board: #IRB00007137
    • Creighton University's Institutional Official (IO) is:
      • Juliane K. Strauss-Soukup. B.S. Ph.D.
        Associate Vice Provost for Research and Scholarship
        Creighton University
        2500 California Plaza,
        Omaha, NE 68178

    Obtaining Institutional Official Signature for Certificate of Confidentiality Assurance Document

    As part of the online Certificate of Confidentiality application process, the NIH requires a signed assurance document be uploaded along with the application. That assurance document can be created using the template language on the NIH website. This document should be created on departmental letterhead and include signature blocks for the Principal Investigator and the Institutional Official.

    To obtain the Institutional Official's signature for the assurance document, please send a request to IRB@creighton.edu containing electronic copies of the following items:

    • the assurance document for the Institutional Official's signature,
    • current notice of IRB approval (not required for FDA Certificate of Confidentiality applications),
    • all currently approved consent forms or scripts (not required for FDA Certificate of Confidentiality applications),
    • copy of the Certificate of Confidentiality application
    • and, if applicable, the DEA Certificate of Registration (not required for FDA Certificate of Confidentiality applications).
    • For FDA Certificate of Confidentiality applications, include a copy the application itself signed by the Principal Investigator.

    Signed assurances are typically returned within 3 business days.

    SEE ALSO:

    Common Rule Revisions

    The Federal Policy for the Protection of Human Subjects announced revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991. This final rule is intended to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. These revisions are an effort to modernize, simplify, and enhance the current system of oversight.

    This compliance date for this rule is effective on January 20, 2019.

    Read more below.

    Will This Affect Me as a Researcher?

    It is likely the Common Rule revisions will affect you in some way. The IRB Office is working to identify policies, procedures, applications as well as our standard operating procedures to see what needs to be modified and how to make these changes in accordance with the January 20, 2019 deadline.

    Here is a summary of the things we are working on and how they may affect your interactions with the IRB office. 

    In the meantime it would be good for you to familiarize yourself with the Revised Common Rule.

    What Are Some of the Major Changes?

    IRB Operations

    Single IRBs for multisite research ("cooperative  research?" (46.114))

    • Single IRBs generally required; however, some flexibility is provided in determining and documenting when a single IRB is not appropriate

    External IRBs (46.103)

    • Reliance arrangement with non-institutional IRB must be documented

    Checking the box (46.101)

    • Option for FWA holders to check the box has been eliminated

    Continuing review (46.109 & 46.115)

    • Continuing review of research is no longer required under various circumstances

    Informed consent

    New language/clarity (46.116)

    • Consent forms must be clearer and more focused; many changes added to emphasize that information provided must facilitate a potential subjects? understanding of why one would participate or not

    Basic and additional elements of informed consent (46.116)

    • New basic element on collection of identifiable private information or identifiable biospecimens; three new additional elements on commercial profit, return of clinically relevant research results and whole genome sequencing

    Broad consent  (46.111 & 46.116)

    • Broad consent is an option for storage, maintenance, and secondary research use of identifiable private information and identifiable biospecimens

    Recruitment/screening  waivers  (46.116)

    • Allows waiver of informed consent for subject recruitment or screening, under certain conditions

    Clinical trials consent forms (46.116)

    • Some clinical trials must post consent form online

    Electronic consent (46.117)

    • Electronic consent is ok; must provide written copy

    Legally authorized representatives (46.102)

    • If no law, institution can designate a representative

    Scope

    Definition: Research (46.102)

    • Defines what's NOT research: certain journalistic, public health surveillance, and criminal justice or intelligence activities

    Definition: Human subjects (46.102)

    • Includes "information or biospecimens" obtained from through intervention and interaction OR ?identifiable private information or identifiable biospecimens?

    Definition: Clinical trial (46.102)

    • Clinical trials are now specifically defined

    Definition: Identifiable biospecimen/identifiable private information (46.102)

    • Will be re-examined within one year and every four years after

    Definition: Vulnerable populations (46.111)

    • Pregnant women and "handicapped" removed; replaces "mentally disabled"  with "individuals with impaired decision-making capacity"

    Tribal law (46.101, 46.114, 446.116)

    • Tribal law applies where applicable; added throughout

    New guidelines for exemptions

    Additional exemptions for low-risk studies (46.104- see also 46.103, 46.109, 46.110, 46.111)

    • Exemptions added for secondary research on identifiable private information and identifiable biospecimens under various circumstances and regulatory requirements, such as limited IRB review and broad consent, may apply

    Compliance dates

    1 year (1/19/18), 3 years for multisite (1/20/20) (46.101)

    • Previous Rule applies to research approved prior to 1/19/18; new rule to approvals 1/19/18 or later
    Workflow for transitioning ongoing research

    Related Regulations and Resources

    Review Categories

    The three levels will include Exempt, Expedited and Full Committee Review with the addition of Not Human Subjects Research (or Quality Improvement). Read more about each review category below.

    Proposals are exempt from federal regulations, not from IRB review.  Exempt research poses no more than minimal risks (risk level similar to what is encountered in everyday activities) to subjects and proper procedures are used to implement ethical principles for the protection of human subjects. The IRB staff determines whether a research project will undergo an exempt review. As necessary, the chair or designee will consult with other IRB members when making this decision. The following types of research may fall into the exempt category:

    • Anonymous survey/interview procedures or observation (without intervention) of public behavior;
    • Survey/interviews in which the participant cannot be linked and information obtained is innocuous. Disclosure of this information would not reasonably place the participant at risk of criminal or civil liability or be damaging to the participants' financial standing, employability or reputation; and/or
    • A project using existing data or pathological specimens providing the information is recorded anonymously.

    The expedited review category is used for certain types of research involving no more than minimal risk, as well as for minor changes to research previously approved by the full committee during the period for which approval has been authorized. Proposals can be reviewed by one or more members of the University's IRB. Reviewers may refer the proposal to the full committee. The following types of research may fall into the expedited review category (See 45 CFR 46 for a more detailed description of OHRP Expedited Categories):

    • Surveys which can be linked to participant and may request "sensitive" information;
    • Blood draws; non-stressful research on individuals or group behavior;
    • A project using existing data or pathological specimens if the information recorded can be linked to participant
    • Recording of data using non-invasive procedures; and/or
    • Surveys which can be linked to participant and may request "sensitive" information.

    Any research not covered under the exempt or expedited review categories is referred to the IRB for full committee review. The Principal Investigator will be invited to attend the IRB committee meeting. The committee will either: (i) approve the research as written or pending specific minor changes; (ii) require modifications to secure approval; or (iii) table the research. The committee will notify the Principal Investigator in writing about the committee's decision. The following types of research may fall into the full committee review category:

    • Invasive medical treatments;
    • Physical or psychological risk;
    • Special populations (minors, pregnant women, prisoners, incompetent participants); and/or
    • Criteria for exempt or expedited review are not met.

    Any project that does not meet the definition of research usually are Quality Improvement Projects. The following types of research may fall into the Not Human Subjects Research category:

    • It has been determined that this project does not meet the definition of research under 45 CFR 46.102(d). IRB review is not required.
    • The project does not involve human subjects under 45 CFR 46.102(f). IRB review is not required.
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