Frequently Asked Questions

Certificate of Confidentiality FAQs

Any clinical trial that meets the below definition:

A Certificate of Confidentiality helps researchers protect the privacy of human research participants enrolled in biomedical, behavioral, clinical and other forms of sensitive research. Certificates protect against compulsory legal demands, such as court orders and subpoenas, for identifying information or identifying characteristics of a research participant.

As of October 1, 2017 a Certificate of Confidentiality became a term and condition for NIH grant awards that commenced or were ongoing after December 1, 2016. Any NIH-sponsored research that collects identifiable data or biospecimens or generates human genomic data automatically receives a Certificate.

In addition, any research project that collects personally identifiable, sensitive information and that has been approved by an IRB is eligible for a Certificate. NIH or federal funding is not a prerequisite for a Certificate.

Sensitive information includes (but is not limited to) information relating to sexual attitudes, preferences, or practices; information relating to the use of alcohol, drugs, or other addictive products; information pertaining to illegal conduct; information that, if released, might be damaging to an individual's financial standing, employability, or reputation within the community or might lead to social stigmatization or discrimination; information pertaining to an individual's psychological well-being or mental health; and genetic information or tissue samples.

As of October 1, 2017 a Certificate of Confidentiality became a term and condition for NIH grant awards that commenced or were ongoing after December 1, 2016. Any NIH-sponsored research that collects identifiable data or biospecimens or generates human genomic data automatically receives a Certificate.

In addition, any person engaged in research in which sensitive information is gathered from human research participants (or any person who intends to engage in such research) may apply for a Certificate of Confidentiality. NIH issues these certificates at its own discretion.

Individuals who participate as research subjects (i.e., about whom the investigator maintains identifying information) in the specified research project during any time the Certificate is in effect are protected permanently.

If your research is not supported with NIH funding, you may apply for a Certificate through the NIH Institute or Center (IC) funding research in a scientific area similar to your project. Contact information is available on the NIH website:

As of October 1, 2017 a Certificate of Confidentiality became a term and condition for NIH grant awards that commenced or were ongoing after December 1, 2016. Any NIH-sponsored research that collects identifiable data or biospecimens or generates human genomic data automatically receives a Certificate.

If you do not have NIH funding, an application for a Certificate of Confidentiality should be submitted to the Einstein IRB after the Institutional Review Board (IRB) responsible for its review approves the research project (because IRB approval or approval conditioned upon issuance of a Certificate of Confidentiality is a prerequisite for issuance of a Certificate). Since the informed consent form should include language describing the Certificate and any voluntary disclosures specified by the investigator, the Applicant could tell the IRB that they are applying for a Certificate of Confidentiality and have included appropriate language in the informed consent form. Applications for Certificates should be submitted at least three months prior to the date on which enrollment of research subjects is expected to begin.

When a researcher obtains a Certificate of Confidentiality, the subjects must be told about protections afforded by the Certificate and any exceptions to those protections - i.e., the circumstances in which the investigators plan to disclose, voluntarily, identifying information about research participants (e.g., child abuse, harm to self or others, etc.). This information should be included in the informed consent form unless a research subject is no longer actively participating in the project so amendment of the informed consent would be impractical The researchers should eliminate provisions in consent form templates that may be inconsistent with the Certificate protections (such as references to disclosures required by law, since the Certificate enables researchers to resist disclosures that would otherwise be compelled by law). In addition, researchers may not represent the Certificate as an endorsement of the research project by the DHHS or use it in a coercive manner when recruiting subjects.

The Einstein IRB consent template has the following language:

As a way to protect your privacy, we have obtained a Certificate of Confidentiality from the National Institutes of Health, which is funding this study. If information from this study was requested or subpoenaed by government agencies or the courts, we will use the Certificate to attempt to legally refuse to provide it. This is rare – in only a few cases did researchers have to use the Certificate, and it was honored most of the time, but not every time. There are several kinds of situations that the Certificate does not apply. For example, we are still required to report child abuse and some diseases, and we must make data available to the government for a review or evaluation of our research. The Certificate does not prevent you or a member of your family from voluntarily sharing information. Similarly, if an insurer, employer, or other person obtains your written consent to receive research information, then the researchers may not use the Certificate to withhold that information.


Certificado de confidencialidad Con el fin de proteger su privacidad, hemos obtenido un certificado de confidencialidad de los Institutos Nacionales de la Salud de los Estados Unidos (National Institutes of Health), que es la que financia este estudio. Si la información de este estudio fuera solicitada u ordenada por una orden judicial por las agencias del gobierno o las cortes, usaremos este certificado para legalmente negarnos a proporcionar tal información. Esto es una situación poco probable solamente en unas pocas ocasiones, los investigadores tuvieron que usar el certificado, y se respetó la mayor parte del tiempo, pero no siempre. Existen varios tipos de situaciones en las que el certificado no es aplicable. Sin embargo, se nos exige, por ejemplo, denunciar abuso infantil y algunas enfermedades, y debemos poner a disposición del gobierno la información para un análisis o una evaluación de nuestra investigación. El certificado de confidencialidad no le impide a usted o a un familiar suyo compartir información de manera voluntaria. De manera similar, si una compañía de seguros, empleador u otra persona obtiene su autorización por escrito para recibir información sobre la investigación, entonces los investigadores no pueden usar el certificado de confidencialidad para no entregar esa información.

No, as long as this is the only update that you are making.


No. Certificates of Confidentiality offer an important protection for the privacy of research study participants by protecting identifiable health information from forced disclosure (e.g., by court order). While the Privacy Rule does establish protections for covered entities’ use and disclosure of PHI, it permits use or disclosure in response to certain judicial or administrative orders. Therefore, researchers/contractors may obtain Certificates of Confidentiality to protect them from being forced to disclose information that would have to be disclosed under the Privacy Rule.

According to NIH, it generally requires that state reporting requirements be followed, and that Certificates of Confidentiality generally will not exempt reporting in accordance with state law. Researchers should notify public health authorities regarding all reportable diseases and conditions ( For additional information on NIH’s policy on reporting communicable diseases, see

As a policy matter, NIH generally is unwilling to issue a Certificate of Confidentiality that exempts reporting of child abuse. In addition, Section 413 of the New York State Social Services Law requires that suspected or actual instances of child abuse be reported to the appropriate authority. To date, it does not have similar policies on reporting of elder abuse or spouse abuse. Should you obtain a Certificate of Confidentiality for either spouse abuse or elder abuse, in the unlikely event you become aware of threatened or actual abuse which has not already been reported, contact the Einstein IRB for additional directions. Instances or suspected instances of child abuse always need to be reported to the New York State Child Protective Services Office ( FAQs

Any clinical trial that meets the below definition:

If your study is NIH funded:

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.

If your study contains an FDA drug, biologic or device:

  • Trials of drugs and biologics: controlled clinical investigations, other than Phase 1 investigations, of a product subject to FDA regulation.
  • Trials of biomedical devices: controlled trials with health outcomes of devices subject to FDA regulation, other than small feasibility studies, and pediatric post-market surveillance.

It is always better to register your study if you are not sure.

Event Timeline Notes
Registration Required: No later than 21 days after the first subject is enrolled
ICMJE Requirement: Registration must be completed prior to first subject enrollment.
A study is considered registered once the responsible party releases the record to PRS for review.
Actively enrolling studies Recommended: Update/verification every 6 months The record must be verified even if no changes need to be made.
Actively enrolling studies, studies closed to enrollment or pending results Required: Update/verification annually The record must be verified even if no changes need to be made.
Change in study status Required: Within 30 days of status change  

Education and Training FAQs

Required training is listed on our Training and Education page.

If you would like to merge two learner accounts, please send an e-mail to and include the following information:

  • Your first and last name.
  • The name of your institution.
  • The username or Member ID for the account to keep.
  • The username or Member ID for the account to merge.

For further assistance please contact the CITI Program help desk at (888) 529-5929 or

Good Clinical Practice (GCP) is the standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials or studies that provides assurance that the data and reported results are credible and accurate, and the rights, integrity, and confidentiality of trial subjects are protected. GCP follows the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and includes protection of human rights for the subjects and volunteers in a clinical trial. It also provides assurance of the quality, reliability, and integrity of the data collected. GCP enforces tight guidelines to ensure that clinical research adheres to the ethical codes governing research.

Effective January 1, 2015, all Montefiore, Einstein and PAGNY employees who participate in clinical research (including faculty investigators) must have certification of completion of GCP training in order to submit a protocol to the IRB for review and approval – and reapproval.

  • Effective January 1, 2017, all Montefiore, Einstein and PAGNY employees who participate in clinical research must have certification of completion of GCP training that has been taken or renewed within the past three years in order to submit a protocol to the IRB for review and approval. This was changed from our previous renewal requirement of 5 years in response to a recent NIH policy on clinical trials ( As a result, if you completed the CITI GCP course prior to January 1, 2017 the 5 year expiration date noted on your completion report is no longer valid and the new expiration date is now 2 years earlier.
  • Effective January 1, 2017, all investigators and clinical trial staff (individuals, identified by the investigator, who are responsible for study coordination, data collection and data management) on NIH-funded clinical trials must complete GCP training. 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.
  • Do you have an NIH-funded clinical trial that does NOT involve drugs or devices that was submitted to the Einstein IRB prior to January 1, 2017?
    Please contact the Einstein IRB for guidance on submitting an amendment to update your IRB application so GCP requirements may be automatically checked by the Einstein IRB.

Log into your existing CITI account, click “Add Course or Update Learner Groups”, choose “Yes” to question #3, scroll to the end and click “Submit”. Under your course list on the Main Menu, you’ll now have a “GCP” course available, consisting of 14 modules.

  • To add the refresher course: Under Question 3, select "Yes, I would like take the Refresher GCP course (I previously completed the Initial GCP course at Einstein. NOTE: Completion of this course does NOT satisfy the Human Subjects Education requirement.)"

No. Human Subjects Research training is a separate module that provides “basic training” regarding the ethical aspects of clinical research. If your project involves the treatment or study of human subjects as described above, you will need this additional GCP certification.

Every 3 years

What GCP Courses/Programs Satisfy The Requirement?
  • Collaborative Institutional Training Initiative (CITI);
  • Academy of Physicians In Clinical Research (APCR);
  • FDA Investigator Course;
  • TransCelerate Biopharm, Inc. approved courses;
  • National Institute of Allergy and Infectious Disease (NIAID) Program;
  • GCP courses offered by ACRP or SOCRA.

As long as your “preferred” email address in CITI matches your email address in iRIS, and you have taken the GCP course while affiliated with Einstein, we will receive automatic notification from CITI.

The Einstein IRB offers a selection of seminars and workshops for small to large groups upon request. We also have tutorial videos on our OHRA Training & Educational Videos page (access to this page is restricted to Montefiore Einstein employees; you will need to enter your MMCAD credentials to log in).

Informed Consent FAQs

It is a new regulatory requirement under the Revised Common Rule that potential subjects be first presented with "a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension." The Full Board (Greater than Minimal Risk) and Expedited (Minimal Risk) consent templates available on our website have the Key Information Section already integrated.

Full Board and Expedited studies approved after 1/20/2019 are all required to include a Key Information Section, unless:

  • Your study is MINIMAL RISK [expedited]


  • Your consent form is five pages or shorter (including the Signature blocks).

The key Information Section is required for all studies submitted after 12/15/2018 for FULL BOARD review and after 12/20/2018 for EXPEDITED review.

No. If your study is MINIMAL RISK (expedited) and your consent form is five pages or shorter (including the Signature blocks) the new Key Information section is not required.

The new section has been required for all studies approved by Full Board or Expedited review after 1/20/2019. Studies that received Full Board review prior to 1/20/2019, but did not receive final IRB approval until after 1/20/2019 are also subject to this requirement.

The Key Information Section is required for all studies submitted after 12/15/2018 for Full Board Review and after 12/20/2018 for Expedited review.

Any study that received final IRB approval prior to 1/21/2019 will not need to amend its consent documents to meet this requirement.

Not verbatim. The intent of the rule is to consider what key information a potential subject would need to know up front. It is the most important information that would influence a potential participant to say "yes" and the most important thing that would influence a potential participant to say "No" to participation. This allows the individual to weight the key pros and cons of volunteering early in the process.

In some cases it will be, but it depends. The most significant deterrent could be a serious potential risk or a number of benign but unpleasant risks. In other cases, it may be merely inconvenience. the key reason to participate could be a personal gain or to help advance science. A proven alternative treatment may be considered more advantageous than an experimental treatment. The most influencing factor could be the implication of the risk. A breach of confidentiality may have minor repercussions for a survey study, while the same occurrence with genetic testing could affect family planning. The idea is not to present all considerations first, but start with the most influential pros and cons to participation.

The choice may be based on the investigator's experience with the study population. Support groups or associations may provide insight into participant perceptions. you may also search for empirical research (e.g., Participant perception of risks and benefits of genetic research; or Participant perceptions on data sharing). The patient-centered and participant-centered movements have prompted considerable research on subject perceptions of research consent.


IRB review is required for research involving human subjects.

Yes. Only the IRB can make a determination of exemption.

The FDA has a broad definition of research: Any experiment that involves a test article (drug, biologic, device or diagnostic test) and one or more human subjects, and that meets any one of the following:

  • any use of a drug other than the use of an approved drug in the course of medical practice
  • any activity that evaluates the safety or effectiveness of a device or diagnostic test
  • any activity the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit

All other research at Montefiore Einstein is under the HHS definition (45 CFR 46.102(3)): Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

The FDA also has a broad definition of human subject: An individual who is or becomes a subject in research, either as a recipient of the test article (drug, biologic, device or diagnostic test) or as a control. A subject may be either a healthy human or a patient. A human subject includes an individual on whose specimen (identified or unidentified) a medical device is used.

All other research at Montefiore Einstein is under the HHS definition (45 CFR 46.102(3)): A living individual about whom an investigator obtains:

  • data through intervention or interaction with the individual, or
  • identifiable private information.

Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. The Einstein IRB considers all private information that contains any of the 18 HIPAA identifiers to identifiable private information.

HIPAA IDENTIFIERS (most common in bold pink)

  • Patient Names
  • Geographical elements (such as street address, city, county or zip code)
  • Dates related to the health or identity of individuals (including birthdates, date of admission, date of discharge, date of death, or exact age of a patient older than 89)
  • Telephone numbers
  • Fax numbers
  • Email addresses
  • Social security numbers
  • Medical record numbers
  • Health insurance beneficiary numbers
  • Account numbers
  • Certificate/license numbers
  • Vehicle identifiers
  • Device attributes or serial numbers
  • Digital identifiers, such as website URLs
  • IP addresses
  • Biometric elements, including finger, retinal, and voiceprints
  • Full face photographic images
  • Other identifying numbers or codes

Your submission will be rejected by iRIS due to education failure. You will need to remedy the situation, withdraw the submission, then resubmit.


Logging In To iRIS

iRIS is compatible with most browsers. The preferred browsers are: Internet Explorer 9.0+ and Safari 6.0+. Chrome (30.0+) and Firefox (24.0+) are also supported. Browser notes:

  • Internet Explorer (all versions): To ensure all (external) links work: Go to "Tools > Internet Options > Security (tab) > Internet > Custom Level > Scroll down to the "Display Mixed Content" option in "Miscellaneous" section > Enable > OK > OK"
    Note: Users at Montefiore whose computers only have IE 8.0 or earlier may contact the EHIT helpdesk to request that Firefox be installed on their computers.
  • Firefox (all versions): To ensure all (external) links work: Type "about:config" in the address bar. Click "I'll be careful, I promise!" On the search menu, type "mixed". Change the value of "security.mixed_content.block_active_content" to "false".
  • Internet Explorer 7.0 and 8.0: There is a known incompatibility that affects users at Montefiore.
  • Internet Explorer 10.0+: If you encounter problems, try compatibility mode.
  • Safari: Built in pop-up blockers prevents various windows from loading (with no warning). Disable the pop-up blocker (instructions) or use another browser.

An internet browser is the program you use to access web pages (typical examples include Internet Explorer, Firefox, Safari, etc.).

You must log into iRIS with MMCAD credentials. After logging in the first time, email the following information to to have your iRIS account activated:

  • Your full name
  • MMCAD username
  • Institution (e.g. Einstein, Montefiore or NBHN)
  • Academic department (and for the Department of Medicine, division name)
  • Status (e.g. faculty, staff, or student)

Generally Einstein faculty, Einstein employees, Einstein students and Montefiore affiliates already have MMCAD accounts. An MMCAD account is the Montefiore Einstein user ID used to access Kronos, Banner, Montefiore email, Montefiore portal, or EPIC.

If you've confirmed you have an MMCAD username but don't know your password, contact the Montefiore Einstein service desk at 914-881-4554.

If you have an Montefiore Einstein email address, you may change your password by contacting the Montefiore Einstein service desk at 914-881-4554. Contractors and volunteers with MMCADs should also contact the Montefiore Einstein service desk for password changes.

Einstein and Montefiore employees, faculty, students and affiliates must use their institutional emails, you may not change the email address in your account. For all other users, you may contact the Montefiore Einstein service desk at 914-881-4554 to request that they open a ticket with IT Security to update your email address in the 'email' attribute field. After the service desk reports that your email address has been updated, you'll need to log into iRIS to have the update reflected there.

You will need to obtain an MMCAD username. Email to request an MMCAD. Please note requests typically take 5-10 business days to process.

  • If you are a faculty member, researcher, or an employee of Montefiore, you do not need to request a user ID for iRIS. Use your Montefiore user ID and the password you use for EPIC or Montefiore Email. Once you have logged in, email your department/division name and your request for account activation to
  • If you are an Einstein staff member or student, you DO NOT need to request a user ID for iRIS. Einstein staff and students can login using their Einstein user ID and password. Staff members should use the user ID and password used to login to Kronos or Montefiore Portal. Once you have logged in, email your academic department/division name and your request for account activation to

**If the sections above do not apply to you e-mail for further instructions.

General iRIS FAQs

The iRIS handbooks are available for download by clicking the "Help" link in the upper-right corner of iRIS (after logging in).

If you're using Internet Explorer, you will need to make the following change in your IE security settings in order for our external links to work: "Tools > Internet Options > Security (tab) > Internet > Custom Level > Scroll down to the "Display Mixed Content" option in "Miscellaneous" section > Enable > OK > OK." If you encounter this problem in another browser, contact us.

Submissions to iRIS

IRB #s are assigned once an application is started and are visible in the top-left corner of the screen. The format is YYYY-NNNN (4-digit year followed by a 4-digit number).

Project Contact (in addition to KP) Delegates >N/A
Reportable Event Adverse Event  
Reportable Event Deviation  

You can always check the status of your protocol by clicking on the “My Studies” link in iRIS. Refer to page 46 of the Researcher’s Handbook (available for download from the iRIS help menu) for further guidance. However, there are three things that must happen before your protocol is received by the IRB:

  • All designated signatories (usually the PI and his/her department chair) must approve the application. They will need to log in to iRIS to do so. Please note that the application does not need to be sent to Other Investigators or Research Support Staff.
  • All Investigators must have an electronic COI disclosure on file.
  • All KP must satisfy the human subjects research education requirement.

To see the education history and e-mail addresses for all KP on the study follow these instructions:

  • To find the study, log in to iRIS, click on Study Assistant (on the left side of the screen), then on My Studies.
  • Select your study by clicking on the notebook icon on the left under "Click to open."
  • Click on "study mgmt." in the "Navigation" section of the header.
  • Click on the Study Management tab (on the upper left).
  • Click on Study Summary/Profile.
  • Click on the head icon next to each study personnel. The CITI status is under Education History. If the Education History is blank or only has expired courses, the KP will NOT pass the CITI check in iRIS.

Note that CITI status is synchronized via the e-mail address in iRIS (which is imported directly from MMCAD). The e-mail address is under Contact Information on this page. Click the “Back” button (upper right) to return to the Study Summary/Profile page.

Note that CITI status is checked for all study personnel unless they are ONLY listed as Study Contacts.

Exempt and Expedited applications and their associated transactions are reviewed upon receipt. We have recently amended our practice so that full review submissions are now accepted on a rolling basis; there are no more deadlines. Once submitted, your submission will be reviewed by an IRB analyst for regulatory compliance within 7-10 days.

iRIS uses electronic signatures. Upon completing your application you'll need to route it for approval to the PI and other appropriate individuals (see here for a complete list). Detailed instructions are available in the researcher handbook (available for download within iRIS) beginning on page 43.


All project materials (consent forms, protocols, advertisements, etc.) must be attached to an appropriate transaction in iRIS.

Informed Consent Documents (ICDs)

Templates incorporating HIPAA Authorization are available within iRIS, as well as on our Forms and Templates page.

Progress Reports (PRs)

Any and all changes to the Application/Protocol must be done through an Amendment.

If you've previously completed a PR in iRIS, you can access it through iRIS.


You should not begin an amendment until your initial submission is approved.

An amendment is required.

Didn’t find an answer you were looking for? Email!