Frequently Asked Questions

• ORRC
• IRB
• Research Integrity
• Compliance Programs

The Office of Regulatory Research Compliance operates as a facilitator, educator and as a resource center to help ensure that Howard University research activities are conducted with the highest legal and ethical standards.

National Institutes of Health (NIH)
A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

National Science Foundation (NSF)
A systematic application of knowledge toward the production of useful materials, devices, and systems or methods, including design, development, and improvement of prototypes and new processes to meet specific requirements.

Office for Human Research Protections (OHRP)
A systematic investigation designed to develop or contribute to generalizable knowledge.

Research may be conducted by any Howard University faculty, staff, or student. However, only a Howard University faculty member (or cabinet-level staff member in some cases) may be the Principal Investigator (PI) of a study.

An investigator is any person (regardless of title or position) who is responsible for the design, conduct, or reporting of a research study or project.

• Principal Investigator (PI): A faculty member (or cabinet-level staff member in some cases) who leads, oversees, and ensures the responsible conduct of a study.
• Co-Investigator (COPI): An individual who assists the PI with the design, conduct, reporting and other aspects of a study.
• Student Investigator (SI): An individual who conducts research under the guidance of a faculty mentor as part of an academic requirement (thesis or dissertation) or a non-faculty study.

The ORRC may be contacted by email at: theorrc@howard.edu or by phone at (202) 865-4957. 

The ORRC has oversight over the following compliance programs:

• Animal Care and Use
• Export Controls
• Financial Conflicts of Interest in Research
• Human Subjects Protection
• Laboratory Safety
• Radiation Safety
• Research Integrity
• Research Misconduct
• Research Protection
• Research Safety
• Research Security

Research integrity concerns may be sent to the Research Integrity Officer (RIO).

• The RIO may be contacted by email at: rio.orrc@howard.edu or by phone at (202) 865-4957

Research misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research or in reported research results.

1. Fabrication is making up results and recording or reporting them.

2. Falsification is manipulating research materials, equipment, or processes or changing or omitting data or results such that the Research is not accurately represented in the research record.

3. Plagiarism is appropriating another person’s ideas, processes, results, or words without giving appropriate credit, including those obtained through confidential review of other’s research proposals and manuscripts.

The Institutional Review Board (IRB) is a regulatory compliance committee responsible for reviewing and approving research involving human participants to ensure ethical standards are met. The primary goal of an IRB is to protect the rights and welfare of research participants by evaluating research protocols and related materials. This includes assessing the risks and benefits of the research, ensuring informed consent is obtained, and monitoring ongoing studies to maintain compliance with ethical guidelines. IRBs play a crucial role in maintaining public trust in scientific research by safeguarding participants from potential harm.

The Medical IRB Committee is generally charged with reviewing research applications that originate in the Health Sciences division along with research protocols that involve medical procedures, devices, and drugs.

The Non-Medical Committee typically reviews those research applications that originate from the Academic Affairs division along with research protocols that are generally socio-behavioral in scope.

A new study should be submitted to the IRB as soon as possible.

IRB Medical and Non-Medical Meetings rotate weekly. Supplemental or emergency meetings are scheduled if necessary. For a comprehensive schedule of IBC meetings and study submission deadlines, please see Meeting Schedule.

The three types of review processes are: Exempt, Expedited, Full Board Review. However, there are cases where studies may be reviewed for exclusion if the study does not meet the requirements to be considered “Research” and is proven to not involve human participants, animals, or biosafety concerns.

There are several criteria for research with human subjects that would make it qualify as “Exempt” under the 45 CRF Part 46.

For research to qualify as Expedited Review it must meet the federal definition of minimal risk, which is: "the probability and magnitude of harm or discomfort anticipated in the research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests" (Protection of Human Subjects 2017). If you are submitting for a Renewal/Continuation of your protocol with no modifications or modifications that do not increase risks to participants, this is considered as Expedite review. Expedite review does not mean “faster review”. Expedited Review information is under IRB-Human Participants, then click on Qualify for Expedited?

1. The A form should be completed for studies that include activities that pose greater than minimal risk to participants.  

2. The B form should be completed for studies that include accessing patient medical charts and other Private Health Information (PHI). 

3. The C form should be completed for studies that include activities that pose minimal risk to participants. The federal definition of minimal risk is: "the probability and magnitude of harm or discomfort anticipated in the research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests" (Protection of Human Subjects 2017). 

4. The D form is needed for studies that meet the criteria for exempt review. 

Make sure that you thoroughly read the IRB Outcome letter that was sent to you. It will provide details as to the determinations of the IRB and will contain the comments that you need to address to get Full Approval. The outcome letter will list a review category for your protocol. Here are the following outcomes: 

1. If you received “Full Approval”, no further action from your part is necessary. 

2. If you receive “Approved pending Administrative Review”, you MUST address the comments made by the IRB. These would be minor changes to the protocol that when made, do not need to be reviewed at a IRB meeting. 

3. If you receive “Tabled”, the IRB determined that major revisions are necessary to make final decisions on your protocol. You MUST address these comments so that your protocol can be reviewed by the next scheduled IRB meeting. 

4. If you received “Disapproved”, your protocol does not meet the requirements to comply with the Common Rule. A re-assessment of the entire submission is required. 

You MUST keep your letter of approval if you wish to publish your research. Many research journals will require an IRB approval letter. 

Submission timelines vary depending on the type of submission, complexity of the protocol, and the completeness of the submission. A submission can be reviewed within 72 hours or up to six weeks or more. The following gives an overview of typical timelines. [Link to IRB submission timeline]

The C-1 Form is the IRB application for minimal risk studies. The federal definition of minimal risk is: "the probability and magnitude of harm or discomfort anticipated in the research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests" (Protection of Human Subjects 2017).

All communication to the IRB should be sent to the ORRC. The ORRC will forward these communications to the IRB.

• The ORRC may be contacted by email at: theorrc@howard.edu or by phone at (202) 865-4957

• The Medical IRB may be contacted by email at: irb-medical.orrc@howard.edu

• The Non-Medical IRB may be contacted by email at: irb-nonmedical.orrc@howard.edu

The IACUC generally meets on the third Tuesday of every month. Supplemental or emergency meetings are scheduled if necessary. For a comprehensive schedule of IACUC meetings and study submission deadlines, please see Meeting Schedule.

All communication to the IACUC should be sent to the ORRC. The ORRC will forward these communications to the IACUC.

• The IACUC may be contacted by email at: iacuc.orrc@howard.edu. The ORRC should be copied by email at: theorrc@howard.edu

• The ORRC may be contacted by phone at (202) 865-4957

The IBC generally meets on the third Monday of every month. Supplemental or emergency meetings are scheduled if necessary. For a comprehensive schedule of IBC meetings and study submission deadlines, please see Meeting Schedule.

All communication to the IBC should be sent to the ORRC. The ORRC will forward these communications to the IBC.

• The IBC may be contacted by email at: ibc.orrc@howard.edu. The ORRC should be copied by email at: theorrc@howard.edu

• The ORRC may also be contacted by phone at (202) 865-4957

• A Central IRB is the IRB of record that provides the ethical review for all sites participating in more than one multi-site study. The sites are usually in a network, consortium or particular program.

• A Single IRB is the IRB of record, selected on a study-by-study basis, which provides the ethical review for all sites participating in a multi-site study.

Questions and concerns regarding reliance agreements can be forwarded to the ORRC.

• The ORRC may be contacted by phone at (202) 865-4957
• The ORRC may be contacted by email at: theorrc@howard.edu

Questions and concerns regarding material/data transfer agreements can be forwarded to the ORRC.

• The MTA committee may be copied by email at: mta.orrc@howard.edu. The ORRC should be copied on MTA communications by email at: theorrc@howard.edu
• The ORRC may also be contacted by phone at (202) 865-4957

Questions and concerns regarding export controls should be forwarded to the ORRC.

• The ORRC may be contacted by email at theorrc@howard.edu or by phone at (202) 865-4957

Yes. Howard University requires that all Principal Investigators/Project Directors (PIs/PDs) and key personnel proposing or receiving grants, contracts or cooperative agreements from the Public Health Service (PHS) and all other sponsors to disclose at least annually their outside interests related to any University responsibilities as requested on the Financial Conflict of Interest Disclosure (FCOID) form, attached hereto the content of which is subject to periodic review and change. The FCOID must be completed prior to submitting a grant proposal or a research compliance application, and with each continuation/renewal submission. When it comes to research, you must disclose financial conflict of interest. Howard University FCOI Policy.

All PHS sponsored research projects must follow PHS COI disclosure guidelines as described in 42 CRF Part 50, specifically, 42 CFR Part 50 Subpart F related to Promoting Objectivity in Research.

Clinical research must follow FDA COI disclosure guidelines as described in 21 CFR Part 54 related to Financial Disclosure by Clinical Investigators.

Questions and concerns regarding conflicts of interest can be forwarded to the ORRC.

• The ORRC may be contacted by email at theorrc@howard.edu or by phone at (202) 865-4957

iRIS (formerly iMedRIS) is an electronic compliance platform used by the University to increase research growth while reducing administrative burden and regulatory risks. This platform will be used to create and manage research protocols that require the review of the IRB, IBC, or IACUC. The platform will also be used to manage conflicts of interests (COI), Material/Data Transfer Agreements (MTA), and export controls.

Access to iRIS must be requested. You must fill out the Access Request Form and click submit. Within 2 business days the ORRC staff will create and configure your account in iRIS so that you may have full access to the system.

Please note that this Microsoft Form is only accessible to individuals with an active HU or Bison email address. In cases where an individual who needs to be added to a study does not have an active HU or Bison email address, contact the ORRC for further assistance.

The iRIS platform can then be accessed in four ways:

1. A link to the platform is provided on the ORRC website
2. In Microsoft 365 Online, search for “iMedRIS” and select the “iMedRIS - Prod” option under Apps.
3. From Access HU, search for “iMedRIS” and select the “iMedRIS - Prod” option.
4. IRIS may be directly accessed at http://hu.imedris.net/.

Please note that there is a Development (Dev) and Production (Prod) environment available for this platform. The Development environment is used for testing and training purposes ONLY. All submissions that will require review and approval must be submitted in the Production environment.

The Modification form is in iRIS, under Start a new Study Submission form:

1. Click on the All Studies tab
2. Click on Forms
3. Click on Modification form
4. Click on start a new submission
5. Select the type of modification
6. Complete the form and submit for review

Pending Signoff from an approver
Received by the review board Assigned to a review process
Assigned to a Meeting
Reviewer have completed review
Returned for correction
Approved

A document may be pulled from the review and approval process if it has not been assigned to a committee member for review. To Retract a submission:

1. Sign into iRIS then access study assistant workspace.
2. Scroll down to the Studies panel, and select the ALL tab.
3. Find the study that includes th submission that needs to be retracted.
4. Click on the Notebook Icon in the “Click to Open Study Dashboard” column.
5. In Outstanding Submissions section of the study dashboard, click on the “Retract Submission” button next to the submission that needs to be retracted.
6. Confirm the retraction by clicking the Confirm button.

New Study Submissions

As a Study Modification 

Questions and concerns regarding iRIS can be forwarded to the ORRC.
The ORRC may be contacted by phone at (202) 865-4957
The ORRC may be contacted by email at: theorrc@howard.edu
The ORRC hosts a virtual iRIS demonstration on Mondays at noon. In cases where a Monday falls on a holiday, the demonstration will take place the following available Monday. Access information to the iRIS demonstration can be found below.

Zoom Link: https://howard.zoom.us/j/86345250512?pwd=ZFAwOStjTTMra3ZXVkdvUytWUjJrdz09
Meeting ID: 863 4525 0512
Passcode: 33330765
One tap mobile: +13017158592,,86345250512# US (Washington DC)

The Collaborative Institutional Training Initiative Program (CITI) is a leading online training program maintained by the University of Miami. It offers curricula in human participants research, animal research, and the responsible conduct of research. Certificates of completion are provided to those who complete course modules within this training program. The CITI Program may be found at http://www.citiprogram.org.

All study personnel listed on a research study protocol, regardless of their position, must complete CITI modules related to the research. Investigators, research nurses, coordinators, students, technicians working with identifiable data, and faculty advisors would all need to obtain CITI certification.

Courses in modules that are the most appropriate for the type of research should be completed.

All study personnel must complete the following modules:

• Responsible Conduct of Research (Biomedical, Socio-Behavioral, Physical Science, Humanities, or Engineers)
• Conflicts of Interest
• Information Privacy and Security
• Export Controls

For human participant research related to biomedical sciences, the following modules must be completed in addition to the ones required by all study personnel:

• Responsible Conduct of Research (Biomedical)
• Human Subjects Research (Biomedical)
• Good Clinical Practice Clinical (only if the study is a clinical trial)
• Clinical research Coordinator (only for Clinical Research Coordinators)

For human participant research related to the humanities and social, humanistic, or behavioral sciences, the following modules must be completed in addition to the ones required by all study personnel:

• Responsible Conduct of Research (Socio-Behavioral, Physical Science, Humanities, or Engineers)
• Human Subjects Research (Socio-Behavioral)

For animal research, the following modules must be completed in addition to the ones required by all study personnel:

• Working with the IACUC
• Appropriate species-specific modules
• Aseptic Surgery (if aseptic surgery is involved in the study)
• Minimizing Pain and Distress (if the study includes the potential of causing more than momentary pain and distress to mice or rats)
• Antibody Production (if the study involves antibody production)

For research that involves biosafety concerns, the following modules must be completed in addition to the ones required by all study personnel:

• Biosafety/Biosecurity

Refresher Courses are available and should only be completed if the basic course was completed and the certification for that course has expired.

Most CITI certifications are valid for 3-4 years. Once certification has expired, the module or a refresher course must be completed to renew certification.

Once certification has expired, the module or a refresher course must be completed to renew certification.

Yes. If the same email address is used on both platforms, the iRIS platform can reflect the course completion information from the CITI Program. There are rare cases where the CITI information will not transfer even though the same email address is used in both systems. For this reason, the ORRC recommends that copies of CITI certifications of completion be included with submissions.