Help and FAQs

JHU eDisclose Help

For assistance with the technical aspects of using the University's online disclosure system, JHU eDisclose, please click here to be redirected to a selection of issue-specific user guides.  For all other inquiries not addressed below, please contact the appropriate office for your school or division.


Frequently Asked Questions

JHU eDisclose

I can't remember my JHED ID and/or password.  What should I do? 

Contact JHED directly at jhed@jhmi.edu or call (410) 516-HELP. 

I use a Macintosh computer.  Are there any special considerations for Mac users?

Mac users should not experience difficulty using eDisclose, provided that a compatible web browser is used.  For the best experience, please use one of the following recommended browsers:

Platform               

Browser

Microsoft Windows (all versions)

Internet Explorer 7 or later, Firefox 7 or later, Chrome 9 or later

Apple Mac OS X 10.4x or later

Safari 4 or later, Firefox 3 or later

What happened to the disclosures I entered in the old disclosure system, eOPC?

All “active” disclosures were migrated from eOPC to eDisclose. In addition, all legacy data (previous versions of disclosures) is retained in eOPC, which remains available with read-only access.  All updates to disclosures that were made in eOPC and all new disclosures must be made in eDisclose.

Who sees the information I submit via eDisclose?  Is the information safe?

Staff members in your school or division’s reviewing office have access to your disclosures.  In addition, members of your school or division’s conflict of interest committee will be provided access to the information necessary for their review.  Staff members in the IRB offices and the Johns Hopkins Technology Transfer Office have limited access to the information in eDisclose.  Department directors and chairs and their designees, in some cases including department administrators, have access to the disclosures of faculty members in their departments.  A financial interest that is judged to be related to PHS-supported research and is determined to be a financial conflict of interest under regulatory standards is subject to additional disclosure requirements.  The University is required to provide certain information about the conflict of interest to the PHS awarding agency and to make certain information available to the public.

Why can’t I delete a disclosure?

eDisclose (and previously, eOPC) retains a record of all user disclosures.  When a user updates a disclosure to indicate that the relationship has ended or the financial interest no longer exists, the “ended” status is reflected in the system.  So disclosures do not need to be deleted when an activity or interest ends.  (Please note that if an update to a disclosure was submitted erroneously, staff from your school or division's reviewing office may "withdraw" the update.)

Can I submit one disclosure for two companies if I am performing the same consulting services for each of them?

No.  eDisclose is an entity-based system.  You must create a new disclosure for each company or organization with which you have a relationship or interest.  Reporting by entity allows the institution to effectively manage each relationship and provide accurate reporting of outside commitments and conflicts of interest.

I am providing two different services (or have two separate agreements) with one company.  Should I submit two disclosures?

No.  eDisclose is an entity-based system.  All aspects of your relationship with one company or organization (e.g., services provided, ownership of equity, other financial interests or roles related to the entity) should be included in your disclosure.  Moreover, relationships with an entity are reviewed as a whole, and remuneration received based on that relationship may be considered in the aggregate for purposes of reviewing and reporting financial conflicts of interest and monitoring compliance with institutional policies.  Reporting by entity allows the institution to effectively manage each relationship and provide accurate reporting of outside commitments and conflicts of interest.

Will the information that I submit via eDisclose be available to the public? 

Federal regulation requires that the University respond to requests from any member of the public for information regarding arrangements the institution determines are financial conflicts of interest associated with PHS-funded research.  (Note: not all disclosures of outside interests or activities are determined to be financial conflicts of interest with PHS-funded research.) Within five business days of the receipt of a sufficiently complete written request, the institution must provide the following information:  (1) investigator’s name; (2) investigator’s title and role with respect to the research project;  (3) name of the entity in which the investigator’s significant financial interest is held; (4) the nature of the significant financial interest; and (5) the approximate dollar value of the significant financial interest (with the following dollar ranges being permissible: $0-$4,999; $5,000-$9,999; $10,000-$19,999; amounts between $20,000-$100,000 by increments of $20,000; amounts above $100,000  by increments of $50,000) or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value. 

Disclosure Basics

Who has to disclose?

Disclosure requirements are outlined here.

When do I have to disclose?

It is important to make disclosures times, including: (1) prior to undertaking a disclosable outside commitment; (2) no later than the time of application for PHS support; (3) within thirty days of acquiring or discovering a financial interest related to your institutional responsibilities; and (4) whenever a disclosed interest or activity changes (e.g., in terms of remuneration, type of service, or time commitment) or ends.  In addition, full-time and salaried part-time faculty, must submit an Annual Certification stating that their disclosures are accurate and up-to-date.

What do I have to disclose?

Disclosure requirements vary by school/division and employment or appointment status.  Please click here for disclosure information based on your affiliation or role.

Do I need to get departmental or divisional approval before I disclose consulting or other outside services?

Generally not, although your department or division may require that you disclose your outside activities and time commitments to the unit before disclosing in eDisclose.  If your school or division’s reviewing office decides that director or chair approval is required for a particular arrangement, your review will not be processed until that approval is received.  Department directors and chairs are able to view all of their faculty members’ disclosures in eDisclose.  They have the authority to limit outside activities if they believe the activities interfere with a faculty member’s ability to fulfill his or her Johns Hopkins duties.  

How is information regarding a faculty member’s outside activities and/or financial interests conveyed to his/her department director or chair?  What information is provided?

Department and division directors and chairs have access to eDisclose so they can review the disclosures of faculty members in their department or division.

What happens to my disclosure?

Staff members review disclosures for completeness and compliance with policies on conflict of interest and professional commitment.  Some arrangements require review by the school or division’s conflict of interest committee.  You will be notified via e-mail when a review is complete.  The e-mail will direct you to your eDisclose account to read and accept (or appeal) the outcome of the review.  The outcome will list the conditions or management plan associated with the review and you may be required to make some changes to your role in research and/or financial interest or relationship with the entity.

Do students and post-docs need to disclose?

All individuals who meet the definition of “investigator” on a PHS-supported research project must report their outside activities and financial interests.  Under JHU’s conflict of interest policy, an investigator is:

  • The project director or principal investigator and any other person responsible for the design, conduct, or reporting of research.  Includes collaborators and consultants.
  • All study team members on IRB applications.

This definition is independent of whether one is appointed or employed by the Johns Hopkins University.  The phrase “responsible for the design, conduct, or reporting of research” should be interpreted to mean any individual involved in the research who works independently enough to affect the objectivity of the design, collection, or analysis of research data or reporting of research results.  In addition to faculty members, this may include graduate and post-doctoral trainees, research staff, consultants, or other collaborators.  The ultimate determination as to who is considered an investigator in PHS-supported research is the decision of the PI of the project.

If I am on sabbatical, do I need to submit disclosures?

Yes.

What if I write a book chapter and, although I do not receive any income, the publisher gives me a copy of the book?  Should I disclose receipt of the book?

The receipt of the book does not need to be disclosed.

I receive royalties from sales of an academic textbook.  Do I need to disclose this?

Yes.  Pursuant to revised federal regulations on conflict of interest and institutional policy, income received from publishing, editing, or authoring must be disclosed.

I’m involved in research using licensed intellectual property for which I’m entitled to royalties, although there are no royalties flowing yet.  Do I need to disclose this since I haven’t received any income from royalties?

Yes.  Entitlement to future royalties under a licensing agreement or contract is a disclosable financial interest. 

What if Johns Hopkins owns equity in the start-up company in which I have equity or a licensing interest?

You still need to disclose your equity and licensing interests in the company for review under the policy on individual conflict of interest.   The university’s ownership interest in the start-up can create an institutional conflict of interest, which is reviewed under the University’s policy on institutional conflict of interest. 

How do I determine whether a company in which I own stock is related to my institutional responsibilities?

Institutional responsibilities are those responsibilities and roles that covered parties are assigned in the course of their appointment or employment at the university.  This includes, for example, clinical practice, teaching, research, research consultation, professional practice, administrative roles, committee service, purchasing-related responsibilities, and service on IRBs or DSMBs.  Ownership of equity in an entity whose business is in the same field as any of your institutional responsibilities is considered related.  For example, if you are a consultant to a pharmaceutical company because they are considering developing a drug for a disease you treat in your clinical practice, that must be disclosed whether or not you conduct research related to the drug, the disease, or the company. 

I am an SOM faculty member. Do I need to disclose my Pfizer stock if it is included in a mutual fund or IRA?

No.  Only stock purchases over which you can or do exercise direct control should be disclosed.

Do I need to disclose honoraria received for teaching in a Johns Hopkins CME course?  What if the payment came from an outside entity?    

You do not need to report an honorarium received for teaching in a Johns Hopkins CME course.   You probably received payment from a third party because the Johns Hopkins CME office contracted with an external organization to handle certain logistics such as payment to instructors.  However, since you were engaged to teach in this course by the Johns Hopkins CME office, you do not need to disclose the income.

What if Johns Hopkins Medicine International asks me to consult overseas?

Johns Hopkins Medicine International (JHMI) is a Johns Hopkins entity, so you do not need to report payments from JHMI. 

Do I need to disclose if I am advising Johns Hopkins students who started a company based on the technology they invented at the university? 

If you are advising the students in their roles as company founders, you are engaging in an activity with an outside organization and you need to make a disclosure.  This is especially important if you are compensated in any way.  If you are mentoring the students with regard to their university-based research activity, no disclosure is needed.

Can you provide some examples of when to disclose the financial interest of a spouse/domestic partner/dependent child?

Examples include:

  • ownership of stock in an entity that relates to your institutional responsibilities; and
  • service on the board of directors of an entity that relates to your institutional responsibilities; and
  • receipt of remuneration for consulting or any other service provided to an entity that relates to your institutional responsibilities. 

My spouse works for a company that is related to my institutional responsibilities and I am required to disclose his income and stock options to JHU.  However, his employer imposes confidentiality requirements on disclosure of his compensation. 

To comply with institutional policy and federal regulation, limited information about interests of immediate family members must be disclosed.  If you have questions about a particular case, please contact your school or division’s reviewing office.

If both members of a married couple or domestic partnership are faculty and/or investigators at Johns Hopkins, do they need to disclose each other’s interests or activities?

Yes.  Although each member of the couple has certain disclosure requirements, it is important for each to include the other’s disclosable financial interests and indicate they are the spouse or domestic partner’s interests.  This is so the institution can determine whether an individual’s financial interests are related to the research being conducted by the other member of the couple.  

Do I need to disclose if my spouse is employed by NIH? 

No.

Do I need to disclose my spouse’s employment for a company whose business is related to my institutional responsibilities? 

Yes.

Do I need to disclose if my spouse is a lobbyist for a company whose business is related to my institutional responsibilities (e.g., for SOM, a pharmaceutical company)? 

Yes.

What happens if I fail to make a disclosure or my disclosure is “late”?

Late disclosure and failure to disclose may have serious consequences.  Under applicable regulation, if there is a failure to disclose, belated disclosure, or belated review of financial interests that the institution determines create financial conflicts of interest with PHS-supported research, the institution must undertake a retrospective review of the completed research to determine whether there was bias in the research conducted to date.   In addition, failure to comply with policies on conflict of interest and commitment may lead to review under your division’s professional misconduct procedures.

Travel

When do I have to disclose travel?

If you are an investigator on any PHS-supported grant or contract, you need to disclose each instance of travel that is reimbursed or sponsored by an outside entity, when the amount of travel during the preceding 12 months reaches or exceeds $5,000 in the aggregate for a particular entity.  (Note:  This aggregate value includes travel for spouses, domestic partners and dependent children unless the travel occurs in the course of their employment by the entity.)  Disclosures must be made within 30 days of reaching the $5,000 threshold and of every instance of sponsored or reimbursed travel occurring thereafter.

Do I need to disclose travel if I’m not an investigator on a PHS grant or contract? 

No.  Only investigators on PHS grants and contracts are required to disclose sponsored or reimbursed travel. 

What is meant by “reimbursed” and “sponsored” travel?

When an entity purchases your airline or train ticket or pays for your hotel stay, that is “sponsored travel.”  When an entity directly reimburses you for your purchase of transportation or lodging, that is considered “reimbursed travel.”

What if I don’t know the specific value of the sponsored travel I am disclosing?

eDisclose allows users to provide either the specific value, an estimate of the value, or a description of the travel costs covered by the entity.  To determine whether the aggregate value of sponsored and reimbursed travel has reached $5,000, investigators should make their best efforts to learn the value of the sponsored and reimbursed travel.

Do non-faculty investigators such as research coordinators need to disclose sponsored or reimbursed travel if they’re listed on a PHS-sponsored grant?  What if a research coordinator is a study team member on an IRB protocol?

All individuals who meet the definition of “investigator” on a PHS-supported research project must report their outside activities and financial interests.  Under JHU’s conflict of interest policy, an investigator is:

  • The project director or principal investigator and any other person responsible for the design, conduct, or reporting of research.  Includes collaborators and consultants.
  • All study team members on IRB applications.

The phrase “responsible for the design, conduct, or reporting of research” should be interpreted to mean any individual involved in the research who works independently enough to affect the objectivity of the design, collection, or analysis of research data or reporting of research results.  In addition to faculty members, this may include graduate and post-doctoral trainees, research staff, consultants, or other collaborators.  The definition of investigator is independent of whether or not an individual is employed or appointed by Johns Hopkins University.  The ultimate determination as to who is considered an investigator in PHS-supported research is the decision of the PI of the project.

I am a consultant on an NIH grant to Johns Hopkins, and the grant paid for me to go to a conference.  Do I have to disclose that?

No.  Travel payments made by the institution do not need to be disclosed.

What if I give grand rounds out of town and the trip is paid for by my professional society?

If you are an investigator on any PHS-supported grant or contract, the travel must be disclosed when/if the aggregate value of the travel sponsored or reimbursed by the professional society reaches or exceeds $5,000.

What if my travel is sponsored or reimbursed by a non-U.S. institution of higher education?

Only institutions of higher education chartered under U.S. law are exempt from the reporting requirements. Therefore, if you are an investigator on any PHS-supported grant or contract, you need to disclose travel that is sponsored or reimbursed by a foreign institution of higher education when/if the aggregate value of the travel sponsored or reimbursed by the institution reaches or exceeds $5,000.

What if an academic society or disease-advocacy organization pays for me to attend its annual meeting?  Do I need to disclose this as sponsored or reimbursed travel?  What if they waive my registration fee for the annual meeting?

If you are an investigator on any PHS-supported grant or contract and the organization pays (or reimburses you) for your flight or hotel stay, you need to make a disclosure when/if the aggregate value of the travel sponsored or reimbursed by the entity reaches or exceeds $5,000. Waiver of the registration fee does not need to be disclosed. 

What if I travel to a meeting where dinner is included and the sponsoring entity buys an expensive bottle of wine?  And what if they pay for my cab fare?  What if they just pay for meals during my trip?

For the purposes of reporting travel-related expenses, you need to disclose only sponsored or reimbursed transportation and lodging.  Please remember that the JHM Policy on Interaction with Industry prohibits acceptance of meal and other gifts from industry and, with limited exceptions, travel support from industry.  Please see the policy for further information. 

What if I extend a “disclosable” trip at my own expense?  How do I disclose this?   For example, I am traveling to Singapore to give a talk at a Singaporean medical society and the society will pay for my transportation and two nights at a hotel.  I am going to take a vacation and extend the trip for one week at my own expense.

You must disclose the transportation and lodging that are paid for by the Singaporean medical society.

If I take one trip at the invitation of multiple organizations, do I need to submit a disclosure for each entity from which I receive reimbursement/sponsorship?  For example, I am invited to give talks at three different organizations in Germany and each will pay for about one-third of my travel and lodging expenses. 

Yes, you need to disclose each organization’s sponsorship of your trip (provided the aggregate value of any travel sponsored or reimbursed by that entity over the past 12 months reaches or exceeds $5,000) and indicate, if possible, what each organization paid for.

Conflict of Interest and Professional Commitment/Federal Regulations

Why have new policies and requirements been adopted? 

Johns Hopkins has revised its policies and procedures with respect to both disclosure and professional commitment and conflict of interest in order to comply with revised Public Health Service regulations on objectivity in research (conflict of interest), which took effect on August 24, 2012.

What is “PHS”?

PHS is the Public Health Service of the U.S. Department of Health and Human Services.  PHS agencies include

  • Administration for Children and Families (ACF)
  • Administration on Aging (AoA)
  • Agency for Healthcare Research and Quality (AHRQ)
  • Agency for Toxic Substances and Disease Registry (ATSDR)
  • Centers for Disease Control and Prevention (CDC)
  • Centers for Medicare & Medicaid Services (CMS)
  • Federal Occupational Health (FOH)
  • Food and Drug Administration (FDA)
  • Health Resources and Services Administration (HRSA)
  • Indian Health Service (IHS)
  • National Institutes of Health (NIH)
  • Substance Abuse and Mental Health Services Administration (SAMHSA)

Who is covered by the PHS regulation?  Must all institutions that receive PHS support adhere to the regulation?

Yes.  The regulation is applicable to all institutions that apply for or receive PHS support by means of a grant, cooperative agreement, or contract and, through the implementation of the regulation by the institution, to all investigators on PHS-supported projects.

What is meant by a “U.S. institution of higher education”?

A U.S. institution of higher education is defined here.  To qualify as a U.S. institution of higher education under 20 U.S.C. 1001(a), an institution must be public or non-profit, legally authorized by states to provide post-secondary education accredited, and award bachelor’s degrees or provide full credit toward bachelor’s degrees, and meet other criteria.

Is income from for-profit institutions of higher education like the University of Phoenix exempt from reporting requirements? 

No.  To be exempt from reporting requirements, an institution must be either public or non-profit.

Why do I need to disclose information about income from non-profit organizations?

Revisions to the federal regulation on conflict of interest require that institutions obtain this information from investigators.

Do students and post-docs need to disclose?

All individuals who meet the definition of “investigator” on a PHS-supported research project must report their outside activities and financial interests.  Under JHU’s conflict of interest policy, an investigator is:

  • The project director or principal investigator and any other person responsible for the design, conduct, or reporting of research.  Includes collaborators and consultants.
  • All study team members on IRB applications.

This definition is independent of whether one is appointed or employed by the Johns Hopkins University.  The phrase “responsible for the design, conduct, or reporting of research” should be interpreted to mean any individual involved in the research who works independently enough to affect the objectivity of the design, collection, or analysis of research data or reporting of research results.  In addition to faculty members, this may include graduate and post-doctoral trainees, research staff, consultants, or other collaborators.  The ultimate determination as to who is considered an investigator in PHS-supported research is the decision of the PI of the project.

Does the policy apply only to new awards as of August 24, 2012?   What if my grant is in year four of a five-year award?  

The revised regulation applies to all PHS awards made on or after August 24, 2012, including new awards, competitive renewals, non-competitive renewals, supplements, and no-cost extensions.

What is a “FCOI”?

“FCOI” stands for “financial conflict of interest.”  Under PHS regulations, an FCOI exists when the institution determines that an investigator’s significant financial interest could directly and significantly affect the design, conduct or reporting of research. 

What happens if the review of my arrangements results in an FCOI determination and I don’t agree?  Can I appeal?

The outcomes of the review can be appealed.  The appeal can be submitted electronically in eDisclose.  Please see the applicable eDisclose user guide for information on how to appeal your review outcome.

What if changes to my research are required in order to manage my conflict of interest?  Who is notified of the required changes?

The review outcome or management plan sent to you via eDisclose will explain the conditions necessary to manage the conflict of interest.  For example, you may need to revise your eIRB protocol by submitting a Further Study Action for a Change in Research.  In that case, the IRB will be notified of the required change.  However, it is your responsibility to ensure that the change to the eIRB protocol is made.  

What disclosure information has to be made public and why?

Federal regulation requires that the University respond to requests from any member of the public for information regarding arrangements the institution determines are financial conflicts of interest associated with PHS-funded research.  (Note:  not all disclosures of outside interests or activities are determined to be financial conflicts of interest with PHS-funded research.) Within five business days of the receipt of a sufficiently complete written request, the institution must provide the following information: (1) investigator’s name; (2) investigator’s title and role with respect to the research project;  (3) name of the entity in which the investigator’s significant financial interest is held; (4) the nature of the significant financial interest; and (5) the approximate dollar value of the significant financial interest (with the following dollar ranges being permissible: $0-$4,999; $5,000-$9,999; $10,000-$19,999; amounts between $20,000-$100,000 by increments of $20,000; amounts above $100,000  by increments of $50,000) or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.  This requirement exists to support transparency about interests of investigators that may affect the objectivity of publicly-supported research.

Will an investigator receive a notification if a member of the public asks for information regarding his/her FCOI?

Yes.

What happens if I fail to make a disclosure or my disclosure is “late”?

Late disclosure and failure to disclose may have serious consequences.  Under applicable regulation, if there is a failure to disclose, belated disclosure, or belated review of financial interests that the institution determines create financial conflicts of interest with PHS-supported research, the institution must undertake a retrospective review of the completed research to determine whether there was bias in the research conducted to date.   In addition, failure to comply with policies on conflict of interest and commitment may lead to review under your division’s professional misconduct procedures.

What are “institutional responsibilities”?

Institutional responsibilities are those responsibilities and roles assigned to an individual in the course of their appointment or employment with the institution.  These may include, among other things, research, teaching, clinical care/practice, and administrative responsibilities.

When do I have to complete conflict of interest training?

There are various triggers for the training requirement.  You must complete training prior to engaging in PHS-funded research and at least every four years thereafter; immediately after a change in institutional conflict of interest policy that affects the requirements placed upon investigators; if you are new to an institution; whenever the institution determines that are you not in compliance with the institutional conflict of interest policy or your management plan.

I am an investigator on a sub-award for research funded by a PHS agency.  Does this regulation still apply to me?

Yes.  If you meet the definition of an “investigator,” the regulatory requirements apply to you.  The awardee institution is required to incorporate conflict of interest terms in agreements with sub-recipients that specify which institution’s conflict of interest policy will apply to investigators at the sub-recipient institution.  If the sub-recipient institution does not have a policy that complies with the regulation, the prime awardee’s policy must be followed.