Frequently Asked Questions



General Questions

1. Why did we change the disclosure process?

Entrepreneurial and consulting partnerships with outside entities are important to the research and educational missions of the University of Miami (UM). Importantly, these relationships must be undertaken with a clear understanding of potential conflicts of interest that might endanger patient safety, data integrity, the integrity of our educational and training programs, and our reputation.

Although UM has been among the nation's leaders in promoting transparency in our external relationships and sponsored activities, academic institutions are being asked to comply with an increasing number of regulations in this regard, including the recently updated Public Health Service (PHS) regulations. Since we receive PHS funds, UM (and other universities) will be responsible for more disclosure and reporting than in the past. The Office of Research Compliance has been working since last fall to respond to the new regulations, which go into effect on August 24, 2012. The new regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research performed under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest.

Importantly, the responsibility for determining if an Investigator's relationships could represent a Conflict of Interest (COI) with their sponsored work will now rest with the University. As a result, UM must garner from Investigators (anyone involved in research or sponsored activities, including faculty, trainees, staff and subcontractors) disclosures of interests related to their institutional responsibilities.

To that end, we have launched the new electronic Disclosure Profile System (DPS), which streamlines the disclosure processes at UM: it combines into one simple process the Faculty Disclosure Form (FDF), the Financial Interest Declaration (FID) form and the Individual Interest Disclosure (IID) form. Most users will disclose interests on an annual basis, and some Investigators (as defined above) will use the DPS to disclose interests in a timelier manner. Further, Project Directors and/or Principal Investigators will need to submit information on each sponsored project to allow a review of their team members' potential COI.

2. Do we still need to complete the FID and IID forms?

For now, the answer is yes. Once all faculty and staff (only staff involved in sponsored activities) enter all of their disclosures in the new Disclosure Profile System (DPS) (by the end of 2012), the FID and IID Forms will no longer be necessary.

3. Who needs to disclose their Outside Professional Activities (OPA)?

All full-time faculty, University of Miami Medical Group (UMMG) members, and Miller School faculty members that could provide clinical or teaching services for UHealth must disclose their OPA to UM by the end of each calendar year. In prior years, faculty disclosed their OPA via the Faculty Disclosure Form (FDF) which will now be incorporated as part of the Disclosure Profile System (DPS).

In addition to all Investigators (anyone that could possibly be involved in research or sponsored activities, including faculty, trainees, staff and subcontractors) are required to complete their OPA, Financial and Obligatory Interests disclosures prior to submission of a proposal or contract on which they will be a team member, or at least once a year using the DPS. Further, if currently funded by the PHS, all Investigators must complete travel disclosures that related to their Institutional Responsibilities (IR).

4. I did not engage in any OPA. Do I still need to disclose?

Yes. Each Investigator is responsible for submitting their own disclosures (or certifying to a lack thereof) through the DPS.

5. Do faculty members still need to complete a Faculty Disclosure Form (FDF)?

No. The new DPS will replace the FDF in January of 2013; however the FDF is still available for use until the end of 2012. Faculty who have not updated their FDF for CY12 are encouraged to use the DPS for their annual disclosures.

For now, full-time faculty, University of Miami Medical Group members, and Miller School faculty members that could provide clinical or teaching services for UHealth, must disclose their OPA to UM by the end of each calendar year using the current FDF or the new DPS.

You can update your disclosure profile an infinite number of times throughout the year, and any information you enter is saved and will be available for editing until data collection for the next year begins. However, if you receive funding for sponsored activities or are paid by sponsored accounts, you are required to enter your disclosures within 30 days (not when you are compensated for them). If you do not receive funding for sponsored activities or are paid by sponsored accounts, we strongly recommend that enter your disclosures within 30 days. We also recommend that you use the DPS as your mechanism for recording and tracking your OPA.

In accordance with the new Department of Health and Human Services (HHS) regulations, in addition to the OPA section faculty members involved in sponsored activities will also be required to complete the Financial and Obligatory Interests (FOI) section of the DPS. FOI are outside interests or relationships that are related to your Institutional Responsibilities (IR).

PHS funded Investigators must also disclose the occurrence of any reimbursed travel or sponsored travel (i.e. that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their Institutional Responsibilities (IR).

This disclosure requirement does not apply to travel that is reimbursed or sponsored by a federal, state, or local government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.

6. What happens if a disclosure is not made in a timely fashion?

For faculty not involved in sponsored activities, failure to comply with the required annual disclosure of OPA as stated in the Faculty Manual may lead to disciplinary action by the Provost, Dean and/or Chair.

For investigators involved in sponsored activities, failure by an Investigator to disclose within thirty (30) days an OPA, FOI or travel event (if PHS funded) that relates to sponsored activities could lead to disciplinary action by the Provost, Vice Provost for Research, Dean and/or Chair, including but not limited to withdrawal of pending proposals and/or placing a hold on, or terminating, an active award, contract or cooperative agreement.

Non-compliance related to PHS funded activities requires the University to conduct a retrospective review of the Investigator's activities in order to determine whether the research or scholarly activity, or any portion thereof, conducted during the time period of noncompliance, was biased in design, conduct, or reporting.

Additional information related to the retrospective review can be located in the UM COI Policy.

7. What do staff members need to complete?

Anyone (including staff) who could be involved in the design, conduct or reporting of research or externally sponsored scholarly activities must complete the disclosure process. Those not involved in research or sponsored activities will have to certify as such in the DPS.

Staff members who are involved with sponsored activities will be required to disclose their Outside Professional Activities (OPA), Institutional Responsibilities (IR) and Financial and Obligatory Interests (FOI) and possibly their sponsored travel in the DPS.

8. Where is the disclosure data stored? Who has access to it?

Data captured in your disclosure profile are housed and monitored on internal UM servers by UM personnel with permission explicitly granted to select individuals and compliance groups. A limited group of University officials including (as appropriate) the Provost, Vice Provost for Research, Vice Provost for Faculty Affairs, Conflict of Interest Committee, Research Administration, Deans, and Department Chairs will have access to view disclosure information.

9. Do voluntary or part time faculty members need to disclose?

If involved in research, sponsored scholarly activities or are a member of the University of Miami Medical Group (UMMG) that could provide clinical or teaching services, then you are required to complete your Disclosure Profile.

10. How does the DPS derive its answers for the questionnaire?

In order to determine who needs to complete the different sections within the DPS, the pre-populated answers for the questionnaire are derived from a combination of UM human resources employment titles and UM account information.

11. Why does UM review all research projects and related outside interests as though they were PHS-funded projects?

As a community of scholars, scientists and physicians, we have an obligation to our colleagues, patients, research participants, research sponsors, and the general public to be transparent about the external relationships that relate to our institutional responsibilities. The importance of this transparency has been underscored by recent changes in federal regulations. As a matter of ethical principle, however, we are obliged to hold all research performed under the auspices of UM, regardless of funding source, to the same high standards of excellence and integrity.

12. Why does UM have a financial disclosure threshold that is more stringent than required by Federal regulations?

The University recognizes that the need for transparency must be balanced with the desire to reduce unnecessarily burdensome tasks for UM investigators. Toward that end, in 2012, UM’s threshold for financial disclosure was raised from $0 to $600 – the threshold for reporting income to the Internal Revenue Service on the 1099 tax form.

13. How is it determined whether a person is involved in the design, conduct, or reporting of research/sponsored educational activities, and thus qualifies as an “investigator”?

At UM (and in accord with PHS regulations) the term “investigator” is used to indicate individuals with defined roles in sponsored research, other human subject research, or sponsored scholarly activities. Depending on academic discipline, an investigator could be responsible for “substantive contributions” to one or more of the following: writing/editing proposals for funding, designing protocols, conducting experiments, educating students, collecting or analyzing data, interpreting results, or conveying results in publications and/or presentations. It is the responsibility of the Principal Investigator/Program Director to determine which members of a study team are substantively contributing to such efforts.

14. Do members of UM’s leadership have to make disclosures?

As one of the nation’s leading private research universities, UM is committed to maintaining objectivity in research and upholding the highest scientific and ethical standards. When a member of UM’s leadership team also has a role as investigator, he/she is required to comply with the same policies/procedures as all other members of the UM community.

UM is governed by a Board of Trustees that includes many of South Florida’s most prominent business and community leaders. Under the direction of the UM Office of the General Counsel, the Office of the Secretary coordinates all activities of the UM Board of Trustees, including disclosures related to outside interests held by board members.

15. Why should I disclose private information about my outside interests to UM?

Disclosure of interests related to institutional responsibilities not only ensures an investigator’s compliance with federal regulations and UM policies, but also allows identification and management of identified conflicts of interest. Outside interests, including those that cause conflicts, are not inherently negative, as long as they are disclosed and appropriately managed. In the end, disclosure serves to protect the reputations of the investigators and of the institution.



Top Outside Professional Activities (OPA)

1. What is an Outside Professional Activity?

All non-University professional activities performed for remuneration, including lecturing, delivering professional advice, expert witness testimony, arbitration, government services, corporate board activities, royalties, and private practice (which is only allowed for services that do not violate UMMG by-laws or compete with services that are or could be offered by the University). Only OPA performed for $600 or more must be disclosed to the University.

Examples of OPA include paid consulting, artistic performances, or board membership for, or royalties received from, an external entity.

2. Is there anything improper about performing OPA?

No. In fact, the University encourages the creation and maintenance of mutually beneficial relationships between the faculty and non-academic entities (i.e. industry, other private sector organizations). These entrepreneurial and consulting partnerships facilitate the flow of knowledge between the corporate world and academia, expedite research applications, and promote the educational and clinical missions of the University.

3. Are there entities/payors that are excluded from the regulations?

Yes. Compensation received for OPA from the following entities do not need to be disclosed: Federal, state, or local government agencies, institutions of higher education as defined at 20 U.S.C. 1001(a), academic teaching hospitals, medical centers, or research institutes that are affiliated with an institution of higher education.

4. How do I add an outside professional activity (OPA)?

Click on the "ADD OPA" Icon in the center of the OPA section webpage and answer the questions to the best of your ability.

5. What if I have multiple OPA with the same entity?

Your disclosure profile is capturing your relationship with the entity, so you should be making only one disclosure and including all activities for that entity therein. All compensation is cumulative and the dates for the relationship should be for the start of the relationship to the end of the relationship, not for each activity.

For example, if your consulting and lecturing relationship started in January and the lecturing ended in March but the consulting is ongoing, you should use January for the start date and "ongoing" for the end date.

6. What if I don't know the exact amount of compensation or duration of the OPA?

Enter information to the best of your ability at the time of entry. You can update your disclosure profile an infinite number of times throughout the period, and any information you enter is saved and will be available for editing. Keep in mind that if you perform research, receive funding for sponsored activities or are paid by sponsored accounts, you are required to enter your disclosures within 30 days of acquiring the OPA (not when you are compensated for them). Even if you do not perform research or receive sponsored funding, we strongly recommend that enter your disclosures within 30 days.

7. Do I disclose the OPA when performed or when I am compensated?

You should enter the OPA at the earliest possible time. You can update your disclosure profile an infinite number of times, and any information you enter is saved and will be available for editing.

8. How long do I have to disclose a newly acquired OPA or FOI?

You must disclose a new OPA or FOI within 30 days of performing the new activity, acquiring the new interest, or discovering one that was not disclosed in a timely fashion. Also, if any of your disclosures change, you must update the change within 30 days. If your are involved in research or sponsored activities and your disclosures are not made in a timely manner, your interest and work must undergo a comprehensive retrospective review to determine if bias has occurred.

9. Am I required to disclose OPA when payment is made to the University?

No. Since the payment for services is paid to the University, your disclosure is not required. However, if payment for services is paid directly to you, the remuneration must be disclosed, no matter if the Investigator turns the money over to the Institution or if the money will be used to support the Investigator's future sponsored activities.

10. I have an appointment at the VAMC. Is that considered an OPA?

No. A dual appointment at the Veteran Affairs Medical Center (VAMC) is not considered an OPA.

11. I have a 9-month appointment at UM. Do I disclose OPA done in the summer?

Yes. UM is committed to maintaining the integrity of our community of scholars and to re-enforcing the public trust in the academy. With that in mind, full-time faculty, University of Miami Medical Group members, and Miller School faculty members that could provide clinical or teaching services for UHealth, must disclose their OPA to UM by the end of each calendar year. This includes those faculty members with 9-month and 12-month appointments.

12. I am on sabbatical or on leave. Do I need to disclose?

Yes. Full-time faculty, University of Miami Medical Group members, and Miller School faculty members that could provide clinical or teaching services for UHealth, must disclose their outside professional activities (OPA) to UM by the end of each calendar year. This includes those on sabbatical or leave.

13. Why do I have to disclose unexercised stock options?

Unexercised stock options are classified as compensation due to their potential/future value.

14. When do I need to enter compensation/reimbursement for travel?

Sponsored or reimbursed travel is considered to be compensation, and as such, must be disclosed to the institution. if travel is paid for by an award through UM's sponsored programs, it does not need to be reported as an Outside Professional Activity (OPA).

Regardless of source of funding, PHS funded Investigators must use the "Travel" section of the DPS to disclose within 30 days, the occurrence of any reimbursed travel or sponsored travel, related to their Institutional Responsibilities (IR). The estimated cost of the anticipated travel can be disclosed ahead of a travel event (e.g. beginning of the year) but must be updated within 30 days of the end of the travel.

This disclosure requirement does not apply to travel that is reimbursed or sponsored by a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.



Top Institutional Responsibilities (IR)

1. What is an Institutional Responsibility (IR)?

"Institutional Responsibilities" means an Investigator's professional responsibilities on behalf of UM or their Institution. Examples include teaching, conducting research, or performing clinical duties for UM.

2. How do I know if an interest is related to my IR?

An interest is related to Institutional Responsibilities if both are associated with a common idea, practice, or are in the same field of expertise for which a person is employed.

For instance, voluntary membership on the board of an art foundation is associated with a UM artist's IR; royalties received for a clinical device patented through a prior employer are associated with a UM physician's IR; or stock ownership in an engineering company is associated with a UM engineer's IR; while no one in the examples above would have Institutional Responsibilities associated to their spouse's employment as a certified public accountant.



Top Financial / Obligatory Interests

1. What is a FOI?

A Financial Interest (FI) is:

  • Ownership (valued at $600 or more) in a public company
  • Any ownership in a privately held company
  • Protected Intellectual Property (IP), whether or not income is received from the IP

An Obligatory Interest (OI) is a relationship (regardless of compensation) that involves a responsibility or commitment to an external entity.

Your list of FOI should include:

  • Your financial interests (as defined above) related to your institutional responsibilities
  • Your obligatory interests related to your institutional responsibilities
  • Your spouse's and dependent children's financial or obligatory interests related to your institutional responsibilities, regardless of amount of compensation or value

2. Is there anything improper about having a Financial or Obligatory Interest (FOI)?

No. The University needs to be able to identify interests and relationships that may pose potential conflicts of interest that could endanger patient safety, data integrity, the integrity of our education and training programs, or our reputation.

3. How do I add a FOI?

Click on the "ADD FOI" icon in the center of the FOI section webpage and answer the questions to the best of your ability.

4. What is the difference between disclosure of an OPA and disclosure of a FOI?

An OPA disclosure is required if you are compensated more than $600 for performing an activity that is related to your profession. Disclosures for FOI include interests or relationships held or performed by your spouse and dependent children. A FOI disclosure is required if you (or your spouse or dependent children) have either a financial or obligatory interest.

A Financial Interest (FI) means anything of monetary value, whether or not the quantitative value is readily ascertainable, that is related to your institutional responsibilities (IR). You do not need to perform any activity to have a financial interest.

An Obligatory Interest (OI) means a relationship (regardless of compensation) that involves a responsibility or commitment to an external entity, including but not limited to being a founding member of that entity, or holding scientific advisory or governing board membership.

  • With regard to any publicly traded entity, a financial interest exists if the value of any remuneration received from the entity inthe twelve months preceding the disclosure or the value of any equity interest in the entity as of the date of disclosureexceeds $600. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g. consulting fees, honoraria, paid authorship, travel); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.
  • With regard to any non-publicly traded entity, a financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure exceeds $600, or when the Investigator (or the Investigator's spouse or dependent children) holds any equity interest (e.g. stock, stock options (vested or unvested), or other ownership interest.
  • With regard to Intellectual Property (IP) rights and interests (e.g. patents, copyrights), a financial interest is considered to be present as soon as protection is sought (e.g. filing an invention disclosure, patent application, etc).

The term Financial Interest does not include the following types of interests: salary, royalties, or other remuneration paid by the University of Miami to the Investigator if the Investigator is currently employed or otherwise appointed by the University of Miami, including intellectual property rights assigned to the University of Miami and agreements to share in royalties related to such rights; income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles; income from seminars, lectures, teaching engagements, service on advisory committees or review panels for, or sponsored by a United States Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.

5. Do I need to separate entries for my spouse and/or dependent children's FOI?

No. Your disclosure profile is capturing you and your spouses and dependent children's relationship with the entity. If your spouse owns equity in a company, for Department of Health and Human Services (HHS) regulation and University policy purposes, then so do you. So you should be making only one FOI disclosure and including all activities for that entity therein. All compensation is cumulative and the dates for the relationship should be for the start of the relationship for any one of you to the latest date of the relationship for any one of you.

For example, if you are an uncompensated* consultant for a private company and your spouse own 10% of that same company, you should make one FOI disclosure capturing both of these relationships. The start date for the relationship is the earliest of the consultant activity or equity ownership and the end date would the latest date for of the consulting activity or ownership of the equity.

Please remember, if you are compensated over $600 for an activity, it should be listed in your OPA section.

6. Do I need to report changes in value of stock or other similar interests?

No. Generally, the requirement to update your disclosures annually will be sufficient to provide updated information regarding any previously disclosed Financial and Obligatory Interests (FOI) (e.g. the updated value of a previously disclosed equity interest).



Top Travel

1. When do I need to enter compensation/reimbursement for travel?

PHS funded Investigators must disclose the occurrence of any reimbursed travel or sponsored travel (i.e. that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their institutional responsibilities.

This disclosure requirement does not apply to travel that is reimbursed or sponsored by a federal, state, or local government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.

2. How do I add travel entries?

Click on the "Add Travel Disclosure" icon in the center of the Travel section webpage and answer the questions to the best of your ability.

3. Do I have to disclose travel that does not relate to an IR?

No. Travel is considered to be compensation, and as such, travel associated with your work at UM should be disclosed. All of your travel disclosures should be related to your Institutional Responsibility (IR).

4. Can I have reimbursed or sponsored travel not related to an IR?

Yes. If you have a travel event that does not relate to the Institutional Responsibility (IR) you perform for the Institution, you do not have to disclose the trip.

5. My award includes money to attend a meeting. Where do I disclose it?

Even if received from an award or contract, travel paid for or reimbursed by a private or not-for-profit organization (neither a US government entity nor a US institution of higher education) must be reported under the travel section, if you are sponsored by a Public Health Service (PHS) including the:

  • National Institutes of Health (NIH)
  • Food and Drug Administration (FDA)
  • Substance Abuse and Mental Health Services Administration (SAMHSA)
  • Agency for Healthcare Research and Quality (AHRQ)
  • Agency for Toxic Substances and Disease Registry (ATSDR)
  • Centers for Disease Control and Prevention (CDC)
  • Health Resources and Services Administration (HRSA)
  • Indian Health Service (IHS)

If the travel is paid by a award or contract through UM's sponsored programs, it does not need to be reported as an Outside Professional Activity.



Top Sponsored Projects / Awards / Contracts

1. What is the purpose of the Sponsored Projects / Awards / Contracts section?

PD/PIS use this section to indicate:

  • That external funding for a project is imminent
  • To designate the team members (including subcontractor and subawardees) involved in the design, conduct or report
  • To provide additional details about the proposed work

Investigators who are not PD/PIs use this section to certify that they are involved with a project, an award, or a contract.

Remember that under the new federal regulations, the University must be aware and review each team member's disclosures are related to that person's research or sponsored activities. Therefore, no new UM accounts will be opened until each TM's disclosures have been reviewed. It is the responsibility of the PD/PI to enter project/award/contract information into the DPS in order to ensure that TM disclosures are reviewed in a timely manner.

2. How do I add a Project/Award/Contract?

PDs/PIs click on the "Add Project/Award/Contract" icon in the center of the Sponsored Projects/Awards/Contracts webpage and answer the questions to the best of your ability.

3. What is the source for the pre-populated information?

InfoEd. Since you are only completing this section when the Project/Award/Contract is imminent, research administration must have already uploaded all Project/Award/Contract information into InfoEd.

4. As a PD/PI, how do I add people to my team?

There are two ways to add people to your team:

  • Insert their C number on the "Project/Award/Contract Details" page and upload. To obtain a C number use the Individual Compliance Report (to access click here two times; first to log into the RRS and second to access the report). See our Research Reporting system Compliance Status Tools page (to access click here two times; first to log into the RRS and second to access the page) for more information and a guide.
  • If the person has been on your sponsored Projects/Awards/Contracts in the past two years, you can add them from your pre-populated roster page.

5. How can I check the COI compliance status of my project and team members?

  • The Individual Compliance Report (to access click here two times; first to log into the RRS and second to access the report) allows anyone to see the Conflict of Interest (COI) compliance status of any individual campus-wide.
  • The Project Compliance Report (to access click here two times; first to log into the RRS and second to access the report) allows the PD/PI or an individual with administrative access see the COI compliance status of their project and the study team members.

Please see our webpage for more information on our Research Reporting System (RRS).

6. What is the "Team Roster" page?

A roster is a list of Investigators who have been TMs on a PD/PI's project/award/contract in the past.

7. Why does the DPS not list all of the awards or contracts on which I work?

The Project/Award/Contract information in the DPS is pre-populated by information in InfoEd, the Office of Research Administration's proposal tracking system. As such, the DPS lists only externally funded projects/awards/contracts, sorted by the PD/PI's last name.

When external funding is imminent, the PD/PI submits information into the DPS and designates team members for that award or contract. Once the team is designated, team members will receive an email indicating that he/she was added to the team. The team member will enter the DPS, confirm their role on the team, and each team member's disclosures will be reviewed for potential relationships to the sponsored work.

For a team member, until the PD/PI designates an externally-funded award or contract is imminent on their DPS profile, the trial will not be listed in a team member's project/award/contract section in their DPS profile.



Top Human Subject Research Studies (HSRS)

1. What is the purpose of the HSRS section of the DPS?

  • The electronic Disclosure Profile System (DPS) streamlines the disclosure processes at UM, and now combines into one simple process the disclosures formerly made into the eProst system, the Faculty Disclosure Form (FDF), the Financial Interest Declaration (FID) form and the Individual Interest Disclosure (IID) form.
  • Prior to study submission, each Team Member on human subject research (HRS) protocols must disclose to UM their interests in the Disclosure Profile System (DPS) by completing the "Outside Professional Activities" (OPA), "Financial and Obligatory Interests" (FOI) and "Travel" sections of the DPS. These sections must be recertified annually, even if an Investigator has no interests to disclose.
  • The Human Subjects Research Studies (HSRS) section allows the Team Member to associate their interests (disclosed in the OPA, FOI and Travel sections) to the HSR study.

2. How is the study included in the DPS?

Only new HSR studies or those studies with a modification open in the IRB7 system will appear in the HSRS section of a Team Member's DPS.

3. Who is included on the study team; who must make disclosures?

Study team members will appear in the DPS only if included in the Study Team list in the IRB7 system.

4. What must be done to complete the HSRS disclosure process?

Before a Team Member completes the questions associated with a HSR protocol, he/she must disclose interests in the "Outside Professional Activities" (OPA), "Financial and Obligatory Interests" (FOI) and "Travel" sections of the DPS. He/she should then proceed to complete the HSRS section, answering the questions directly related to the HSR study.

5. The entity I have a relationship with is not on the list. What do I do?

If "Yes" is answered to the Relationship to the Study question, the Payor/Company/Entity drop down list will be shown. The list will contain any entities previously disclosed in the user's OPA, FOI, Travel or Sponsored Projects sections. If an entity is not listed, return to the respective section and disclose the pertinent interest. Please see the instructions listed above for further information on what needs to be disclosed in each section.

6. Why are my ongoing studies not listed in the DPS?

Only studies and modifications that are newly initiated after the launch of the IRB7 system will appear in the DPS.

7. What is an Institutional COI?

  • Institutional Conflicts of Interest (COI) are those that may not be directly related to the Principal Investigator (PI) or other Team Members, but are related to the University or affiliated institutions. An institutional conflict of interest can arise when the financial interests of an institution, or an institutional official who is acting within his or her authority on behalf of the institution, may influence or appear to influence the research, education, operations, business transactions, or other activities of the institution. Such financial interests might exist as intellectual property, royalties, stockholdings, stock options, gifts, equity, or direct payment for Board service or consulting.
  • Among such potential conflicts that must be disclosed by the PI or Team Members are
    • The research involves a drug, device or other invention created at the University or affiliated institution, or by an employee currently or formerly at the University or affiliated institution
    • The research involves a drug, device or other invention created by someone other than the PI or Team Members for which the University or affiliated institution holds a financial interest

8. How do I get additional information?

Questions about the IRB7 software or a specific clinical study should be directed to the Human Subject Research Office (HSRO) at 305-243-3195; HSRO webpage, or Kenia Viamonte at kviamonte@med.miami.edu.



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