Corporate Sponsors:

Working with DRDA

Elaine L. Brock, MHSA, JD

Associate Director, DRDA

May 10, 2004

Clinical Research Grand Rounds

Today we’ll touch on policies, procedures, and tips dealing with:

• Nondisclosure Agreements (NDA)

• Clinical Trials• Policies and Laws

Publication and InformationIntellectual Property

• Materials Transfer Agreements (MTA)

• Conflict of Interest

• When Things Go Wrong

Who to call in the Brock Group

Sponsors starting with:

A-B, S-T Jeff Longe (JD), jlonge, 4-9118

C-D, U-Z Krista Campeau (JD), kcampeau, 5-0672

E-K, Tom Zdeba (JD), tzdeba, 6-1292

L-R, Anna Schork (JD), meanna, 6-1356

Auto companies, various sponsor accts, Dept of Commerce, “clubs”, misc. govt. agencies, Sharyn Sivyer, ssivyer, 6-1296

Misc., backup, whatever she wants, Elaine Brock (JD), ebrock, 3-7188

Pat Roe, patroe, 6-1289, secty. for Brock, Campeau, Longe

Sue Murphy, murwig, 7-3263, secty. for Sivyer

Jill Reed, jillreed, 4-7250, secty. for Schork, Zdeba

FAX 3-4053, 4-8510

A plea from my staff:

PLEASE provide the Project Rep with contact information for the sponsor AND

any correspondence, including email, that would be helpful to understanding the project or previous discussions between the PI and the Sponsor.

Categorize the activity

• Conduct a project supported by $$

Research, Other Sponsored Activity,

Clinical Trial

• Get information only

• Get materials only

e.g., software, prototype, biological

materials

PAF

MTA

ND

A

Who signs what at the University?

PI PAF, MTFOther forms as instructed by DRDA, IRBForm 1572 Agreements only as instructed by DRDA

Chair, Dean PAF, MTFOther forms as directed by DRDA

DRDA PAF, MTFProposal Applications for UniversityNondisclosure AgreementsMaterials Transfer Agreements

VP-Finance ContractsPurchase Orders, Consulting Agreements

If you need to get information from a Sponsor, e.g., a Protocol, in order to evaluate whether you want to conduct a project, e.g., a clinical trial, you may be asked to sign a Nondisclosure Agreement or NDA.

What is a Non Disclosure* Agreement? (*a.k.a. Confidentiality, Proprietary Information, Secrecy)

• Formal agreement signed prior to the exchange of confidential information (nondisclosure or secrecy agreements).

• Requires receiving party to maintain the confidentiality of designated information.

• NDAs involving University personnel acting within the scope of their employment must be signed by an authorized University official.NOTE: DRDA handles agreements for info. coming into

UM, OTT handles agreements for info. going from UM to a potential licensee.

Confidential Information: FOIA

Under the Michigan Freedom of Information Act (FOIA), any writing that is prepared, used, owned, possessed or retained by the University is subject to disclosure unless that record is specifically exempt from inspection under FOIA.

Exemptions covered by FOIA include:a. information of a personal nature where public disclosure would constitute

a clearly unwarranted invasion of privacy (e.g., patient records);.. ..f. Trade secrets or commercial or financial information voluntarily provided

to an agency for use in developing governmental policy if: (i) The information is submitted upon a promise of confidentiality by the public body. (ii) The promise of confidentiality is authorized by the chief administrative officer of the public body …[when] the promise is made. (iii) A description of the information is recorded ….

Sponsor Confidential Information: CRIA

The Confidential Research Information Act (CRIA) exempts from disclosure trade secrets and commercial or financial information voluntarily provided to the University if all the following are met:

1. the information is covered by an authorized confidentiality agreement entered into by the University;

2. the information is designated as confidential before or when it is received;

4. a description of the information is recorded by the University within a reasonable time after it has been received, . . . NOTE: FOIA and CRIA are why NDAs need to go to DRDA for

negotiation and signature and why DRDA negotiates confidential information clauses in CTAs.

How do I process an NDA?

There is no University processing form for NDAs.

Send the agreement to the appropriate PR with as much lead time, circumstances, and contact information as possible.

The PI will receive an email when DRDA assigns an SSP# to a NDA, again when requested changes are sent to the sponsor, and another when the NDA is fully negotiated and signed by the University.NOTE: Faculty, chairs, departmental administrators, etc. do not have the authority to accept these agreements on behalf of the University.

What is a Clinical Trial (CT)?

A study on humans of the effects of an Investigational New Drug (IND) or a device with an Investigational Device Exemption (IDE) as defined by the FDA.

• Indirect cost rate is 25% of total direct cost (including patient care costs, equipment, subcontracts, etc.).

• Access to the protocol is often preceded by a NDA.

• Often come to DRDA as a “Complete Package” = PAF, Protocol, Budget, Contract

• IRB approval is required before p/g# will be given to PI.

Who does what to get a CT started?

1. Sponsor sends NDA; DRDA negotiates and signs it.

2. Sponsor sends protocol, budget, contract to PI.3. PI negotiates Protocol, submits IRB application4. Dept/PI negotiate budget prepare PAF.

- Send PAF and Contract to DRDA as soon as PI

decides to do the study for available budget.- Draft Budget/Protocol OK to send with PAF.

5. DRDA negotiates contract, prepares Project Award Notice (PAN)

6. Contract Admin. signs contract, sends to Fin. Ops.

Who are the Parties to these Clinical Trial Agreements (CTAs)?

ACB, Inc. and The Regents of the University of

Michigan• Investigators acting within the scope of their

employment are not parties.

• Investigators have responsibility to conduct the Study per the Protocol and Clinical Trial Agreement (CTA) as employees and as required by signature as an Investigator on FDA Form 1572.

What are the issues in CTAs?

Issue Basis for UM Negotiating Position

Publication of results University policy, Dissertation research, Federal regulations, Tax exempt status

Protection of Sponsor’s Confidential Information

Freedom of Information ActConfidential Research Information Act

Intellectual property/Inventions:definition and rights

University policy, Federal regulationsProbability of IP, Use of preexisting IP

Ownership and use of data University policy, Federal regulationsTax exempt status

Liability/risk Michigan Constitution, Assessment of risk

Other business terms, e.g., payment, reports

Project specifications, University procedures,Sponsor requirements, Common sense

Proprietary Information, Data,

Publication

• Proprietary or Confidential Information provided by Sponsor

• Study Results, Data, and Case Report Forms

• Protected Health Information

• Intellectual Property

Agreements address various types of information

Confidential/Proprietary Information - Different Basic Positions in CTAs

UM view: ABC, Inc. view:

All information can be freely disseminated EXCEPT in limited clearly defined cases.

UM is subject to the Michigan Freedom of Information Act.

All information is confidential EXCEPT in limited clearly defined cases.

1. "Standard Restrictions" (i.e., acceptable) The following restrictions are outer limits of what has been routinely accepted in research grants, contracts, and agreements by the University provided that the principal investigator agreed to them. Restrictions which exceed these limits have been accepted and may be accepted in the future, but they will require… [special approval, i.e., PAF-R].

The University accepts with reluctance, and only with the concurrence of the principal investigator, a sponsor's requirement to delay exercise of the investigator's prerogative to determine the appropriate timing for the release of research results. A delay is considered to begin…

Regents' Policy on Research Grants,Contracts and Agreements

(publication policy)

a. Delay in publication or other dissemination of research results for a period of time deemed reasonable for the specific agreement, but usually not to exceed 120 days, to permit sponsor review for:

1. Comment (not for prior approval). 2. Protection of confidential information provided by the sponsor. 3. Possible participation in the protection of intellectual property.

 Any publication delay of greater than 120 days shall be reported annually to

the OVPR. (If > 180 days requires PAF-R unless in exempt category b. or c., below.)

 b. Delay in publication or other dissemination of research results…

multi-center or consortia project to conclude their studies.

c. Beta test agreements… where the results are not expected to be publishable as research findings.

d. Agreement to refrain from disclosing the sponsor's confidential information

for a determinate time…

Standard Restrictions, cont’d

What publication terms does the University prefer in CTAs?

• The right to disseminate* results without Sponsor approval or censorship

• Time limited review and comment period for the Sponsor (<180 days)

• OK to delay publication for limited, designated period to allow patent application to be filed

• OK to delay publication of data from site as part of multi-center trial for limited, designated period

• OK to allow Sponsor to require deletion of Sponsor’s confidential information

• No restrictions on use, disclosure to foreign nationals

*NOTE: Dissemination is broader than formal publication and includes the right to disclose to colleagues, students, patients and others on an informal basis.

Types of Data: Case Report Forms (CRFs)

UM and Company agree that Company can own the CRFs.

UM distinguishes ownership of the CRFs from ownership of the information contained in them.

Health Insurance Portability and Accountability Act (HIPAA) considerations apply.

*HIPAA in Clinical Trials

Under HIPAA, Covered Entities are required to restrict access to and disclosure of individually identifiable health information (protected health information - PHI) for research purposes – therefore, if a project is not HIPAA compliant, access to necessary data may be blocked.

Patient permission or “authorization” is usually needed to use or share PHI for research.

Conduct of research generally is governed under federal regulations for the protection of human subjects (the “Common Rule”); and use or sharing of PHI for research is governed by HIPAA.

What is Protected Health Information (PHI)?

PHI includes all of the following:

NOTE: Information does not need to include diagnosis or treatment information to be considered PHI.

Names License Numbers

Geographic information smaller than state (3-digit zip usually ok)

Vehicle Identification Numbers

All dates Account Numbers

Telephone & Fax Numbers Biometric Identifiers

E-mail Addresses Device Identifiers

Social Security Numbers Full Face Photos

Medical Record Numbers Any Other Unique Identifying Number, Characteristic or Code

Health Plan Numbers

Some PHI Authorization Requirements are of particular concern to CT sponsors

Required Elements of Authorization:

What information will be used or disclosedWho can use or discloseWho can receive the informationPurpose of disclosuresRight to revoke authorizationNotification of any consequences of refusing to sign the authorization (e.g., no participation in the research project)Warning: once authorized information is disclosed, it may no longer be protected under HIPAAExpiration date or event (may be “at the end of the project” or “none”)Signature, date, and (if applicable), authority of representative to sign

Intellectual Property (IP):

The Basics

IP Summary

Protection Protectable Material, e.g.

Patent Patent issued by: USPTO (after determination that invention is New, Useful, Non-obvious.)

Useful process, machine, algorithm composition of matter, ornamental design, business process

Trade Secret

Recognition of value and utility in a contract between parties who know the secret.

Know-how and formulae

Copyright Attaches to an original work once reduced to fixed tangible medium. Filing with US Copyright office is optional.  

Book, manuscript, music, software

Intellectual Property Policy/Law

University policy assigns ownership of employee developed IP to UM Section 3.10 of the Regents By-laws UM IP Policy (1996) 3.10 Certification signed by employees

Federal government regulation and policy controls ownership and rights to intellectual property made using government funds Bayh-Dole Act Veterans Administration acts Agency policies

Per RFPs Per regulations, e.g., NIST Advanced Technology

Program

What Intellectual Property (IP) terms does the University prefer in industry-sponsored agreement?

• Ownership of IP developed by University employees

• Joint ownership if University and Company employees both invent

• Option period for Company to decide to acquire exclusive commercial rights

• Resulting license will be royalty - bearing based on value of University contribution

• Defer decision on royalty-rate until after IP is identified

• Retained use of the IP by University

• Reservation of rights in the IP for the government prime sponsor

Practical Concessions Regarding IPin Sponsor initiated CTAs:

If the Sponsor writes the Protocol to cover the Study of a Drug that they have patent rights on and the Investigator conducts the Study according to the Protocol the probability of IP being developed by the Investigator is low.

Why do we need an IP clause at all and why does it become an issue to be discussed?

IP: ABC, Inc., Viewpoint

Companies usually recognize the low probability of inventions not covered under the Company’s patent rights but need freedom to practice just in case there are any inventions made in performance of the study, particularly those that cover a new use.

Patent law favors the inventor, i.e, the University, so absent contractual provisions the sponsor would acquire no rights in the University’s inventions.

Costs, Budgets, Payment

Clinical trial budget considerations:

• What is the likelihood of completing a subject?

• Can expenses be prorated by visit, procedure?

• What about screen failures, dropouts?

• How long will it take to “complete” a subject?

• Fees - IRB, pharmacy

• Upfront - advertising, pre-enrollment, recruiting

• Fixed Price rule

Payment Terms in CTAs should reflect the budget considerations in order to maximize likelihood of covering costs.

• Progress Payments: Usually based on number of participants, events

• Pre-Payment: Upfront costs, e.g., advertising, pre-enrollment, IRB fee, pharmacy fees

• Termination costs:- actual cost recovery- costs of withdrawing participants from the protocol

•Adverse Event cost:- not covered by insurer- addressed in informed consent

Payment of costs of related to Adverse EventsGeneral Rule: the sponsor should cover the cost of medical care required due to an adverse event.

Cost of study devices or drugsGeneral Rule: the sponsor should provide the study drug or device to the University at no cost to the University or the subject.

To bill a subject/insurer/government/3rd party:• IRB must approve • the informed consent must disclose the billing to the subject• the CTA must described the University’s obligations and be

consistent with the IRB approval and informed consent• the administrator must know about billing procedures.

If you tell DRDA about upfront costs, unusual considerations, etc., we can try to put terms in the CTA to protect against unrecoverable expenses.

Sponsors are not likely to propose these protective terms unless we ask for them.

DRDA can help

Materials Transfer Agreements

What is a Materials Transfer Agreement (MTA)? (Biological Materials, Software, Prototypes, Data)

*NOTE: Faculty, departmental administrators, etc., do not have the authority to accept MTAs on behalf of the University.

Essentially these are sponsored projects but without funding from the sponsor. The sponsor provides the material but someone else, often UM or NIH, pays for the research.

A Materials Transfer Agreement* describes the conditions under which another organization will provide requested material to UM.

A Materials Transfer Approval Form must be completed.

A Materials Transfer Form informs the Chair, Dean

and DRDA of the materials to be received and the

project in which they will be used. DRDA uses

answers on the MTF to insure that the proposed use

will be consistent with UM policies, sponsor

conditions, informed consent, and overlapping

agreements or licenses.

What is a Materials Transfer Form (MTF)and why do I need one?

How do I process an MTA?

The PI requests the material from a Provider. (DRDA is not usually involved in the initial request to the Provider.)

The Provider sends an agreement.

Administrator completes an MTF and has it signed by PI, Chair, Dean.

The signed MTF is sent to the appropriate PR with the agreement and the request. (Provide as much lead time, circumstances, and contact information as possible.)

The PI will get a an email when DRDA assigns an SSP# and PR to a MTA, and another when it is completed and signed by the University after the PR has negotiated any changes.

When the transfer of material or the exchange of confidential information occurs in a project financially sponsored by the provider of the material or information these issues will be addressed in the sponsored research agreement and approvals covered by a PAF.

Clarification

Conflict of Interest

Conflict of Interest ManagementUnderlying Premise

“You do not have to do anything improper to have a conflict of

interest; it is strictly situational”

Paul J. Friedman

• FDA Financial Disclosure Rule1. Title 21 Code of Federal Regulations Part 54

2. Effective February 2, 1999

• Sponsor Financial Disclosure Form

• University Financial Disclosure/Conflict

of Interest Disclosure

Financial Disclosures

Disclosures to Sponsors (e.g., NSF, NIH)(Keeping Jim, Elaine and Marvin out of jail)

The submission of the proposal is Certification by Authorized

Institutional Representative that the institution has

implemented and is enforcing a written policy on conflicts of

interest consistent with the provisions of Grant Policy Manual

Section 310; that, to the best of his/her knowledge, all

financial disclosures required by the conflict of interest

policy were made; and that actual or potential conflicts of

interests, if any, were, or prior to funding the award, will be

satisfactorily managed, reduced or eliminated in accordance

with the institution's conflict of interest policy or disclosed to

NSF.

Disclosure by Clinical Trial Sponsor to FDA

“As the Sponsor of the submitted studies I certify that I have not entered into any financial arrangement with the listed clinical investigators (CI) whereby the value of compensation to the investigator could be affected by the outcome of the study. I also certify that each CI required to disclose to the sponsor whether the investigator had a proprietary interest in this product or significant equity in the sponsor did not disclose any such interests. I further certify that no CI was the recipient of significant payment of the sort defined in 21CFR 54.2*(Form 3454, 3455)”

University-wide Policy and Procedures for Dealing with Financial Conflicts of Interest in Sponsored Projects and Technology Transfer

(1) The University of Michigan will exercise care in accepting or entering into sponsored agreements in which the faculty investigators or professional staff involved (or, to their knowledge, their spouses or dependents) have interests that create conflicts. Such agreements will not be accepted if the conflict:

(a) can be expected with reasonable certainty to compromise the integrity of those investigations or undermine the employee's obligations to the University, to the sponsor, or to students; and

(b) cannot be satisfactorily managed with appropriate

administrative oversight

It all starts with disclosure. PAF Instructions; CONFLICT OF INTEREST

Conflict of Interest -- Certain financial or management interests held

by key investigators or their families in sponsors of research or

entities directly related to the sponsored project requires disclosure

and review. More information* about conflict of interest and

Procedures for disclosing and managing conflict*

The Principal Investigator is responsible for ensuring that every key

investigator of the proposed research has either (a) certified that he

or she does not have a significant financial interest or (b) has

disclosed such interest(s) on an official disclosure form*.

*http://www.research.umich.edu/policies/um/conflict_of_interest.html

Medical School Disclosure

Faculty members are to prospectively disclose outside activities to their Department Chair, who will approve based upon adherence to Medical School policy. Faculty members are to indicate if a potential Conflict of Interest exists. It is the responsibility of the faculty member to read and understand the Conflict of Interest Policies of the Medical School.

The guidelines are available online at: http://www.med.umich.edu/med school/orgs/Research Policies

Some Conflicts of Interest have to be approved by a two-thirds vote of the Board of Regents.*

Those involving contracts, including license agreements, research agreements, purchase orders, leases, between the University and any entity, non-profit or for-profit, in which a University employee, directly or indirectly, is an owner, officer, director, partner, or member.

*NOTE: Since the Regents meet only 8 times per year this may mean a delay in getting a sponsored activity or license signed by the University.

Conflicts of Interest in sponsored research can arise from Roles of Investigators relative to the the Sponsor, Trainees, other Participants

Consultant to Licensee, Sponsor Product development Scientific Advisory Board member Review of other technologies, research areas

Management of Company that is a Sponsor, Licensee Director, Officer

Investigator on Research Contract from LicenseeLeave of Absence/Sabbatical/Split Appointment - Employee at CompanySupervisor and Mentor of employees/students of University and Company

Research Project 2

Consulting A

Consulting B

Scope of UM employment

Consulting CLicensed IP

Licensed IP

Research Project 1

Avoiding Overlap is Critical

Management plans protect basic values of the University against risks posed by entrepreneurial activity. Basic values of the University include:

• Objectivity of research• Open and timely publication of research results• Appropriate use of sponsor and University funds • Fulfillment of obligations to colleagues • Fulfillment of obligations to trainees/students • Fulfillment of administrative duties • Integrity of academic decision-making • Appropriate transfer of intellectual property• Full informed consent of human participants

When things go wrong.

No $$$$ from Sponsor

• Watch your accounts!• Check cash balance and payment status

before asking for nctx (no cost time extension).

• Watch for Past due Notices from Fin OPs• Check with DRDA - maybe we can help

mediate.• Department is responsible for bad debt.• Turning project over to a collection agency

could cost 30% - department absorbs loss.

Breach of Contract by UM

Consequences of UM’s failure to perform:- Termination and loss of funds- Injunction forcing performance or some activity, e.g.,

disclosure of results- Willful breach could be misconduct by PI, others

DRDA can build some protections into exceptional contracts that need them:

- Extra insurance (included in project budget?)- Unemployment compensation (escrow)- Nonrefundable payments if terminated without cause- Costs of withdrawing subjects from protocol

Proliferation of laws and regulations affecting University/Industry relationships, e.g.:

• NIH, NSF Conflict of interest policies (effective July 1995), NSFhttp://www.nsf.gov:80/bfa/cpo/gpm95/ch5.htm#ch5-6

• FDA Financial Disclosure Rule (effective February 2, 1999) 21CFR 54,http://www.fda.gov/oc/guidance/financialdis.html

• Generic Drug Enforcement Act of 1992 (use of debarred or convicted individuals) 21USC 335b,http://www.fda.gov/opacom/laws/lawtoc.htm

• Stem Cell Research regulations (various) http://www.nih.gov/news/stemcell/index.htm

• Health Insurance Portability and Accountability Act (HIPPA), (effective 4/14/03) 45 CFR 160, 164

• FDA Human Cell and Tissue Products, (effective 1/31/03) 21 C.F.R. § 1270 et seqhttp://www.fda.gov/cber/tissue/issue.htm

• Export Controls, Use of Foreign Nationals, Control of Dangerous Substances - flurry of activity since 9/11, See Council on Governmental Relations site for summaryhttp://www.cogr.edu/restricted/index.htm (Note: umich.edu domain access only)

• Get things to DRDA promptly after you get them.

• Stay in touch with your project rep.

• Read the Protocol, Informed Consent, and Contract!

• Talk to DRDA before making commitments to the Sponsor.

• Identify Sponsor clearly (Provide contact information!).

• Answer PAF or MTF questions as fully as possible.

• Secure IRB, IACUC, BioSafety Level approvals promptly.

What can you do to move CTAs faster and make them run more smoothly?

• Read the PAN and the Agreement as soon as you get it. Report errors to DRDA.

• Identify related IP that will be involved at the proposal stage.

• Identify conflicts of interest at the proposal stage.

• Tell PR what your timing needs are.

• Clarify/Understand your role and obligations relative to those of DRDA and FinOps.

Moving CTAs faster, cont’d

Contact hipaaquestions@umich.edu if you have any questions about the Privacy Rule or applicable UMHS policies or procedures; or if you would like to make a complaint.

Contact the Health System Legal Office at 734-764-2178 if you have any legal questions.

Contact IRBMED at 734-763-4768 if you have any questions about IRBMED forms or procedures. Visit IRBMED’s HIPAA website often for HIPAA research updates at: http://www.med.umich.edu/irbmed/NewIRBMEDHIPAA.htm

For more information about the Privacy Rule, visit www.dhhs.gov/ocr/hipaa.

HIPAA Questions

More about NDAs:

http://www.research.umich.edu/policies/um/nondisclosure.html

More about MTAs:

http://www.research.umich.edu/projects/transfers/materials_transfer.html

More about UM Tech Transfer, IP policy:

http://www.techtransfer.umich.edu

More about UM Copyright policy:

http://www.copyright.umich.edu.copyright.umich.edu

More about Publication and Exceptions to policy:

http://www.research.umich.edu/policies/um/Regents_policy.html

More about COI - University policy:

http://www.research.umich.edu/research/policies/um/conflict_of_interest.html

Websites of Interest:

Audience Comment

I just want you to reemphasize, we’re seeing a lot of PI’s interacting with us saying that there assume that you’re also negotiating the financial contract, meaning the budget. Your office doesn’t do that, that’s up to the PI to do that and there are a lot of misconceptions about that.

Audience Question

“So do we have to decide on a final budget number before sending in the packet?”

Audience Question

“We had a new one that came up last week that I actually bounced over the Office of Research and Graduate Studies… a number of other major academic medical centers are charging for document storage space, because you have to retain documents for a certain period of time and its costly to do so. And the information I got back sort of informally is that that should already be covered in our indirect cost and I was wondering what your read on that was?”

Audience Question

“Non disclosure agreements… a lot of times we might have different roles with industry and we might start out and we might start out by being a consultant with them where we don’t necessarily need DRDA or the university to sign the non disclosure agreement but then that morphs them to where there might be sponsored research that occurs at the institution. If that occurs … do we then have to take a new NDA and get that signed? And until there’s a sponsored research agreement with the university there isn’t a requirement?”

Audience Question

“I just want to clarify… you don’t have to have a written IRB approval before you work on something?

That’s been drilled into my head since I’ve been here and I honestly have gotten a little tired of doing IRB stuff and waiting for IRB renewals when I don’t even have a contract signed.”

Audience Question

“Is there a claim eventually for your office to be hooked in with the M Prime system so that there would be some sort of automatic notification or parallel processing or is that going to be incumbent on the investigators to do that?”

Audience Question

“The topic of incentive payment has come up again recently and I can’t find policy on the web anywhere to refer someone to incentive payments for equipment to spur improvement..”

Audience Question

“It seems like they are still offering quite a bit of trips and other things.

Is there going to be something written down that we can point people to or is it just going to stay in a form?”

Audience Question

“If you go anywhere else you won’t find anything as good as the DRDA.

What’s the current status of the PEERS self education and certification process related to writing checks?”

Audience Comment

“If you are getting NIH money you have to at least do the human subjects and conflicts of interests modules.”