SCIENTIFIC COLLABORATION · UNITED STATES & COLOMBIA

Lead the science. Agree how it is delivered.

A framework for clinicians, investigators, institutions and legal teams: scientific approval, permissions, data, contributions and resources defined before work begins.

THREE DISTINCT DECISIONS

Admission. Scientific approval. Permission to execute.

Membership provides access to defined benefits. Each project needs scientific approval, then the permissions and agreements its activities require. Each decision has a distinct purpose.

You bringThe question, expertise, active supervision and authority over your contributions.

microscopIA coordinatesThe agreed team, methods, technical capacity and publication support.

The parties documentScope, budget, data, IP, responsibilities and milestones.

From proposal to execution

Every new research project, case report, case series or innovation proposal requires written approval from the corresponding Observatory Executive Director or research group principal investigator. Admission or membership does not replace this approval.

  1. Submit the aim, methods, proposed team, data, resources and expected outputs to the responsible scientific authority.
  2. The scientific authority reviews and approves the proposal, documenting its scope and conditions.
  3. Once approved, the Executive Director or principal investigator notifies microscopIA to initiate execution of the approved project.
  4. microscopIA coordinates responsibilities, staff, budget, milestones and data/IP agreements. Activities begin with the required ethics, institutional and regulatory permissions in place.

If leadership is vacant, microscopIA coordinates proposal intake and review; execution awaits approval from a formally designated scientific authority.

Protocols and collaboration agreements

PLAN THE REVIEW

What are you proposing, and where?

Use this selector to prepare the scientific, institutional and legal review. It does not grant authorization or determine an exemption.

Reviews & public datasets

Document the question, search or sampling plan, data licence, provenance and reproducible analysis. Confirm whether any individual-level information changes the institutional review or privacy requirements.

UNITED STATESIRB, institutional engagement & reliance

For covered human-subject research, identify the reviewing IRB and each institution’s responsibilities. Assess Common Rule applicability, HHS-supported institutional engagement/FWA and applicable single-IRB requirements. Scientific approval by microscopIA is a separate decision; no FWA or IRB status is implied by this page.

HHS · institutional engagement
UNITED STATESHIPAA: identify the disclosure route

When a covered entity uses or discloses PHI, document a permitted research route: authorization, applicable IRB/Privacy Board waiver or another allowed basis. A limited data set requires a data use agreement and remains protected. HIPAA de-identification must meet Safe Harbor or Expert Determination requirements; removing names alone is insufficient.

HHS · HIPAA & research
UNITED STATESBAA, data use & overseas access

A research disclosure does not automatically require a business associate agreement. A BAA depends on the function performed for a covered entity; document that analysis. Overseas ePHI storage or access requires appropriate risk assessment, agreements and controls where HIPAA applies, and must also satisfy employer and other applicable rules.

HHS · researcher and business associate roles
UNITED STATESDrugs, devices and clinical AI

Evaluate IND/IDE requirements and any supported exemption. Assign sponsor, investigator, monitoring and safety-reporting duties. Significant-risk device studies need the relevant FDA and IRB permissions before starting. Medical-image AI is not automatically non-device CDS because a clinician reviews the output.

FDA · CDS guidance, January 2026
UNITED STATESTrial registration, results & funding

Identify the responsible party and registration/results obligations under applicable law, NIH policy and journal rules. Define updates and deadlines in the project plan. For funded work, review award restrictions, foreign involvement, subcontracts, reporting and allowable costs before committing resources.

NIH · trial dissemination policy
UNITED STATESEmployment, clinical practice & conflicts

US clinicians should confirm outside-activity permission, institutional IP obligations, conflict disclosures and authority to use their employer’s data or name. Research collaboration does not authorize patient care in another state or country. Site credentialing, professional licensing and coverage remain project-specific.

Institutional agreement and local professional review
UNITED STATESCompensation and referral independence

Document any fees, discounts, remuneration or revenue share and assess federal/state fraud-and-abuse rules when applicable. No payment rewards patient referrals or orders. Fair market value alone does not establish Anti-Kickback Statute compliance. Scientific independence and publication rights remain protected.

HHS OIG · fraud-and-abuse guidance
COLOMBIAEthics review and vulnerable participants

Review Colombian health-research requirements, the applicable ethics committee, risk classification, consent and safeguards for children and other vulnerable participants. Resolve permissions before recruitment. The 2026 proposal to revise Resolution 8430 must not be treated as an enacted replacement without verifying the final rule.

MinSalud · published consultation; verify enacted rules
COLOMBIASensitive data and cross-border roles

Apply Law 1581 and relevant implementing rules to Colombian personal data. Document the lawful basis, sensitive-data safeguards, controller/processor roles and participant rights. Distinguish international transfer from transmission; determine the permitted route and required contract or authority before disclosure.

Colombia · Law 1581/2012
COLOMBIAClinical investigations and INVIMA

Assess Colombian drug/device study requirements and the responsibilities of authorized sites. For human drug research, consider applicable GCP and INVIMA registration/authorization requirements. A US approval or observatory approval does not replace Colombian permissions.

INVIMA · Resolution 2378/2008

Sources reviewed 3 October 2026. Other state, institutional, funder and study-location rules may apply; the agreement identifies them and the person responsible for verification.

What your project agreement should cover

Scope and terms can be negotiated. Ethics, privacy, integrity and contribution-based authorship remain requirements. Existing agreements change only with the parties’ authorization.

01Scientific protocol

Request the study question, objectives, design, population, eligibility, data sources, sample-size rationale where relevant, analysis plan, quality controls, limitations and intended outputs.

Confirm protocol version, amendments, ethics approval or exemption and trial registration where applicable.

Access to restricted documents follows authorization or a confidentiality agreement; a public project card is not the full protocol.

02Participating institutions

Identify the coordinating organization, clinical sites, data custodians, sponsors and ethics bodies by role.

Confirm each institution’s written participation and permissions before naming it as a study partner.

A researcher’s employment affiliation, author affiliation or personal network membership does not establish institutional sponsorship.

Prospective sites remain proposed until confirmed.

03Investigator and team roles

Distinguish group director, observatory director, project principal investigator, site investigator, methodological or technical support, coordinator and trainee.

Name the accountable PI for each study and agree supervision, decision rights, deliverables, effort, training and escalation.

Leadership of a group does not automatically make its director the PI of every linked manuscript.

04Authorship and contributions

Plan contributor roles early using CRediT, then review actual contributions before submission.

For biomedical manuscripts, authors must satisfy the four ICMJE criteria: substantive scientific contribution, intellectual drafting or revision, final approval and accountability.

Author order and corresponding-author duties are agreed transparently by the qualifying team.

Payment, membership, funding or status alone does not purchase authorship.

Preserve earned credit when participation ends.

05Data governance and rights

The project agreement must distinguish source-data custody, lawful authority to process personal information and rights to derived datasets or analyses.

Define controllers/processors where applicable, permitted purposes, access roles, de-identification, security, transfer safeguards, retention, audit, incident response, secondary-use approval and withdrawal or termination arrangements.

Source custody is not transferred merely by joining microscopIA.

No patient-level dataset is public by default.

Research access remains subject to consent or another applicable legal basis and ethics conditions.

06Intellectual property

List pre-existing software, protocols, datasets, devices, know-how and third-party licenses before work begins.

Agree rights to new code, models, inventions and other outputs, permitted use, licensing, patent costs, commercialization and publication review.

There is no blanket assignment of all an investigator’s IP through this public page.

Inventorship follows actual inventive contribution and applicable law; it differs from manuscript authorship.

A confidentiality or patent review must not become indefinite suppression of findings.

07Funding and economic participation

Negotiate a written project-specific budget and distinguish staff support, publication fees, membership, service fees, expense reimbursement, remuneration and any proposed revenue-sharing arrangement.

Define who pays, eligible receipts, gross or net calculation, exclusions, attribution, milestones, currency, taxes, payment dates, audit and termination.

No universal percentage or personal remuneration applies across all groups.

The ROP leadership call’s proposed 10% is specific to that call, conditional on funder rules and a prior written agreement; it is not a general entitlement or this group’s offer.

Do not apply prohibited success fees to grants.

Donors do not acquire scientific control.

08Decisions, independence and disputes

Agree scientific and administrative authority, conflicts-of-interest disclosures, recusal, project review, financial authorization, change control and a documented dispute route.

Project committees must identify their appointed members and actual remit.

Protect independent analysis and publication, including unfavorable or inconclusive findings.

Exit arrangements cover data, code, funds, unfinished work, safety and earned credit.

Mandatory legal, ethical and funder requirements cannot be waived by negotiation.

09Security and authorized access

Agree data locations, authorized personnel, least-privilege access, encryption, audit logging, backup, retention, deletion and incident escalation.

Request actual security evidence and any required BAA, data-use or processing agreement before patient data are transferred.

General website forms, email and AI chat are not approved channels for patient records or clinical images.

AI model training or secondary reuse needs a separately authorized purpose; it is not granted by joining a project.

10Clinical safety and regulated responsibilities

Name the sponsor and responsible clinicians where relevant.

Define monitoring, safety reports, participant complaints, vulnerable-population safeguards, insurance and injury arrangements before enrollment.

Delegated duties, service scope and institutional permissions are written explicitly.

Scientific support is not an automatic assumption of trial sponsorship, clinical delivery or regulatory representation.

11Contract, milestones and responsible exit

Record legal parties, deliverables, acceptance criteria, review dates, dependencies, currency, taxes, change requests and remedies for unmet commitments.

Governing law, forum, indemnity, liability, insurance and mandatory rights are resolved in the signed agreement with the parties’ legal teams.

Set a dispute contact, escalation and handover plan; financial disputes do not erase earned authorship or permit suppression of valid findings.

The documentation to review before joining

Scientific brief

Question, protocol/version, confirmed institutions, accountable PI and approval status.

Execution plan

Team, contributions, training, budget, milestones, reviews and clinical responsibilities.

Agreements and permissions

Data, security, IP, funding, publication, insurance and exit arrangements for the project.

This page guides negotiation; it is not a signed contract or evidence of regulatory, institutional or security authorization. Confirm study requirements and documentation with the relevant authorities and legal teams.

START WITHOUT SHARING CLINICAL DATA

A short proposal. A focused review.

Prepare a non-identifiable inquiry. This form opens your email application; it does not store or automatically send the proposal.

Jorge Racedo · Managing Director
jorge.racedo@microscopiatech.com

Do not include patient names, clinical images, identifiers, records or passwords. Request an approved channel before transferring data.

References for documented decisions