This text is the Draft Code of Ethics for Human Research Protection Consultants, circulated by Klote Medical Research Advisors. It is not yet final: several articles refer to thresholds and registry rules a coalition has still to set. Review before publication — see the notes below.
Human research protection consultants occupy an unusual position of trust. We advise the institutions that operate the systems protecting research participants, we are paid by those institutions, and we owe no formal duty to the participants those systems exist to protect. This code exists because that structural position creates hazards that no generic professional code addresses, and because the participants whose welfare our advice ultimately touches cannot see our work, evaluate it, or object to it.
Aspirationally, we hold that competent, independent, honest advice to research institutions is itself a form of participant protection, and that the standing to give unwelcome advice is the most valuable thing this profession has to offer. The enforceable articles below exist to protect that standing.
1.1. Where a consultant’s professional judgment is that a client’s preferred course would materially compromise the protection of research participants or the integrity of the human research protection system, the consultant shall say so to the client explicitly, in writing.
1.2. A consultant shall not deliver advice, draft documents, or structure findings so as to obscure a risk to participants or a material noncompliance in order to satisfy a client preference.
1.3. A consultant retains the right (and, in the circumstances defined in Article 3, the duty) to withdraw from an engagement rather than subordinate participant protection to client preference. Signatories agree that invoking this article in good faith is a protected act under Article 8.2 (non-retaliation).
2.1. A consultant shall disclose to the client, in writing, at or before engagement: financial ties to any party whose interests the engagement touches; referral, commission, or revenue-sharing arrangements; ownership or compensation interests in any product, tool, or vendor the consultant may recommend; and any relationship that a reasonable client would consider capable of biasing the advice.
2.2. Disclosures shall be renewed when circumstances change during an engagement, and material conflicts shall additionally be disclosed within the affected deliverable itself.
2.3. Where disclosure cannot cure the conflict (where no reasonable client would accept the advice as independent), the consultant shall decline or withdraw. Recuse or disclose; never conceal.
2.4. A consultant serving simultaneously in a governance, review, or accreditation role shall not use that role to advantage their own clients or practice, and shall recuse from any matter involving a current or recent client.
3.1. Client information is confidential by default, survives the engagement, and is used for no purpose other than the engagement.
3.2. Exception: duty to escalate. Where a consultant discovers (a) serious or continuing noncompliance that places research participants at material risk of harm, or (b) conduct that would require reporting to an oversight body under applicable regulation, the consultant shall: first, advise the client in writing of the finding and the client’s own reporting obligations; and if the client declines to act and the risk to participants is imminent and serious, escalate to the appropriate institutional official, and where the regulation itself so requires, the appropriate oversight body. Confidentiality is not a shield for concealing harm to participants.
3.3. Every engagement agreement shall state this article’s threshold and pathway in advance, so no client is surprised by the obligation.
3.4. The threshold in 3.2 is deliberately high: disagreement about interpretation, inefficiency, or immaterial noncompliance does not trigger escalation. A consultant who invokes 3.2 shall document the basis contemporaneously.
4.1. A consultant shall accept only engagements within their demonstrated competence, disclose material gaps at proposal stage, and decline or refer work beyond them.
4.2. A consultant shall maintain currency with the regulations, guidance, and practice of the domains in which they advise, and shall not advise at the edge of a regulation they do not command.
4.3. Delegated and subcontracted work remains the signatory’s responsibility.
5.1. A consultant shall not misstate or inflate credentials, experience, roles, or results, and shall not claim or imply certification, accreditation, or conformance status not actually held (see Registry tier rules).
5.2. A consultant shall not imply endorsement by, special access to, or continued influence over any regulator or accreditor, and shall not guarantee regulatory or accreditation outcomes.
5.3. Public statements about the consultant’s own work shall be accurate and verifiable.
6.1. A consultant who formerly held a governmental oversight role shall disclose that role, its scope, and its recency to any client where it is relevant to the engagement, and in any marketing that references government service.
6.2. Such a consultant shall observe all post-employment restrictions applicable to their former office, and beyond them, shall not represent or imply that former office confers continued influence, inside knowledge of non-public agency positions, or preferential treatment.
6.3. For a period following government service (coalition to set; straw-man two years), such a consultant shall not accept engagements whose principal subject is a specific matter over which they exercised official authority.
6.4. This article binds the founders and sponsor of this effort explicitly.
7.1. A consultant shall decline or withdraw from an engagement whose purpose, as reasonably apparent, is to manufacture the appearance of compliance or protection without its substance, including drafting documents that misdescribe actual practice, staging conditions for an inspection or site visit, or laundering a foregone conclusion through an “independent” review.
7.2. A consultant may assist a client in remediating genuine deficiencies, including urgently and discreetly; remediation is not complicity. The line is misrepresentation: fixing reality is the work, faking it is a violation.
7.3. A consultant is not responsible for a client’s rejection of competent advice, but shall not certify, sign, or lend their name to representations they know the client has made false.
8.1. A consultant shall not use their own credentials or certification to disparage non-credentialed practitioners as a class, or to imply that lack of a credential constitutes incompetence.
8.2. A consultant shall not retaliate against any person for a good-faith complaint, for escalation under Article 3, or for invoking Article 1.
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