Policy and Terms of Reference

Council for Nutritional and Environmental Medicine (CONEM)
Version: 1.0
Effective date: 5 January 2026
Approved on behalf of CONEM by: Geir Bjørklund, President

§ 1 Purpose

The CONEM Research Ethics Committee provides independent ethical review of research projects conducted under, submitted through, or formally associated with the Council for Nutritional and Environmental Medicine.

The purpose of the Committee is to promote ethical research practice, the protection of research participants, respect for human dignity, scientific integrity, confidentiality, responsible data use, and compliance with applicable ethical standards.

§ 2 Mandate and scope

The Committee may review research involving human participants, human-derived data, biological material, health-related information, laboratory data, questionnaires, registries, records, or other research materials.

The Committee may review prospective, retrospective, observational, interventional, survey-based, laboratory-based, and data-based studies. It may also review requests for waiver of informed consent, protocol amendments, and determinations of exemption or that no formal ethics review is required.

Review by the Committee applies within CONEM’s research ethics mandate. It does not replace any legally required national, institutional, university, hospital, governmental, or regulatory ethics approval. Investigators remain responsible for ensuring compliance with applicable laws, institutional rules, contractual obligations, funder requirements, data-protection requirements, and journal policies.

§ 3 Independence

The Committee shall make its decisions independently. Although established under CONEM, the Committee shall base its decisions on ethical principles, participant protection, scientific integrity, risk–benefit assessment, confidentiality, and applicable standards of responsible research conduct.

No person or body outside the Committee may require the Committee to approve a study.

§ 4 Composition

The Committee shall consist of members with relevant competence in medicine, biomedical science, public health, ethics, law, data protection, research methodology, or related fields.

Voting members shall be formally appointed by CONEM. Appointments, changes in membership, and designated Committee roles shall be documented in writing.

Members may be based in different countries. The Committee shall normally include at least three voting members. Additional external experts may be consulted when specialized expertise is required. External experts may advise the Committee but shall not vote unless formally appointed as voting members.

The Committee shall have a Chair, who shall be a voting member. A Vice-Chair or Secretary may be appointed when appropriate.

§ 5 Conflicts of interest

Committee members must declare any actual, potential, or perceived conflict of interest before participating in a review. Conflicts may include authorship, planned authorship, financial interest, institutional responsibility, supervisory responsibility, personal relationships, or other direct involvement in the study.

A conflicted member shall not participate in deliberations or vote on the decision. The conflict and the member’s non-participation shall be recorded.

If the Chair is conflicted, the review shall be led by an unconflicted voting member appointed by the Committee.

§ 6 Review procedures

The Committee may conduct reviews and make decisions through online meetings, email correspondence, secure electronic document exchange, or a combination of these methods.

For full review, a valid decision requires the participation of at least three unconflicted voting members.

For expedited review of a minimal-risk study, the review may be conducted by the Chair and at least one additional unconflicted voting member. The decision shall be reported to the Committee.

Decisions shall normally be made by consensus. If consensus cannot be reached, the decision shall be made by majority vote among the participating unconflicted voting members. Silence or failure to respond shall not be counted as approval.

§ 7 Types of review

7.1 Full review

Full review is required for studies involving more than minimal risk, direct participant involvement, collection of new biological material, identifiable personal information, sensitive data, complex consent issues, or other ethical concerns requiring broader Committee consideration.

7.2 Expedited review

Expedited review may be used for minimal-risk studies, including retrospective analyses of coded, de-identified, anonymized, or aggregate data, provided that appropriate safeguards are in place.

7.3 Exemption or no formal review required

The Committee may determine that a project is exempt from formal ethics review or does not require formal ethics review, for example when the project involves only publicly available information, fully anonymized aggregate data, or research that does not involve human participants.

Such determinations shall be documented in writing.

§ 8 Documents required for review

Investigators shall submit, as applicable:

1. the study title and protocol or project summary;
2. the names, affiliations, and roles of the investigators;
3. the study objectives and design;
4. a description of the participants, data source, or research material;
5. the variables or materials to be analyzed;
6. the consent procedure or justification for waiver of consent;
7. the proposed data-protection and confidentiality measures;
8. an assessment of identifiability, coding, de-identification, or anonymization;
9. a risk–benefit assessment;
10. funding and conflict-of-interest statements;
11. the planned publication or dissemination of the findings; and
12. confirmation of any other required approvals, where applicable.

The Committee may request additional information before issuing a decision.

§ 9 Ethical review criteria

The Committee shall consider, as applicable:

1. the scientific and ethical justification of the study;
2. the proportionality of the risks and expected benefits;
3. the protection of privacy and confidentiality;
4. the adequacy of the consent procedures or justification for waiver of consent;
5. the safeguards for personal, health-related, or sensitive data;
6. the identifiability, coding, de-identification, or anonymization of the data;
7. the proposed use, storage, retention, sharing, and destruction of data or materials;
8. the protection of individuals or groups requiring special ethical consideration;
9. transparency regarding funding and conflicts of interest; and
10. responsible publication and dissemination.

§ 10 Waiver of informed consent

The Committee may approve a waiver of individual informed consent when ethically justified.

A waiver may be considered when:

1. the study involves no more than minimal risk;
2. the research uses existing data or materials;
3. obtaining individual consent is impracticable;
4. the rights and welfare of the individuals concerned are not adversely affected;
5. adequate confidentiality and data-protection safeguards are in place; and
6. the study has sufficient scientific or public-interest justification.

The reasons for granting a waiver shall be recorded in the approval letter or Committee records.

§ 11 Data protection and confidentiality

Investigators must protect personal, health-related, and sensitive data in accordance with applicable legal and ethical requirements.

The Committee shall consider whether data are identifiable, coded, de-identified, anonymized, or aggregate. Where re-identification is possible through a code key held by any person or organization, the data shall not be described as fully anonymous.

Access to data shall be limited to authorized persons. Data shall be stored securely, used only for approved purposes, and retained or destroyed in accordance with applicable requirements.

Committee members and external experts shall maintain the confidentiality of submitted documents, deliberations, personal information, and Committee records.

§ 12 Decisions

The Committee may issue one of the following decisions:

1. approved;
2. approved with conditions;
3. revision required before approval;
4. not approved;
5. exempt or no formal ethics review required; or
6. outside the Committee’s remit.

All decisions shall be documented in writing.

§ 13 Approval letters

Approval letters shall include:

1. the name of the Committee;
2. the study title;
3. the name of the principal investigator;
4. the approval number;
5. the approval date;
6. the type of review;
7. the decision;
8. any waiver of informed consent;
9. any conditions attached to the approval;
10. a statement that the approval applies within the Committee’s mandate; and
11. the signature of the Chair or an authorized representative.

Recommended wording:

This study was reviewed and approved by the Research Ethics Committee of the Council for Nutritional and Environmental Medicine (CONEM; approval no. [insert], [date]).

Where the requirement for informed consent has been waived:

The requirement for individual informed consent was waived because the study met the Committee’s criteria for waiver of consent.

Approval by the CONEM Research Ethics Committee confirms ethical review within the Committee’s mandate and does not replace any legally required national, institutional, or regulatory approval.

§ 14 Amendments

Substantial amendments to an approved study must be submitted to the Committee for review before implementation.

Substantial amendments may include changes to the study aims, design, data source, participant involvement, identifiability of data, consent procedures, data sharing, or level of risk.

Minor administrative changes may be recorded without full re-review at the discretion of the Chair.

§ 15 Responsibilities of investigators

Investigators are responsible for conducting the study in accordance with the approved protocol, applicable ethical standards, data-protection requirements, institutional policies, contractual obligations, and legal requirements.

Investigators must report serious ethical concerns, confidentiality breaches, significant protocol deviations, or unexpected risks to the Committee.

Approval by the Committee does not remove the investigators’ responsibility to obtain any other approval required by law, an institution, a funder, a journal, or a research site.

§ 16 Records and archiving

The Committee shall retain records of submitted documents, decisions, votes, meeting minutes or email decisions, approval letters, amendments, and conflict-of-interest declarations.

Records shall normally be retained for at least ten years unless a longer retention period is required by applicable law, institutional policy, funder requirements, or journal requirements.

§ 17 Language and communication

The working language of the Committee shall be English unless otherwise decided.

Meetings may be held online. Reviews and decisions may be documented through email or electronic signatures where appropriate. Electronic records shall be retained as part of the Committee’s official documentation.

§ 18 Review of this policy

This policy shall be reviewed periodically and updated when necessary to reflect changes in ethical standards, legal requirements, research practices, publication requirements, or CONEM procedures.