We all know how challenging drafting an effective informed consent form for research can be. As a researcher, you have the dual duty to disclose all the information considered to be legally and ethically necessary to make an informed decision in a manner that will be understandable to the prospective research participant.

Many efforts have been put over the years to develop lay expressions for common biomedical research terminologies. It seems however, that, when it comes to disclosing how confidentiality of personal information will be maintained, sponsors, researchers and IRBs often revert to language that is inappropriate for research participants. By focusing too much on compliance with privacy standards we might undervalue the participant’s right to make an informed decision.
Applying the 5 Ws commonly used in journalism – “who did what, where and when, and why” – could help comply with regulatory disclosure requirements in terms that are understandable to research participants.

WHY is the participant’s personal information required?

By answering this question, you establish the purpose for the collection, the use and the conservation of the research participant’s personal information. Under Canadian and US privacy normative documents, you may not collect information for an unspecified purpose.

WHAT personal information will be collected and used?

By answering this question, you provide a description of the personal information to be used and disclosed for the purpose of the research project. There is often a distinction between the information collected and used at the research site, which identifies the research participant by name, and the information disclosed to the sponsor/CRO where the name is usually replaced by a code. Personal information may sometimes be stripped of some or all of its identifiers prior to its disclosure (we say that this information is de-identified or anonymized). These situations need to be clearly established, as this will provide answers to the next question.

WHO will collect, use and have access to which information?

When answering this question, you should distinguish between the persons who will have access to nominative data at the research site and those who will have access to and use coded, de-identified or anonymized data. Under Canadian and US privacy normative texts, you simply need to identify the class of persons who will have access or use the personal information (e.g. sponsor of research, sponsor’s representatives, regulatory agencies). It is important to keep in mind that research participants have, under most privacy legislation, a right to access their personal information.

WHERE will the personal information be kept?

This question provides you with the opportunity to explain to prospective participants about how their personal health information will be protected. It is best practice to explain clearly which security measures are being put in place to ensure the confidentiality of the collected information. These security measures can be physical (e.g. locked cabinets), technological (e.g. passwords) and administrative (e.g. confidentiality agreements). Also, by answering this question, you will establish where research participants can access their personal information.

WHEN will the personal information collection, use and access stop?

Through this question, you establish whether the access and use of personal information is limited in time or not. You also provide information as to whether the information may be used for future research. If this is the case, research participants should have the option to opt-out and not provide their authorization for the secondary use of their data. Finally, the answer to this question allows you to establish limitations to research participants’ right to revoke their consent in order to maintain the integrity of the research.

Final thoughts

By applying these 5 Ws, you cover the core elements required under privacy standards. Some privacy regulations, such as HIPAA in the United States, may require that you incorporate specific required statements. Nevertheless, it is possible to be compliant with the regulations without using legalistic language. Ensuring that research participants make an informed decision is one of the many ways to foster a fair partnership for the advancement of scientific knowledge.
The Veritas IRB Inc. Editorial Board

The Veritas IRB Editorial Board covers questions of research ethics, clinical trial conduct, and human research participant protection primarily for sponsors, CROs and investigators/researchers. // Le blogue de Veritas IRB aborde des questions de l'éthique de la recherche, de la bonne conduite des essais cliniques, et de la protection des participants à la recherche dans une perspective axée sur les promoteurs de la recherche, les organismes de recherche sous contrat (ORCs ou CROs), et les chercheurs.