An institutional editing service for consent documents
An institution can make the readability of its consent documents somebody's job by placing scientific editors in their review. The editors work on consent documents before the ethics committee sees them and on changes after approval. They build a library of committee-approved lay language, a one-page overview that can be given to the participant beside the form, and templates for each kind of study. Relying on these resources without questioning their accuracy again would be a dangerous complacency.
Editors in the review of consent documents
A US cancer centre hired a group of scientific editors to edit every initial consent document and every revision for readability.
Every new scientific editor at the centre is required to take the American Medical Writers Association's plain language workshop, to train in preparing health information materials for readers with limited literacy skills and to learn about writing for them, at reading levels for grades 4 to 8.
The editors develop each consent document together with the principal investigators, research faculty and ethics committees. The investigator submits a draft to the scientific editor for review of its literacy level; the editor makes changes and returns it with queries; the investigator answers them, sometimes with input from the study sponsor, and returns it; the editor makes any further changes and submits the revised document to the ethics committee for review.
As a service to researchers, the centre's ethics committee office runs a pre-review, conducted by a staff of ten scientific editors whose goal is to make consent documents as clear and concise as possible. They edit consent documents before the committee reviews them, attend every committee meeting to answer questions about them, and revise them on the committee's recommendation. After approval the same editors pre-review changes arising from a sponsor's amendment or from new safety information, and help draft and finalise the revision before it goes back to the committee.
The centre's consent documents use simple paragraphs and bulleted lists and tables. Where a sponsor requires particular information to be included, the editors explain it as simply as possible. They also go to great lengths to get the language just right: a question such as whether to write "teaspoon" or "teaspoon full" can run to 76 emails before it is settled.
A library of approved lay language
The editors created glossaries, or boilerplates, of commonly recurring medical words, phrases, procedures, adverse events and drug definitions, all written at the sixth-to-eighth-grade reading level. The editors' customised databases and glossaries define hundreds of side effects and procedures in concise terminology validated by medical and literacy experts.
The boilerplate database holds standard phrases and definitions for drafting a new consent document: recurring medical words, phrases and procedures, procedural definitions and drug descriptions. Its advantage is that every phrase and definition has been rigorously reviewed by several parties, including scientists and lay people. Its entries include:
- Vital signs: your vital signs (blood pressure, heart rate, temperature and breathing rate) will be measured.
- Electrocardiogram: you will have an electrocardiogram (ECG) to check your heart function.
- Placebo: a placebo is not a drug; it looks like the study drug but is not designed to treat any disease or illness, and it is designed to be compared with a study drug to learn if the study drug has any real effect.
- Pharmacokinetic (PK) testing: PK testing measures the amount of study drug in the body at different time points.
Standard operating procedures govern adding an entry to the database, and they may be applied to build a similar database at any institution. A new procedure arrives in a submitted document; an editor researches it, describes it in lay language, and sends the description to the study's principal investigator. If the investigator approves it, the ethics committee reviews it, the editor makes any changes the committee asks for on the investigator's behalf, and the description enters the database. If the investigator does not approve it, the investigator revises the wording, the editor sends that revision to the committee, with comments attached where the editor disagrees with it, and the committee determines the final language, which then enters the database.
The database gives the editors committee-approved language to support changes to a document. This can be an advantage when working with trial sponsors, because the language the committee allows is already established. The boilerplates also make consent documents consistent across the institution and speed their drafting and editing for research staff and editors alike. They have increased the clarity of highly complex information. Research participants and their families are then in a better position to make a voluntary and informed decision about whether to take part. A boilerplate database can be customised and implemented in diverse clinical research settings.
The information technology department added a program that uses the database to turn technical terms into lay terms in the word processor and, when a drug's name is entered, lists its side effects in lay terms, which speeds the preparation of consent documents for research staff and editors.
Lay language for side effects
Side effects, one of the required elements of informed consent, are described as simply as possible using an institutional glossary of side effects developed with a side-effects committee of doctors, nurses and lay people. The glossary must also be vetted by an ad hoc committee of the ethics committee made up of doctors, research staff and community members. It lists more than 2,000 side effects translated from their technical description to a lay description, and it continues to expand every day.
Alongside the glossary, the editors maintain a database of ethics-committee-approved side-effect profiles for hundreds of drugs and procedures. Researchers composing a consent document in the institution's software can import the approved side-effect language into it with one click. The glossary and the database are both models that other institutions can implement to standardise their consent forms.
A one-page overview for the participant
The centre's editors, who handle the consent documents for more than 4,000 open protocols, built a template for a one-page overview of a study's tests, treatments, side effects and study visits, to help patients understand the study and the consent document. The overview can be given to the patient along with the consent document.
Consent templates
The editors help create consent templates for every kind of study at the institution, including clinical, psychosocial, behavioural and laboratory studies, working with the legal department and the ethics committees. When a new template is released, they help investigators and research staff bring every existing consent document in the institution onto it.
Consistency and clarity across the institution
The editors developed several resources to communicate scientific information consistently and effectively and to emphasise the most critical information. The boilerplate database, the side-effect database, the side-effect glossary and the consent templates together foster consistency among consent documents across the institution while increasing the clarity of complex information. This consistent presentation helps disclose the relevant information to potential participants, allowing them to make a voluntary and informed decision about whether to take part. These resources were implemented at one institution, but similar ones could be created at any institution to improve patients' understanding.
Keeping the resources accurate
For the process to stay relevant, it is vital that medical writers keep communicating with each other about ways to make writing more understandable and to share what they learn. Once templates and databases are built, it would be easy to rely on them without ever questioning their accuracy again. That would be a dangerous complacency. New discoveries are made every day, and they cannot be allowed to pass unnoticed. Writers must strive to consider everything and question everything; only then can they say they have done their very best to protect and inform the people who have entrusted the research community with their lives.