Defining Consents

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Consents and the IRB

Before participants can be enrolled on a study, there is an ethical and legal requirement that they give informed consent, to ensure that they understand the study and that agreement is voluntary. Consent documents are reviewed and approved by the Institutional Review Board (IRB). A study can have a variety of consents, which are often revised during the study, all with IRB approval.

The role of CRMS is to document the consenting process by keeping track of: who has given consent, what consent version was signed, who obtained consent, and so on. This does not eliminate signing the written informed consent document - it is a place to record what was signed. Keeping consent information up-to-date in CRMS is the study team's responsibility.

Consents defined in CRMS need to represent the IRB consents approved for your study. The study team is then responsible for tracking all consents that were signed including re-consents.

In addition, consents may contain an Embedded Agreement. An Embedded Agreement is a question or series of questions within a consent form asking the study participants to agree to participant to optional parts of the study. Embedded agreements should be defined in CRMS, and participant responses to those questions must be recorded in CRMS as part of the consenting process. This will be discussed in greater detail below.

Consent Types

Main consent is agreement to participate in the main purpose of the study. If your study only has one consent form, it must be defined in CRMS as a main consent. In CRMS, accruals to your study are measured by counting main consents. To avoid undercounting accruals, every study needs at least one Main consent form.

Supplemental consent is an additional consent given to a participant who has already signed a main consent, and is already counted as an accrual, for a purpose not covered in the original main consent. CRMS tracks two types of supplemental consent:s:

  • Supplemental Banking consent: the participant agrees that extra or leftover tissue (e.g.,a supplemental consent allowing the PI to store/bank blood samples) collected for this study can be saved for use on other studies., tissues etc.
  • Supplemental Other consent: supplemental consent given for any other purpose.

Linked consent is consent given by a person linked to someone on the study. Linked consents are not included in study accrual totals. CRMS tracks three types of linked consents:

  • Linked Donor consent: consent given by a donor (e.g., a tissue donor on a transplant study).
  • Linked Caregiver consent: consent given by a person who gives care to, or answers questions for a participant on the study, such as a parent, spouse, or family physician.
  • Linked Other consent: linked consent given by any other person.

Finally, CRMS tracks a participant's reconsents. If a participant signs a consent form after already signing an earlier version of the same consent form, this is considered a reconsent. In CRMS, you will enter all consents a person signs and document when it is a reconsent. This allows you to have a record of all consents a person has signed.

Things to Consider Before Defining Consents in CRMS

Number and Types

How many different consent documents are being used in your study? If only one, then the consent you define in CRMS must have type Main. If more than one, decide which ones are main. A study can have multiple main consents. For example, a study with multiple main consents could be enrolling different groups of participants and have a different consent form for each; participants in all groups count as accruals to the study.

Then decide if any the supplemental or linked consents also apply to your study: Supplemental Banking, Supplemental Other, Linked Donor, Linked Caregiver, or Linked Other.

Helpful Names

Pick a name for each of your consents so that team members can easily match them to the signed consent documents. Name embedded agreements with the same idea in mind.

Embedded Agreements

Determine whether any of your consents has any embedded agreements. You will have to define all of the embedded agreements individually, so a participant's responses they can be recorded accurately.

Managing Consents

Defining a New Consent

To create a new consent in CRMS to represent an IRB-approved consent document:

  1. Go to your study.
  2. Choose Protocol Consents from the left navigation bar to go to the Consent List page.
  3. Select the New Consent button.
  4. On this Consent page, you must select a consent Type from the drop down menu. Make sure your study has at least one Main consent. Enrollments are calculated based on the main consent(s).
  5. Enter a Name that clearly identifies the IRB-approved consent document.
  6. Record the IRB Approval Date and the Version Date of your consent (These two dates may be the same.)
  7. Select Save to create the consent, and be taken to the View Consent page for the new consent, or select Cancel and return to the Consent List without creating a new form.
  8. If you are ready to use this, Choose Back to Consent List
  9. Find the consent you just defined and select Make Active (Do not Make Active if you need to add an embedded agreement - see below).
  10. If you are not ready to use this version, wait until your actual consent is IRB approved until you make this active.

Adding Embedded Agreements

To add embedded agreements to the consent form you just created:

  1. Select Add Embedded Agreement but only if your consent has questions within the consent document that you are asking the participant to answer. This takes you to the Edit Embedded Agreement page.
  2. Select the Type of Embedded Agreement that best describes the question from the drop down menu.
  3. Enter a Name that clearly identifies the agreement.
  4. Enter a Description that will help the person entering consent data to match this agreement with a printed consent document. Entering the actual question is most effective.
  5. Select Save to create this embedded consent, and take you back to the View Consent page.
  6. If you have another Embedded Agreement (another question), select Add Embedded Agreement and repeat steps 2 through 5.
  7. When you are finished adding Embedded Agreements, choose Back to Consent List to return to the Consent List page.
  8. If you have defined everything and are ready to use this form, choose Make Active.

Here is how the embedded agreements look to a person entering a signed consent document:

Note that the description rather than the name of each agreement is shown, and that the participant's response to each agreement is recorded separately. These agreements were phrased so that participant agreement corresponds to a Yes answer.

The Consent List Page

Once you have defined study consents, they are managed from your study's protocol consent list page. Select Protocol Consents from the left hand navigation to get there.

This example study has two versions of a single main consent form. This would be typical when a study is open to accrual and a there is new consent version waiting for IRB approval. The new version would be activated after IRB approval, causing the old version to be archived. Here is the Consents List page:

Blue text (like 5 and 6), is a link to some action: go to an edit page, create or delete something. You can delete a consent that is in development, but once you do, the information in the consent is lost.

The annotations refer by number to these aspects of the consent list page:

  1. The Consent Status menu determines which consents are shown, filtering by status. By default, only Active and In Development forms are shown. These are the options:
  2. For each form, consent status is color-coded: Active forms are marked with a green Image:ActiveGreen.png dot, In Development orange Image:InDevOrange.png, and Archive gray Image:ArchivedGray.png. This study has one defined consent with two versions: one is active and the other is in development.
  3. A yellow folder Image:Embedded.gif icon indicates that a consent form has Embedded Agreements.
  4. The Version Date and IRB Approval Date should match the dates on the IRB-approved consent document.
  5. Only consents that are In Development can be edited. Others can only be viewed. Either link takes you to the View Consent page, described below.
  6. To create a new version of an existing consent form, select the New Version link. This creates a new version, and takes you to the View Consent page, described below.
  7. This version cannot be made active because there is no IRB Approval Date.
  8. Select the New Consent button to create a new consent form. This takes you to the Edit Consent page, described below.

Getting More Help

Clinical Research Management System (CRMS) Support Pool:

e-mail: crmshelp@jhmi.edu
phone: 443-615-1186

CRMS Training Website:

http://www.hopkinsinteractive.com

CRMS Website:

https://research-prod.jhmi.edu

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