Let’s take a consent form road trip!
With the next 1,000 words as our GPS, let’s go on a cross-country trek—a road trip across U.S. state laws affecting consent forms for human subject research.
Although some state laws duplicate or echo federal requirements, others call for additional protections beyond what federal regulations describe. State laws sometimes require content in the consent form that U.S regulations or industry standards do not.
What does this mean for you?
Sponsors and investigators should seek legal guidance regarding specific consent requirements applicable to the state, or states, where they conduct research. As the U.S. Food and Drug Administration (FDA) puts it in its July 2014 guidance Informed Consent Information Sheet, “The clinical investigator is responsible … for ensuring that legally effective informed consent is obtained from each subject before that subject takes part in the clinical investigation.” Legally effective informed consent includes applicable federal, state, and local laws.
Investigators transitioning from local to independent Institutional Review Boards (IRBs)—or sponsors seeking ethics review for multisite studies—should check that the independent IRB has knowledge and services to support and streamline investigators’ efforts to comply with state laws.
In addition, sponsors and investigators who use a remote eConsent process should verify that their consent form addresses all state laws where participants might consent and not just the laws of the state where a specific research site is located.
(Keep in mind that our route covers state laws commonly requiring information in consent forms that federal regulations do not.)
Stop 1: The Garden State – New Jersey
For applicable research,1 New Jersey’s Access to Medical Research Act describes consent form requirements such as:
- The name, address, and phone number for an “impartial third party … to whom the subject may address complaints about the research.” Note that the Act mentions the third party in addition to a “contact for the institutional review board,” suggesting that the third party and the IRB cannot be one in the same.2
- The signature and date provided by a signatory “who can attest that the requirements for informed consent to the medical research have been satisfied” and “who is not the subject, his guardian or authorized representative, or the researcher.”3
Stop 2: The Empire State – New York
New York state law calls for specific information in consent forms for genetic testing, such as “a statement indicating that the individual may wish to obtain professional genetic counseling…”4
Stop 3: The Crossroads of America – Indiana
Consent forms often include a HIPAA authorization describing what participants are agreeing to if they allow the use and sharing of their information for research, in accordance with the U.S. HIPAA Privacy Rule. Bear in mind that a HIPAA authorization in Indiana might require additional content beyond what federal regulations require, such as the participant’s name and address.5
Stop 4: The Golden State – California
California’s laws can shape consent forms and HIPAA authorizations.
The California state law describes consent form requirements for research that meets the state’s criteria for a “medical experiment.”6 Highlights include:
- The name, address, and phone number for “an impartial third party … to whom the subject may address complaints about the experiment.”7 Sound familiar? In contrast to the New Jersey’s comparable statute (discussed above), the California law doesn’t separately mention an IRB in this context—which suggests that the consent form can potentially list the IRB as the entity that should field complaints.
- The amount of time a participant might need to recover from study participation.8
- An “experimental subject’s bill of rights,” which potential participants should receive “prior to” informed consent. Consent forms might not include the bill of rights itself, but they often mention it (as a trigger for study staff to provide it to potential participants early in the consenting process).9 , 10
California state law describes required features of a HIPAA authorization, notably:
- A 14-point or larger font 11
- Positioning that allows the authorization to be “separate” from other text appearing on the same page 12
- The participant’s (or appropriate designee’s) signature and date specifically for the authorization 13
- A date when the authorization expires 14
Stop 5: The Evergreen State – Washington
Washington state law requires a specific expiration date or “event” in the HIPAA authorization.15
Ready, set, go
Is the interstate superhighway of consent calling your name yet?
Remember, the key rule of the road is to not go at it alone; state laws present a complex legal cartography. Research stakeholders should work with legal experts to ensure that their consent forms, and how they conduct research generally, align with state laws. In other words, for comprehensive state law compliance, let a lawyer drive.
1 For a description of applicable research, see N.J. Rev. Stat. § 26:14-3 (2013))
2 N.J. Rev. Stat. § 26:14-4(a)(10)
3 N.J. Rev. Stat. § 26:14-4(c)
4 N.Y. CVR § 79-l(2)(a)
5 I.C. §16-39-1-4
6 For the definition of a “medical experiment” under California state law, see Cal. Health & Saf. Code § 24174(c)
7 Cal. Health & Saf. Code § 24173(c)(10)
8 Cal. Health & Saf. Code § 24173(c)(5)
9 Cal. Health & Saf. Code § 24172)
10 Cal. Health & Saf. Code § 24173(a)
11 Cal. Civ. Code § 56.11(a)
12 Cal. Civ. Code § 56.11(b)
13 Cal. Civ. Code § 56.11(c)
14 Cal. Civ. Code § 56.11(h)
15 Wa. Rev. Code § 70.02.030(f)