- What does the JHM IRB need to know about recruitment of study subjects?
- What types of recruiting tools may be used to inform potential subjects about a study?
- When is IRB review of clinical trial websites not required?
- Are informed consent and a HIPAA privacy authorization needed for recruitment?
- What privacy issues arise in the context of subject recruitment?
- What information must be included in recruiting tools? What other information may be included?
- What are restrictions on recruitment ads?
Federal regulations (both DHHS and FDA) require that IRBs make sure that the selection of subjects for a study is equitable. Each protocol submitted to the JHM IRB for review must explain how subjects will be identified and recruited for the study. Once the pool of potential subjects is identified, the IRB must consider how the investigator proposes to approach those individuals. Any approach to subjects must be non-coercive and the potential subjects must voluntarily participate in the recruitment process. The IRB and the investigator must respect and protect subject privacy – the subject’s right to control access to him or herself. In order to assure that these principles are met, the JHM IRB will review the study recruitment plan and all recruitment materials to determine how the materials will be used, whether the plan will reach the target audience, and how communication between the investigator and the potential subjects will occur.
Note: The JHM IRB will also review a recruiting plan to make sure that it complies with HIPAA and institutional requirements. Certain populations, such as students and employees, receive added protections from the JHM IRB to ensure that their decision to participate in a study will be truly voluntary and not vulnerable to coercion or undue influence exerted by the teacher/supervisor. Patients also receive added protection. Please see http://www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/guidelines/patient_recruitment.html for information about recruiting patients into research studies. Under HIPAA, the use of a person’s protected health information (PHI) in research generally is not permitted without an authorization from the subject or an IRB waiver of authorization. Therefore, HIPAA requires either an authorization from the subject or a full or partial IRB waiver of HIPAA authorization for recruitment.
Advertising and other recruiting tools may be used to inform potential subjects and/or other clinicians about a study. All proposed printed advertisements or brochures, web postings, social networking site advertisements (i.e. on Facebook), or audio/video advertising, and all communications with primary care physicians, other investigators, or potential subjects informing them about a study must be submitted for IRB review and approval prior to use. The JHM IRB will consider the text of the recruitment material and its placement. These tools are considered to be part of the subject selection and the informed consent process for the study. The type of recruiting tool should be specified (e.g., posted flier, website notice, newspaper ad, radio, newsletter from support groups, social networking site ad, etc.) Also, the specific location (e.g., name of the newspapers, radio stations, etc.) of the tool must be provided. All proposed recruiting tools associated with a recruitment plan must be reviewed and approved by the JHM IRB prior to use. This includes any recruitment plans, tools, or campaigns that will be undertaken by the sponsor or any contract research organization involved in the research.
In the case of social networking or search site advertisements:
- If the site provides a summary sheet of the arrangement, that summary should be uploaded into the application. If the investigator’s ad links to another website, a copy of the linked web page(s) should be submitted.
- If information from users will be collected through the interaction on a social networking site, the application must address how privacy will be maintained.
When choosing limiters (terms to target ads at categories of search or social network users) please consider carefully whether a given term could cause your ad to be presented to audiences for whom it is not intended or may not be appropriate (e.g., children), particularly when the ad refers to topics or behavior that may be sensitive or controversial.
Also, investigators are encouraged to consult the Hopkins Medicine Internet Marketing and Web Services group http://www.hopkinsmedicine.org/webcenter/index.html for strategic advice about how to target recruitment ads effectively.
Any significant proposed changes to previously approved recruiting tools, including how the tool will be used or placed, must be submitted to the JHM IRB for review and approval before they may be used to recruit subjects for a study.
Clinical trial websites that provide only directory listings with basic descriptive information about clinical trials in general do not need to be reviewed by an IRB. Basic descriptive information includes:
- Study title
- purpose of the study
- protocol summary
- basic eligibility criteria
- study site location(s), and
- how to contact the study site for further information
Clinical trial websites that include more than this basic descriptive information must be reviewed and approved by the IRB prior to posting. Examples of clinical trial listing services that do not need IRB review and approval include the National Institutes of Health (NIH) ClinicalTrials.gov website, the NIH National Cancer Institute's cancer clinical trials listing (Physician Data Query [PDQ]), and the government-sponsored AIDS Clinical Trials Information Service (ACTIS). See http://www.hhs.gov/ohrp/policy/clinicaltrials.html
The JHM IRB generally will require informed consent and HIPAA privacy authorization for recruitment unless it is impracticable to obtain consent/authorization for the recruitment process. If the JHM IRB determines that it is impracticable to obtain consent/authorization, the JHM IRB may grant a partial waiver of privacy authorization. (Please note that waiver of consent generally is not available for FDA studies.) Again, the investigator should describe the exact plan for the recruitment process in the protocol and request a partial waiver of informed consent/privacy authorization if the investigator believes it is needed for the protocol.
The DHHS and FDA regulations require that investigators protect the privacy of study subjects. The regulations do not, however, define what privacy means. Invasion of personal privacy is a subjective matter and it is difficult to assess what each individual subject will consider to be an invasion of privacy. The subject has the right to control access to him or herself, and that right extends to the entire subject selection, recruitment, and enrollment process. Any recruitment plan proposed for a research study must address privacy issues.
When the JHM IRB approves a partial waiver of consent and HIPAA privacy authorization for the purpose of recruiting subjects for a study, the individual being recruited will not know how the investigator obtained his/her PHI. If a recruiting letter is used, even if signed by the individual’s referring physician, it is advisable to include the following language (or something similar):
“The researchers have been given permission to contact you by a Johns Hopkins committee established under federal law to review uses of patient information.”
Remember: Even when the IRB partially waives HIPAA authorization for recruitment purposes, in most cases the investigators must still obtain subject informed consent and a HIPAA privacy authorization in a Hopkins-approved form for the use of subject information in the study itself.
The content of the recruiting tool must be informative to the potential subject. The information must be accurate and delivered without “overselling” the concept to the reader. The recruiting tool may not unduly influence the participant’s decision to participate in the study. The tool may not state or imply a certainty of favorable outcome or other benefits beyond those that are outlined in the consent document and protocol. The following information must be included in any proposed printed recruiting tool:
- The name of the principal investigator;
- The contact information to learn more about the study;
- The condition under study and/or the purpose of the research;
- A specific reference to “research study” in the text; and
- The JHM IRB protocol number.
(This information is not required on social networking site advertisements if its inclusion is impossible due to the small size of the advertisement. Investigators should include this information on linked websites whenever possible.)
Audio and video recruitment tools do not need to include the JHM IRB protocol number. In addition, recruiting tools may include the following additional information:
- The criteria that will be used to determine eligibility for the research;
- A brief list of the benefits offered to participants, if any;
- The type of “payment” to participants may be stated, but should not be emphasized by use of font enhancement or distinction;
- The time or other commitment required from participants; and
- The location of the research.
- Advertisements that are unduly coercive or promise a certainty of cure beyond what is outlined in the consent and the protocol.
- Advertisements that make claims, either explicitly or implicitly, that the drug, biologic, device or other research procedures are safe or effective for the purposes under investigation, or that the test article or other research procedures are known to be equivalent or superior to any other drug, biologic, device, or procedure.
- Advertisements that use terms such as "new treatment," "new medication" or "new drug" without explaining that the test article or the research procedures are investigational or experimental.
- Advertisements that promise "free medical treatment," when the intent is only to say subjects will not be charged for taking part in the investigation.
- Advertisements that emphasize the payment or the amount to be paid, by such means as larger or bold type, although it may state that subjects will be paid.
- Advertisements on social networking sites that target subjects under the age of 21 for studies involving illegal activities (i.e. underage drinking, illegal drug use) or for studies involving subject matter that the IRB determines is too sensitive for targeted advertising.