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Report on the Health Literacy of America’s Adults: Results From the 2003 National Assessment of Adult Literacy

Health literacy resources compiled by Paul D. Smith, MD.

Research Ethics Consult Service

Research Ethics Consult Service is a free service sponsored by the CCTSI.  It is available to all biomedical and behavioral researchers at the University of Colorado Denver, as well as its clinical affiliates, who seek advice about ethically complex aspects of their research, including recruitment of research participants.

Recruitment Oversight

CU Denver Recruitment Guidelines

Acceptable Methods

The following methods of recruiting subjects have been used in studies being conducted at the University of Colorado Denver and its affiliated institutions. Depending on circumstances, any of these methods may be in compliance with both the federal Common Rule (45 CFR 46) and the federal HIPAA Privacy Rule (45 CFR 164), but there also may be ethical and practical problems with any of the methods. The methods of recruitment must be outlined in the COMIRB application, and all materials distributed to potential research participants must also be approved by the COMIRB prior to use.

• Investigators maintain a separate database that asks research participants if they will agree ahead of time to be contacted for research in the future. Investigators contact patients about particular studies in accord with their signed consent.
  
  
• Study investigators enter recruitment information on the School of Medicine list of University of Colorado Denver Clinical Trials web page or a similarly managed website. Subjects then contact the study investigators.
  
  
• Advertisements, notices, and/or media are used to recruit subjects. The COMIRB must first approve the text of these. Subjects who respond to these will contact the study investigators. Note: No HIPAA-regulated Protected Health Information is used in this recruitment strategy.
  
  
• Study investigators provide their colleagues with a "Dear Patient" letter describing the study. This letter can be signed by the study investigators and would inform the patients how to contact them.
  
  
• Study investigators send a COMIRB-approved letter to colleagues asking for referrals of eligible patients interested in the study. The study investigators may provide the referring physicians a COMIRB-approved information sheet about the study to give to the patients. If interested, the patient will contact the PI.
  
  
• Study investigators who are also clinicians providing direct care recruit their own patients directly. Nurses or staff working with the investigators also may approach the patients. This respects privacy but also raises ethical concerns because of the difficulty of saying no and the therapeutic misconception.
  
  
• Study investigators recruit potential participants who are unknown to them. Examples include snowball sampling, use of social networks, direct approach to unknown people in public situations.
  
  
• Study investigators request a Waiver of Consent/Authorization for recruitment purposes. In all cases, the waiver must be justified in the "Waiver of Consent/Authorization for Recruitment Purposes" section of the COMIRB application. Waivers are granted in three primary situations:
  
  
  • In minimal risk studies in which subjects will be not be contacted (e.g., many chart review studies) researchers request a complete waiver of consent/authorization. The application must explain why the study cannot be done without the waiver.
    
    
  • If the study requires researchers to review charts to identify prospective subjects who will then be contacted and asked to be in the study, the justification for the waiver to review charts must show why the study cannot be done without the waiver. The waiver covers collecting only the minimum amount of information needed to make contact; consent is obtained before additional information is gathered. The CHR’s usual policy is that patients identified through chart review should be approached by someone already involved in their care. "Already involved in their care" includes health care professionals directly involved in their care as well as administrative and research staff working with the health care professionals.
    
    
  • In some circumstances it may be necessary for members of the research team who are not involved in the patient’s care to make the approach, either in person or by phone or letter. The application should explain why the study cannot be done unless the researchers approach subjects directly. Direct approach by someone not involved in the patient’s care is an exception to the usual policy but may be approved in exceptional circumstances such as emergency care research.

   

Who May Recruit

Individuals initiating contact (in person or by phone) with potential subjects must have basic knowledge about the study (so they can answer questions) and training in the voluntary nature of research participation. They also should be prepared to provide prospective subjects with:

• A researcher’s name and phone number (for questions about the study) and
• The phone number of the COMIRB (for questions about a research subject’s rights).

For purposes of recruitment, people are considered "involved in the patient’s care" (and therefore eligible to review HIPAA-protected information without an authorization or waiver) if they are:

• Health care professionals actually involved in the care or administrative or
• Research staff working with the professionals involved in the care.

SMC Oversight

The purposes of the CCTSI Study Monitoring Committee (SMC) include:

• Oversee the safety of studies conducted within the Clinical and Translational Research Centers (CTRC).  The SMC is charged to prospectively review the Data and Safety Monitoring Plans (DSMP) of all studies conducted on a CTRC and review studies that are active. 
• Oversee the recruitment and retention plan for all clinical research studies conducted at the University of Colorado Denver with COMIRB oversight.

CCTSI SMC Committee

The CCTSI SMC consists of SARC members as follows: (1) CCTSI Research Subject Advocate, (2) biostatistician, (3) physicians, and (4)  senior research scientists. The goals of the CCTSI SMC include:

Safety

• Provide independent monitoring to assure study safety and study integrity of active studies on a CTRC.
• Educate and support investigators to develop detailed and effective data and safety monitoring plans for their study.
• Ensure that there is appropriate oversight for significant risk studies (in conformity with NIH guidelines).
• Provide SARC with updates on the progress of current studies on a CTRC as needed.
• Ensure that new literature or research information is considered by on-going studies and revised appropriately.
• Review safety reports from other safety bodies and ensure that recommendations have been appropriately addressed.
• Oversee and liaise with safety officers.
• Act as a resource for DSMBs, safety officers, investigators, SARC, COMIRB, and the CTRCs.

Active studies on the CTRC shall undergo at least annual review by the SMC for safety based on risk assessment. 

Study monitoring requirements will vary depending on the nature and structure of the study to be undertaken.  Minimal or low risk studies can be monitored appropriately for safety by the investigator.  Moderate and high risk studies require a level of oversight other than can be provided by the investigator. These studies will utilize, in addition to the investigator, additional monitoring such as a safety officer or DSMB.

The extent of SMC safety monitoring for CCTSI studies will be based upon a risk assessment.  Factors to be taken into account include the following:

• Risk
• Investigator experience
• Multicenter vs single site investigator initiated studies
• Inclusion of normal, healthy subjects
• Inclusion of special populations
• Continued oversight of DSMB
• Continued SAE and AE monitoring

Recruitment

Delays in recruiting participants to clinical studies are a major barrier to progress in clinical research. Initially, it is important to develop realistic recruitment goals and have a means of tracking enrollment.  Recruitment milestones are expected to be met by the investigators at specific time periods.  It will be the responsibility of the CCTSI SMC to ensure the timely assessment of recruitment milestones.  If, at any time, recruitment falls significantly below the milestones projected by the principal investigator, the CCTSI will consider taking one or more actions, depending on the severity and duration of the recruitment shortfall.  The CCTSI SMC generally will work with the investigator to correct the deficiencies before taking action. 

Ethical Concerns

The researcher and the study team members should consider the following ethical questions when evaluating a recruitment strategy:

• Respect for privacy: Does the recruitment strategy respect an individual’s reasonable expectations for privacy? Will patients be upset when they learn researchers not involved in their care have read their medical records without permission?
  
  
• Lack of pressure: Is the study introduced in a way that allows subjects ample time to consider, with no undue pressure because of timing of the request, who makes the request, how the request is made, or the offering of excessive inducements? Will patients be put in a situation where they may hesitate to say "no" to their own physician? How will pressure be minimized?
  
  
• Unbiased presentation: Is all information accurate, balanced, and free of misleading emphases that make the study excessively attractive? Is the information as complete as is appropriate for each stage of recruitment?
  
  
• The "Therapeutic Misconception": Patients tend to believe a clinical trial—or anything proposed by health care providers—will benefit them, even if they’re told there is no assured benefit. Does the recruitment strategy work to counteract this misconception?
  
  
• Conflicting concerns
  
  
  • Subjects may prefer that someone involved in their care contact them about research, but they may find it hard to say "no" to a care provider.
  • Clinicians may find their clinical judgment in conflict with a desire to enroll patients in their research.

  
  

Principles

• Use of medical records: Access to medical records and identifiable health information by people not directly involved in a patient’s care should be avoided.
  
  
• Use of Protected Health Information: The amount of identifiable information gathered and the number of people who have access to identifiable information must be minimized.
  
  
• Contact: Prospective research subjects should be contacted by people directly involved in their care, not by unknown researchers.

COMIRB Recruitment Guidelines

Potential subjects cannot be specifically identified or contacted until COMIRB approval for the research has been obtained. It is possible to obtain general data relating to the availability of a specific population to ascertain the feasibility of the study.

There are a number of ways to recruit subjects:

• Existing Research Relationship
• Clinical or Professional Relationship
• Recruitment Database
• HIPAA A Authorization
• Advertisements
• ResearchMatch

Students as Subjects

When UCD students and/or employees are being recruited as potential subjects, researchers must ensure that there are additional safeguards for these subjects. The voluntary nature of their participation must be primary and without undue influence on their decision. Researchers must emphasize to subjects that neither their academic status nor grades or their employment will be affected by their participation decision.

To minimize coercion, investigators should avoid, whenever possible, the use of their students and employees in procedures which are neither therapeutic nor diagnostic. In these latter situations, investigators should solicit subjects through means such as bulletin board notices, flyers, advertisements in newspapers, and announcements in classes other than their own. When entering a classroom to recruit students and conduct research, e.g. administer a survey, investigators must do so at the end of the class period to allow non-participating students the option of leaving the classroom, thereby alleviating pressure to participate.

Finder's Fees and Incentives

Finder’s fees include any payment or gift to an individual who identifies a prospective subject. Principal Investigators and research personnel may not individually receive incentive payments or finder’s fees on a per participant basis. PIs may accept monetary rewards that are offered by
the sponsor only after the research is closed to enrollment and only if the reward is directed to the research team as a whole (e.g. funds allocated for purchasing educational materials or to support attendance at educational conferences).

Note: For Faculty and staff employed by the Denver VA: Questions regarding finder's fees and incentives involving VA studies should be directed to the Denver VA Research office or VA regional counsel.

Advertisements

The investigator will provide the COMIRB with all recruiting materials to be used in identifying participants including: the information contained in the advertisement, the mode of its communication; the final copy of printed advertisements or the COMIRB Advertising Components Submission Form (CF-260); the final audio/video taped advertisements.

The COMIRB must approve any and all advertisements prior to posting and/or distribution. The COMIRB may review:

• The information contained in the advertisement
• The mode of its communication
• The final copy of printed advertisements
• The final audio/video taped advertisements

This information should be submitted to the COMIRB with the initial application or as an addendum to the Protocol.

The COMIRB reviews the material to assure that the material is accurate and is not coercive or unduly optimistic, creating undue influence to the subject to participate which includes but is not limited to:

• Statements implying a certainty of favorable outcome or other benefits
• Claims, either explicitly or implicitly, that the drug, biologic or device was safe or effective for the purposes under investigation
• Claims, either explicitly or implicitly, that the test article was known to be equivalent or superior to any other drug, biologic or device
• Using terms like "new treatment," "new medication", or "new drug" without explaining that the test article was investigational
• Promising "free medical treatment" when the intent was only to say participants will not be charged for taking part in the investigation"
• Emphasis on payment or the amount to be paid, such as bold type or larger font on printed media
• Does not include exculpatory language
• Offers by the sponsor to include a coupon good for a discount on the purchase price for the product once it has been approved for marketing

Any advertisement to recruit subjects should be limited to the information the prospective subjects need to determine their eligibility and interest.

Payments to Subjects

Payment to research subjects is a way to reimburse a subject for travel and other experiences incurred due to participation. However, payment for participation is not considered a research benefit. Regardless of the form of remuneration, investigators must take care to avoid coercion of subjects. Payments should reflect the degree of risk, inconvenience, or discomfort associated with participation. The amount of compensation must be proportional to the risks and inconveniences posed by participation in the study.

The panel must review both the amount of payment and the proposed method of disbursement to assure that neither entails problems of coercion or undue influence.

Credit for payment should accrue and not be contingent upon the participant completing the entire study. Any amount paid as bonus for completion of the entire study should not be so great that it becomes coercive.

COMIRB Application

You will need to indicate the methods of recruitment to be used in the study such as:

• In-person or face-to-face
• Direct mailings to potential subjects (Letters/Postcards, etc)
• Electronic correspondence (E-mails)
• Telephone
• Advertisements
• Other Methods

All recruitment materials must be approved by the COMIRB before use. All recruitment materials must include the COMIRB number and the PI's name.  All advertisements must include the word "Research".

Selection of Subjects is Equitable

The COMIRB will review the recruitment methods and inclusion/exclusion criteria for the research to ensure equitable selection of subjects.  In making this assessment the COMIRB takes into Account the purposes of the research and the setting in which the research will be conducted, and is particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, fetuses, pregnant women, human in vitro fertilizations, persons who are decisionally challenged, or persons who are economically or educationally disadvantaged.