Rio Salado Community College Data Management Plan
Rio Salado Community College Data Management Plan
Chapter 2. Recruitment and Informed Consent
2.1 Best Practices for Recruitment
The most successful clinics from a recruitment perspective adopt a very organized approach to
recruitment that includes planning, developing and implementing multiple strategies in an
organized manner. It is typically necessary to pursue 2 or 3 strategies simultaneously in order
to be highly successful with recruitment. Success in simultaneous implementation of multiple
strategies requires dedicated effort, organization, coordination and persistence.
Recruitment strategies include:
1. Many clinics will have access to a patient database that can be searched via a
computerized search. Develop this resource early, including any relationships with
information services personnel that will be required. Assure that you will have the ability
to screen for basic eligibility criteria and to obtain contact information for mailings and
telephone contacts. Clinics that do not have electronic medical records may have
electronic billing databases that can be used to identify patients who have had
encounters for hypertension (but not diabetes).
2. Mailings can be useful for contacting patients identified through the electronic database
queries. A recruitment brochure or postcard with a toll free number and/or website can
help engage potential participants. Similar mailings can be sent to residents in your
clinic’s catchment area by purchasing mailing lists or contracting with local organizations
that provide this service. For example, in Winston-Salem, NC, the local newspaper
provides this service, and we have used their services with good results in previous
studies. Development of the brochure can be a central task, but if a local or regional
phone number is needed, local adaption is required. This can be done using adhesive
labels, or via local printing of centrally developed and locally modified brochures.
3. Brochures can also be useful for placement in waiting rooms of potential referring
physicians’ practices and in pharmacies as possible prescription bag stuffers for patients
picking up prescriptions for blood pressure medications. Recruitment information can
also be added to appt. reminder cards/letters. These relationships should be developed
early. Rio Salado Community College Data Management Plan
4. Similarly, wall posters can be useful for display in physicians’ offices and other places.
In comparison with brochures, posters have the relative disadvantage of not being
placed in a potential participant’s hands. Since the potential participant cannot take the
poster home, they must write the contact information down. This step is a potential
barrier. Posters can be developed centrally, but must be adapted locally; if a local
phone number is to be used (tear-off labels w/local contact information may be affixed to
posters, where possible).
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5. Advertisements can be useful, especially in newspapers, given the age range of our
target population. In some communities, radio ads may be particularly useful. In our
experience, billboards, bus ads and television have been less helpful than newspapers.
Newspaper ad copy can be developed centrally and modified locally to include
appropriate phone numbers. A phone service can reduce the need for local adaptation.
(Advertisements in local church or senior center bulletins/newsletters are other potential
FINAL VERSION 2-2
areas to pursue). A telephone script has been developed for the clinics to use as a brief
screening tool to identify potential participants.
6. A central website that can be linked to other sites that people visit to find clinical
research opportunities can be very helpful. The site can include simple screening
questions and a look-up function for a nearby clinic, if any. The website can include a
“contact us” function for requesting more information and submitting potential screenees
contact and screening information. The site should also include telephone numbers for
information, telephone screening, and/or scheduling of a screening visit.
7. A central phone bank can reduce the burden on busy clinic coordinators who may
otherwise need to play telephone tag with potential participants between other pressing
activities. In previous studies, we have used a central phone bank to receive calls and
promptly return calls to conduct telephone screening. After initial telephone screening,
tentatively eligible persons can be referred to local clinics for in-persons visits, so local
coordinator time can be devoted to in-clinic screening of a higher yield population. The
typical salary of a telephone data collector is lower than that of a study coordinator, so
the budget is usually favorably affected. The telephone screening instrument can be
developed centrally.
8. Public presentations can be useful. High blood pressure is quite common; hence,
presentations to community groups can be quite useful. In addition, presentations to
health professional groups can help develop referral sources. Slides were developed
centrally to support lay and health professional presentations. For lay group
presentations, simple screenings can be conducted when possible and allowable.
Brochures are excellent supporting materials in these venues. Rio Salado Community College Data Management Plan
Organizational approaches
It is important for the recruitment team to develop a schedule of activities such that the team
members know what events will be conducted each day during the recruitment period. It is
advised that each clinic have at least 3 active strategies ongoing in any given month. Clinics
that become overly reliant on a single method can see recruitment slowrapidly if that approach
begins to falter. Development and implementation of multiple strategies leads to a greater
likelihood of success. Some successful clinics have found it useful to have a recruitment
calendar on which they write the recruitment oriented activities planned for each day, week, and
month. By doing so, it is easy to see the planned and previously conducted activities and avoid
overloading a specific day, week, or month with activities representing a single strategy.
Oversight
The clinic PI and coordinator should meet on an every week (or two) basis during recruitment to
reviewthe past week’s and month’s (and recruitment period to date) recruitment productivity
(e.g., telephone screenings conducted, clinic screenings conducted, number of potential eligible,
number randomized), the next week’s schedule for screening and randomization visits, and the
next month’s schedule of recruitment activities (days on which newspapers ads are planned,
presentations are planned, practices or pharmacies will be visited, mailings will be
disseminated, etc.) We encourage each CCN to support clinic recruitment activities and to
assess CCN and clinic recruitment performance during monthlyCCN calls or meetings. Clinics
should share successes and challenges.
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2.2 General Recruitment and Regulatory Guidelines
Participant Screening within the ClinicalPractice
Each SPRINT site should consult their local IRB regarding prior approvals to access internal
medical record searches for potential SPRINT patients. SPRINT sites should work with the
respective networks to complete HIPAA Privacy rule documents, preparatory to research
waivers and training prior to patient medical record searches. Once the local regulatory
requirements have been approved, investigator-based clinics can be reviewed using the
SPRINT inclusion/exclusion criteria to identify potential study patients in their own practice. The
investigator can contact the potential patient and ask about their interest by providing study
information such as approved recruitment materials to them in person or by other means such
as mail or email access.
Depending on the institution, it may also be necessary to request approval from other
physicians in the clinical practice to request a consultation for a screening referral to the
SPRINT clinic. The patient can then be contacted via an approved IRB screening letter or from
the referring physician to discuss their interest in SPRINT. Informed consent procedures must
be initiated first and obtained prior to performing any procedures related to the trial (see section
below).
Large scale data base searches may also yield an accurate assessment of the study population
using the basic inclusion criteria of the ICD-9 code for a hypertension diagnosis, no diagnosis of
hypertension but have clinic readings of SBP > 130 mm Hg, no diabetes mellitus, stroke or
polycystic kidney disease. Other study parameters should include a breakdown by qualifying
age, race, gender and the sub-set of potential patients with Stage 3 CKD. Depending on the
institution, prior approvals may be needed to obtain de-identified patient information and are
known commonly as data transfer agreements. Investigators usually must sign a privacy
agreement to protect the patient’s private health information (PHI) as part of this process with
the local IRB in coordination with the institution’s designated privacy, security and compliance
services. Some institutions may also require a HIPAA waiver to reviewpatient records for
recruitment and possibly, consent waivers. Reviewdata base searches with your respective
institutional reviewboards and sometimes, it is best to complete these requests during the initial
submission.
Individuals Recruited Outside Existing Clinical Site Practices
Individuals identified by any media strategy or who are otherwise identified outside of the
practice of the SPRINT clinical site will have to be appropriately screened. Approved study
general questionnaires could be completed utilizing the general inclusion/exclusion criteria to
self identify potential patients with hypertension, no diabetes mellitus, stroke or PKD. A study
brochure and a return post card can be used by potential study participants by mailing back
their responses. Rio Salado Community College Data Management Plan
Telephone screenings can be useful to clinics for participants who call in or respond by post
card. Once basic inclusion and exclusion criteria are ascertained, the participant can be invited
to the clinic to reviewand sign the informed consent and HIPAA document to complete an indepth screening using the SPRINT Inclusion and Exclusion Form.
FINAL VERSION 2-4
Recruitment of StudyParticipants and Study Recruitment Reports
Patient recruitment is of prime importance to the success of this study. Each SPRINT site will be
responsible for identifying and recruiting participants into the study. Once potential participants
are identified, the site will collect information to determine eligibility. Potential participants who
are eligible for and are interested in the study will be asked to sign an informed consent form
and HIPAA document will subsequently be enrolled into the study. The site will track each
potential participant from the time s/he is identified until s/he is enrolled or not enrolled.Each
site will document and report a summary of recruitment and enrollment progress as provided by
the CC with the Recruitment, Retention and Adherence Sub-Committee (RR&A). The CC will
provide numerous recruitment reports on the SPRINT web site for RR&A and study leadership
to closely monitor recruitment targets.
2.3 SPRINT Recruitment Materials
The SPRINT Recruitment, Retention and Adherence Sub-Committee and other committees
have developed recruitment tools to assist sites in their local recruitment efforts. As previously
stated, all patient and recruitment materials must receive local regulatory approval prior to their
usage. Any recruitment materials that are posted to the SPRINT web site require Coordinating
Center (CC) IRB approval prior to posting. The CC also provides most recruitment material in
Spanish translations. Belowis a chart to help your site organize a multi-strategy recruitment
plan. From previous clinical trials, emphasis must be reiterated about the active support of the
local investigator, site team with the doctors within your institution. The strategies can help a
site organize their recruitment plans that include the doctors, mid-level providers and staff to
identify and promote SPRINT.
The purpose of these materials is to provide potential participants with enough information to
allow them to determine if they are eligible and interested in the study.
Note: All CC IRB approved recruitment materials, including Spanish translations, are
posted on the SPRINT website, located under Documents > SPRINT Study Recruitment
Materials. Please referto the web site forthe listing of centrally generated materials that
are available.
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Recruitment Strategies
Suggested Sources: Suggested Strategies:
1. Clinics
• Cardiology
• Vascular
• Lipid
• Blood Pressure
• Cardiac risk
• Obesity
• Geriatrics
1. Direct contact
� Approach patients or doctors in the wards and clinics. Display posters and
pamphlets in the clinics and wards.
2. Clinic chart reviews
� Performing a thorough clinic chart reviewcan help to identify potential
participants. Once potential participants are identified, a letter can be sent
describing the study to the participant.
� If the participant agrees to come in for a screening visit, send a letter describing
what the visit will entail, as well as what they can expect to happen once
randomized into the study.
FINAL VERSION 2-5
• Peripheral Arterial
Disease
• Renal disease
2. General and family
medicine clinics
3. General Public
� Once a participant is randomized, a letter describing the participant’s participation
in the study should be sent to their family physician and/or specialist.
3. Physician referrals
� Approach the various doctors. Request that any patients with the inclusion criteria
be referred to the SPRINT Study for a screening visit. Also, sites may provide the
doctor with a pocket eligibility card to assist with identifying potential participants
from his/her practice.
� An invitation letter requesting physician referrals can also be sent to doctors.
4. Advertisements
� Printed media – press release, news stories, advertisements in your local paper
or community magazine, bus posters that advertise non-profit groups; mail inserts
through the local community newspapers.
� Religious facilities in their church bulletins, health clinics, senior centers, doctors’
offices
� Electronic media – advertise on radio or your hospital’s website, public service
announcements
� “Tag lines” on medical institutions’ phones lines, e.g., “Wake Forest has a blood
pressure study called SPRINT. Call XXXXXXXX for more information.”
5. Educational Events
� Public forums – slide presentations for these events are available on the website.
Also display posters and provide pamphlets.
Medical rounds –
Both professional and lay audience slide presentations for these events are
available on the website.
To provide potential participants with a better understanding of the study, the following topics
will be explained in one or more of the introductory materials (letters, fact sheets, etc):
• Purpose of the study; Rio Salado Community College Data Management Plan
• Voluntary nature of any response;
• Randomization;
• Extent of confidentiality of information;
• Time period for maintenance of records;
• Disposal of records; and
• Assurances regarding continued care for non-responders.
The recruitment materials should be used as they are presented. Any modifications to
recruitment materials, as well as additional recruitment materials that the site may develop,
FINAL VERSION 2-6
must be approved by their local regulatory institutions in advance of their use in the study.
2.4 Informed consent.
Obtaining Consent from Participants
Informed consent is not just a form. Rather, it is a process that involves the following steps:
• Giving a participant adequate information about the study;
• Providing adequate opportunity for the participant to consider all options;
• Responding to the participant’s questions;
• Ensuring the participant has comprehended the information;
• Obtaining the participant’s voluntary agreement to enter the study;
• Continuing to provide information as the participant or situation requires.
In order to be effective, the process should provide ample opportunity for the investigator and
the participant to exchange information and ask questions. Participants should be fully informed
about the study and have adequate time to evaluate the pros and cons of participation.
Participants should be encouraged to discuss the study with anyone they wish, particularly
family and friends who might be affected (for example, persons who might be needed to provide
transportation).
Close associates of the participant may raise questions and considerations that the participant
has overlooked, and questions that concern the family are better answered sooner than later.
Furthermore, there is evidence to suggest that family support for studies of this kind increase
the probability of participant cooperation and compliance during the course of the research.
The setting in which consent is obtained should be as private as possible so participants can
freely ask questions without embarrassment.
Below are some frequently asked questions about the consent process.
• Who can obtain consent from potential participants?
FDA does not specify who can obtain consent from a potential participant. Some sponsors and
IRBs require the clinical investigator to conduct the consent interview. Regardless, the person
who conducts the consent interviewshould be knowledgeable about the study and able to
answer questions. If someone other than the investigator obtains consent, the clinical
investigator should formally delegate this responsibility and the person so delegated should
have the appropriate training to perform this activity.
• 21 Code of Federal Regulations (CFR) 50.27(a) requires that a copy of the consent
document be given to the person signing the form. Does this have to be a photocopy of
the form with the participant’s signature affixed?
No. The regulation does not require the copy of the form given to the participant to be a copy of
the document with the participant’s signature, although this is strongly encouraged. It must,
however, be a copy of the IRB approved document that was given to the participant to obtain
their consent.
• Do you have to have a witness to the consent process?
An impartial witness is only required if the participant cannot read, if the participant is incapable
of understanding the consent document, or if the participant does not speak English.
Otherwise, a witness is not required.
FINAL VERSION 2-7
• When a witness is required, must they observe the entire consent interview or only
the signature of the participant?
When a witness is required, they must be present throughout the entire consent interview. The
intended purpose is to have the witness attest to the presentation and the apparent
understanding of the participant, not just the validity of the participant’s signature.
• How do you obtain informed consent from someone who speaks and understands
English but cannot read?
Illiterate persons who understandEnglish may have the consent read to them and “make their
mark,” if appropriate under applicable state law. Federal regulations do permit the use of a
short form for patients that cannot read. A short form is a document that states that the
elements of informed consent as required by the Code of Federal Regulations have been
presented orally to the participant. When this method is used, there must be an impartial
witness to the oral presentation. Also, the IRB should approve a written summary of what is to
be said to the participant. The participant must sign the short form. However, the witness must
sign both the short form and a copy of the IRB approved summary. A copy of the summary and
short form must be given to the participant. If you encounter an illiterate participant, consult with
your IRB Chair to discuss your local guidelines.
• How do you obtain consent from a person that does not speakEnglish?
The SPRINT Informed Consent documents are translated into Spanish for Spanish speaking
participants. Clinical sites that recruit and enroll Spanish speaking participants should have
Spanish speaking staff or interpreter available to answer questions. The Office for Human
Research Protections (OHRP) strongly encourages the use of this procedure whenever
possible. Department of Health and Human Services regulations for the protection of human
research participants require that informed consent information be presented in language
understandable to the participant and, in most situations, that informed consent be documented
in writing.
Where informed consent is documented in accordance with federal regulations, the written
consent document should embody, in language understandable to the participant, all the
elements necessary for legally effective informed consent. Participants who do not speak
English should be presented with a consent document written in a language understandable to
them.
Human research subjects are protected through informed consent procedures and the HIPAA
document. The signing of these documents is a criterion for eligibility to participate in SPRINT.
Each site investigator will ensure that the participant understands the purpose of the study, risks
and rights, study procedures and visit schedules. ThePI is ultimately responsible for the proper
oversight of these procedures prior to enrolling anyone in SPRINT.
The informed consent addresses the following important points:
• Each participant must be fully informed of all study procedures and requirements in
order to be considered a “knowing” participant; and
• Participation is voluntary and all information provided by participants will be kept
confidential.
• The site investigator or his/her designee will be fully responsible for obtaining written
consent from each participant.
FINAL VERSION 2-8
• Sites recruiting individuals who have very little or no knowledge of the English language
must submit a translated consent in the respective language for IRB reviewand
approval. Rio Salado Community College Data Management Plan
• In the development of the informed consent forms, each site will use the templates
provided by the CC as a guide. The prototype consent forms and accompanying cover
letters are found in the following Appendices: All information in the essential elements for
the informed consent template must be included in the site consent forms. Additional
information may be added based on individual IRB requirements, but information in the
prototypes may not be excluded from the forms. Any changes made by the IRB will be
submitted to the network and the CC for review.
• The participant will be given a copy of the consent form after it is signed. The original will
be kept in the participant’s file at the site in a secure and locked specified location.
• Administration of the consent form involves providing the participant with background
information about the study and its requirements.
• The implications of randomization and the necessity for completing the required
procedures should be emphasized to each potential participant.
• When the consent form is provided to the potential participant, s/he must be offered
sufficient time to carefully read the document and must be given sufficient opportunity to
have all questions regarding the study answered before s/he is asked to make a
decision regarding participation. If requested, s/he can also take the consent home to
review with family members or significant others prior to signing.
Other Tips
• Use of the first person (e.g., “I understand that …”) can be interpreted as suggestive,
may be relied upon as a substitute for sufficient factual information, and can constitute coercive
influence over a participant. Use of scientific jargon and legalese is not appropriate. Think of
consent as a teaching tool not as a legal instrument.
• Anyone who signs a consent form should personally date it.
• If consent is obtained the same day that the participant’s involvement in the study
begins, the participant’s medical records should document that consent was obtained prior to
participation in the research. The following statement could be included in the records: “All the
required elements of informed consent were presented to the patient. Voluntary consent was
obtained and the patient’s questions were answered prior to initiation of any research
procedures.”
