DA003 - National Database Recruitment and Consent

DA003 Guidelines and Strategies for TBIMS National Database Recruitment & Consenting
Review Committee: Data Start Date: 4/01/2007
Attachments: None Last Revised Date: 3/20/2023
Forms: None Last Reviewed Date: 3/20/2023

Introduction:

The TBIMS use established procedural steps to recruit and consent potential participants in the TBIMS National Database (NDB) including strategies and considerations for recruitment and consent.

Purpose:

To institute standard procedural steps for recruiting and consenting potential subjects into the NDB.

Scope:

Current TBIMS centers which are recruiting and consenting participants into the NDB.

Responsibilities:

TBIMS staff responsible for recruiting and consenting into the NDB (e.g., TBI researchers or clinicians, research assistants, study coordinators).

Procedural steps:

Who should be approached for consent?

  • All individuals who meet the inclusion criteria and are identified through the NDB sampling procedures (SOP 103) – potential subjects are eligible regardless of immigration status, residence, language barriers, anticipated or actual length of stay, ease of follow up etc. as established by the center’s IRB requirements.

  • Centers should use local institutional resources and policies for providing translation for the consent process when the patient and/ or consenting family member does not speak English.

  • Persons with TBI &/or their SO (if the individual with TBI does not have capacity for consent)

  • Centers should be aware of their individual IRB procedures for determining the capability to give informed consent.

Who can approach potential participants?

  • A member of the clinical team
  • A member of the research team

  • HIPAA consideration: At some institutions, interpretations of HIPAA regulations may require that permission for research staff contact be given by the potential participant/SO to a member of the clinical team.

  • Members of the research team may have a better understanding of the parameters of data collection and the research projects.

  • A potential participant may initiate contact with the research team.

When should potential participants first be approached and subsequent informed consent pursued?

  • Acute care hospital (if it is known that the person will be transferred to the TBIMS inpatient rehabilitation facility) or acute rehabilitation hospital.

When do you stop approaching for consent?

  • Continue to re-approach until nine months post-discharge from TBIMS inpatient rehabilitation facility, until consent is obtained or until the investigators and research staff make a judgement that the participant or their proxy does not wish to participate.

What if consent/participation is refused?

  • Record as refused consent and do not re-approach.

Is formal annual re-consent needed?

  • No, unless your IRB requires it. Consent is an ongoing process. At the beginning of each annual follow-up contact it is generally a good idea to briefly review the project, the reason for the call and what will be asked, and to confirm permission to proceed with the contact.
  • A participant may refuse further participation or decide to withdraw from the study at any time. If so,

  • Clarify their intent: withdrawal or selective non-participation.

  • If withdrawn, the participant would be recorded as withdrawn from further model system follow up data collection and no further data collection or contact would occur.

  • A participant may choose not to answer a specific question, set of questions, or participate for a specific follow up interval, but still be allowed to participate in other data collection and subsequent years. In this situation the participant would still be considered a model system participant and not withdrawn.

Documentation and storage of signed consent forms or forms completed when a waiver of documentation of consent is approved by your IRB:

  • Copy of consent form or documentation of verbal consent to research files (electronic or physical)
  • Your local IRB/ privacy office may be a helpful resource to learn about storing consent forms in a manner that maintains privacy.

  • Copy of consent form or documentation of verbal consent to participant/SO

  • Copy on chart

  • Caution: Clarify with your IRB as each local project and IRB may have unique considerations and requirements, especially regarding chart copies of study consent forms or documentation of verbal consent.

Inclusion of consent for Geographic Identifiers (GEO-ID):

  • Ideally, the consent will include permission to share the participant’s address with the NDSC.

  • Participants should be able to “agree” or “not agree” by providing their initials to a statement as approved by their IRB. The following is an example:

  • The TBI Model System research team has my permission to provide my address to the National Data and Statistical Center (NDSC). This does NOT give the NDSC permission to contact me. My address will only be used to get information about the community where I live. Studies show that the places where people live are important to their health and wellbeing.

Inclusion of consent for Federal Interagency TBI Informatics System (FITBIR):

  • The consent should include permission to share the participant’s data with FITBIR.

  • Participants should be able to give their permission (or not) as approved by their IRB. The following is an example of verbiage that could be used:

  • To maximize the value of the data we collect about recovery from TBI, the TBI Model System would like to combine our data with data collected in other studies on TBI. We need your permission to do this. With your permission, the data we collect about you, without personal identifiers, will be added to the Federal Interagency TBI Informatics System, known as FITBIR. The FITBIR database was established by the United States Department of Defense (DoD) and the National Institutes of Health (NIH) and serves as the data repository for many TBI research studies. There will be no cost to you or any additional responsibilities for you to participate in this project. The data collected as part of the TBI Model System will be de-identified and transmitted securely to the FITBIR database coded with a global unique identifier (GUID) which will allow researchers to share data without exposing personally identifiable information.

Coercion

Any research involving human subjects is guided by regulations provided in CFR Title 21 regarding the proper consent process. For example, Data Coordinators, Clinicians and Investigators should be cautious when approaching subjects and their families and not be coercive when discussing their participation in the TBIMS. We recommend referencing resource materials that will help navigate these regulations, such as, http://www.clinicalresearchresources.com/books/bookstore.html and http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm219433.htm

What is coercion?

  • Coercion is the practice of compelling a person to behave in a certain way (whether through action or inaction) by use of threats, intimidation or some other form of pressure or force.

  • Clinicians should be aware that in the clinician–patient relationship that the clinician may hold a potential “power” or perception of power over the patient.

  • Although overt coercion is easy to spot (and to avoid), clinicians should also be aware of more subtle influences on the patient approached for research by a trusted member of his/ her clinical team. For example, a patient may think “This has to be okay because my doctor wants me to do it” and thus fail to think carefully through the risks and benefits.

  • Patients commonly believe that they will benefit personally from research or that the research project is part of clinical care, even when told otherwise. Being offered participation in a research project by a clinical team member may further blur the boundaries and exacerbate confusion about the nature of the research.

  • Tips to avoid coercion or unintended pressure:

  • Have the clinician ask the patient if he/she can be approached by a research staff person in order to discuss potential research projects, and have the research staff person explain and obtain written consent.

  • Don’t put too much focus on monetary incentives.

  • Don’t promise any direct benefit.

  • These points should not be interpreted to mean that clinicians should not be involved in recruitment. On the contrary, clinicians are often in the best position to answer questions the potential participant may have about the study. Referring the patient to a clinician for the purpose of explaining the research is not considered coercive (as long as the patient has not already declined participation).

Strategies for a Successful Research Recruitment Campaign

  • Understand your subject population pool. (This may be especially important for minority populations – i.e., that there are over 500 Native American tribes and over 100 dialects spoken among Asian American Pacific Islanders). Review materials related to cultural humility on the NDSC website (https://www.tbindsc.org/Members/Cultural.aspx).

  • Establish rapport and trust in the program and staff.

  • Ensure that all recruitment staff is properly trained and that their skills are assessed regularly.

  • Promote awareness of the project.

  • Promote interaction with direct-care staff.

  • Secure translators for commonly seen ethnic groups.

  • Explain real benefits of participation in clinical research (contribution to science, advance new learning). Note: Don’t overplay the expected project benefits.

  • Enhance the capability and perceived self-efficacy of potential participants to participate (this has proven very effective in the minority populations).

  • Understand the needs, fears, and attitudes of participants about research and their condition.

  • Help participants solve problems interfering with participation.

  • As opportunities present themselves, help participants meet needs not directly related to your research project (e.g., identifying needed resources, such as specialty physician care or agencies that can help with applications for state or federal aid).

  • Take an educational approach to project involvement and recruitment.

  • Distribute an educational packet or brochure that includes information about TBI in general and information about your specific project.

  • Obtain business cards for research and clinical staff.

  • Post photos of research team members on the unit.

  • Arrange for permissions to add research appointments to patients’ schedules.

  • Have direct-care staff share research brochures with patients.

  • Leave MSKTC flyers in patient’s room.

Strategies for approaching for consent post-discharge:

  • Attempt to consent should begin shortly after discharge (allow a few days for patients to get settled before calling).

  • Check with members of the clinical team regarding their impressions on capacity to consent at discharge and plan how to approach accordingly (person with TBI vs SO).

  • If you have not been able to reach an eligible participant after 2 weeks of attempted contact, try to:

  • Complete phone call attempts at each of the following times: normal business hours (at different times of day); weekday evenings (on different days of the week); and weekends.

  • Check with providers to see if the patient may be returning for an outpatient clinic appointment. Make arrangements to be in clinic at their appointment time. Ask to be introduced to the patient after the visit, so that you can share information about the research program.

  • Send an introductory letter and copy of the consent form to the eligible participant or a family member that was involved with their care while in rehabilitation.

Training requirements:

Whatever your TBIMS center or IRB requires (e.g., HIPAA training, IRB training, Cultural Competency/Diversity training).

Compliance:

Comply with institutional/IRB policies and procedures. Each Model System will review specific procedures and policies regarding recruitment and consent with the NDSC during the quality support visits.

References:

Berlin EA, Fowkes WC, Jr. A teaching framework for cross-cultural health care. Application in family practice. West J Med 1983; 139(6):934-938.

History:

Date Action
04/01/2007 Version of inclusion criteria used to create this SOP
09/16/2008 Transferred to SOP template and approved by SOP Review Committee
10/01/2008 Added stop time for attempting consent as 3 months post-discharge
12/12/2008 Revised definition with approval of Planning Committee and Project Directors
06/19/2011 Changed the time to consent from 3 months post discharge to nine
01/01/2013 Removed bullet regarding collection of reason for refused consent
09/08/2014 Removed note on coercion within the section,” Who can approach potential participants.” Added links for additional guidance on avoiding coercion: http://www.clinicalresearchresources.com/books/bookstore.html and http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm219433.htm . Added section on approaching elderly patients/caregivers for consent.
02/19/2018 Added “Leave MSKTC flyers in patient’s room.” to list of strategies.
10/01/2019 Removed Cultural Considerations
08/27/2020 Added note about sampling for NDB enrollment
03/10/2023 Added “Post photos of research team members on the unit, Arrange for permissions to add research appointments, and Have direct-care staff share research brochures” to list of strategies
03/10/2023 Added “Strategies for approaching for consent post-discharge” section
03/10/2023 Added instruction regarding storage of documentation of consent when completed verbally.
03/10/2023 Added details regarding storage of documentation of verbal consent.
03/10/2023 Added instructions regarding consent for GEO-ID and FITBIR.

Review schedule:

At least every 5 years.