IRB Guidelines -Establishing/Utilizing Subject Recruitment Databases (cont.)

A. Establishing a Recruitment Database - Establishing a subject recruitment database requires prior IRB review and approval. Applications to establish databases are not submitted in e-Protocol, but requested using the Application for Establishing a Subject Recruitment Database form. The researcher's plan for establishing a database should respond to the guidance below:

1. Who has responsibility for the integrity of the database? Who can have access to it for research purpose? How is access granted?

Before a subject recruitment database may be established to store data for future research purposes, the IRB shall review and approve plans for the database. Applications must be submitted by a qualified University of Massachusetts Amherst (UMass) investigator (CITI trained faculty member), who will exercise control over the data. The plan must include a description of each data element to be stored.

The plan should also describe:

•  The role(s) of other UMass researchers who may have access to the data;

• how the information will be updated;

•  notation of the frequency that subjects can be contacted.

Databases with particularly sensitive data may require expanded operating procedures.

The database principal investigator (PI) should describe procedures for releasing data to UMass researchers authorized to use the information for recruitment. Such procedures should correspond to information described within the recruitment database consent form. Note: the database PI can only release information in the database to CITI-qualified UMass researchers for studies that have current IRB approval.

2. What is the process for informed consent related to the recruitment database and what would be included in the informed consent document?

Establishing a subject recruitment database would typically include a separate informed consent document for that purpose only. Many of the standard elements of informed consent should be included. See template for consent form for Subject Recruitment Database for guidance.

In order to collect and maintain information pertaining to a minor, the IRB will consider the following information:

• Informed consent provided by parents and guardians to maintain information.

• Assent by minors, as appropriate.

• Whether data in the database are subject to informed consent upon the child reaching the age of majority.

3. How is privacy and confidentiality ensured?

a) Since breach of confidentiality is the greatest risk for database protocols, a plan for protecting confidentiality is critical. Provide as many of the details listed below as possible:

•  Identification and qualifications of persons who are authorized to access the information.

•  Training of UMass persons who will collect, maintain and use information for inclusion in the database, (i.e. CITI training certificate).

•  Safeguards to prevent accidental or inappropriate release of information.

•  Methods used to organize and store information.

•  Methods that will protect confidentiality.

b) Examples of preserving confidentiality:

•  A rigorous back-up method is recommended for database storage of especially sensitive data.

•  If data will be backed up, or downloaded, on a portable computer or data drive, describe methods to secure data via password protection and other mechanisms.

•  Passwords would be needed to access the database and/or limiting knowledge of the passwords to authorized persons(s).

•  A coding system with the key to the code being stored in a separate location apart from the database. If the information must have identifiers, the IRB will require extensive electronic protections, such as firewalls or passwords for access the database.

•  Access to the key is provided to limited authorized individuals who are trained about the database and human research protections, including the preservation of confidentiality (i.e. CITI training).

4. How to recruit to a subject recruitment database?

The IRB should be provided with all proposed methods to recruit to the database. Standard recruitment methods would apply as documented in the Recruitment Guidance. Recruitment from existing lists of subjects should only take place if those subjects previously agreed to be contacted about further studies.

B.  Access to information in a Subject Recruitment Database

Database PIs control access to the data contained in the subject recruitment database.  Information would be released to eligible UMass researchers (those listed in the application form) who have received IRB approval for that particular study.

Plans to use data retained in a subject recruitment database would be included in the recruitment section of the IRB application for each independent study. Reference to the subject recruitment database approval number should be included.

For additional information, see Frequently Asked Question regarding subject recruitment databases.

References:

Office for Human Research Protections (OHRP) Participant Brochure

UMASS Informed Consent Template

Office for Human Research Protections (OHRP) Guidance on Research Involving Coded Private Information or Biological Specimens