This section of the Investigator Manual covers participant recruitment, compensation, consent processes, special population considerations, translation requirements, privacy and confidentiality, identifiability, communication with participants, special procedures, regulatory information, VA research requirements, and information on different types of research.


Participant Remuneration and Compensation

The IRB is responsible for ensuring that any payment or remuneration offered to participants in human subject research is fair and not an undue inducement to participate. Remuneration for participation in research should be reasonable and the amount paid should be comparable to other research projects involving similar time, effort, and inconvenience. Payment amounts should not be large enough to constitute an undue inducement to participate in a risky or uncomfortable procedure. Additional guidelines for specific situations:

  • Short research studies involving one visit:Participants may be provided payment contingent upon completion of the study. Participants who are disqualified through no fault of their own must be paid for the time and effort they expended prior to their termination from the study.
  • Research studies involving multiple visits or lengthy or repeated participation:Partial payment should be provided to participants who withdraw, are discharged early from the study by the investigator, or otherwise fail to complete the study as agreed. The amount of partial payment should relate to the amount of time, effort, or discomfort involved. Payment schedules may be designed on a per-day, per-visit, or per-procedure rate, or some combination thereof. The terms for partial payment must be described in the application and in the consent form.
  • Completion bonuses:Such remuneration may be acceptable to encourage the completion of all study procedures/visits. The amount of such incentives depends on the risk and duration of the study interventions.

For additional information on payment requirements, see HRP 316-WORKSHEET-Payment. For information on the campus policy for payments, see Payments to Research Participants.

Translation and Interpreter Requirements

If the subject/representative has limited English proficiency, you must obtain the services of an interpreter fluent in both English and the language understood by the subject/representative. The interpreter may be a member of the research team, a family member, or friend of the subject/representative. If the research involves medical care and/or is more than minimal risk, use of family or friends to interpret is discouraged.

Research with UW Health patients requires the use of professional interpreters, however the individual and/or their representatives may insist upon the use of a friend or family member to provide them with interpreting services. In this case, you should retain a healthcare interpreter to participate in the exchange to ensure that it represents accurate communication of information between investigators and patients.

For assistance in obtaining translation and interpreter services, contact UWHC Interpreter Services.

Identifiability

Identifiability of data under the under the Common Rule (45 CFR 46) and the Health Insurance Portability and Accountability Act (HIPAA) differs.

Identifabilty under the Common Rule

An identifier includes any information that could be used to link research data with an individual subject.

  • The Common Rule defines “individually identifiable” to mean that the identity of the subject is, or may be, readily ascertained by the investigator or associated with the information.
  • A data set may be identifiable under the Common Rule if it contains: initials, address, zip code, phone number, gender, age, birth date, occupation, employer, racial or ethnic group, type of biopsy performed, date sample taken, diagnosis, primary care physician, referring physician, and genealogy.
  • Age, ethnicity/race, gender may be identifiers under the Common Rule if fewer than 5 individuals possess a particular cluster of traits.
  • Data may be identifiable if any combination of variables could potentially identify a subject.
  • Some of the identifiers listed above become less problematic if the sample size is large enough so that the potential identifiers could describe several individuals and thus cannot be linked to only one person. Conversely, if the sample size is small, the potential to identify an individual may increase, even in the absence of direct identifiers.

Identifiability under HIPAA

The HIPAA Privacy Rule regulation specifies 18 identifiers, most of which are demographic. Inclusion of even one of the following identifiers makes a data set identifiable. However, there are levels of identifiability. The following are considered limited identifiers under HIPAA: geographic area smaller than a state, elements of dates (date of birth, date of death, dates of clinical service), and age over age 89. The remaining identifiers in the bullet list are considered to be direct identifiers. If the data set contains any limited identifiers, but none of the direct identifiers, it is considered a limited data set under HIPAA.

Definitions

What it means for data to be coded, de-identified or anonymous is important when it comes to understanding the identifiability of data.

  • Coded data

    This refers to data which have been stripped of all direct subject identifiers, but in this case each record has its own study ID or code, which is linked to identifiable information such as name or medical record number. The linking file must be separate from the coded data set. This linking file may be held by someone on the study team (e.g. the PI) or it could be held by someone outside of the study team (e.g. a researcher at another institution). A coded data set may include limited identifiers under HIPAA. Of note, the code itself may not contain identifiers such as subject initials or medical record number.
  • De-identified data

    This refers to data which have been stripped of all subject identifiers, including all 18 HIPAA identifiers. This means that there can be no data points that are considered limited identifiers under HIPAA, i.e. geographic area smaller than a state, elements of dates (date of birth, date of death, dates of clinical service), and age over age 89. If the data set contains any limited identifiers, it is considered a limited data set under HIPAA. If the data includes an indirect link to subject identifiers (e.g. via coded ID numbers), then the data is considered by the IRB to be coded, not de-identified.
    Please note that data can be considered de-identified under the Common Rule but NOT the HIPAA Privacy Rule (e.g., limited data sets), and vice versa (e.g., no HIPAA identifiers are included but the combination of data points could make subjects identifiable).
  • Anonymous data

Essentially the same thing as de-identified data, this refers to data which have been stripped of all subject identifiers and which have no indirect links to subject identifiers. There should be no limited identifiers in an anonymous data set.

Communicating with Participants

Throughout the course of a study, researchers may wish to communicate with participants using a range of methods. Depending on the method used, you may need to follow specific guidelines, particularly if your study falls under HIPAA or FERPA.

  • Using email to schedule initial study visit: Upload a copy of the email script you will use to schedule initial visits in the IRB application. You must obtain permission from participants before using email to schedule a visit. Permission may be obtained by emailing subjects to ask if they agree to set up an appointment by email before sending scheduling information. Emails scheduling an initial visit may not include information about the subject’s health unless they provide permission to do so. Even with subject permission, the email should contain as little health information as is necessary to convey the intended message.
  • Using email as part of study participation: The consent form must include information on how email will be used in the study and the study team must obtain permission to communicate with the subject by email. You cannot require that subjects provide an email address in order to participate in a research study unless the study cannot be carried out without access to email. Additionally, subjects may request that email no longer be used to communicate about the study, without any loss or penalty.
  • Phone: Whether calling potential subjects for recruitment purposes or communicating with participants during the study, you should avoid leaving voicemail messages that include any information about the subject’s health (e.g., identifying that you are calling from a specific clinic).