OR
(2) that the research presents no more than minimal risk of harm to subjects and
involves no procedures for which written consent is normally required outside of the
research context. Examples of such activities include completing surveys, performing an
abbreviated physical exam, or providing a urine sample.
When the PHRC approves a waiver of the requirement to obtain a signed written
consent based on consideration (1), the full consenting process for these subjects
including being given a written informed consent document embodying all the elements
of informed consent remains the same except that the subject will have the option to not
sign the consent document or have information linking them to the study placed in their
medical records.
When the PHRC approves a waiver of the requirement to obtain a signed written
consent form based upon consideration (2), investigators must fully inform prospective
subjects (in person or remotely) about the study, answer their questions and obtain their
verbal informed consent. In some instances a subject may be informed that completing
a task, such as filling out a survey, suffices as consent and there is no verbal agreement
- this is also called "implied consent." If written consent is waived, the PHRC usually
requires the investigator to provide subjects with a written statement regarding the
research, which could be provided in person, by mail, or electronically. Examples of
information sheets are available on Research Navigator site under IRB Policy &
Guidance. Investigators should specify in the submission how verbal or implied consent
is documented, for example, by retaining a list of names of participants who completed
a survey or participated in a focus group.
The PHRC requires the abbreviated HIPAA authorization statement below, be included
in letters, statements, websites, or information sheets when investigators are collecting
Protected Health Information (PHI) pursuant to verbal or implied consent. Note that this
statement provides the link to the complete Partners HIPAA Privacy Notice available
online, for those who want more information.
We are required by the Health Insurance Portability and Accountability Act (HIPAA) to
protect the privacy of health information obtained for research. This is an abbreviated
notice, and does not describe all details of this requirement (see Partners Privacy
Notice*). During this study, identifiable information about you or your health will be
collected and shared with the researchers conducting the research. In general, under
federal law, identifiable health information is private. However, there are exceptions to
this rule. In some cases, others may see your identifiable health informatioin for
purposes of research oversight, quality control, public health and safety, or law
enforcement. We share your health information only when we must, and we ask anyone
who receives it from us to protect your privacy.