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January 8, 2019 - New UMB Informed Consent and HIPAA Authorization template posted (Consent Form Templates).
- Concise summary requirement
- Update to Procedures section regarding whether clinically relevant research results will be returned to participants.
- Update to the Biospecimens section
- Combining of IC template and HIPAA authorization
Consent and Assent Form Templates
The Reference Department at the Health Sciences and Human Services Library will review your consent form and make comments and suggested edits to help ensure that it is at an appropriate reading level for study participants.
* As a free service to all UMB faculty, researchers are strongly encouraged to use this service.
They will return the edited form to you within three business days. For any questions or concerns, please contact the Reference Desk at 410-706-7996.
- New Informed Consent and HIPAA Authorization Form Template: This template should be used as a guide for all NEW research studies approved as of 1/21/2019 including parental consent forms and LAR consent forms. (Informed Consent Concise Summary Examples 2019)
- Consent Form Template: This template should be used as a guide for all research studies including parental consent forms and LAR consent forms.
- Assent Form Template: This template should be used to assent participants ages 13-17 and, if applicable to your study, cognitively impaired participants.
- VA Consent Form Template This template should be used if your study is being conducted at the Baltimore VA.
- HIPAA Authorization Form: All uses other than VA.
- VHA HIPAA template (VA Form 10-0493 Sept 2015)
VAMHCS Tutorial for VHA HIPAA (VAF 10-0493)
Revocation of HIPAA authorization
- UM Dental School additional Consent Form Template: If you are conducting business through the School of Dentistry, add this paragraph.
- Sponsor’s Template (NOTE: Sponsor's Consent/Assent Form templates will no longer be accepted by the IRB as of March 1, 2012)
The following basic elements of informed consent are required to be disclosed in all research consent forms pursuant to 45 CFR 46(a-b):
Basic elements of informed consent.
- A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures that are experimental.
- A description of any reasonably foreseeable risks or discomforts to the subject.
- A description of any benefits to the subject or to others that may reasonably be expected from the research.
- A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
- A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained, including the possibility that the Food and Drug Administration (FDA) may inspect the records if applicable.
- For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
- An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject.
- A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
Additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject:
- A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) that are currently unforeseeable.
- Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent.
- Any additional costs to the subject that may result from participation in the research.
- The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject.
- A statement that significant new findings developed during the course of the research that may relate to the subject's willingness to continue participation will be provided to the subject.
- The approximate number of subjects involved in the study.
Informed consent is required to be presented in language understandable to potential participants.The following website provides plain-language alternatives for patient information and consent materials.