The following instructions will enhance the readability of the consent and decrease the required revisions. Please use the below instructions to develop standard consent form wording.
The UMBC Office of Research Protections and Compliance assigns an IRB protocol number as well a “valid through”(or“ end”) date indicating the end of the IRB approval period; this will appear at the bottom of all pages of the UMBC assent form. Obtaining and documenting informed consent is required for all participants in a research project. As a general rule, investigators must::
- Provide “key information” to participants essential to decision making;
- Present informed consent information in sufficient detail and in a way that helps with participant comprehension, not just running down a list of risks and procedures;
- Provide a copy of the consent form to the participant and/or legal representative;
- Keep a copy of the consent form for the approved protocol file
- Seek consent only if the potential participant has the decisional capacity to give consent; if not, consent must be obtained by a legal representative;
- Obtain parental permission for minor participants;
- Provide sufficient opportunity to the potential participant or legal representative to consider whether or not to participate;
- Ensure that the possibility of coercion or undue influence is absent;
- Enhance each participant’s comprehension of the information; and
- Utilize a consent form appropriate to the age level.
For more information, click on the below:
Helpful Hints to create consent form
Consent Document Section explanations
Readability Statistics measured with the Flesch–Kincaid scale
Consent Documentation and Exempt Research
Although a study is granted an exemption from IRB review, investigators are ethically bound to follow the principles listed in the Belmont Report, particularly the first principle, respect for persons, which emphasizes the importance of ensuring that subjects are fully informed about the nature of a research project in order to make an informed decision to participate. The use of a signed consent document, for example in cases of anonymous data collection, would not be required, but those participants must be informed about the purpose of the study. An investigator will provide a participant an IRB approved information sheet or use an oral consent script explaining the purpose of the study, how the data will used, how the data will be kept anonymous, etc.