Recruitment cannot begin until a study has received IRB approval. Protocol submissions must include copies of all the flyers, letters, emails, web postings, and verbal scripts that will be used to initially attract potential subjects.
These materials should not overstate any potential benefits nor understate potential risks. Their aim should be simply to generate interest from the subject, determine their eligibility, and provide the researcher's contact information. To this end, they may for example include the following elements:
- A statement that the study is a research project.
- An explanation of the study’s purpose.
- Eligibility information (e.g. a brief summary of inclusion/exclusion criteria).
- A brief summary of any benefits.
- The name of the researcher and/or research institution.
- Contact details for further information.
- An indication of the time and/or other commitments involved.
If the recruitment materials indicate an amount of compensation offered for participation, the amount should not stand out more than the rest of the content (for example by increasing the font size, bolding the text, or putting it in a different color).
For more details on these requirements, as well as rules on using biospecimens or information to pre-screen individuals for eligibility, see sections 9.3. and 9.4 of MTU’s HRPP Policies and Procedures.