After Heartland Institutional Review Board reviews your research protocol and required materials, you might be required to make some revisions or modifications in your protocols and materials to meet regulations or to clarify aspects of your research or program evaluation process. Heartland IRB, a commercial IRB, will provide you with a list of required revisions. The researcher must submit the revised forms with the changes highlighted or in bold type. Once said modifications are made, the lead researcher is required to re-submit the revised paperwork to Heartland IRB.
If any changes need to be made in a protocol previously approved by Heartland IRB (for example, the funding agency has made specific requests), the researcher will submit a written request to Heartland IRB describing the modifications (See Section 13: Forms). No change in procedures may be made without prior written approval from Heartland IRB. If the modification requires a new consent form, interview protocol, or revised survey questions, the researcher must submit the revised forms with the changes highlighted or in bold type. Once these modifications have been approved, a new HIRB letter of approval will be emailed to the lead researcher along with any revised documents given the Heartland IRB approval time stamp.
These modifications will be reviewed at the appropriate level by Heartland Institutional Review Board. If the changes are minor, the Director or Associate Director will need to review it; if the changes are extensive or if the initial review was a Level 2 review, then it will be reviewed by the subcommittee again.