Click on the name of your institution (below) to see relevant information.
NOTE: An automated educational webinar for completion of this form is available on the link.
- Log onto the healthresearch.wayne.edu website as a coordinator
- Click on New Research Study
- Select IRB of Record (the institution which approves and reviews the protocols)
- Enter the Approval Date of the study obtained from the IRB approval letter. Note, that after the annual renewal, this date will need to be updated (including uploading the new stamped consent form if appropriate).
- Enter the Principal Investigator
- Enter the Clinicaltrial.gov registration number, if known
- Enter the exact research title
- Fill the background and rationale of the study. This information should come directly from the MSU Initial Review section 17.
- Leave the goals/aims/hypothesis of the study blank.
- Enter the start date of the study (the date of the IRB approval or annual renewal date).
- Enter the location of where the study will take place (from the MSU Initial Review section 8a)
- Check whether the study is recruiting Males, Females or both (see MSU Initial Review section 20a)
- Enter the age range (from the MSU Initial Review section 20b)
- Click the box if you would like to include a copy of the consent form on the website for volunteers and then upload the select files. This should be a copy of the most recent IRB approved, stamped consent form.
- Include the contact person, email and phone number.
- Check the box, if you would like potential volunteers to be able to see the contact information.
- Click on the category for the disease or condition (if you do not see the category for the particular disease/condition, please contact Karen Collins at 313-993-8706 or email@example.com)
- Check the box by “Healthy volunteer required” if you will be recruiting healthy volunteers such as for physiology or pharmacodynamic studies.
- Check the box by “Compensation offered” if you will be providing compensation to subjects
- Add keywords for “search” ability by individuals viewing the website. Separate each by a comma. Such as "brain, cranium, cortex"
- Check the box “Make Visible Now” if you would like to make this information on the study visible to the public now. If you are not ready to have the protocol displayed on the website, do not check this box.
**To save your work, click on the word "Create". This will not make it visible to the public unless you click on the button to make it visible. If you do not click this button before you leave the page, all of the information you entered will be lost.Version: May 10, 2011
1) For a study already approved by the IRB, submit an expedited amendment to WSU IRB along with Appendix B (Internet use).
For this amendment:
Question 18, The Advertisement box should be checked. The location of the advertisement should say “DCaTS website will include this study. Appendix B for Internet Use has been revised to include this”.
For Appendix B: Internet Use in Research:
- Question 1, Check DCaTS – Health Research Volunteer Website
- Question 1a). YES
- Question 2: N/A
- Question 3: NO
- Question 4: N/A
- Question 5: Other: information posted on the volunteer registry
- Question 6: On a secure server should be checked
- Question 7: DCaTS coordinators and investigators
- Questions 8 & 9: N/A
2) For a new study, add the DCaTS website to the Protocol Summary Form:
Question 36: Internet and Advertisement should be checked. For Advertisement, “the DCaTS website will include this study”.
Question 37a: Include DCaTS website as a method of recruiting subjects. Include Appendix B with your submission (instructions for filling out Appendix B is located above)
3) After you have obtained IRB approval to use the DCaTS website for a study, contact Karen Collins at 313-993-8706 or firstname.lastname@example.org to obtain your password.
4) You may now add your study.
** After you receive your password, you may register other studies that have IRB approval to use the DCaTS website without contacting Karen.Version 03.03.2011