Brooks College of Interdisciplinary Studies
Human Subjects Procedures: Brooks College
Active scholarship is an integral part of university life. Faculty, staff and students benefit from the process as well as the product of scholarly and creative work. In many cases, scholarship involves the use of human subjects as the focus of the scholarship. As such, all scholars at Grand Valley State University are required to adhere to the ethical and practice standards for human studies. All human subject-based research must be approved by the Brooks College review system before any data are collected. This document is meant to guide practice as well as provide guidelines for human subject research conducted within the Brooks College of Interdisciplinary Studies. Units within the College are encouraged to further define their own policies in order to refine procedures specific to the field of study.
Policies and Procedures
Step 1. Identify the Principle Investigator
While scholarship is conducted by both students and faculty as principle investigator, students must have a IRBNet-registered faculty advisor as a sponsor in order to propose a project. This advisor may be different than the student's regular academic advisor.
The principle investigator will be responsible for submitting all materials, serving as the sole correspondent with the review committees (in some cases even presenting to the committees) and shall be responsible any required, follow-up reporting. In addition, when the study is completed (or if it needs an extension), the principle investigator will be responsible for this as well. Choose wisely!
Step 2. Get Appropriate Training
Responsible Conduct of Research (RCR) online training is now available! Go to THIS LINK to affiliate with GVSU and access the modules. National Science Foundation (NSF) funded research approved January 3, 2010 or later requires some RCR training for all key research personnel by the project end date.
The Federal Office of Research Integrity also provides resources to educate about Responsible Conduct of Research. http://ori.hhs.gov/education/products/
Faculty who are conducting scholarship with classes or groups of students as researchers or research assistants should have all students complete training before they prepare a project proposal.
Step 3. Determining the Level of Review
There are three levels of review, and each level poses different requirements for investigators and reviewers. The review level determination is made on a number of factors, but primarily focuses on the potential risk to research subjects. The three levels are Exempt, Expedited, and Full Board.
Exempt studies must fit into 6 specified categories of research and be minimal risk. A simple description of how the proposed study fits into one or more category is usually all that is required on the application.
Expedited studies must fit into 9 specified categories of research and be minimal risk.
Full Board studies include all studies that do not qualify as exempt or expedited.
Both expedited and full board studies must explain in detail how the proposed study plans to be compliant with all relevant regulations. Most research involving federally protected vulnerable populations(children, prisoners, and pregnant women, neonates, and fetuses) requires full board review with few exceptions.
Be sure to review the above catagories to determine if you should submit for Exempt, Expedited or Full Board review.
| Checklist.Exempt Protocol |
| Checklist.Expedited and Full Board Protocols |
Step 4. Prepare and Post the Proposal
The proposal is submitted on-line, and the forms are all accessible from the on-line process. Be sure that you complete all parts of the proposal. Check for errors! Incomplete proposals should NOT be approved to be sent forward for HRRC review.
| Instructions for Submitting Materials on IRBNet |
Revision Date |
||
| 1 | Submitting a New Protocol | 01/20/10 | |
| 2 | Editing a Study Package after Submission | 01/20/10 | |
| 3 | Signing a Research Protocol | 01/20/10 | |
| 4 | Revising a Tabled Study | 01/20/10 | |
| 5 | Change in Approved Protocol | 01/20/10 | |
| 6 | Continuing Review | 01/20/10 | |
| 7 | Closing a Protocol | 01/20/10 | |
| 8 | Unanticipated Problem/Serious Adverse Event | 01/20/10 | |
| 9 | Guidance for Constructing an Informed Consent Document | 03/10/10 | |
Prior to any review by the HRRC, the academic unit should have a process in place that examines the proposal to ensure that it follows best practice for the field of study and complies with the standards of research at Grand Valley. Note: the Dean's office should NOT be the first line of review for any proposals.
Unit level review should determine:
1. Is this a project that meets best practice for research in the given field?
2. Have the investigators used due diligence in providing for the safety of the subjects?
3. Have to investigators prepared a plan for the safe keeping of the data?
4. Are the required parts of the on-line submission all in place?
5. The academic unit should log and track all proposals that go through their approval.
Authorizing Officials (would have to have IRB.NET registration)
Ø For students, it is the research advisor (may be different from academic advisor).
Ø For faculty, it is the unit head, department chair, or designee.
Ø For unit heads, it is the college dean, or designee.
Ø For deans, it is the Provost.
Step 7. Navigating the approval process
Some keys to success:
- Don't wait until the last minute to submit! Remember that you cannot begin data collection until you have written approval from the HRRC. Full board reviews are only conducted at their monthly board meetings and require 8 working days advance submission on IRB.Net. Expedited and exempt reviews are conducted on an ongoing basis.
- If your project requires Full Board review, be aware of the committee meeting dates, so you can plan your submission accordingly
- Allow time for the unit level review and approval through IRB.net Do not assume that it will have tacit approval without changes or required clarifications.
- For studies requiring Full Board review (usually greater than minimal risk studies), the investigator is invited to present the project in person to the HRRC committee. If so, prepare your presentation with a eye toward the non-field expert, as few on the committee will be in the same field.
- If you are working with a group of students as researchers, please oversee their submissions for accuracy and completeness in order to expedite the review process. It can be complicated!
After closing (completing) your study, you must complete the Closed Protocol Reporting Form. The protocol reporting form is a quick and easy way for the HRRC to collect required information from investigators about characteristics of their study, and to track the research activity at Grand Valley involving human participants. To complete the form, you will need the data from your study, including participant demographics.
Closed Protocol Reporting Form: http://www.gvsu.edu/hrrc/?action=home.protocolreporting
After submitting the Closed Protocol form online, please follow the instructions below to upload the form content to IRBNet.
Page last modified August 18, 2010
