Review Procedure (revised 8/26/08)

Submission of Proposals. Before any activity involving humans as participants in research may be undertaken at Hope College, the investigator (or faculty sponsor if the investigator is a student) must submit to the HSRB chair (inman@hope.edu, electronically, by email is preferred) the plan of investigation.

The HSRB Committee reviews proposals as they are submitted. The HSRB Expedited Review Team reviews protocols that are minimal risk or below with an average turn-around time of two weeks. Please note that turn-around time is dependent on the completeness of the application packet and the PI's responsiveness to the review requirements and requests. At-risk studies are reviewed at HSRB meetings (first Tuesday of each month). At-risk proposals must be send 10 days prior to the HSRB meeting.

The plan/proposal must include each of the following:

1. A completed Application for Review of Research Involving Human Subjects (see Appendix A). The application includes a question that asks investigators to assess whether their projects put their participants at no risk (defined as no greater risk than that associated with normal, everyday activities) or at risk (defined as greater risk than that associated with normal, everyday activities). Sign and include the Certifications page (page 2) & indicate when the lead researcher(s) completed the relevant CITI tutorials. Faculty are responsible for teaching their students about the ethics in research.
2. A brief description of the project. The description should follow the outline specified in Appendix B.
3. Copies of any materials to be used, including interview protocols and survey instruments.
4. A copy of the informed consent form. Participants should sign a copy of the form for the investigator's files and should receive a copy of the form for their own use. The informed consent form should:
   1. a) state that the study has been “approved by the Hope College Human Subjects Review Board” and that the subjects may contact the Hope College Board if necessary;
   2. b) describe the activities in which the participant will be engaged;
   3. c) describe any benefits to the participant or to others which may be reasonably be expected from the research;
   4. d) state whether data will be collected from the participants anonymously and whether those data will be held in confidence;
   5. e) advise participants that they are free to withdraw from the study at any time without penalty;
   6. f) describe any reasonably foreseeable risks or discomforts the participant may experience;
   7. g) tell participants whom to contact for answers to questions about the research, about their rights as subjects, and about any research-related stress or injuries;
   8. h) include the principle investigator’s contact information;
   9. i) indicate that subjects receive a copy of the consent form;
   10. j) should include a signature of a witness
5. If minors or compromised vulnerable subjects are involved in the study, a copy of the assent form should be submitted. Describe how assent will be obtained and documented.
6. A copy of any recruitment document (include advertisement flyers / invitation letters / invitation emails) to be used.
7. A copy of your on-line training certificate, if you haven't submitted one already. Complete the CITI on-line training course before submitting your plan. Other certifications, such as the NIH online certification is acceptable. Researchers/experimenters are required to complete the course, print and forward a copy of the Completion Certificate to the HSRB, Mary Inman, 1162 Schaap Science Center. The HSRB will not issue final human subjects clearance or approval until the training certificate is on file.
8. If participation in the study is one way for students to fulfill a research requirement it must be clear that participation is voluntary. When surveys are administered through the mail or over the telephone, it will not be necessary to ask participants to return a signed copy of the informed consent form unless the HSRB makes doing so a condition of approval.
9. Indicate if there is any conflict of interest for all research personnel for this project. Disclose any potential or perceived conflicts of interest.
10. A description of how confidentiality/anonymity will be protected. The Department of Health and Human Services stipulates that information taken from educational tests be recorded in such a manner that subjects cannot be identified directly or through identifiers linked to the subjects. Explain how this will be done. Will the subjects be given code names or numbers, for instance?
11. The name(s) and address(es) of official(s) authorizing access to any subjects in cooperating institutions not affiliated with Hope College or in cooperating institutions not under indirect control of Hope College. Please provide this list if it applies to your research. In cases of human subject research involving subcontracts, institutions having their own Institutional Review Boards should provide Hope College with a copy of their IRB approval letter or other evidence of completed review. It is the responsibility of the PI to request and ascertain the receipt of this document(s) from the subcontracting institution(s). A copy of the document(s) is to be sent to the HSRB, Mary Inman, 1162 Schaap Science Center. The PI is to be the Hope College representative responsible for providing a contact at the subcontracting institution(s).

The above items are required by Hope's HSRB. If you do not include all of the above information, your request may be held until it is complete. You will be asked to provide additional information if necessary. Please keep in mind that depending upon the type of review your project requires, it takes about two weeks or more to compete a review. If a reviewer has questions for you to answer, this process may be slowed down. This time-frame may be an important consideration if you are seeking support from an outside agency.

Review of Proposals

If the investigator indicates on the Application for Review of Research Involving Human Subjects that the proposed project involves no risk to participants, and if the chair of the HSRB agrees with that assessment, the chair will distribute copies of the plan of investigation to each board member. If at least four members provide the chair a written notice of approval of the project, no meeting will be held and the chair shall give the investigators permission to begin data collection. Board members may offer approval with the provision that minor procedural changes be made in the protocol. If the suggestions appear to the chair to be reasonable, and the chair conveys them to the investigator, and the investigator agrees to implement the suggestions, it will not be necessary to convene the board to discuss them. If at least one member of the committee does not want to approve the project without a meeting, or if the chair believes that the suggestions offered by one or more board members should be discussed, then the chair shall schedule a meeting to review the project. The HSRB uses criteria 46.111 to evaluate research and criteria 46.416 to evaluate Informed Consent forms of the OHRP federal code, Title 46.

If the investigator indicates on the Application for Review of Research Involving Human Subjects that the proposed project involves putting the participants at risk or if the HSRB chair disagrees with the investigator's assessment that the project involves no risk to participants, the chair will distribute copies of the plan of investigation to each committee member. If the committee feels that sufficient safeguards are not in place to protect the participants, the chair will schedule a meeting to discuss the project.

All members of the HSRB shall be sent materials pertaining to each proposal and shall be given timely notices of all meetings. No meeting can be held with fewer than four members present. The HSRB shall strive to arrive at a consensus in its decisions, but no project can be approved without the support of at least four members. Decisions of the HSRB can be appealed to the Deans' Council of Hope College.

The HSRB chair shall notify all investigators of the board's decisions regarding their applications.

Approval of applications will last for twelve months; investigators will be given an expiration date when they receive their approval. In the event that the HSRB did not approve an application, the chair will explain to the investigator why approval was not granted and will specify the changes that would be necessary for the application to be approved. The chair also shall notify investigators of their right to appeal HSRB decisions to the Deans' Council.

The chair shall place in the Frost Center files copies of all correspondence with committee members, correspondence with investigators, and minutes of all meetings (including discussions of substantive issues, the resolution of those issues, and any vote counts). All records shall be retained for at least three years.