For the purposes of the IRB, "research" is defined as a systematic investigation designed to develop or contribute to generalizabel knowledge.
Follow the procedures of your home institution to obtain IRB approval. Send a copy of the following documents to the IRB Chair at firstname.lastname@example.org: (1) a brief description of the purpose of your study, (2) IRB approval letter from your home institution, (3) a description of the recruitment methods and recruitment materials to be used at Holy Cross, and (4) copies of the surveys and/or interview questions to be used. The IRB Chair will inform you of whether or not you have been given permission to use members of the Holy Cross community as subjects.
You will need Holy Cross IRB approval. Once you have received approval, you will need to contact the institution where you anticipate recruiting and see what requirements they may have for permission to recruit in their community.
All projects that meet the definition for conducting research with human participants must be submitted for review and approval or determination of exemption before beginning the study. This includes proposed research involving exisiting data, and student projects.
Yes, if the study meets the definition for research with human participants. Many projects using surveys are now deemed exempt, so we have developed a simplified form if you think your project may qualify. Written approval from IRB must be in place before any interventions or interactions with human participants (recruitment) actually begin.
If your research project involves use of existing information collected from human participants but no identifiers link individuals to the data, then the activitiy may be exempt from oversight. The IRB will make this determination; you should still submit your protocol for review.
Yes, projects conducted by the College of the Holy Cross students need iRB approval if they fit the definitions of "research" and "human subjects". If the project is to be used, for example, in a classroom setting only to teach research methods, the project might not constitute human participant research. Students should discuss these issues with their instructor or faculty advisor before beginning a project, so that they can determine whether IRB review is necessary. If it is, they should subit the protocol through their advisor, who will review and sign it.
Yes, you still have to submit an application and request an exemption. Even if a project seems to meet the definition of human subjects research, investigators cannot declare their own projects exempt; only IRB can do that. A simplified application is available if you think your project is exempt.
You must receive written approval from the IRB before beginning participant recruitment, data collection, or data analysis. A memo will be sent to you via e-mail when your project has IRB approval. It may be taken as written approval; a formal letter will follow for your files.
Every new protocol submitted to the IRB must include a completed New Protocol Cover Sheet. Be sure that you include any other required documents, as specified on the cover sheet. They are explained in the New Protocol Guidelines.
The Application Process
No, students are not allowed to serve as a Principal Investigator (PI) for a project. Your faculty mentor or advisor must be the PI, and the faculty member must be the one to sign the form at the bottom. Even if the student is the person who actually fills out the form, the faculty member who signs the form assumes total responsibility for the accuracy and thoroughness of the information on the application.
The IRB evaluates every research protocol according to the ethical principles described in the Belmont Report. Basically, this means the IRB considers whether the risks and benefits of a study are acceptable and managed appropriately, and whether individuals being asked to participate are adequately informed about the research and its possible risks. The Review Criteria page describes some of the key points the IRB uses when reviewing protocols.
All applications must be submitted via e-mail to email@example.com with the subject line "Human Subjects Research Protocol - [Name of Principal Investigator]." Be sure to include any supporting documents as attachments that are clearly labeled.
That depends on the nature of your study and the characteristics of the people you intend to recruit. If you are requesting to have your project granted an exemption, the Chair of the IRB or his or her designee typically can make an initial determination within five working days or up to 7-10 days during busy times when the IRB is processing many applications. If the reviewer requires clarification, then it can take longer. If you requested an expedited review, you typically will receive an initial response from the reviewer in 7-10 days. If the application goes before the full IRB, then the approval process will take somewhat longer. The committee meets to review all appliactions requiring a full review. If you submit a protocol for a full review you may need as long as a month for a decision, especially during the Summer. Its always important to plan ahead to make sure that you are allowing enough time for your review prior to the time you hope to start your data collection.
The Consenting Process
In general, yes, but there are some limited exceptions. The College of the Holy Cross IRB is responsible for ensuring that basic ethical principles are abided by in all research. The expectation that the informed consent of research participants be obtained is based upon the Belmont principle of respect for persons, and regarded as extremely important in conducting research ethically. The IRB has the authority to waive some or all of the federal requirements for informed consent in certain extenuating circumstances.
All faculty, students, and staff proposing to use human participants in research under the auspices of College of the Holy Cross are required to complete the human participants training.
If there are multiple individuals who are part of a team for a research project, then all team members must complete the training prior to submission of an application. For example, if a team of students will be collecting data for a client as a part of a team effort for a capstone project, then all members of the group must complete the training before the IRB will review the proposal. Completion reports are automatically sent to the Sponsored Research Office.
The IRB may accept alternate training in lieu of the CITI training if the researcher can produce documentation related to the training course/s, the institution offering the training, the date of completion and the score received. Such documentation should accompany the protocol submission. However, it is up to the discretion of the IRB to accept the alternate training or have the researcher complete Holy Cross CITI training as well.
When you complete the training, you will receive a certification date from CITI. The College of the Holy Cross IRB accepts your certification as valid for three years from that date. Once the three years have passed, you will need to do the training again to keep your certification valid if you wish to continue to do human subjects research at College of the Holy Cross.
Lifecycle of the Protocol
Yes. It is not uncommon for researchers to want to make changes after they begin a study. Any and all changes to an approved research study must be submitted for review and approval prior to implementing the change(s) into the research study.
To request a modification or amendment to an approved research study, researchers must complete and submit the Modification Form to firstname.lastname@example.org along with all required documents (noted on the form).
It is the responsibility of the Principal Investigator (PI) to ensure continued approval of his or her human participant research study. If an investigator allows his or her approval to expire, all research on the study must cease until renewed approval is granted. Progress of approved research must be reported, in the manner prescribed by the IRB, on the basis of risks to participants, no less than once a year. Go to the IRB Application and Other Forms page for the Continuing Review form. Approval granted by full committee review lasts a maximum of one year. Approval granted by the expedited process does not expire, but once the study has ended, you should submit a termination form.
Unanticipated Problems/Adverse Events
Serious adverse events must be reported to the IRB immediately, with a written report by the PI following within 24 hours of the PI’s becoming aware of the event. Serious adverse events are (1) death of a research participant; or (2) serious injury to a research participant.
All other non-serious unanticipated problems should be reported by the PI to the IRB within 2 weeks of the first awareness of the problem. Prompt reporting is important, as unanticipated problems often require some modification of study procedures, protocols, and/or informed consent processes. Such modifications require the review and approval of the IRB.
Yes. If an unanticipated problem poses risks to the participants or others, the IRB may temporarily discontinue a research project until a thorough investigation has been conducted. Dependent on the investigation, the IRB may request changes to a research study or permanently discontinue the research study.
Yes. As a result of the IRB's investigation of the unanticipated problem, revisions to the approved research study and the informed consent form may be requested.