How to Apply for IRB Approval

Any directed or independent research projects involving human subjects which employ systematic data collection with the intent to contribute to generalizable knowledge will require approval by the IRB. For further detail in what constitutes a research project vs. research practica please refer to definitions located in section Who Must Apply - Student Projects.

Special notes for students:

• The IRB must receive notification from your faculty advisor of his/her approval of your project. Your advisor may either email his/her approval to the IRB or may sign the cover page of a paper submission. Student proposals will not be reviewed until advisor approval is received.
• All email correspondence to the IRB must include cc: to Co-PIs and faculty advisor
• Mount Holyoke College recognizes the importance of research in the educational program of its students. In order to facilitate student research experiences, the IRB urges any student who is planning on conducting a summer research project involving human subjects, to submit a proposal for review by the IRB by mid-April. Submitting proposals for IRB review by this suggested date will enable any and all issues that may be associated with the proposal to be resolved prior to the end of the semester/beginning of the planned summer research. Reminder: no summer research involving human subjects may be conducted without the approval of the IRB.

All researchers covered by this policy whose research is funded by federal grants must complete training in human subjects protection prior to submission of a proposal to the Board. More specifically:

Students on federally funded grants must complete:

1. CITI Training: Human Subjects Research
2. CITI Training: Responsible Conduct of Research

Primary Investigators and Senior Personnel* on federally funded grants must complete:

1. CITI Training: Human Subjects Research
2. CITI Training: Responsible Conduct of Research
3. Research Securities Training (specifically for NIH and NSF grants)
4. Research Security training is available in Workday. The training is in the Safety, Security, and Environmental Awareness section of Workday Learning.
5. Submit the certification via the Mentor IRB system.

*Senior personnel are determined by the PI and refers to anyone considered essential to the grant and labeled as such in the proposal (e.g., Co-PI, Co-Investigator, Lab Manager/Director, Project Manager).

In addition, the Board may require such training of other researchers whose coursework, background and experience, based on information submitted with a proposal, seems inadequate. Those researchers will be notified by the Chair when training is required. Online training options are the following:

• CITI Training: Select the appropriate course (Human Subjects Research and/or the appropriate Responsible Conduct of Research module), and identify the appropriate learner group that pertains to you (faculty, staff or student). If you are doing ethnographic research, or if your research deals with underserved or underrepresented populations, you should complete the Cultural Competence in Research module as well.
• To access CITI training, click on "Log In," and select "Log in through my Organization," then click on "See our full list of SSO-enabled organizations," and select "Mount Holyoke College." Click on that and it will bring you to the log in for Mount Holyoke, then type in your MHC username and password.

Investigators should register online, complete the module, and then print out a certification of completion. Submit the certification via the Mentor IRB system. The training is free of charge when only the certificate of completion is requested.

Prior to conducting research (except research involving only anonymous surveys, naturalistic observations, or similar research), researchers enter into an agreement with participants that clarifies the nature of the research. Participants are informed of all features of the research that might influence their willingness to participate. Further, researchers respect each participant's freedom to decline to participate in research or discontinue participation at any time for any reason and without penalty.

Deception
While most proposals will require a process for obtaining informed consent, in some cases, especially for projects that involve deception, fully informed consent may not be practical. The Board may approve a consent procedure that does not include, or alters any or all of the elements of informed consent, if and only if:

• The research involves no more than minimal risk to the subjects;
• The waiver or alteration of informed consent will not adversely affect the rights and welfare of the subjects;
• The research could not be carried out practicably without the waiver or alteration of informed consent.

When appropriate, the subjects will be provided additional pertinent information about the research after they have participated.

Audio and Video Taping
When researchers audio/video tape subjects, the Board requires a signed consent form. But some subjects would be reluctant to sign an official form. This should be explained in the application, and the Board will consider alternative means of documenting consent such as obtaining verbal consent on the tape. Subjects must be informed of their rights, confidentiality, and all other aspects of consent.
Further information about the requirements for documenting informed consent is available at the OHRP site.

Please consult with the Board if you need advice about specific requirements for obtaining informed consent orally or in writing.

Institutional Review Board Policy on Online Participant Recruitment and Data Collection

The internet is quickly becoming a powerful research tool. Researchers have quick and fairly easy access to populations that may have been out of reach in the past. On-line survey companies such as Formsite and Survey Monkey have made it easy to develop sophisticated online questionnaires. However, the internet does pose some significant challenges to conducting good, ethical research. The intent of this document is to 1) provide researchers with some resources that will help them to make good design decisions for their projects, and 2) to outline some of the ethical considerations that are unique to conducting on-line research.

When subjects do not speak or understand English well, the researcher must prepare documents in the language that subjects can understand. The researcher must provide to the Institutional Review Board a copy of the document(s) in English, a copy in the language to be used, and a letter from an unbiased individual with expertise in the language (e.g., a Mount Holyoke College faculty member) indicating that the translated version is complete and contains the same information as the English version.

If the PI can provide documentation of fluency in a language, the Board will review the documentation and take it under consideration.

Special note on research in foreign countries
When faculty, staff, or students conduct research with human subjects in a foreign country, there may be cultural differences that should be considered. Some of the differences are listed below.

Language
When research is to be completed in a language other than English, additional requirements apply.  Please refer to guidelines for projects involving Non-English Speaking Subjects for details.

Minors
When subjects are younger than 18 years of age, researchers are required to get written parental permission. However, if local regulations are such that parental permission for research in a school setting would be inappropriate, the researcher must give the Board proof that this is inappropriate. For example, proof could be a letter saying that parental permission would be inappropriate from an authorized official in the country, or from a Mount Holyoke College faculty member who is familiar with the culture.

If there are no changes to a research project previously approved by the IRB, the researcher should submit a written request to the IRB (via the Mentor IRB system) requesting an extension, documenting the following:

1. The date the research approval expires
2. Confirm that the research is being conducted by the methods previously approved by the IRB.
3. If new students will be assisting with the research, provide updated name(s) and detail the experience/coursework which demonstrate the students training in the ethical conduct of research conduct.

If the documentation listed above is received by the IRB, the researcher will be granted automatic approval of the extension requested for a period of one year.

If there are changes to a research project previously approved by the IRB, the researcher should submit a new proposal for consideration by the Board.

Consent of the parent/guardian is required for all research involving children.  If conducting research involving children as subjects, the parent letter must be submitted to the IRB for approval with your proposal.

The IRB has noticed that submissions often have common errors that require correction/resubmission by the part of the Principal Investigator.  Please make note of these suggestions as you prepare your proposal:

When responding to the question "How will participants' right to terminate or refuse participation be guaranteed?", please note that all participants:

1. always have the absolute right to terminate participation in a survey for any reason. Participants do not need to be uncomfortable to terminate.
2. always have the option to "skip any question".