College policies and federal laws require that every research project involving human participants be reviewed. Anyone affiliated with The College of Saint Rose (as faculty, staff, or student) who is conducting research with human participants, or anyone outside the College who is obtaining research participants though the participants’ affiliation with the College, must get approval from the IRB before initiating the collection of data.
Federal guidelines define research as a formal investigation designed to develop or contribute to generalizable knowledge and a human participant as an individual about whom an investigator (whether professional or student) conducting research obtains a) data through intervention or interaction with the person, or b) identifiable information.
The policies and laws described above are for the protection of the research participants, the researcher(s), and the institution. The role of the IRB is to ensure that the welfare and rights of participants have been properly safeguarded. By having a system in place that requires researchers to assess risk and provide safeguards for participants, the College also helps protect researchers and the institution from liabilities posed by those risks.
Protocols are evaluated by members of the Institutional Review Board (IRB). Faculty representing each of the four schools are appointed for three year terms to the IRB by the Provost. Members of the IRB review protocols to ensure that the rights and well being of human participants are protected.
Exempt protocols are usually reviewed by a faculty member from your school. Expedited protocols are reviewed by a subset of the IRB consisting of one faculty member each from the School of Education and the School of Math & Sciences, plus a faculty member from at least one other school. Full reviews involve all IRB members.
The IRB uses federal guidelines outlined in the Belmont Report and by the Office for Human Research Protection (OHRP) to evaluate research protocols. The actual criteria that are applied differ across the exempt and expedited/full forms. The differences between the forms are explained in FAQ 5.Office for Human Research Protections, U.S. Department of Health and Human Services
Depending on the nature of the research, you must submit an exempt, expedited or full protocol for review. The issue that determines which form you should submit is the level of risk for potential psychological and/or physical harm posed to research participants. Greater risk implies the need for a formalized process for ensuring informed consent from participants and specific efforts from the researcher to mitigate potential risks.
Exempt protocol: If a study involves independent adult participants and poses minimal risks (see FAQ 6 for more information on what constitutes a risk), then the exempt form may be appropriate. If the participants are minors, an exempt form may be appropriate if the research is conducted in a standard educational setting and is part of standard educational practices for that setting (see the exempt form for more information). The exempt form assesses risk through a series of questions. If your research meets the criteria of minimal risk set forth in the form, then you may submit the exempt form in order to get your research approved. Research that presents a minimal risk and falls under the exempt category usually does not require informed consent and/or assent.
Expedited protocol: If your research exposes participants to potential risks (either psychological or physical), then you must submit the expedited form. This form requires researchers to provide detailed information about potential risks, informed consent procedures, and efforts to mitigate risks to participant. Keep in mind that questionnaires and interviews often bring up issues that are emotionally sensitive or threatening to respondents, and therefore would require careful attention to informed consent procedures, maintaining confidentiality, and procedures to mitigate risks posed by the experience. These are the issues addressed by the expedited form.
Full review: Should a study pose significant physical or psychological risk to participants that can not be readily mitigated, the expedited form is used, but goes to full review, meaning that all IRB members will meet to review the protocol. Medical research involving treatments with unknown side effects would be an example of a protocol requiring full review.
Risks include anything that can cause emotional distress or physical harm to the participants. A breach of confidentiality is also a risk. Participants are at risk if their participation or breach of confidentiality may compromise their emotional state, physical health, employment or education. Invasion of privacy, use of personal information, deception and embarrassment are also potential risks.
Potential participants must give their informed consent before participating. Research that presents some risk and requires an expedited or full review always requires informed consent and/or informed assent. Research that presents a minimal risk and falls under the exempt category usually does not require informed consent and/or assent. For a potential participant to give informed consent, that participant must be given the following information:
1. A fair explanation of the purpose of the study (it is not necessary that you give away your research hypotheses to the participants up front, but if you withhold this information, it should be provided afterward in your debriefing).
2. A description of the procedures to be followed
3. A description of potential risks to the participants
4. A description of the potential benefits to the participants
5. A statement that the participant should be at least 18 years of age
6. The researcher’s offer to answer any questions about the study
7. An instruction that the participant is free to withdraw from the study and discontinue participation at any time without penalty
8. Instructions that the participant is not required to respond to all questions in surveys, interviews, etc.
9. A statement that participation is confidential
10. Astatement that participation is voluntary
Include all these elements in your consent form or your verbal consent script. You can find a sample consent form by clicking on the links on the right of the Saint Rose IRB webpage.
Potential participants are often unable to give consent for reasons of mental state, legal restrictions or age (under 18). In these cases a parent or legal guardian must give consent. The individual who is a minor can give assent. Provisions for oral or written assent should include all elements contained in informed consent. You can find links to samples on the right of the Saint Rose IRB webpage.
When participation is confidential it means that the researcher knows the identity of the participants and can trace information from interviews, surveys, etc. back to individual participants. The identity of participants and sources of information are not known to anyone other than the researcher. Confidentiality can be maintained through the use of pseudonyms or codes to conceal identity. A researcher can also maintain confidentiality by keeping all records and identifying information separate from data. It should be noted that, depending on the number of participants and the demographics of the group, certain demographic information can reveal the identity of participants.
Sometimes expedited or full review protocols will receive an “accepted pending revisions”. When this occurs, the researchers should make the changes set forth by the IRB and resubmit these changes as instructed. Researchers can submit changed protocols for re-review at any point if they have received an “accepted pending revisions” notification from the IRB (i.e., they do not have to wait until the following Wednesday). The IRB chair will review the changed protocols within 1-2 business days of resubmission and the researcher will be notified if the changed protocol is accepted. Please note that the researcher cannot begin to collect data until she/he has received IRB approval of the changed protocol.
Keep in mind that the purpose of this brief summary is to help the IRB assess the extent to which your research project is actually in compliance with the federal guidelines for exempt research. Thus, you should describe your research question, describe the participants (such as who they will be and how you will obtain them), and briefly describe the research methodology (such as explaining clearly what will be done to participants and data). Basically, the IRB is looking for more detail about your study in relation to what you’ve indicated on your exempt form. Thus, you should make sure that your responses to questions about demographics, confidentiality, risk and the identity of your participants on your form correspond clearly to what you write about in your description. Additionally, for educational research make sure that your responses to K.1 and K.2 correspond clearly to what you write about the setting and activities in the methods used in your study. Also, don’t forget to please attach copies of surveys or interview questions (if applicable to your study).
Yes. The members of the IRB are listed on the home page of the IRB website. It is suggested that you contact one of the members from your school, since those members are more likely to be familiar with the issues particular to your research study. You may also contact the IRB committee by calling the Administrative Secretary in the Thelma P. Lally School of Education at 454-5208 or the Office Assistant in the School of Mathematics and Sciences at 454-5266, and asking to be put in touch with a committee member from your school.