1. Who must submit a protocol?

College policies and federal laws require that every research project involving human participants be reviewed. Anyone affiliated with Lycoming College (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.

Please use the decision tree to determine whether your specific research study will need IRB approval.

If you have questions regarding your specific research study, please contact your IRB Departmental Representative.

2. What is the purpose of the IRB approval process? Why does Lycoming College require me to get my research approved by the IRB?

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.

3. Who evaluates protocols? How do I submit my protocol for review?

Protocols are evaluated by members of the Institutional Review Board (IRB). Faculty representing diverse departments that enroll human participants in research activities are appointed for three year terms to the IRB by the Provost and Dean of the College. Members of the IRB review protocols to ensure that the rights and well-being of human participants are protected. Expedited protocols are reviewed by a subset of the IRB consisting of two faculty. Full reviews involve all IRB members. IRB submissions should be electronically submitted using one attached document directly to the IRB departmental representative.

Review Board Departmental Representatives

4. What criteria are used to evaluate protocols?

The IRB uses federal guidelines outlined in the Belmont Report and by the Office for Human Research Protection (OHRP) to evaluate research protocols. Review criteria include: 1) the rights and welfare of the participants, 2) the appropriateness of the methods used to secure informed consent, and 3) risk and potential benefit of the investigation.

5. How do I know which form to use?

Depending on the nature of the research, you must submit either an 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.

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.

6. What are possible risks?

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.

7. What is informed consent?

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. Exempt 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. a statement that participation is voluntary

Include all these elements in your consent form or your verbal consent script.

• Sample Consent Form
• Sample Consent Template.

8. What is informed assent?

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.

• Sample Consent/Assent Form.
• Consent/Assent Form Template.

9. How can confidentiality be maintained?

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.

10. How are revised protocols handled by the IRB?

Sometimes expedited or full review protocols may be approved contingent upon the provision of additional information ("explicit changes required" status). When this occurs, the researchers should make the changes set forth by the IRB and resubmit these changes to the IRB departmental representative. Researchers can submit changed protocols for re-review at any point if they have received an "explicit changes required" notification from the IRB (i.e., they do not have to wait until the following Wednesday). The IRB departmental representative 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.

11. What should I include in the brief summary that is to be attached to my expedited 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 expedited 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 expedited 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. Also, don't forget to please attach copies of surveys or interview questions (if applicable to your study).

12. How do I create an electronic signature?

An electronic signature is the scanned file of an ink signature. To make an electronic signature, sign a white piece of paper and scan it to make an electronic document. Open the electronic document and cut and paste your signature on the form.

13. If I have questions about filling out the appropriate IRB form and how to create the appropriate consent forms, debriefing scripts, etc, who do I contact? Can I ask for help from the IRB committee?

Yes. The IRB departmental representative is listed here. You may also contact the IRB committee by calling the secretary for the Provost and Dean of the College at 321-4102, and asking to be put in touch with a committee member representing your department.

14. When are IRB submissions due? How long do reviews take?

Applications are due on Wednesday. Applications received after 4 PM Wednesday will be included in the review cycle beginning the following Wednesday. Incomplete protocol packets will be returned, without review, to the researcher for completion. The expedited review process requires one week and a full review requires approximately one month. Researchers will be notified of denial or acceptance of their protocol following the committee's review. Researchers will be notified on Thursdays of IRB decisions.

Under some circumstances protocols may be approved contingent upon the provision of additional information ("explicit changes required" status). Under these circumstances, the additional information must be provided before approval will be given and data are collected.

15. Do IRB approvals expire?

Yes. Approved protocols remain active for one year from their approval date unless the researcher specifically indicates a shorter duration. Procedures extending beyond one year must be resubmitted to the IRB for a "continuing renewal" at the end of the first year. Any substantive changes in an approved protocol must first be subjected to review by the IRB before the changes are implemented.

• Continuing Renewal Form

16. Is there something I should add to my materials if my research is exempt?

The study you are about to complete meets requirements for exempt research. Thus, it was not reviewed by an IRB (Institutional Review Board). However, all responses will be kept anonymous and confidential (no personal identifiers will be collected).