Guide to Obtain Ethics Approval for Research
Whether you are a faculty member or student, if you are planning to conduct research at Wesleyan through the Department of Psychology, ethics approval from the Psychology Ethics Committee or the University Institutional Review Board (IRB) is required prior to initiating data collection for your research. Research conducted in faculty labs, the community, on-line, and for theses or independent projects, all require ethics approval. If you are a student, it is necessary for you to have a faculty sponsor in the Department of Psychology to submit a protocol. If your proposed research poses minimal or no risk to participants, does not involve vulnerable populations, or include the collection of sensitive data, then you may submit a protocol for your proposed research to the Psychology Ethics Committee. If you plan to conduct higher risk research, study vulnerable populations, collect sensitive data, or if your research involves other complications, then you are required to submit your protocol to the University IRB.
Instructions for Submitting your Protocol
To prepare a new protocol, first, complete the Psychology Ethics Committee Protocol Cover Page. Check “New Protocol” in the pull-down menu. Next, use the protocol outline to describe your proposed research. Adhering closely to these guidelines and taking care to provide the required information will facilitate a timely review of your protocol. A protocol that does not contain all of this information will be returned for completion without review and therefore will incur significant delay.
(1) A brief description of the objectives and design of the study.
(2) A description of the study procedure, including a description of who the participants will be and how many will be involved.
(3) In addition, the protocol must include all of the following:
(a) A specific description of where the data collected will be stored (e.g., specific room numbers) and under what conditions (locked cabinets).
(b) An explicit statement (identifying persons by name) about whom will have access to the data.
(c) An explicit statement about when the data will be destroyed.
(d) An explicit statement about how the data will be coded to protect subject identity.
(4) A description of how and when the debriefing will be conducted (e.g., in person immediately after the study).
(5) A copy of the debriefing script that will be used. This must be written in nontechnical language easily understood by the general public. For educational purposes, the Psychology Ethics Committee encourages a written debriefing summary, including references for further reading, to be given to participants.
(6) A copy of the consent form, or an explanation of why a consent form will not be used (e.g., research involving a telephone survey where no identifying information is collected). If a consent form is used, the proposal should include two copies, one labeled “Participant Copy” and a second labeled “Researcher Copy.” Refer to Sample Consent Form and guidelines for The Elements of Informed Consent below.
(7) In the consent form, a description of any potential risks to participants beyond “minimal risk” (i.e., the level of risk encountered in daily life) and of any potential benefits.
(8) If the study entails minimal risk (e.g., a deceptive cover story), an explanation of:
(a) Why the risk is unavoidable.
(b) Why the benefits of the study outweigh the risks.
(c) What steps are being taken to safeguard the welfare of participants.
Once you have completed the Psychology Ethics Committee Protocol Cover Page and your protocol adhering the above outline, follow the instructions below Submitting your Completed Protocol to the Psychology Ethics Committee.
It is not unusual for the Ethics Committee to have questions about a protocol submission. In such instances, the committee will ask for written clarification to address any questions raised in the review process and for accompanying changes in the protocol as appropriate. It is incumbent on the researcher to address those questions and revise the protocol to the satisfaction of the committee in order to gain approval for their protocol and move forward with their research project.
To prepare a revised protocol, complete the Psychology Ethics Committee Protocol Cover Page. Check “Revised Protocol Not Yet Approved” in the pull-down menu. Address each question raised in the prior review by the Ethics Committee within the body of an e-mail addressing each question raised about the protocol point by point. To facilitate the most expeditious re-review of your proposal, we ask that you highlight areas within the protocol where changes were made to address question from the committee.
Once you have completed the Psychology Ethics Committee Protocol Cover Page and revised your protocol with all changes made highlighted, follow the instructions below Submitting your Completed Protocol to the Psychology Ethics Committee.
Often, a researcher will need to make a small change to their research protocol. If the change is minimal, you do not need to submit a new protocol. Examples of a minimal change include change of the names of members of the research team, change in how participants will be recruited or compensated, the addition of a few survey questions, and so forth.
To prepare an addendum to amend an already approved protocol, complete the Psychology Ethics Committee Protocol Cover Page. Check “Addendum to an Already Approved Protocol” in the pull-down menu. Provide a brief but detailed description of the proposed changes to the protocol. If you are changing the consent form, study stimuli, or debriefing sheet, be sure to include revised forms as appropriate in your protocol. You do not need to submit the originally approved protocol with your Addendum request.
Bear in mind that you may be asked to submit a New Protocol if the Psychology Ethics Committee determines that your request for an Addendum to an Already-Approved Protocol is substantial.
Once you have completed the Psychology Ethics Committee Protocol Cover Page and developed a written description including any documents that have been changed or added, follow the instructions below Submitting your Completed Protocol to the Psychology Ethics Committee.
A complete protocol will consist of: (a) the completed Ethics Committee Protocol Cover Page; (b) the study protocol or description of proposed amendments; and (c) any supporting documents (if applicable). Remember, revised protocols require that you address questions raised in the prior review in the body of the e-mail. All completed protocols should be submitted electronically to Cathy Race at firstname.lastname@example.org. Please do not send or “cc” protocols to committee members.
Students are required to submit their protocols through their faculty advisor for their project. If you are a student, you should forward your complete protocol to your faculty advisor for their review. Once your faculty advisor has approved it, they should include the following statement in the body of their e-mail sending your materials to Cathy Race.
“I have read this protocol for conformity to the Psychology Ethics Committee guidelines and I approve it.”
Q: Why do I need ethics approval for my research?
A: All universities that receive federal funding for research have committees with oversight for the conduct of ethical research. Such committees were established at the behest of the Department of Health and Human Services to ensure the protection of humans studied by researchers, and a failure to follow those guidelines can jeopardize the receipt of federal funds even if the failure occurs for a research project that is not supported directly by federal funding. Universities and other research institutions typically adhere to the guidelines set forth by the DHHS Office of Human Research Protections. At Wesleyan, there are two such committees: the Department of Psychology Ethics Committee and the University Institutional Review Board (IRB).
Q: Do I need to get my research approved by both the Psychology Ethics Committee and theUniversity IRB?
A: No. The Psychology Ethics Committee was established to help expedite the process of gaining approval to conduct research that poses little or no risk. The University IRB instilled trust in the Psychology Department to ensure that all research approved by the Ethics Committee meets both University and Federal guidelines for ethical research, and it is important that the Psychology Ethics Committee adhere to these guidelines to preserve that trust. To conduct research in the Psychology Department, approval from either one of these committees is acceptable.
Q: How do I decide whether I should submit my research ethics protocol to the Psychology Ethics Committee or the University IRB?
A: In general, the University IRB is for research that may be sensitive or higher-risk, or involve other complications. In contrast, the Psychology Ethics Committee was established to help expedite the process of gaining approval to conduct research that poses little or no risk. If your proposed research is of minimal risk to participants, does not involve collection of sensitive data, and does not involve vulnerable populations, you may consider submitting your protocol to the Psychology Ethics Committee. For the Ethics Committee to review your protocol, it is necessary that the primary mentor for your research be a faculty member in the Psychology Department. If you are collaborating with another research institution or university, your research protocol will need to be reviewed by the Wesleyan University IRB because a letter from the IRB of the other institution attesting that they have approved the collaborative research at their site is normally required. The Psychology Department Ethics Committee cannot receive such communications from other institutions.
Q: What if I’m collaborating with a researcher at another institution or university?
A: If you are conducting collaborative research with another research institution or university, and you are analyzing data or have access to the data at Wesleyan, you will need approval from the University IRB and from the collaborative institution. A letter from the IRB of the other institution attesting that they have approved the research at their site is normally required. In such cases, the Psychology Ethics Committee can neither review or approve your protocol.
Q: Can the Psychology Ethics Committee approve my research protocol if I plan to collect data on another college campus?
A: No. Neither the Psychology Ethics Committee or the Wesleyan University IRB has purview of research practices or policies of other colleges or universities. If you plan to collect data at another such institution, you will need to obtain ethics approval through the IRB of the institution that you plan to collect data. Be aware that most IRBs require that protocols be submitted by full-time faculty member of the respective institution, so a collaborator at other campus sites is almost always needed. Also note that because you are a member of the Wesleyan community, approval by the Wesleyan University IRB is required. Note that the Psychology Ethics Committee cannot review or approve protocols that involve another institution.
Q: Are there any instances where my research doesn’t require approval?
A: If your proposed project is being conducted as an learning activity in a Psychology course and the results will not be presented to the public beyond the classroom (e.g., student journals, university or conference poster sessions, or other publications) or used otherwise to inform the development of future research, in other words, purely for educational purposes in the classroom, ethics approval may not be required. However, the proposed project must also meet all of the following conditions: (1) minimal risk to participants; (2) does not involve collection of sensitive data; and (3) does not involve vulnerable populations.
Q: Must participants always sign the consent form?
A: No, not always. Sometimes asking a participant to sign a consent form creates a problem by making it difficult for a participant to remain anonymous. For instance, in an on-line survey, it may be preferable to present participants with consent form prior to survey questions and then simply ask them to check a box to advance to the survey questions. This ensures that the participant understands the risks and purpose of the study and that their participation is voluntary while ensuring their anonymity.
Q: How do I decide if my research is more than minimal risk, or determine if I am asking participants to report sensitive data?
A: It is often not immediately obvious if a study is minimal risk. Examples of when risk is more than minimal may include asking questions that may upset a participant, or place them at some risk, for instance, when asking what might be regarded as sensitive or personal information. Asking about a person’s religious beliefs or their sexual behavior in many instances may not be considered sensitive or necessarily place a person at risk. However, depending on the nature and extent of such questions, some people may become understandably upset by such questions. Among certain cultures, the answers to questions like these may make a person vulnerable to ridicule or sanction. Personal questions that constitute sensitive data include health information, including questions about mental illness, or questions about drug abuse or illegal behaviors. Questions such as these may pose more than minimal risk because they may be upsetting to a participant and also because if such information were obtained by a third party, for instance via court-ordered documents, that information may jeopardize the participant legally or otherwise. Therefore, a protocol asking about such information generally requires review by the University IRB.
Q: Will the Psychology Ethics Committee consider my protocol if my research is in a department other than psychology?
A: No. The Psychology Ethics Committee reviews only research that originates with a faculty member in the Psychology Department, or a student whose primary mentor is a faculty member in the Psychology Department. Faculty from other departments may be involved, but if data are not stored in the Psychology Department, or if research is conducted in another department, it is not in the purview of the Psychology Ethics Committee and will need to be reviewed by the University IRB. Having a member of the psychology department join a research project that originated in another department or major is not an acceptable solution to utilize the Psychology Ethics Committee.
Q: How long will it take to review my protocol?
A: The Psychology Ethics Committee tries to review and act on protocols within 3-5 business days. Sometimes it may take longer. Factors that affect how long it may take include the complexity of the protocol and how well it is organized. The time of the year may also have an impact. The turn around time may be lengthened during break periods or during very busy times of the semester. Over the summer, a reviews may take longer, and proposals submitted during July or August may take 2-4 weeks for review, so be sure to plan ahead for summer research. In general, it is never a good idea to wait until the last minute to submit your protocol so you don’t put yourself in the position of not being able to start your project. The Psychology Ethics Committee tries their best to turn around proposals as quickly as possible, but also takes action on proposals in the order in which they were received.
Q: How can I find out about the status of my protocol?
A: If you are wondering about the status of your protocol, you may contact Cathy Race. She plays a crucial role by coordinating all protocol submissions and approvals and notifying applicants the result of the committee review. She also has the charge of logging all protocols and keeping track of their status. Thus, communication that does not go through her can make her job more difficult. Please be patient, keeping in mind the usual turn-around times for protocol review and try not to bother her unnecessarily. Cathy does a superb job of keeping careful track of protocols and helping the committee to take action on protocols in the most timely manner feasible.
Q: Should I contact the members of the Psychology Ethics Committee if I have a question about my research?
A: No. It is generally not helpful and can introduce problems to contact members of the Psychology Ethics Committee directly with a question about a protocol that you are developing. Committee members can rarely answer the question without the full context of your protocol. Also, members may vary in their initial opinions about certain matters that might not be resolved until the committee meets, and so communication outside the normal channels may invite misleading advice. If you are a student and have a question, you should speak with your faculty advisor for your project. In very rare instances for an unusual issue, they may contact the committee directly on your behalf.
Sensitive data. Sensitive data include behaviors that are typically sensitive to individuals, such as drug or alcohol use, illegal conduct, or sexual behavior, as well as information that could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject’s financial standing, employability, or reputation.
According to the DHHS Office of Human Research Protections, federal regulations require that certain information be provided to each research participant, including:
(1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the participant’s participation, and a description of the procedures to be followed.
(2) A description of any reasonable foreseeable risks or discomforts to the participant.
(3) A description of any benefits to the participant or to others which may reasonably be expected from the research.
(4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant.
(5) A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained.
(6) For research involving more than minimal risk, an explanation as to whether there are any treatments or compensation if injury occurs and, if so, what they consist of, or where further information may be obtained. Note that a risk is considered “minimal” when the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
(7) An explanation of whom to contact for answers to pertinent questions about the research and research participant's rights, and whom to contact in the event of a research-related injury to the participant.
(8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.
Note: It is essential that consent forms be written in plain language that research participants can understand. In addition, the consent form should not contain any exculpatory language. That is, participants should not be asked to waive (or appear to waive) any of their legal rights, nor should they be asked to release the investigator, sponsor, or institution (or its agents) from liability for negligence.
When a signed consent form is used in a research protocol, the Psychology Ethics Committee asks that two copies be used. These should be identical except that one should be labeled “Participant Copy” (as in the example below) and the other “Researcher Copy.” The Participant Copy is for the participant to keep for their own records, and the Researcher Copy is for the researcher’s files. Each copy should be signed by both the participant and researcher should a participant give their consent to be in a study. Be sure to include both the participant copy and the researcher copy when submitting your protocol.
I state that I am over 18 years of age and agree to participate in a program of research being conducted by Professor [X] of the Wesleyan University Psychology Department. The focus of this research is on [describe research topic and procedures. Also describe any expected benefits and risks. Note: all studies involve some risk; if minimal only, state that the risk is no greater than that found in everyday life].
I understand that all of my responses will be held in strict confidence and will not be identified in any publication of the results. Specifically, I understand that the data collected from this research will be stored in locked cabinets and that only [identify persons by name] will have access to the data. The data will be coded so as not to identify me by name and will be destroyed by [list specific time period].
I understand that in return for serving in this experiment, I will receive one hour of credit toward the Research Participation requirement in Psychology 105 [or monetary compensation, list amount here]. I further understand that participation in this research is voluntary, that I may ask questions, and that I am free to withdraw from the experiment at any time. I understand that if I choose to withdraw during the experiment, I will still receive full credit [or full monetary compensation]. I further understand that I will be given a copy of this consent form to keep for my own records. Finally, I understand that if I have any comments, questions, or concerns following the experiment, I may contact Dr. [X] by telephone (860-685-XXXX) or in person (Room XXX of Judd Hall). I may also bring complaints about the experiment to Dr. Andrea Patalano, Chair of the Wesleyan Psychology Department (860-685-2310).
Name of participant (print clearly):____________________________________
Signature of participant: _________________________ Date: ______________
Name of researcher (print clearly):____________________________________
Signature of researcher: _________________________ Date: ______________
Whether participants in your research study are paid, recruited from the Psychology Department Participant Pool, or volunteer with no compensation, the Psychology Ethics Committee values learning components that may accompany the experience of being a research participant. Not only might research participants learn about the specifics of a certain study, but they also may gain an appreciation for how research can advance knowledge scientifically and benefit society. Thus, the Psychology Ethics Committee requires that protocols have a written “Debriefing Script.” Ideally, this should be a printed copy handed to the participant at the conclusion of the study. If the study is web-based, the script may be presented in electronic form with an option for the participant to print the form for their records.
Example Debriefing Script
Debriefing: The “Two String” Study
The purpose of the study is to understand how people solve problems, and in particular, the mental processes by which people may develop creative solutions to problems. We are interested in a phenomenon called functional fixedness where people tend to focus on the mainstream or intended function of objects and how this can prevent them from seeing other ways to use objects creatively.
In the experiment you just completed, your task was to tie together the two strings hanging from the ceiling using only objects available in the room. The challenge, of course, was that the two strings were too far apart for you to reach each of them at the same time, and so this required you to use objects in the room, such as the chair or pliers, that were available to help you successfully complete the task. To do so, you had to “think outside the box.” So, for instance, the usually intended use for pliers is to grip things, but in this experiment, the pliers could be tied to the string to create a pendulum so that one string could swing back and forth and allow you to catch it while holding the other. By standing on the chair (usually used for sitting) you could catch the swinging string and then tie the two strings together after you caught it.
This work is part of a research program with the broader goal of understanding both the conditions and cognitive processes, both those in and outside of awareness, that lead to creative problem solving. In our studies, we try to introduce a variety of different situations and conditions that may either encourage problem solving or make it more difficult. Our research aims to better understand when people are more or less likely to think outside the box and also to clarify the cognitive processes by which that may or may not occur. There are many practical applications of this work in terms of turning it around and helping people be more creative in everyday, work or educational settings.
We ask that you not talk about the details of the experiment to other people who might participate in this study. You could see how if you knew the details about the experiment ahead of time, you may well have responded differently to the task. Thank you for helping us preserve the integrity of our work, and thank for participating in the experiment today!
To learn more about this work, we suggest the following readings:
Landrum, R. E. (1990). Two-string problem revisited: evidence for spontaneous transfer?Psychological Reports, 67, 1079-1088.
Maier, N. R. F. (1931). Reasoning in humans: II. The solution of a problem and its appearance in consciousness. Journal of Comparative and Physiological Psychology, 12, 181-194.
If you have more questions after reading these sources, you may also contact the principal investigator of the study at “email@example.com.”