This is an overview for faculty and graduate students in the Department of Psychological Sciences, West Lafayette campus, about conducting research that involves human subjects. Human Subjects Research Guide
Department of Psychological Sciences
Purdue University, West Lafayette Campus
Can I conduct research using human subjects?
What is the IRB?
What regulations govern human research?
Do I need any certification before conducting research?
Does my research project need reviewing?
What research is exempt from review?
What research qualifies for expedited review?
What is full review?
What is the full review process like?
What are the risk levels?
How do I find out the assessed risk level of my protocol?
Where can I get the application forms?
How do I revise my protocol?
What is the surveillance form?
How long must I keep copies of the consent forms?
What other information must I track?
What do I do if my study involves deception?
Can I use graduate students or PSY 390 students as subjects?
What common mistakes delay approval?
How do I get access to the PSY 120 subject pool?
What common mistakes should I avoid when using the PSY 120 subject pool?
What about PSY 120 students who are under 18 years old?
Where is a copy of the Departmental Procedures?
What are stamped consent forms and how do I get mine stamped?
My question wasn't answered here. What do I do?
Can I conduct research using human subjects?
On July 1, 2004, the new eligibility policy [pdf document] will go into effect.
Graduate students cannot serve as a PI.
IRB stands for Institutional Review Board. The mission of Purdue's IRB. is to protect the privacy, safety, welfare, and rights of human research subjects through a thorough evaluation of recruitment procedures, informed consent processes, and analyses of the risks to the subjects relative to the benefits of the research.
What regulations govern human research?
Lots. The "Common Rule" provides the basic regulations that govern human subject research. Formally, this is known as Title 45 of the Code of Federal Regulations, Part 46, which is usually abbreviated as 45 CFR 46. Depending on the exact nature of your research, other regulations may apply.
Do I need any certification before conducting research?
Short answer: Yes.
Long answer:
- If you are an undergraduate enrolled in PSY 390, you need to complete the on-line course at NIH. You will need to show your certificate before you are allowed to begin research. You will also need to attend an orientation. This is usually scheduled during the first two weeks of the semester. The exact date, time, and location will be sent via email to all registered students, and will also be posted here.
- If you are a graduate student, you will need to complete the CITI training at: www.miami.edu/citireg/.You will need to register (this is free). You need to complete the basic course for behavioral and social researchers with 80% or higher in order to get your certificate. You will need this before you can be listed on any protocol.
- If you are a faculty member, you will need to complete the CITI training at: www.miami.edu/citireg/. You will need to register (this is free). You need to complete the basic course for behavioral and social researchers with 80% or higher in order to get your certificate.
If you do not have PI status on an active protocol as of July 1, 2004, then you must complete this training before you can submit a protocol. If you have PI status on an active protocol as of July 1, 2004, then you have up to 1 year to complete your training. The exact date depends on when your surveillance forms are due.
- If you are someone other than an undergraduate or graduate student or faculty, but you are listed as key personnel on any protocol or grant, then you, too, need to complete the CITI training program at www.miami.edu/citireg/.
Does my research project need reviewing?
Most likely, if it involves humans or data from humans in any way, your research project needs to be reviewed before the project begins (see statement)
What research is exempt from review?
The criteria for research that is exempt can be found here. If you believe that your research proposal qualifies, submit two (2) copies of "Request for Research Exemption" (Form HS-95/4) [PDF format, Word format] to Connie Stump. Your request is then evaluated by the IRB. Research that uses PSY 120 students does not qualify as exempt.
What research qualifies for expedited review?
The criteria for research that can qualify for expedited review can be found here. The term "expedited" is used to refer to the type of review process, not to the speed of the review process. You should allow a minimum of 2 weeks during the Fall or Spring semesters, and longer during school holidays.
If you believe that your research proposal qualifies for expedited review, AND it involves PSY 120 students, submit the original and two (2) copies of "Application To Use Human Research Subjects" [PDF format, Word format] to Connie Stump. Your request is then evaluated by three members of the Department of Psychological Sciences Human Subjects Advisory Group. It is then reviewed by the co-chair of the HSAG, and then by the chair (who is also co-chair of the IRB). All of this is done within the department. If approved by the chair of the HSAG, the proposal is reviewed by the vice president for research compliance.
If you believe that your research proposal qualifies for expedited review, but it does not involve PSY 120 students, then your application will be processed by the IRB, not by the department. Submit two (2) copies of "Application To Use Human Research Subjects" [PDF format, Word format] to Connie Stump, who will forward it to the IRB.
If a protocol does not qualify for exempt or expedited review, then it must undergo full review. In general, if your protocol involves the potential for more than minimal risk, or your protocol involves prisoners or groups who may have diminished capacity to provide consent or who may be at high risk, then it must undergo full review.
You use the same forms for both expedited and full review (Application To Use Human Research Subjects, [PDF format, Word format]). Full review means that the proposal will be reviewed by the Full Committee at its monthly meeting.
What is the full review process like?
Submit the original and 20 complete copies of "Application To Use Human Research Subjects" [PDF format, Word format] to Connie Stump. She will forward the application to the IRB. The IRB meets on the fourth Tuesday of each month (except for November and December). The IRB must receive these 10 working days before the meeting.
The IRB members may have questions and/or comments. If so, you will receive these via email usually a couple of days before the meeting. This is your opportunity to address these concerns by revising your application. The full committee can then consider your revised application at the Tuesday meeting.
If there are many comments, you will be invited to attend the meeting. You should look at this as an opportunity to speed up the process. By answering questions at the meeting, your proposal might be approved then and there rather than giving you feedback and then waiting another month for the next meeting.
You will most likely receive an email within a couple of days after the meeting informing you of the decision. Official paper work will then follow.
Each proposal is evaluated by the IRB for the potential risk it might pose to human subjects. The lowest level is "minimal" which means
the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life.If the risk is higher than "minimal" then full review is required. If the risk is higher than "minimal" then the research cannot use PSY 120 students. After "minimal" the next level of risk is "low."
How do I find out the assessed risk level of my protocol?
When your protocol is approved, you will receive formal notification from the IRB. The form you receive will also indicate the risk level.
Where can I get the application forms?
All University forms are available for download here. Make sure you get your forms directly from the IRB as the forms often get updated and revised.
The departmental's form for accessing the PSY 120 subject pool is available in [PDF format, Word format]. Templates for consent forms and debriefing forms are available in [PDF format, Word format]. Do not use old copies that you may have on your word processor. Always download new copies. Applications submitted on old versions of the forms will not be processed.
If you want to make any substantive changes to your research protocol, submit a "Revision of Protocol" form [PDF format, Word format] to Connie Stump. This form is required for all protocols regardless of the type of review they underwent (Exempt, Expedited or Full). You need 2 copies for exempt and expedited protocols, and 20 copies for full review protocols.
What is the surveillance form?
If you have a protocol that has been approved, you will find that approval expires after (usually) 1 year. Before approval expires, you will receive a surveillance form via campus mail. You need to complete the form and return it before the expiration date. If you do not, then your protocol is terminated and you can no longer recruit or test subjects. If you do complete and return the form in time, the form is reviewed (known as continuous review) and either the protocol is approved for another (usually) 1 year period or requests for changes or further explanations are made.
How long must I keep copies of the consent forms?
You must keep the consent forms until three (3) years after the termination of your protocol. For example, if your protocol was approved in 2001 and the project is terminated in 2005, you must keep the consent forms from all subjects until 2008.
What other information must I track?
You must keep track of the number of subjects you have tested in your protocol. The IRB will want to know (1) the number of subjects tested since the last surveillance form and (2) the total number of subjects tested.
What do I do if my study involves deception?
If your study involves deception (telling subjects something that is not true), then you need two consent forms. The first consent form can look just like the templates. The second consent form will be administered after the debriefing. This form should describe the exact nature of the deception and the reasons why deception was necessary. This form will ask the subject for consent to use the data collected. The rationale is that in studies involving deception, subjects cannot give informed consent to allow the use of their data until they are informed of the nature of the deception. You will need to provide copies of both forms before you can access the PSY 120 subject pool. This applies to all studies.
A prototype is included with the other Department forms [PDF format, Word format].
Can I use graduate students or PSY 390 students as subjects?
The IRB requires full board review of all protocols that use subjects, like PSY 390 students or graduate students, who are academically involved with the PI. The reason is the increased risk for coercion. Even though you aren't the sort of faculty member who would write a worse letter of recommendation for a student who declined to participate than if the student agreed to participate, the IRB is concerned with what the students themselves think. Do they really believe that they have a choice and that the choice will have no effect whatsoever on their grade or on (potential) letters of recommendations?
One method that has been used in the past is to have some neutral third party keep track of which students participate. You, as the faculty member, have no knowledge, and so your grading and the letters of recommendation that you write cannot be influenced by the students' decisions.
What common mistakes delay approval?
This list is not exhaustive, but does include the most common items.
- Use up-to-date forms
- Make sure all sections are filled in correctly
- Include all sections in the forms
- If you are using subjects from the PSY 120 subject pool, use the following for Section D (recruitment of subjects):
Subjects will be recruited from the Psychology 120 subject pool using the web-based Experimetrix sign-up program.- Corrections made in pen/pencil or white-out are not allowed
- Use the same headings as in the sample forms
- List and assess all possible risks
- Use the standard format for the consent form
- Make sure there is a line at the top of your consent form for the research project number
- Write for an intelligent audience who may be unfamiliar with your specific topic and research methods
- Compensation (paying subjects) is not considered a benefit of participation, but rather is an inducement to participate
- If you have a multi-page consent form, leave room for the subject's initials and date on each page prior to the final page
- Include your recruitment ad (if applicable)
- Include copies of questionnaires if they are not published (e.g., do not include a copy of the MMPI; do include a copy of a questionnaire you made up)
- Include copies of IRB approval from collaborating institutions (if applicable)
- Include copies of letters from school districts giving you permission to test students (if applicable)
- Include your debriefing sheet if the protocol involves PSY 120 students
- Include the text that will appear on the Experimeterix web site (if applicable)
- Include both consent forms if your study involves deception
How do I get access to the PSY 120 subject pool?
First, you must be either tenured or tenure-track faculty OR have approval from the Vice President for Research to conduct research using human subjects. Second, you must have a faculty appointment in the Department of Psychological Sciences at the West Lafayette Campus. Third, your protocol must have been approved (by either expedited review or full review) and your project's risk assessment must be "minimal."
First, obtain Experimetrix numbers from Connie Stump. Then, submit
This information needs to be provided every semester. Please note: Not all projects that have "minimal risk" will qualify for access to the pool. Final judgment rests with the Head of Department (or more usually, the co-chair of the Human Subjects Advisory Group).
- A "Request to use subjects from the psychology 120 subject pool"
- A copy of the consent form that will be used
- A copy of the second consent form if deception is used
- A copy of the debriefing form that will be used
- A list of all people who will have contact with the subjects
- A copy of the experiment description that will be posted on the Experimetrix web site
The departmental's form for accessing the PSY 120 subject pool is available in [PDF format, Word format]. Templates for consent forms and debriefing forms are available in [PDF format, Word format].
Once a semester, you will receive a form that solicits requests for credit hours. This form must be submitted on time. The form will list the deadline for that particular semester. If you miss the deadline, you will have to wait until the next semester.
What common mistakes should I avoid when using the PSY 120 subject pool?
The following are the most common areas where mistakes are made:
- Sign and date the subject's white card
- Provide a white card if the subject does not have one
- Keep a copy of the signed consent form in a secured location
- Provide experiment credit in a timely fashion (within 24 hours after participation)
- Include in the estimated duration of the experiment time for the subject to ask any questions before, during, and after the experiment
- Make sure the room location is specified properly (e.g., PSYC 1111, not PSY 1111 or Psychology 1111)
- The PI (a faculty member) must keep a copy of all consent forms. You need to keep all consent forms until 3 years after the protocol has been terminated. If your protocol was approved in May 2002, and you terminate the proposal in May 2006, you need to keep all the consent forms until May 2009.
What about PSY 120 students who are under 18 years old?
According to Federal and Indiana State Law, students under 18 are not considered adults or emancipated minors. Therefore, they are not legally capable of providing informed consent. However, participation in experiments is one way that PSY 120 students can fulfill their research requirement. Therefore it is the obligation of each PI to determine the age of each PSY 120 student who volunteers to participate after testing. If the student is under 18 years old, then the PI must discard all data at the end of the session. PIs must test all PSY 120 students who sign up, even if they are less than 18 years old.
Where is a copy of the Departmental Procedures?
There are two documents, both available in PDF format. The first document outlines the general operation of the review process within the department. The second document outlines the rules that govern the PSY 120 subject pool.
What are stamped consent forms and how do I get mine stamped?
On September 1, 2003, the IRB began requiring that only stamped consent forms be used. The reason for the stamp is to comply with regulations demonstrating that each consent form has been read and approved by the IRB.
When you prepare your consent form (and second consent form), please make sure that it:
If you are submitting an application to access the PSY 120 subject pool, please obtain Experimetrix numbers from Connie Stump before you submit your application and be sure to include them on your consent form(s) just before the title of your experiment. Include 3 copies of each version of your consent form so that they can all be stamped at one time.
- includes the research project number at the top left
- does not include approval and expiration dates at the top
- includes the relevant Experimetrix number
- leaves enough room for the stamp (approx. 1.5 x 2.3 inches), usually at upper right
If you need to make changes to a stamped consent form (but are not changing anything else about your protocol), submit 3 copies of each consent form to Connie and they will be stamped in the Department by the Chair or Co-Chair of the HSAG.
If you are making changes to your protocol, you will need to submit a procedural revision as usual. Include all versions of your consent forms, and the IRB office will stamp them when it approves your revision request.
My question wasn't answered. What do I do?
You can email Thomas Berndt (berndt@psych.purdue.edu), Chair of the Department's Human Subjects Advisory Group and Co-Chair of the University IRB.