J.D. Winter Writing Project Students - Do You Need Review?
If you have arrived at this webpage, it is assumed that you have read the information provided on your registration form and think that you might need IRB review. This page provides additional information to address the subject and “next steps” for submit
Is My Project Regulated Research?
All research projects meeting the regulatory definition of “research with human subjects” require submittal to, and approval by, an IRB. This includes the IRB determination that the research is exempt. However, not all activities that involve people, their data, or specimens are covered by the regulations governing human subjects research and may not require review by an IRB.
The question that must be considered when determining whether IRB review and approval is required is whether a project fits the regulatory definition of research (“regulated research”), and if so, whether it also involves human subjects.
Core Concepts: Research and Human Subjects
While an activity may be considered research, it is important to highlight that not all research meets the threshold of “regulated research” requiring IRB review. The federal regulations have a very specific definition of what is considered regulated research that requires IRB review. The following provides a brief summary of the definitions used by federal regulations:
The federal regulations define research as “a systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge”
What does a "systematic investigation" mean? A systematic investigation involves a methodical procedure and plan, is theoretically grounded, and specifies a focused and well-defined research problem or question, is informed by the empirical findings of others, is analytically robust, and provides a detailed and complete description of data collection methods.
What does "generalizable" mean? Generalizable knowledge is information that is expected to expand the knowledge base of a scientific discipline or other scholarly field of study and yield one or both of the following:
- Results that are applicable to a larger population beyond the site of data collection or the specific subjects studied.
- Results that are intended to be used to develop, test, or support theories, principles, and statements of relationships, or to inform policy beyond the study.
- Note that publication or other dissemination of findings does not in and of itself make the activity “research.” It has been a long-standing myth that if you publish, IRB review is required.
What isn't generalizable?
- A quality assurance/quality improvement/organizational effectiveness study where the intent is to assess, improve, or develop programs or services for an organization. Outcomes will remain specific to the organization, programs or services, although other organi zations may use the results for their own programs.
- An oral history or journalistic piece. These are published materials that are limited to only documenting or reporting on events, situations, policies, institutions, or systems without the intent to form hypotheses, draw conclusions, or generalize findings. It will not in volve stories that will or may draw broad conclusions about the population, cultures, norms, and practices.
Specifically, regarding course projects like the Winter Writing Project:
- Class projects, course-related research, and research methods classes may involve data collection activities for training purposes that do not require IRB review and oversight because the intent is to teach methods, not to contribute to generalizable knowledge. The intent of other class projects may be to provide the student with real world experiences, information gathering techniques, and report writing.
- In these cases, the primary goals of the work are to gain experience and to fulfill the requirements of the course and/or obtaining credit. There is not a well-defined plan to use or disseminate the data/results beyond the course project’s final product itself (e.g., a fi nal paper). Such activities would not meet the threshold for generalizability and do not need IRB review.
- Note that, when the primary focus and initial intent of the class activities are to collect data to be used by students or other researchers beyond the classroom thereby contributing to “generalizable knowledge,” IRB review may be needed.
It should be noted that even though a research activity may not qualify as "regulated research" now, this does not mean that you may not use these data for future "regulated research" activities. The use of data that was initially collected for non-research purposes is known as “secondary use of data not initially collected for research.”
If your activity meets the federal regulatory definition of regulated research, the next step is to determine whether your research involves human subjects. Let’s look into what a “human subject” is according to the federal regulations.
The federal regulations define a human subject as “a living individual about whom an investigator conducting research obtains (1) information or biospecimens through intervention or interaction with the individual and uses, studies, or analyzes the information or biospecimens or (2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.”
Living individual refers to data (information or specimens) collected from living subjects. For example, research using data from the 1880 Census would not be human subjects research.
About whom refers to the fact that the information collected must be personal information about an individual. For example, a survey that collects data about the activities of an organization, rather than its members, is not human subjects research.
Intervention includes physical procedures and manipulations of the subject or the subject's environment for research purposes. For example, taking a saliva or blood sample from a subject or having a subject view a video would be considered a research intervention.
Interaction refers to communication between the researcher and the subject. For example, research that includes face‐to face, mail, internet and phone interactions (e.g. surveys), as well as other modes of communication would be considered an interaction.
Individually identifiable means the identity of the subject is or may be readily ascertained by the researcher or others. For example, research with a de‐identified data set is not research with human subjects because the data are not individually identifiable.
Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, or information that has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public. Private information must be individually identifiable in order to be considered information to constitute research involving human subjects. Examples of private information include medical or academic records or personal journals.
Next Steps...
After assessing the information above, there are a few paths you may follow to move forward with your Winter Writing Project:
If you are NOT conducting “regulated research”
There is no requirement for IRB review, you do not need to submit anything to the IRB. Your work is being completed as a course project and you currently do not having concrete plans for the data/results beyond that. If this changes in the future and want to use the data you collect in a new project, you should be back in touch with the IRB by contacting cuhs@harvard.edu.
If you ARE conducting research, but it does NOT involve human subjects
There is no requirement for IRB review, you do not need to submit anything to the IRB. While you intend to use your data/results for more than just your course project, the information you have obtained or collected is publicly available and/or not about individually identifiable people.
If you think that you are conducting research that involves human subjects, OR if you are not sure
We will need to determine if IRB review is needed, and you will start by submitting an abbreviated form to the IRB to help us determine for certain. Complete the following:
1. Using the electronic IRB submission system, ESTR, follow the steps outlined on the ESTR support webpage to create a new study . Be sure to choose Winter Writing Project when selecting your department on the Basic Information page.
2. Instead of completing a full IRB protocol template and uploading that to the Basic Information page, please complete the Screening Form linked below. Be sure to include your Winter Writing Project proposal in your application in ESTR as well. You may upload that to the Local Site Documents page.
Winter Writing Project Screening Form
3. Once you have finished uploading these two documents, be sure to press the Submit button on the left side of the page in ESTR. Your submission will be assigned to the current IRB liaison for HLS and this Winter Writing Project. Your reviewer may be in touch through ESTR with any questions or comments.
4. Through this process, you will receive one of three results:
- A “Not Research” determination: If you receive this determination, the ESTR submission is complete and you may commence your project. Your work does not meet the threshold for regulated research and does not need IRB review.
- A message posted in ESTR from your IRB reviewer indicating that your work seems to meet the threshold for human subjects research and further IRB review is necessary. In this case, you will receive more detailed instructions at that time on what documents to submit, likely including a completed IRB protocol. You will continue to work within the same space in ESTR with the same study ID number; you will not need to create a second, separate application.
- A “Not Human Subjects Research” determination: If you receive this determination, the ESTR submission is complete and you may commence your project. Your work meets the threshold for regulated research, but does not involve human subjects and does not need further review.
After assessing the information above, there are a few paths you may follow to move forward with your Winter Writing Project:
There is no requirement for IRB review, you do not need to submit anything to the IRB. Your work is being completed as a course project and you currently do not having concrete plans for the data/results beyond that. If this changes in the future and want to use the data you collect in a new project, you should be back in touch with the IRB by contacting cuhs@harvard.edu.
There is no requirement for IRB review, you do not need to submit anything to the IRB. While you intend to use your data/results for more than just your course project, the information you have obtained or collected is publicly available and/or not about individually identifiable people.
We will need to determine if IRB review is needed, and you will start by submitting an abbreviated form to the IRB to help us determine for certain. Complete the following:
- Using the electronic IRB submission system, ESTR, follow these steps to create a new study. Be sure to choose Winter Writing Project when selecting your department on the Basic Information page.
Instead of completing a full IRB protocol template and uploading that to the Basic Information page, please complete the Screening Form linked below. Be sure to include your Winter Writing Project proposal in your application in ESTR as well. You may upload that to the Local Site Documents page.
Once you have finished uploading these two documents, be sure to press the Submit button on the left side of the page in ESTR. Your submission will be assigned to Elizabeth Parsons, the current IRB liaison for HLS and this Winter Writing Project. Your reviewer may be in touch through ESTR with any questions or comments.
- Through this process, you will receive one of three results:
- A “Not Research” determination: If you receive this determination, the ESTR submission is complete and you may commence your project. Your work does not meet the threshold for regulated research and does not need IRB review.
- A message posted in ESTR from your IRB reviewer indicating that your work seems to meet the threshold for human subjects research and further IRB review is necessary. In this case, you will receive more detailed instructions at that time on what documents to submit, likely including a completed IRB protocol. You will continue to work within the same space in ESTR with the same study ID number; you will not need to create a second, separate application.
- A “Not Human Subjects Research” determination: If you receive this determination, the ESTR submission is complete and you may commence your project. Your work meets the threshold for regulated research, but does not involve human subjects and does not need further review.
