Transcript for:
Essential Forms for Research Compliance

Good day future researchers! How are you? Welcome back to our YouTube channel. This is me again, Teacher Ting May, watching you on your research journey.

For those who are new to this channel, don't forget to subscribe, like, and hit the notification bell so you will be notified of my new lesson vlogs about research. We are still in our Week 2, Module 2, Part 2 in Research 2. Last time, we discussed about how to make a project data logbook. In this video, you should be able to distinguish different research forms. Module 2, Research Process The international rules and guidelines include the requisite forms for recording compliance with the rules.

These types constitute written evidence of what is going to happen in a research project or in some cases has already occurred. In order to ensure compliance with ISEP rules and related project laws and regulations, there is structure to provide the information required to review the project. Until any work takes place, the forms will be filled out and signed. There are 12 forms that should be filled out by every researcher.

Let us define first research forms. Research forms are important documents that should be accomplished and prepared by the student researchers before they conduct their research projects. Those who are competing in any science investigation project research fair research forms are one of those requirements that is being asked by the Intel these forms constitute written documents of what is going to happen in research project or in some cases has already happened it consists of form 1 1 a 1 B 1 C 2 3 4 5 a 5 B 6 a 6 B in form 7 research form 1 is a checklist for adult sponsor It should be completed by the adult sponsor in collaboration with the student researcher.

What? What is an adult sponsor? An adult sponsor may be a teacher, parent, professor, or any other professional scientist in whose club the student is working.

An adult mentor should be experienced in student research and during the course of the project should have a direct contact with the student. Going back to Research Form 1, which is Checklist for Adult Sponsor. name is written here as well as the project title for the five for the first five statements you have to check all that apply so for example number one number one statement says I have reviewed the ISEF rules and guidelines if you did then you have to check this statement okay in addition you're going to check all that apply to the additional forms required if the project includes the use of one or more of the following such as humans, the vertebrate animals, potentially hazardous biological agents, hazardous chemical activities devices, and others.

So you have to check all of those. Below you can see here is the adult sponsor's printed name, signature, date of review, the phone, and the email. So this will be completed by the adult sponsor. So again, when we say adult sponsor, it can be your parent, your teacher, your professor, or other professional scientists.

So that's all for Research Form 1. Now, let us now proceed with Form 1A, which is the Student Checklist. This form is required for all projects, and it should be accomplished by the student researcher. all information about the researcher is being asked in this form such as the email the student's name or the team leader the grade phone team member the team member the title of the project school school phone school address and of course it is written also here the adult sponsor the phone and the email of the adult sponsor and then you have to check does this project need src irb iac use your other pre-approval so if yes so kindly put check in this part And then there is also a question here if there is a continuation progression of a previous year.

So if your project is new, so no need to answer this or you can just check no. But if it is yes, if it is just a continuation of another project or project from the previous year, you can check yes. And here is also the actual start date.

You have to write the date when you started your project. And of course, you have to write. the end date of your research study and then you're going to check where will you conduct your experimentation so you can check all that apply so for example research institution so there are researchers that needs to accomplish in a research institution so there is there are some researchers who can go to other research laboratory and they cannot just do it in their school so you have to check also the research institution but you can check all of this if it applies in the conduct of your experimentation and then of course you have to list the name and address of all non-home and non-school work sites and then this form 1a also includes the research plan or the project summary instructions it is all required for all projects but let us keep that topic for a while because we will have a separate discussion for that and of course an abstract is required for all projects after the experimentation so that's all for research form 1a or the student checklist next let us proceed with form 1b which is the approval form So a completed form is required for each student including all team members.

Research Form 1B is the approval form and this form should be completed because it is required for each student including all the team member. Okay, I just repeated it. Okay, this form is divided into three parts. Part 1, to be completed by the student and the parent. Part 2, it should be completed...

by the local or affiliated fair src next part three is the final isf affiliated fair src or approval or this is required for all projects so what is src when we say src it means scientific review committee And it is a group of qualified individuals that is responsible for evaluation of student research, certifications, research plans, and exhibits for compliance with the rules, applicable laws, and regulations at each level of science fair competition. Okay, going back to Approval Form 1B, Part 1 of this form should be completed and accomplished by the student and the parent. This shows that the students'acknowledgement and it also shows the consent of the parents towards the child's participation in the research.

So this one, the student researchers are expected to maintain the highest standards of honesty and integrity. So this is just the consent of the parent. Okay, let's now proceed with the second part.

So the second part. It should be completed by the local or affiliated fair SRC but this is only required for projects that require prior SRC or IRB approval. And lastly, it also includes the final Intel ISEF affiliated fair SRC approval and this is required for all projects.

SRC approval after experimentation and before competition. at regional state national fair is crucial so this is really important so as you can see there are two parts here in part two required for projects that need prior SRC IRB approval before experimentation so on the or it can also be required for research conducted at regulated research institutions with no prior fair SRC or IRB approval but this one the third part this is required for all projects so meaning to say whether you need the approval of the src or not this should be completed by the final isf affiliated fair src approval Before we proceed with Form 1C, which is the Research Form 1C, Regulated Research Institutional or Industrial Setting Form. So what is RRI?

RRI is a regulated research institution within the U.S. It's defined as the professional research or teaching institution that is regularly inspected by the USDA and is licensed to use animals covered by the Animal Welfare Act and may also be subject to US public health service policy. Okay, let us discuss the Form 1C or the Regulated Research Institutional or Industrial Setting Form.

This form must be completed after, again, this must be completed after experimentation by the adult supervising the student research conducted in a regulated research institution, industrial setting or any work site other than home, school or field. So this includes the name of the students and the title of the project. This form should be completed by the supervising adult in the setting, not the student. Not the student, but the supervising adult after, again, after experimentation. Take note, it should be the supervising adult, not the student.

the student. There are five statements or questions here that should be completed. Form 1C is also consumed or consisted of two pages. As you can see, there's a continuation page. Again, there are five statements here that you should complete.

Okay, you should answer that. And then below, you can see there's a box here that says, I attest. that the student has conducted the work as indicated above that any required review and approval by the institutional regulatory board irb iacuc ibc has been obscene and so on okay and this should be completed by the supervising adults printed name signature the title the institution and the address and of course the date signed and should and please The date sign should be after experimentation. Okay, so that's all for Form 1C. Again, Form 1C should be completed after experimentation.

What is a qualified scientist? Qualified scientist or QS should have earned a PhD. or professional degree in a scientific discipline related to the research area of the student.

The trained scientist must have a detailed knowledge of local, state, and federal regulations regulating the research area of the student. Next is Form 2. Research Form 2 is a qualified scientist form. And when we say qualified scientist again It's anyone who earned a PhD or professional degree in a scientific discipline.

In Form 2, this must be completed by the qualified scientist. May be required for research involving human participants, vertebrate animals, potential hazardous biological agents, and hazardous substances and devices. This must be completed and signed before the start of the student experimentation. Okay, this includes the student's name, title of the project, and of course, in this part, to be completed by the qualified scientist, which includes his name, the educational background, the degree, and the experience or training.

Okay, and then, this will be completed by the QS. So for example, have you reviewed the ISEF rules relevant to this project? So this will be completed by the QS. And below, there are two boxes here, as you can see. On the left side is to be completed by the qualified scientist.

While this part on the right side, this should be completed only by the designated supervisor. when the qualified scientist cannot directly supervise the student researcher. So this should be completed only once. It's either the left side or the right side.

The left side again is for the qualified scientist and then on the right side this will just be completed by the designated supervisor. when the qualified scientist is not around. Okay that's all for form 2. Let us now proceed with risk assessment form or the form 3. Form 3 is the risk assessment form that must be completed before experimentation. It includes the name of the student and the title of the project. This form must be completed by the student researchers with the guidance and help of the designated supervisor or the qualified scientist.

Risk assessment should be indicated to determine the possible hazards that may be encountered by the student researchers. This includes the list of hazardous chemicals, activities, or devices that will be used. They should identify the microorganisms exempt from pre-approval and they should identify and assess the risks involved in this project. Safety precautions and procedures that will be used to reduce the risk should also be described.

And also the disposal procedures that will be used, only if it is applicable. And then you should list the source of the safety information. At the bottom of this, you can see there is a designated supervisor's printed name.

they should be completed and signed by this designated supervisor or the qualified scientist when applicable okay and also the procedure and the the what i mean is the position and institution and the experience or the training as relates to the students area of research next let us proceed with form 4. Human Participants Form Health and well-being are important as students perform work with participants in humans. This is the reason why there is also a rule for every human participant in doing research experiments. There are guidelines that were designed to help student researchers follow to the federal regulations regulating practice. practicing scientists and protect the health of both human subjects and the student researcher. Form 4 or the Human Participants Form.

This is required for all research involving human participants not at a regulated research institution. If at a regulated research institution, use institutional approval forms for documentation of prior review and approval. Take note that IRB approval is required before recruitment or data collection.

So what is IRB? When we say IRB, an institutional review board is a committee that according to federal regulations 45 CFR 46 must evaluate the potential physical and or psychological risk of research involving humans. In this part, in the first part of this form, It must be completed by the student researchers in collaboration with the adult sponsor, designated supervisor, or the qualified scientist. So, this one, this part.

But below, as you can see below, it is written here, IRB use only. Meaning to say, this part should be completed only by the IRB. Okay. It must be completed by the IRB AF.

after the review of the research plan. However, it must be, aside from that, all questions must be answered for the approval to be valid. If not approved, return paperwork to the student with instructions for modifications. So it also includes the human informed consent form.

Okay, here, Below, you can see Human Informed Consent Form. An informed consent as an permission form should be developed in consultation with the adult sponsor, designated supervisor, or qualified scientist. This form is used to provide information to the research participant and to document written informed consent or parental permission. Human as participant in every research experiment is very dangerous.

That's why this form should be filled up and always remember that your human participants must be willing to participate in your activity. So let's say for example, you develop a vaccine against COVID-19 and you ask a COVID-19 patient to take the vaccine for trial. It is really dangerous, right? that is the reason why we have to prepare a human consent form. So in psychology, a great deal of focus has been put on respect for the rights and dignity of individuals.

So the segment on how the participants might withdraw from a study will not be difficult for a researcher to admit or worse the possible harm that anyone participating could cause. Okay, informed consent provides participants with sufficiently detailed information on the study so that they can make an informed, voluntary, and rational decision to participate. So, ayan, so makikita natin that the purpose of the project is written here and then if you participate, you will be asked to. Okay, also the potential risk of the study, the benefits, and how confidentiality will be maintained.

And of course, there should be a parental guardian permission here. It should be signed by the parent. And of course, the research participant printed name. So that's all for human participant.

So next, we have the vertebrate animal form. Okay, let us have now Form 5A or the vertebrate animals. Vertebrate animals are those animals that have backbone.

Rats are commonly the animals that are used in research experiments. So just like humans, vertebrates have feelings also, and health and well-being is of high priority when student researchers conduct research with animal subjects. So there are rules that were developed to help student researchers observe to the federal regulations governing professional scientists and to protect the welfare of both animal subjects and the student researcher.

So this vertebrate animal form is required for all research involving vertebrate animals that is conducted in school, home, field research site. Okay. Take note that SRC approval is required before experimentation. The first part must be completed by the student researcher. They should write the common name and the number of animals that should be used.

They should also describe completely the housing to be provided. It also includes the cage size, number of animals per cage, the environment, etc. The researcher should describe what will happen to the animals after the experimentation.

You should attach a copy of wildlife licenses or approval forms. The researcher should also, there is also a requirement like isaf vertebrate animal rules require that any death illness unexpected weight loss should be investigated okay written here below this should be completed by the local or affiliate fair src before experimentation okay and below is also the then it should also be completed by the veterinarian or the designated supervisor of course okay the printed name of the veterinarian will be written here and also their signature and the approval date form 5b is also for vertebrate animals this is required for all research involving vertebrate animals that is conducted in a regulated research institution IACUC approval required before experimentation. Form must be completed and signed after the experimentation.

This also includes the student's name, title of the project, title and protocol number of IACUC approved project. And on this part, it should be completed by the qualified scientist or principal investigator. It includes the species of animals used and the number of animals used.

The role of the student in this project, animal procedures and related equipment that were involved, oversight provided, and safety precautions employed must be described in detail. Okay, and below, it should be completed by the qualified scientist and the principal investigator. Next is Form 6A.

Form 6A is intended for potentially hazardous biological agents. This requires for research involving microorganisms, our DNA, fresh frozen tissue including primary cell lines, humans and other primate established cell lines and tissue cultures, blood-blood products and blood-body fluids. Take note that SRC, ICU-C, IBC approval is required before experimentation. This includes the student's name, title of the project, and this form should be completed by the qualified scientist or the designated supervisor in collaboration with the student researcher. Remember that all questions are applicable and must be answered.

Additional pages may be attached. This form is divided into four sections. Section 1 for the project assessment. So there are five questions here that you should answer or should be completed and answered by the qualified scientist. Section 2 is the training.

What training will the student receive for this project? Experience training of the designated supervisor as it relates to the student's area of research. Section 3 here written inside the box. for all cell lines microorganisms and tissues to be completed by the qualified scientist or the designated super supervisor and there is also a certification here again to be signed by the qualified scientist and the designated supervisor and section 4 is the certification to be completed by the local and affiliated fair src so src printed name is written here and then the data preview and also the Signature. Okay, now let us have Form 6B.

Form 6B or the Human Invertebrate Animal Tissue Form. It is intended for human invertebrate animal tissue. This form is required for research involving fresh frozen tissue. including primary cell lines, human and other primate, established cell lines and tissue cultures, blood, blood products, and body fluids. If the research involves living organisms, so please ensure that the proper human or animal forms are completed.

Take note that all projects using any tissue listed above must also complete the Form 6A. This Form 6B must be completed by the student researcher. Okay, it also includes the student's name and the title of the project.

It also includes where those tissue will be obtained. The last part of this form must be completed by the qualified scientist. As you can see, there's a box here again. And written inside is, I verify that the student will work solely with organs, tissues, cultures, or cells that will be supplied to him or her by myself or the... qualified personnel from my laboratory so again this should be completed by the qualified scientist or the designated supervisor okay yeah and it is also written here that if vertebrate animals were euthanized they were euthanized for a purpose other than student research so always remember that if you're going to if you're going to use the tissue of a vertebrate animals make sure that the vertebrate animals were utilized by a purpose not utilized by the purpose of research okay that's all for research six research form 6b and for the last we have research form seven there are projects that are considered as a continuation in the same field this form is needed for the kind for that kind of study form 7 is intended for the continuation of a project.

This is a research progression project. This is required for projects that are a continuation progression in the same field of study as a previous project. This form must be accompanied by the previous years abstract and a research plan or the project summary.

This form must be completed by the student researcher. So it includes the student's name again to be completed by the student researcher. The student researcher must list all components of the current project that make it new and different from previous research.

The information must be on the form. Use an additional form for the previous year and earlier projects. The components of this form includes the title, the change in goal, purpose or objective so yeah okay as you can see there are three columns here first column are the components second column the current research project and the third column previous research project so for the component it is written here the title of the project change in goal purpose or objective changes in the methodology variable studied additional changes okay and At the bottom, it must be signed by the student researcher. Okay, that's all for Research Form 7. That is all for today. I hope everyone understood how this research form should be completed because these are really important, especially if you are joining an Intel ISEF research competitions.

In our next lesson vlog, we will discuss the research process international rules in the conduct of research. Thank you for watching. Again, this is Teacher Tin May.

See you again in our next vlog. Bye!