Investigator's FAQs

  1. Who can submit research proposals and / or protocols to a UB IRB?
  2. What are the responsibilities of the Principal Investigator?
  3. How are the rights and welfare of the potential subjects preserved?
  4. How do I "manage" the risks and benefits?
  5. Are there any groups of subjects that need special consideration when planning study recruitment strategies?
  6. How does the PI assure that regulations, procedures and guidelines are observed by all researchers/staff involved in the conduct of the project?
  7. When can I start recruiting subjects for my study?
  8. What if I want to make some changes or additions to my study?
  9. What is timely continuing review?
  10. What other reports am I expected to submit to the IRB once my study is approved?
  11. What other records or files do I need to keep?

1. Who can submit research proposals and / or protocols to a UB IRB?

Principal Investigators (PIs) conducting health sciences and social/educational research including those who are:
Researchers at UB, Kaleida Health System, and Erie County Medical Center who are:
  • Researchers at UB, Kaleida Health System, and Erie County Medical Center who are conducting studies that involve human subjects in medical or health care research.
  • A medical resident or fellow, or a student in a health care discipline, who proposes a research study and is assuming primary responsibility for its conduct can be the PI, with the respective department chair or faculty advisor indicated as sponsor or co- investigator on the IRB application.
Principal Investigators conducting social & behavioral sciences research including those who are:
  • UB faculty and researchers at affiliated institutions
  • Students under the supervision of a faculty mentor

2. What are the responsibilities of the Principal Investigator?

The Principal Investigator submits a study for IRB approval. The PI has ultimate responsibility for the conduct of the study and its congruence with the ethical guidelines as approved by the IRB. This includes:
  • Protecting the rights and preserving the safety and welfare of prospective subjects.
  • Ensuring that current laws, regulations, procedures and guidelines are observed by all researchers/staff involved in the conduct of the project.
  • Ensuring that all research involving human subjects receive IRB review and approval before commencement of the research.
  • Ensuring that all members of the research team comply with the findings, determinations, conditions and requirements of the IRB.
  • Ensuring that the parameters of the protocol are followed in the conduct of the study, including adhering to inclusion/exclusion criteria, number of subjects recruited, etc.
  • Ensuring that studies receive timely continued review and approval.
  • Obtaining prior IRB approval of changes to the protocol, consent forms or recruitment strategy, except where necessary to eliminate immediate apparent hazards to subjects.
  • Discontinuing all research study activities at the end of the IRB-designated approval period.
  • Reporting to the IRB promptly any serious events and problems (SEPs) that are either unanticipated or anticipated.
  • Insuring a conflict of interest does not exist with researchers and the study by completing & submitting an "Annual-Disclosure of Significant Financial Interests and Significant Obligations Form" to their Dean's Office.

3. How are the rights and welfare of the potential subjects preserved?

Rights and welfare of potential subjects are maintained by ensuring voluntary participation, obtaining informed consent, maintaining confidentiality of a person’s enrollment and data created, and informing subjects of the risks and benefits of study participation. This is addressed by:
  • The recruitment plan is approved by the IRB.
  • Screening and enrollment procedures adhere to IRB approved guidelines.
  • Subjects are not recruited from one study cohort to be in another concurrently.
  • If advertisement is used (poster, newspaper) to obtain potential subjects, it should adhere to the IRB guidelines, be IRB approved and contain the name & address of the PI, a summary of the purpose of the research, description of eligibility criteria, clear description of incentives to participate if any (eg. money, free treatment), location of the research and the name & telephone number of the person to contact for further information.
  1. Voluntary participation-
    • Incentives do not influence an unwilling person to consent to study participation.
    • Monetary incentive can reimburse a person for time, travel, inconvenience, but should not be coercive to participation.
    • Social desirability, provider or other’s recommendation does not influence a person to agree to participate in a study.
    • It is clearly stated that the subject has the right to decline participation or to drop out of the study at any time without any interference with his/her usual health care.
    • Participation agreed on behalf of someone not able to consent (infants, comatose, mentally incapacitated) should be by a third party most likely to understand the incompetent subject’s situation and act in the person’s best interest. This is consent by a Legally Authorized Representative(LAR).
    • There is a hierarchy of relationships identified for LAR consent, which is in the following order respectively: legally appointed guardian, durable power of attorney, spouse, adult children, parents, adult sibling, other nearest relative.
    • Use of an incentive for a third party consent should be carefully considered regarding the possibility of undue influence.
  2. Informed consent-
    NYS defines “Voluntary informed consent” (NY Public Health Law, Article 24-A; Section 2442; March 1998) as the legally effective knowing consent of an individual or his legally authorized representative, so situated as to be able to exercise free power of choice without undue inducement or any element of force, fraud, deceit, duress or other form of constraint or coercion….The basic elements are information, understanding and voluntary agreement. Information includes:
    • A fair explanation to the individual of the procedures to be followed, and their purpose, including identification of any procedures which are experimental;
    • A description of any attendant discomforts and risks to be reasonably expected;
    • A description of any benefits to be reasonably expected;
    • A disclosure of any alternative procedures that might be advantageous to the individual;
    • An offer to answer any inquiries by the individual concerning the procedures;
    • An instruction that the individual is free to withdraw his consent and to discontinue participation in the human research at any time without prejudice to him.

    Specifically, the PI assures (directly or by delegating to a research co-coordinator):
    • The informed consent document is accurate: the process to facilitate informed consent is adequate.
    • The person being invited to join a study is given adequate information in an explanation of the research study, in a verbal and written format that is understandable (in language and reading level) and comprehension is ascertained.
    • The informed consent is provided to the potential subject in a location and time frame that does not impose pressure to sign it.
    • Agreement to participate in a study is documented by a participant’s signature.
    • Each page of the informed consent is initialed by the subject to insure that he has read it.
    • A copy of the signed, dated informed consent is given to the subject.
    • PI must retain copies of each informed consent for a minimum of 3 years after study completion or until the subject is 18 years old, whichever is longer.
    • PI must implement a system to insure that consent forms signed and dated are stamped with the IRB approval dates of an interval current to the signature dates.
  3. Confidentiality-
    • Confidentiality of data and privacy of subjects is provided.
    • All research records are kept in a locked office, lab or cabinet of the investigator.
    • Electronic data files are secured.
    • Persons are invited to participate in a study, or interviewed for data collection in a private area.
    • Information will not be divulged or subjects identified without permission of the subject unless there are legal constraints.

  4. Risks/Benefits-
    • The ethical principal of “Beneficence” implies the obligation to not intend harm.
    • The purpose and procedures of the study are conducted such that the PI intends to maximize possible benefits while minimizing harmful ones.
    • Systematic and ongoing assessment of possible harm/anticipated benefit is conducted.
    • Risks should be accurately described to the subject, including anticipated or unanticipated, mild (discomforts), moderate or severe, and what to do in the event of an occurrence.
    • Benefits should be described as direct or indirect.
    • There should be a therapeutic intent, regardless of direct or indirect benefit.

4. How do I “manage” the risks and benefits?

The PI can assess only those risks and benefits that result from the research. The PI:
  • Identifies potential risks associated with the research procedures;
  • Using good practice, takes steps in the procedures to minimizes the risks to the extent possible;
  • Determines probable benefits derived from the research;
  • Contrasts the probable benefits with the possible risks – probable benefit should be greater. PI considers this, IRB considers this and if funding is sought, the funding source considers this.
  • Ultimately the subjects should be fully apprised of the potential risks and anticipated benefits, and this enters into a person’s consent to participate;
  • Determines and put in place any safe guards to protect subjects.
  • Maintains confidentiality to limit risk to privacy of individuals.
In addition, a “safety monitoring plan” should be proactively put in place as part of the protocol if there is any anticipated risk, so that an ongoing determination of each subject’s response to the intervention in terms of safety is assessed in a planned manner. For example, if a one time test is performed, your protocol could include a follow up telephone call the day after to be sure that negative reactions were not experienced.

5. Are there any groups of subjects that need special consideration when planning study recruitment strategies?

Yes, these are “vulnerable populations”, or special classes of subjects that require special consideration for inclusion in a study.
  1. Vulnerable populations under Federal regulation include:
    • Fetuses and human in-vitro fertilization
    • Women-potentially pregnant, pregnant, lactating
    • Children, minors (under 18 years of age)
    • Prisoners
  2. Vulnerable populations within common sense guidelines include:
    • Cognitively impaired persons.
    • Traumatized patients.
    • Comatose patients.
    • Terminally ill persons.
    • Elderly/aged persons.
    • Minorities.
    • {Students, employees (with the possibility of feeling coerced)}.

6. How does the PI assure that regulations, procedures and guidelines are observed by all researchers/staff involved in the conduct of the project?

Education, supervision, communication between the PI and the PI’s research team are essential.
  • A CITI educational tutorial must be completed by new members and documented by all members in an IRB application.
  • The PI delegates responsibility to various team members but maintains ultimate accountability.
  • The PI maintains a good working relationship & direct communication with team members to ensure the activities of the protocol are carried out.

7. When can I start recruiting subjects for my study?

Subjects may begin to be recruited and the study initiated when final approval has been received in writing from the IRB. This includes:
  • A formal letter from the IRB acknowledging approval of the study.
  • The informed consent stamped with the “approval date” and the “approval expiration date”.
  • All advertisements (flyers, signs, pamphlets, newspaper ads, letters, telephone scripts) soliciting research subjects must have IRB approval before use.

8. What if I want to make some changes or additions to my study?

IRB approval must be obtained before making any changes in approved research, even if the study is already approved, unless the change is necessary to eliminate an immediate hazard to a subject.
  • The IRB should be notified at once in the event of a serious hazard to a subject necessitating a change in protocol.
  • Changes are submitted formally using the Amendment Form.
  • If substantial, a copy of the approved protocol with the changes highlighted is requested.
  • Minor changes, those that do not increase risk or discomfort, may be authorized by expedited review by the IRB chairperson.
  • Substantial changes are given full review and formal approval from the IRB board is required.
  • Approval of changes does not extend the study expiration date.
  • Some examples of changes needing amendment are: increasing the number of subjects targeted, changing the sites, using a new method to recruit subjects, becoming funded/sponsored if initially unfunded, altering an intervention, changing a dosage in a pharmacy study.

9. What is timely continuing review?

IRB approval is for a maximum period of one year, or for a shorter period if the degree of risk warrants more frequent review. An Application for Continuing Review should be filed by the investigator in the month preceding the expiration of the previous one, prior to the IRB meeting, so the renewal can be formally approved in a timely fashion.
  • The “Annual Renewal Notice for Continuing Review” Form is sent out to the PI to be completed and returned before the expiration date for ongoing studies. The IRBs notify a PI one month prior to expiration of his/her study, but it is the PI’s responsibility to ensure approval is continuous whether the notice is received or not.
  • The renewal process requires a progress report to summarize subject recruitment, summary of adverse events, any approved changes, preliminary results if available, current risk/benefit assessment, report of internal/external audits, any significant findings or developments from the literature.
  • If the renewal is not formally approved before the expiration date, the study is considered “lapsed” by the IRB and must be suspended and the sponsor notified, if there is one.

10. What other reports am I expected to submit to the IRB once my study is approved?

Serious Events and Problems (SEPs) need to be reported promptly, using the Serious Events/Problems Initial Reporting Form.
  • Prompt reporting to the IRB chairperson is required when any unanticipated problems occur that pose risks to subjects or others.
  • If there is FDA oversight of the project, the sponsor is the usual channel to report the event to the FDA.
  • Progress of the research needs to be reported annually - see # 9.
  • When the approved study is completed, the IRB should be notified using the Final Report Form

11. What other records or files do I need to keep?

It is extremely important to have an administrative/ regulatory binder for each study.
  1. Accurate record keeping with attention to organization will be invaluable if an audit takes place, because you will need to be able to find what is being asked for by the auditors. If you have more than one study, a separate administrative research file per study will help to keep documents in an accessible place.
  2. The following should be kept in a separate “Administrative” research folder for each study:
    • A copy of each IRB approved document, such as the protocol, amendments, serious adverse events report, data safety monitoring board report, and implement a system to comply with approval expiration dates.
    • A copy of the signed, dated consent form of each subject.
    • Appropriate HIPAA documents (authorization forms, waiver, etc.)
    • Any communications to/from sponsor.
    • Any communications to/from subjects.